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TRANSCRIPT
2016-17 Catalog
Redefining Autoimmunity
ConnectedWelcome to the fully integrated autoimmune lab.
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2016-17 Products Catalog
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Table of ContentsCompany Overview ................................................................................................... 3The Integrated Lab ..................................................................................................... 4Systems and Instrumentation ................................................................................ 6 QUANTA Link® ...................................................................................... 6 BIO-FLASH® ........................................................................................... 8 NOVA View® ........................................................................................10 QUANTA-Lyser® ..................................................................................12 QUANTA-Lyser® 2 ..............................................................................13 QUANTA-Lyser® 4000 .......................................................................14 AUTOLoader .......................................................................................16 DS2® .......................................................................................................18 DSX®/best 2000 .................................................................................19QUANTA Flash® ..........................................................................................................20 Celiac Disease.....................................................................................21 Vasculitis ..............................................................................................21 Rheumatoid Arthritis .......................................................................21 Connective Tissue Disease ............................................................22 Antiphospholipid Syndrome ........................................................23 Liver Disease .......................................................................................23QUANTA Lite® .............................................................................................................24 Gastrointestinal Disease .................................................................25 Celiac Disease.....................................................................................28 Liver Disease .......................................................................................30 Antiphospholipid Syndrome ........................................................32 Rheumatoid Arthritis .......................................................................35 Connective Tissue Diseases...........................................................36 Vasculitis .............................................................................................39 Autoimmune Thyroid Disease ......................................................39 QUANTA Chek™ Quality Control Panels .....................................40 Calibration and Standard Sets .....................................................41NOVA Dot® .................................................................................................... 42 Connective Tissue Disease ............................................................43 Liver Disease .......................................................................................43 NOVA Dot Common Components .............................................43NOVA Lite® .................................................................................................... 44 IFA Slide Kits ........................................................................................45 IFA Substrate Slides ..........................................................................54 Common Components ...................................................................57 Demonstration Slides ......................................................................57 IFA Antibody Controls .....................................................................58 IFA Conjugates ...................................................................................60Customer Support ...................................................................................................62
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INSTRUMENTS
� QUANTA Link® data management system
� BIO-FLASH® random access chemiluminescent analyzer
� NOVA View® digital IFA microscope
� QUANTA-Lyser® automated EIA/IFA analyzer platforms
� AUTOLoader automated slide handling
� DS2® and DSX®/best 2000 automated EIA microtiter plate platforms
ASSAYS
� QUANTA Flash® CIA
� QUANTA Lite® ELISA
� NOVA Lite® IFA
� NOVA Dot® Immunoblot
Redefining Autoimmunity
Innovative Instruments and Assays
333
Inova Diagnostics, a Werfen company, is redefining autoimmunity by delivering solutions which anticipate the needs of the autoimmune laboratory. We develop new biomarkers to enhance patient care, and systems to help your laboratory improve the efficiency and quality of testing.
Our innovative Integrated Lab systems include BIO-FLASH®, a rapid-response chemiluminescent analyzer, NOVA View®, an automated digital IFA microscope, QUANTA-Lyser®, for increased EIA/IFA processing speed and flexibility, and QUANTA Link® data management system to make workflow management easier.
Our comprehensive portfolio of reagents supports diagnosis, stratification and monitoring of complex disorders such as connective tissue disease, rheumatoid arthritis, antiphospholipid syndrome, vasculitis, inflammatory bowel disease and celiac disease.
At Inova Diagnostics, we want to be your first choice for autoimmune testing. We work to accomplish this through a persistent focus on quality and the needs of our customers, and by leading the field with new product innovation. We look forward to working with you.
Redefining autoimmune testing with innovative systems and reagents
Inova Diagnostics Company Overview
Systems and Instrumentation
44
55
Inova instruments are seamlessly connected to the LIS by QUANTA Link, a centralized data management system. This integrated system delivers increased productivity, improved sample integrity and more streamlined workflow for the autoimmune laboratory.
QUANTA Link®Seamlessly integrates Inova Diagnostics instruments with your LIS to efficiently manage workflow and quality control.
NOVA Lite® IFA SlidesContain smart barcodes that connect patient samples to a well location.
BIO-FLASH®Fully automated random access chemiluminescent benchtop analyzer for the autoimmunity laboratory.
QUANTA-Lyser®An automated EIA/IFA slide processor capable of reading IFA slide barcodes.
NOVA View®Automates IFA slide interpretation.
AUTOLoaderRobotic arm that transfers IFA slides to and from NOVA View.
The Integrated Lab Data Driven Workflow and Cost Efficiency
Systems and Instrumentation
6
QUANTA Link®Centralized Intelligent Network
Workflow management made easyData management system that consolidates autoimmune results from Inova Diagnostics instruments in a centralized location to improve workflow
• Eliminates transcription errors in IFA sample processing and analysis
• Single point location to access patient data and result history
• Organize, prioritize and streamline workflow
• Centralized location for QC data
• Review and report IFA results
• Digital image training atlas for IFA
• Single LIS connection
• Positive patient identification for IFA
Description Part Number
QUANTA Link Workstation License LINK001
QUANTA Link Workstation LINK010
Barcode Scanner LINK019
LED Fluorescent Microscope OLY1000
LED Fluorescent Microscope with digital camera OLY2000
7
Allows the technologist to view ANCA Ethanol, ANCA Formalin and HEp-2 results from the same patient simultaneously.
Multi-Analyte Screen
QUANTA Link transforms your dark room into a paperless, transcription free environment. Simply enter the information directly on the touch screen.
Paperless Interpretation
User defined atlas used for reference and training.
Atlas
All quality control information is centralized in a single location using Levey-Jennings and employing Westgard rules.
Optimize Quality Control
Systems and Instrumentation
88
BIO-FLASH®
Rapid-Response Chemiluminescent AnalyzerA progressive solution to common problems
Eliminates isotype batching and reagent waste
• Stable on-board reagents allow for samples to be run as they arrive
Improves turn-around time
• Simultaneous random access processing of all isotypes and assays on a single sample
• Delivers results, including STAT orders, in as little as 30 minutes
• Generates up to 450 results in a single shift
Helps reduce test send outs
• Makes even the most specialized assays efficient to perform with stable calibration curves
Frees up floor space
• Small benchtop analyzer achieves excellent throughput
Description Part Number
BIO-FLASH System T3710-0344
High Capacity Rinse Accessory T3410-0887
99
QUANTA Flash® reagents• Chemiluminescent technology delivers precise quantitation
and a broad analytical measuring range
• Cartridge barcode is internally scanned to import the master calibration curve, lot number, expiration date and assay type
Reagent carousel • Stores up to 20 reagent packs with on-board refrigeration• Monitors reagent use and reports inventory• Dedicated reagent probe
Sample carousel• Primary samples placed directly onto the rack and scanned by internal barcode reader• Samples processed in random access with continuous load capability• STAT orders can be run at any time• Dedicated sample probe
230k
200k
170k
140k
110k
90k
60k
30k
0
IU/mL
RLU
0 60 130 190 250 310 380 500440
xx
x
*
*
**
**
Calibration curves• Master calibration curve uploaded through the reagent pack barcode• Calibrators are processed in the sample carousel• BIO-FLASH determines a stable working calibration curve
Intuitive software and touchscreen• Simplifies training and day-to-day operation• Status screen allows immediate access to system information
BIO-FLASH Common Components
NAME DESCRIPTION PACKAGE PART #
BIO-FLASH System Rinse System rinse for use with the BIO-FLASH instrument. 1 X 5L T3000-8205
Trigger 1&2 Package of both triggers for use with the BIO-FLASH instrument 2 x 250mL T3000-8204
Cuvettes Cuvettes for use with the BIO-FLASH instrument 1,400 per box T3000-8206
System Cleaning Solution Cleaning solution for BIO-FLASH instrument maintenance 6 x 4mL T3000-8211
Low Volume Cups Low volume sample cups for use with the BIO-FLASH system 500 Cups T3000-8209
Low Volume Caps Low volume sample cup caps for use with the BIO-FLASH system 500 Caps T3000-8210
Systems and Instrumentation
1010
NOVA View®
The new world of digital IFA testingNOVA View® helps automate the reading and interpretation of HEp-2, ANCA* and Crithidia* IFA slides.
• NOVA View provides positive/negative interpretation, as well as pattern recognition for HEp-2 and ANCA
• Single well titer (SWT) can reduce IFA workload by up to 43% and lower material costs
• DAPI stain provides a built-in control to visualize cells in a negative well
• Calibration technique delivers excellent agreement with manual IFA and improves standardization
Description Part Number
NOVA View Instrument NV2000
HEp-2 Module License NV1050
ANCA Module License* NV1051
Crithidia Module License* NV1052
* Available Outside The USA Only
1111
NOVA View single well -ter predic-on reduces IFA workflow
0
10,000
20,000
30,000
40,000
50,000
60,000
Manual IFA NOVA View SWT
26,000 26,000
26,000
1,300
# of
wel
ls
IFA screen wells IFA titer wells
48% reduction
• NOVA View SWT does not change the number of screening wells needed
• NOVA View SWT reduces the number of extra dilution wells by approximately 48% or 24,700 wells each year
• NOVA View SWT improves turnaround time, lowers material costs and reduces technologist hands-on time
NOVA View single well titer reduces the overall number of HEp-2 wells used
Example in a laboratory with an average volume of 100 ANA tests per day, a 20% positive rate, 5% of which are mixed patterns and performing 5 dilutions per well 260 days per year.
• ANA screen: Both methods require the same number of wells for screening
• Titer: NOVA View SWT uses light intensity from a screening well to predict a titer, whereas manual IFA requires additional wells to provide a similar result
NOVA View single well titer determination improves IFA workflow
• NOVA View SWT does not change the number of screening wells needed• NOVA View SWT can reduce the number of extra dilution wells up to 48%
or 24,700 wells each year• NOVA View SWT improves turnaround time, lowers material costs and
reduces technologist hands-on time
VS.One well using NOVA View
with SWT
Up to six wells using traditional
manual IFA
NOVA View® helps automate the reading and interpretation of HEp-2, ANCA* and Crithidia* IFA slides.
• NOVA View provides positive/negative interpretation, as well as pattern recognition for HEp-2 and ANCA
• Single well titer (SWT) can reduce IFA workload by up to 43% and lower material costs
• DAPI stain provides a built-in control to visualize cells in a negative well
• Calibration technique delivers excellent agreement with manual IFA and improves standardization
Systems and Instrumentation
1212
QUANTA-Lyser®
Automated EIA/IFA Analyser Platform Processing flexibility – different configurations for different tasks
• Both configurations process up to 6 plates or 30 slides per run
• Allows you to meet future challenges without changing platforms
• Operational flexibility – on-board scheduler determines optimal workflow sequence to maximize productivity
• Reads and interprets NOVA Lite IFA barcoded slides to ensure sample and assay integrity
Efficiency
• Automation efficiency – walk-away system minimizes hands-on time
• Training efficiency – easy-to-use software and hardware components
• Throughput efficiency – independent 4-probe system allows for rapid sample pipetting to maximize throughput
• Ceramic coated probes eliminate the need for costly disposable pipette tips
Description Part Number
160 Sample IFA GS0162
160 Sample EIA + IFA GS0160
160 Sample EIA + IFA with incubator GS0163
240 Sample IFA GS0242
240 Sample EIA GS0161
240 Sample EIA + IFA GS0240
240 Sample EIA + IFA with incubator GS0243
QUANTA-Lyser® 160/240
1313
QUANTA-Lyser® 2Automated EIA/IFA Analyser Platform
Description Part Number
IFA Only GS2002
EIA + IFA GS2000
QUANTA-Lyser® 2
Easy-to-use platform satisfies all your EIA and IFA processing needs
Processing flexibility – three configurations to maximize flexibility and efficiency
• A combination 5 slide, 1 plate layout
• A dedicated 15 slide layout
• A dedicated 2 plate layout
Allows you to choose the configuration to meet your testing demands
• Operational flexibility – on-board scheduler maximizes productivity
• Assay Integrity – reads and interprets NOVA Lite IFA barcoded slides
• Automation efficiency – offers walk-away capability with minimal hands-on time
• Training efficiency – easy-to-use software and hardware components
• Ceramic coated probe – eliminates the need for costly pipette tips
Systems and Instrumentation
1414
QUANTA-Lyser® 4000High-throughput IFA processor
QUANTA-Lyser® 4000 is a high throughput IFA slide processor designed for the high-volume laboratory
• Fast operation, first 120 samples completed in 2 hours
• Sample deck holds up to 480 samples for high volume processing
• Automated barcode scanner for NOVA Lite IFA slides and reagents to ensure positive patient identification and reagent integrity
• Proprietary 5-slide carrier can be directly transferred to NOVA View without the need to handle slides
• Pipettes mounting media to protect stained cells
Description Part Number
QUANTA-Lyser 4000 VS4000
1515
Holds up to 480 primary samples for high volume processing
Automated NOVA Lite IFA slide and reagent barcode scanning ensure positive patient identification and assay integrity
Pipettes mounting media to protect stained cells
Slides do not require a coverslip when interpreted using NOVA View
5-slide carrier with open base can be transferred directly to NOVA View to reduce individual slide handling
5-slide carrier lid minimizes exposure to ambient light and evaporation
High throughput and automated scanning
Pipettes mounting media, direct slide transfer
Directly transfer slides to NOVA View
Systems and Instrumentation
1616
AUTOLoaderEfficiently automates slide transfer with NOVA View®
AUTOLoader is a fully automated robotic system that transfers NOVA Lite® IFA slides to and from NOVA View® and reduces hands-on time for the high volume laboratory
• Direct transfer of 5-slide carrier from QUANTA-Lyser® 4000 to AUTOLoader eliminates the need to handle individual slides
• Slides can be added to AUTOLoader at any time without interrupting NOVA View interpretation
• Automated barcode scanner ensures positive patient identification
• Capacity for up to 100 slides or 1,200 wells allows for overnight interpretation
Description Part Number
AUTOLoader ALDR1000
1717
Reduces hands on time
Robotic ArmSlide Stack5-Slide Carrier
Barcode Scanner
Systems and Instrumentation
1818
DS2®
Reliable sample in/result out microtiter plate processor
• Compact design is ideally suited for laboratories where space is limited
• Processes two 96-well microplates and up to 12 different assays simultaneously
• Walk-away automation provides up to two hours of free time for other laboratory tasks
DS2 is a registered trademark of DYNEX Technologies, Inc.
Description Part Number
DS2 D62010
1919
DSX®/best 2000A high-performance walk-away EIA processing system
• A fully automated 4-plate processing system capable of performing up to 12 different assays simultaneously
• Employs a modular design that provides flexible configuration and ease of use
• Incorporates many features to ensure the quality and security of results
• Ability to handle a wide variety of assay protocols
DSX is a registered trademark of DYNEX Technologies, Inc.
Description Part Number
With No Incubators D65100
With 2 Incubators D65200
With 4 Incubators T3710-0337
QUANTA Flash®
Chemiluminescent Immunoassays (CIA)QUANTA Flash CIA technology offers a faster response and broader analytical measuring range than enzyme-based assays for more precise quantitation and confidence in results.
� Antiphospholipid Syndrome
� Connective Tissue Diseases
� Celiac Disease
� Rheumatoid Arthritis
� Vasculitis
� Liver Disease
1. Martis P, et al. The QUANTA Flash® Chemiluminescent Immunoassays for Celiac Disease Show Excellent Analytical and Clinical Performance Characteristics. AMLI Minneapolis, 2011.
Chemiluminescence immunoassay (CIA) technology can significantly increase the analytical measuring range1
QUANTA Flash
ELISA
Measured units
ANALYTICAL MEASURING RANGE
2020
2121
Celiac DiseaseQUANTA Flash celiac assays provide accurate results across multiple markers and isotypes.
NAME DESCRIPTION PRODUCT ITEM PACKAGE PART #
QUANTA Flash h-tTG IgA
Semi-quantitative determination of IgA anti-human tissue transglutaminase (h-tTG) antibodies in human serum on the BIO-FLASH system
Reagents
Calibrators Controls
50 Test Cartridge100 Test Cartridge
2 X 2 vials (0.3 mL each)2 X 2 vials (0.5 mL each)
701103701100701101701102
QUANTA Flash h-tTG IgG
Semi-quantitative determination of IgG anti-human tissue transglutaminase (h-tTG) antibodies in human serum on the BIO-FLASH system
ReagentsCalibrators
Controls
50 Test Cartridge2 X 2 vials (0.3 mL each)2 X 2 vials (0.5 mL each)
701108701106701107
QUANTA Flash DGP IgA
Semi-quantitative determination of IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH system
ReagentsCalibrators
Controls
50 Test Cartridge2 X 2 vials (0.3 mL each)2 X 2 vials (0.5 mL each)
701168701166701167
QUANTA Flash DGP IgG
Semi-quantitative determination of IgG anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH system
Reagents
CalibratorsControls
50 Test Cartridge100 Test Cartidge
2 X 2 vials (0.3 mL each)2 X 2 vials (0.5 mL each)
701173701170701171701172
NAME DESCRIPTION PRODUCT ITEM PACKAGE PART #
QUANTA Flash MPO
Semi-quantitative determination of IgG autoantibodies to myeloperoxidase (MPO) in human serum on the BIO-FLASH system
ReagentsCalibratorControls
50 Test Cartridge2 X 2 vials (0.7 mL each)2 X 2 vials (0.5 mL each)
701133701131701132
QUANTA Flash PR3
Semi-quantitative determination of IgG autoantibodies to serine protease 3 (PR3) in human serum on the BIO-FLASH system
ReagentsCalibratorControls
50 Test Cartridge2 X 2 vials (0.3 mL each)2 X 2 vials (0.5 mL each)
701138701136701137
QUANTA Flash GBM
Semi-quantitative determination of IgG autoantibodies to glomerular basement membrane (GBM) in human serum on the BIO-FLASH system
ReagentsCalibratorControls
50 Test Cartridge2 X 2 vials (0.7 mL each)2 X 2 vials (0.5 mL each)
701143701141701142
NAME DESCRIPTION PRODUCT ITEM PACKAGE PART #
QUANTA Flash CCP3
Semi-quantitative determination of IgG autoantibodies to CCP3 in human serum on the BIO-FLASH system
ReagentsCalibratorControls
100 Test Cartridge2 X 2 vials (0.7 mL each)2 X 2 vials (0.5 mL each)
701125701126701127
VasculitisQUANTA Flash MPO, PR3 and GBM allow for rapid response in critical cases.
Celiac DiseaseQUANTA Flash celiac assays provide accurate results across multiple markers and isotypes.
Rheumatoid ArthritisQUANTA Flash CCP3 assay adds certainty to the diagnosis of Rheumatoid Arthritis.
21
2222
QUANTA Flash® (CIA)
Connective Tissue DiseaseQUANTA Flash CTD assays fully leverage the capabilities of the BIO-FLASH® system to accurately detect analytes at a combined screening level as well as the more disease specific autoantibodies.
NAME DESCRIPTION PRODUCT ITEM PACKAGE PART #
QUANTA Flash CTD Screen Plus*
Qualitative detection of total anti-nuclear antibodies against dsDNA, Ro52, Ro60, SS-B, Scl-70, centromere, Mi-2, Ku, Th/To, RNA Pol III, Pm/Scl, PCNA, Jo-1, anti Sm, anti-RNP and Ribosomal-P antibodies on the BIO-FLASH System
ReagentsCalibrators
Controls
100 Test Cartridge2 x 2 vials (0.3mL each)2 x 2 vials (0.5mL each)
701220701221701222
QUANTA Flash ENA7
Qualitative determination of IgG anti Sm, anti-RNP, anti-Ro60, anti-Ro52, anti-SS-B, anti-Scl-70 and anti-Jo-1 antibodies
Reagents
Calibrators Controls
50 Test Cartridge 100 Test Cartridge
2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)
701258701255701256701257
QUANTA Flash Jo-1
Semi-quantitative determination of anti-Jo-1 antibodies on the BIO-FLASH system
ReagentsCalibrators
Controls
50 Test Cartridge 2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)
701163 701161 701162
QUANTA Flash RNP
Semi-quantitative determination of anti-RNP antibodies on the BIO-FLASH system
ReagentsCalibrators
Controls
50 Test Cartridge 2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)
701118 701116 701117
QUANTA Flash Sm
Semi-quantitative determination of anti-Sm antibodies on the BIO-FLASH system
ReagentsCalibrators
Controls
50 Test Cartridge 2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)
701123 701121 701122
QUANTA Flash Ro60
Semi-quantitative determination of anti-Ro60 (SSA) antibodies on the BIO-FLASH system
ReagentsCalibrators
Controls
50 Test Cartridge 2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)
701148 701146 701147
QUANTA Flash Ro52
Semi-quantitative determination of anti-Ro52 (TRIM21) antibodies on the BIO-FLASH system
ReagentsCalibrators
Controls
50 Test Cartridge 2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)
701263 701261 701262
QUANTA Flash SS-B
Semi-quantitative determination of anti-SSB (La) antibodies on the BIO-FLASH system
ReagentsCalibrators
Controls
50 Test Cartridge 2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)
701153 701151 701152
QUANTA Flash Scl-70*
Semi-quantitative determination of anti-Scl-70 antibodies on the BIO-FLASH system.
ReagentsCalibrators
Controls
50 Test Cartridge 2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)
701328 701326 701327
QUANTA Flash Centromere
Semi-quantitative determination of anti-centromere antibodies on the BIO-FLASH system
ReagentsCalibrators
Controls
50 Test Cartridge 2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)
701198701196701197
QUANTA Flash Ribosomal P*
Semi-quantitative determination of anti-RiboP antibodies on the BIO-FLASH system
ReagentsCalibrators
Controls
50 Test Cartridge 2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)
701193701191701192
QUANTA Flash DFS70*
Semi-quantitative determination of anti-DFS70 antibodies on the BIO-FLASH system
ReagentsCalibrators
Controls
50 Test Cartridge 2 X 2 vials (0.3mL each) 2 X 2 vials (0.5mL each)
701268701266701267
QUANTA Flash dsDNA
Quantitative determination of anti-dsDNA antibodies on the BIO-FLASH system
Reagents
Calibrators Controls
50 Test Cartridge100 Test Cartridge
2 X 2 vials (0.5mL each) 2 X 2 vials (0.5mL each)
701178701175701176701177
* Available Outside The USA Only
2323
Antiphospholipid SyndromeQUANTA Flash APS assays can bring clarity to the complicated diagnosis of Antiphospolipid Syndrome.
Liver DiseaseQUANTA Flash Liver assays increase confidence in the diagnosis of autoimmune liver disease and aid the discrimination of its distinct subtypes.
NAME DESCRIPTION PRODUCT ITEM PACKAGE PART #
QUANTA Flash aPL Controls*
aPL controls are intended for the quality control of the QUANTA Flash APS assays performed on the BIO-FLASH system
Low aPL ControlHigh aPL Control
2 X 3 vials (2mL each)2 X 3 vials (2mL each) 701050
QUANTA Flash aCL IgG
Semi-quantitative determination of anti-cardiolipin (aCL) IgG antibodies in human citrated plasma and serum on the BIO-FLASH system
ReagentsControls
50 Test Catridge2 X 3 vials (1 mL each)
701233701232
QUANTA Flash aCL IgM
Semi-quantitative determination of anti-cardiolipin (aCL) IgM antibodies in human citrated plasma and serum on the BIO-FLASH system
ReagentsControls
50 Test Catridge2 X 3 vials (1 mL each)
701238701237
QUANTA Flash aCL IgA
Semi-quantitative determination of anti-cardiolipin (aCL) IgA antibodies in human citrated plasma and serum on the BIO-FLASH system
ReagentsControls
50 Test Cartridge2 X 3 vials (1 mL each)
701228701227
QUANTA Flash β2 GP1 IgG
Semi-quantitative determination of anti-β2 glycoprotein-1 (β2GP1) IgG antibodies in human citrated plasma and serum on the BIO-FLASH system
ReagentsControls
50 Test Catridge2 X 3 vials (1 mL each)
701248701247
QUANTA Flash β2 GP1 IgM
Semi-quantitative determination of anti-β2 glycoprotein-1 (β2GP1) IgM antibodies in human citrated plasma and serum on the BIO-FLASH system
ReagentsControls
50 Test Cartridge2 X 3 vials (1 mL each)
701253701252
QUANTA Flash β2 GP1 IgA
Semi-quantitative determination of anti-β2 glycoprotein-1 (β2GP1) IgA antibodies in human citrated plasma and serum on the BIO-FLASH system
ReagentsControls
50 Test Catridge2 X 3 vials (1 mL each)
701243701242
QUANTA Flash β2 GP1-Domain1
Semi-quantitative determination of anti-B2 GP1 Domain1 antibodies in human citrated plasma and serum on the BIO-FLASH system
ReagentsControls
50 Test Catridge2 X 3 vials (1 mL each)
701188701187
NAME DESCRIPTION PRODUCT ITEM PACKAGE PART #
QUANTA Flash LKM-1*
Semi-quantitative determination of IgG autoantibodies against LKM-1 (cytochrome P450 2D6) antigens in human serum on the BIO-FLASH system
ReagentsCalibrators
Controls
50 test cartridge2 X 2 vials (0.3mL each)2 X 2 vials (0.5mL each)
701298701296701297
QUANTA Flash M2 (MIT3)*
Semi-quantitative determination of IgG autoantibodies against mitochondrial antigens in human serum on the BIO-FLASH system
ReagentsCalibrators
Controls
50 test cartridge2 X 2 vials (0.3mL each)2 X 2 vials (0.5mL each)
701303701301701302
Calibrators are included in the QUANTA FLASH aCL and β2 GP1-kits
* Available Outside The USA Only
QUANTA Lite®
ELISAQUANTA Lite ELISA tests are made of the highest quality components to enable semi-quantitative† detection of autoantibodies for a variety of disease states:
� Antiphospholipid Syndrome
� Connective Tissue Diseases
� Rheumatoid Arthritis � Gastrointestinal Disease
� Celiac Disease � Liver Disease � Vasculitis � Autoimmune Thyroid Disease
†QUANTA Lite ELISA tests are semi-quantitative unless otherwise indicated in the product description2424
2525
The cause of chronic intestinal upset can come from a number of sources, often making diagnosis difficult. The QUANTA Lite and NOVA Lite (in the case of ANCA) tests below provide reliable results to help clinicians assess the root cause.
Gastrointestinal Disease
Consider irritable bowel syndrome, proceed
with additional testing
(–) (+)
(–)
(–)
Suggestive of Crohn’s Disease
(+)ASCA
Suggestive ofUlcerative Colitis
(+)pANCA
CELIAC & GI DIAGNOSTIC PATHWAY
Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician.
1. Green, P. H. (2009). "Mortality in celiac disease, intestinal inflammation, and gluten sensitivity." JAMA 302(11): 1225-1226.2. Rubio-Tapia, A. and Murray, J. A. (2010). "Celiac disease." Curr Opin Gastroenterol 26(2): 116-122.3. Leffler, D. A. and D. Schuppan (2010). "Update on serologic testing in celiac disease." Am J Gastroenterol 105(12): 2520-2524.
AbbreviationsANCA Anti-neutrophil cytoplasmic antibodiesASCA Anti-Saccharomyces cerevisiae antibodyDGP Anti-deamidated gliadin peptideEMA Anti-endomysial antibodytTG Anti-tissue transglutaminase antibody
Test Associated disease state
Non-celiac gluten sensitivity testingGliadin IgG
tTG, DGP, EMA
ASCA, pANCA
Suggestive of Celiac Disease
(+)
Suggestive ofnon-celiac gluten
sensitivity
2626
Gastrointestinal Disease
QUANTA Lite® (ELISA)
Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician.1. Desplat-Jego, S., Johanet, C., et al. (2007). "Update on Anti-Saccharomyces cerevisiae antibodies, anti-nuclear associated anti-neutrophil antibodies and
antibodies to exocrine pancreas detected by indirect immunofluorescence as biomarkers in chronic inflammatory bowel diseases: results of a multicenter study." World J Gastroenterol 13(16): 2312-2318.
2. Arai, R. (2010). "Serologic markers: impact on early diagnosis and disease stratification in inflammatory bowel disease." Postgrad Med 122(4): 177-185.3. Arias-Loste, et al. (2012). "Presence of Anti-proteinase 3 Antineutrophil Cytoplasmic Antibodies (Anti-PR3 ANCA) as Serologic Markers in Inflammatory Bowel
Disease" Clin Rev Allergy Immunol 45(1):109-16.4. Lewis, JD. "The utility of biomarkers in the diagnosis and therapy of inflammatory bowel disease." Gastroenterology 140(6):1817-1826.5. Corrocio, A. et al. (2003) Diagnostic Accuracy of fecal calprotectin assay in distinguishing organic causes of chronic diarrhea from irritable bowel syndrome: a
prospective study in adults and children. Clin Chem 49:861-7.
AbbreviationsASCA Anti-Saccharomyces cerevisiae antibodypANCA Perinuclear anti-neutrophil cytoplasmic antibodyPR3 Proteinase 3
RESULT PROFILE:
ASCA IgG +ASCA IgA +pANCA -(atypical)
RESULT PROFILE:
ASCA IgG -ASCA IgA -pANCA +(atypical)PR3+
Suggestive of ULCERATIVE
COLITIS
Suggestive of CROHN’S DISEASE
IBD Diagnostic Pathway
DIFFERENTIAL DIAGNOSIS OF ULCERATIVE COLITIS
AND CROHN'S
OVERLAP CONDITIONS
(+) (–)
Suggestive of IBS
MIXED RESULTSMIXED RESULTS
Calprotectin
ASCA, pANCA, PR3
27
Gastrointestinal DiseaseNAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite Calprotectin
A quantitative ELISA for detecting the concentration of calprotectin in human feces. The presence of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD) and to differentiate IBD from Irritable Bowel Syndrome (IBS)
Native 1 x 96 wells 704770
QUANTA Lite Calprotectin Extended Range*
A quantitative ELISA for detecting the concentration of calprotectin in human feces. The presence of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD) and to differentiate IBD from Irritable Bowel Syndrome (IBS)
Native 1 x 96 wells 704860
QUANTA Lite Intrinsic Factor
This assay is designed for the detection of anti-Intrinsic Factor IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of pernicious anemia
Recombinant 1 X 96 wells 708780
QUANTA Lite H. pylori IgA
A qualitative ELISA assay for the detection of anti-H. pylori (Helicobacter pylori) IgA antibodies in human serum. The presence of these antibodies can aid in the diagnosis of H. pylori infection in adult patients with clinical signs and symptoms of gastrointestinal disease
Native 1 X 96 wells 708720
QUANTA Lite H. pylori IgG
A qualitative ELISA assay for the detection of anti-H. pylori (Helicobacter pylori) IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of H. pylori infections in adult patients with clinical signs and symptoms of gastrointestinal disease
Native 1 X 96 wells 708715
QUANTA Lite ASCA IgA (S. cerevisiae)
This assay is designed for the detection of anti-Saccharomyces cerevisiae IgA antibodies in human serum. The presence of these antibodies can aid in the diagnosis of patients with Crohn's disease
Native 1 X 96 wells 708870
QUANTA Lite ASCA IgG (S. cerevisiae)
This assay is designed for the detection of anti-Saccharomyces cerevisiae IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of patients with Crohn's disease
Native 1 X 96 wells 708865
QUANTA Lite GPA (Gastric Parietal Cell Antibody)
This assay is designed for the detection of anti-gastric parietal cell (H+/K+) ATPase IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of conditions with elevated levels of anti-gastric parietal cell antibodies including pernicious anemia
Native 1 X 96 wells 708765
NAME DESCRIPTION PACKAGE PART #
Fecal Collection Device* This device has been designed as an aid in the preparation of fecal samples 100 devices 504837
Common Components
* Available Outside The USA Only
2828
Celiac disease remains highly under diagnosed, especially in children. Inova Diagnostics is very proud to have introduced QUANTA Lite Gliadin II (DGP), the first commercial deamidated gliadin peptide (DGP) ELISA, in 2005. This assay is particularly useful in pediatric populations.
NAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite h-tTG IgA(Human Tissue Transglutaminase)
Detection of anti-tissue transglutaminase (endomysium) IgA antibodies in human serum
Native(human red blood cell)
1 X 96 wells10 X 96 wells
708760708760.10
QUANTA Lite h-tTG IgG(Human Tissue Transglutaminase)
Detection of anti-tissue transglutaminase (endomysium) IgG antibodies in human serum
Native(human red blood cell)
1 X 96 wells 708755
QUANTA Lite R h-tTG IgAIn-vitro measurement of specific IgA autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of celiac disease
Recombinant 1 X 96 wells
10 X 96 wells704605
704605.10
QUANTA Lite R h-tTG IgGIn-vitro measurement of specific IgG autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of celiac disease
Recombinant 1 X 96 wells
10 X 96 wells704610
704610.10
QUANTA Lite h-tTG Screen
Detection of IgA and IgG human tissue transglutaminase (h-tTG) antibodies in human serum
Native(human red blood cell)
1 X 96 wells 704570
QUANTA Lite Gliadin IgA II
Detection of IgA antibodies to synthetic, deamidated gliadin-derived peptides (DGP) in human serum
Synthetic, deamidated
peptide
1 X 96 wells10 X 96 wells
704525704525.10
QUANTA Lite Gliadin IgG II
Detection of IgG antibodies to synthetic, deamidated gliadin-derived peptides (DGP) in human serum
Synthetic, deamidated
peptide
1 X 96 wells10 X 96 wells
704520704520.10
QUANTA Lite Celiac DGP Screen
Detection of IgA and IgG antibodies to synthetic, deamidated gliadin-derived peptides in human serum
Synthetic, deamidated
peptide1 X 96 wells 704545
Celiac Disease
QUANTA Lite® (ELISA)
2929
NAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite h-tTG/DGP Screen
Detection of IgA and IgG antibodies to synthetic, deamidated gliadin-derived peptides (DGP) and human tissue transglutaminase (h-tTG) in human serum
h-tTG native (human red blood cell);
DGP peptide (synthetic,
deamidated)
1 X 96 wells 704575
QUANTA Lite Gliadin IgA Detection of anti-gliadin IgA antibodies in human serum Native 1 X 96 wells 708655
QUANTA Lite Gliadin IgG Detection of anti-gliadin IgG antibodies in human serum Native 1 X 96 wells 708650
QUANTA Lite F-Actin IgA Detection of IgA antibodies to the F-Actin component of smooth muscle in human serum
Native 1 X 96 wells 704500
Celiac Disease (continued)
3030
Inova Diagnostics offers a comprehensive menu of tests to aid in the diagnosis of autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).
Liver Disease
DIAGNOSTIC ALGORITHMLiver Disease of Unknown Cause
ANA+
AIH
Test Associated disease state
PBC CeliacCryptogenic
chronichepatitis
AIC
AIH
F-actin+(lgG) SLA/LP+ LC1+
AMA specificantigens
M2EP (MIT3)*+
gp210+&/or
sp100+
EMA+tTG+DGP+
Negative
PBC AIH PSC
SMA+ LKM+ AMA+ AtypicalANCA+
Additional assays toestablish &/or clarify
diagnosis**
Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician.
From: A.J. Czaja & G.L. Norman, J. Clin. Gastrenterol, 2003, 37:315-327, modified by G.L. Norman 01/09
** Other assays with possible prognostic value: chromatin and dsDNA* M2 EP (MIT3) ELISA contains immunodominant epitope of PDC-E2, OGDC-E2 & BCOADC-E2
AbbreviationsAIH autoimmune hepatitisAMA anti-mitochondrial antibodiesANA anti-nuclear antibodiesANCA anti-neutrophil cytoplasmic antibodiesDGP deamidated gliadin peptideEMA endomysium antibodyLKM liver-kidney microsomal antibodyPBC primary biliary cirrhosisPSC primary sclerotic cholangitisSLA soluble liver antigenSMA smooth muscle antibodytTG tissue transglutaminaseAIC autoimmune cholangitis
QUANTA Lite® (ELISA)
3131
Liver Disease
NAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite Actin IgGDetection of IgG antibodies to the actin component of smooth muscle in human serum
Native1 X 96 wells
10 X 96 wells708785
708785.10
QUANTA Lite M2 EP (MIT3)
Detection of anti-mitochondria IgG antibodies in human serum
Recombinant 1 X 96 wells
10 X 96 wells704540
704540.10
QUANTA Lite gp210 Detection of anti-gp210 IgG antibodies in human serumSynthetic peptide
1 X 96 wells 708995
QUANTA Lite sp100 Detection of anti-sp100 IgG antibodies in human serumSynthetic peptide
1 X 96 wells 708990
QUANTA Lite PBC Screen IgG/IgA
Detection of anti-mitochondrial, -gp210 and -sp100 IgG and/or IgA antibodies in human serum
MIT3 recombinant;
sp100 & gp210
synthetic peptides
1 X 96 wells 704560
QUANTA Lite SLA (Soluble Liver Antigen)
Detection of anti-Soluble Liver Antigen (SLA) IgG antibodies in human serum
Recombinant 1 X 96 wells 708775
QUANTA Lite LKM-1 Detection of anti-LKM-1 IgG antibodies in human serum Recombinant 1 X 96 wells 708745
3232
Antiphospholipid SyndromeInova Diagnostics has long been at the forefront of laboratory tests that aid in the diagnosis of antiphospholipid syndrome, offering a comprehensive menu of serological markers including criteria as well as specialty non-criteria markers. 1
QUANTA Lite® (ELISA)
NegativeAny Positive
PS/PT (IgG/IgM) and β2GP1 Domain 1
Likelihood of APS is moderate to high
Likelihood of APS is
moderate
Potential Testing Algorithm for APS
Likelihood of APS is high
β2GP1 Domain 1
Triple positive
Moderate Risk
Possible Risk
High Risk
Moderate risk for recurring thrombosis
Unlikely
Moderate to High Risk
High risk for recurring thrombosis
Negative
Additional testing in cases of high clinical
suspicion
Positive
High risk for recurring thrombosis
Moderate risk for recurring
thrombosis
Negative
Negative
Negative
Positive
Positive
APS is possible
APS unlikely
Likelihood of APS is
moderate
aCL IgA, β2GP1 IgA
PS/PT (IgG/IgM)
APS unlikely
One or two positive
Likelihood of APS is
moderate
aCL (IgG/IgM)β2GP1 (IgM/IgG)
LAC
Likelihood of APS based on testing outcome Risk outcome
High • Triple positivity is the strongest risk factor for clinical manifestations2-6, 9
Moderate to high• Titers and isotype need to be considered4-6
• Inclusion of PS/PT results in excellent diagnostic accuracy and a predictor of adverse events2-6, 9
Moderate
• PS/PT may identify patients with APS who are negative for serological criteria markers10
• Positivity for at least one of the criteria markers increases likelihood for APS• Titers and isotype need to be considered (Antibodies of IgG isotype represent higher risk than that
of IgM, and higher antibody level implies higher risk)4-6
Possible• All criteria markers negative but one or more esoteric marker positive; APS possible, but
likelihood only marginally increased11-12
• Isolated IgA antibody positivity has been described in association with APS9, 13-14
Unlikely • All markers are negative which makes APS unlikely, but can not be excluded11-12
Suspicion of APS
33
Antiphospholipid Syndrome
NAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite ACA IgG III Detection of anti-cardiolipin IgG antibodies in human serum Native1 X 96 wells
10 X 96 wells708625
708625.10
QUANTA Lite ACA IgM III Detection of anti-cardiolipin IgM antibodies in human serum Native1 X 96 wells
10 X 96 wells708630
708630.10
QUANTA Lite ACA IgA III Detection of anti-cardiolipin IgA antibodies in human serum Native1 X 96 wells
10 X 96 wells708635
708635.10
QUANTA Lite ACA Screen III
Detection of anti-cardiolipin IgG, IgM and IgA antibodies in human serum
Native 1 X 96 wells 708620
QUANTA Lite β2GPI IgG Detection of anti-β2GPI IgG antibodies in human serum Native1 X 96 wells
10 X 96 wells708665
708665.10
QUANTA Lite β2GPI IgM Detection of IgM anti-β2GPI antibodies in human serum Native1 X 96 wells
10 X 96 wells708670
708670.10
QUANTA Lite β2GPI IgA Detection of anti-β2GPI IgA antibodies in human serum Native1 X 96 wells
10 X 96 wells708675
708675.10
QUANTA Lite β2GPI Screen ELISA
A qualitative ELISA assay for the detection of anti-β2GPI IgG, IgM and IgA antibodies in human serum
Native 1 X 96 wells 708660
1. Pengo V, Ruffatti A, Del Ross T, Tonello M, Cuffaro S, Hoxha A, Banzato A, Bison E, Denas G, Bracco A, Padayattil Jose S. Confirmation of the initial antiphospholipid antibody positivity depends on antiphospholipid antibody profile. J Thromb Haemost. 2013 Apr; 11(8):1527-31.
2. Sciascia S, Murru V, Sanna G, Roccatello D, Khamashta MA, Bertolaccini ML. Clinical accuracy for diagnosis of antiphospholipid syndrome in systemic lupus erythematosus: evaluation of 23 possible combinations of antiphospholipid antibody specificities. J Thromb Haemost. 2012 Dec;10(12):2512-8.
3. Otomo K, Atsumi T, Amengual O, Fujieda Y, Kato M, Oku K, Horita T, Yasuda S, Koike T. Efficacy of the antiphospholipid score for the diagnosis of antiphospholipid syndrome and its predictive value for thrombotic events.Arthritis Rheum. 2012 Feb;64(2):504-12.
4. Roubey RA. Risky business: the interpretation, use, and abuse of antiphospholipid antibody tests in clinical practice. Lupus. 2010 Apr;19(4):440-5.
5. Andreoli L, Tincani A. Beyond the "syndrome": antiphospholipid antibodies as risk factors. Arthritis Rheum. 2012 Feb;64(2):342-5.
6. Tarr T, Lakos G, Bhattoa HP, Shoenfeld Y, Szegedi G, Kiss E. Analysis of risk factors for the development of thrombotic complications in antiphospholipid antibody positive lupus patients. Lupus. 2007;16(1):39-45.
7. Mahler M, Norman GL, Meroni PL, Khamashta, M. Autoantibodies to domain 1 of beta 2 glycoprotein 1: a promising candidate biomarker for risk management in antiphospholipid syndrome. Autoimmun Rev. 2012 Dec; 12(2):313-317.
8. V. Pengo, A. Ruffatti, M. Tonello, S. Cuffaro, A. Banzato, E. Bison, G. Denas, S. Padayattil Jose. Antiphospholipid syndrome: Antibodies to Domain 1 of β2-glycoprotein 1 correctly classify patients at risk. J Thromb Haemost 2015
9. Meijide H, Sciascia S, Sanna G, Khamashta MA, Bertolaccini ML. The clinical relevance of IgA anticardiolipin and IgA anti-β2 glycoprotein I antiphospholipid antibodies: a systematic review. Autoimmun Rev. 2013 Jan;12(3):421-5.
10. Pregnolato F, Chighizola CB, Encabo S, Shums Z, Norman GL, Tripodi A,Chantarangkul V, Bertero T, De Micheli V, Borghi MO, Meroni PL. Anti-phosphatidylserine/prothrombin antibodies: an additional diagnostic marker for APS? Immunol Res. 2013 Jul; 56(2-3):432-8.
11. Nayfe R, Uthman I, Aoun J, Saad Aldin E, Merashli M, Khamashta MA. Seronegative antiphospholipid syndrome. Rheumatology (Oxford). 2013
12. Rodriguez-Garcia JL, Bertolaccini ML, Cuadrado MJ, Sanna G, Ateka-Barrutia O, Khamashta MA. Clinical manifestations of antiphospholipid syndrome (APS) with and without antiphospholipid antibodies (the so-called 'seronegative APS'). Ann Rheum Dis. 2012 Feb;71(2):242-4.
13. Kumar S, Papalardo E, Sunkureddi P, Najam S, González EB, Pierangeli SS. Isolated elevation of IgA anti-beta2glycoprotein I antibodies with manifestations of antiphospholipid syndrome: a case series of five patients. Lupus. 2009 Oct;18(11):1011-4.
14. Mehrani T, Petri M. Association of IgA Anti-beta2 glycoprotein I with clinical and laboratory manifestations of systemic lupus erythematosus. J Rheumatol. 2011; 38(3):450-3.
15. Amengual O, Atsumi T, Khamashta M, Hughes, G. Advances in APS. Ann Acad Med Singapore. 1998;27:61-66.16. Bertolaccini M, Amengual O, Atsumi T, Binder W, et al. Non-criteria aPL tests: report of a task force and
workshop at the 13th International Congress on aPL. Lupus 2011;20:191-205 17. Nash M, Camilleri R, Kunka S, et al. The anticardiolipin assay is required for sensitive screening of aPL. J
Thromb Haemost. 2004; 2:1077-1081.18. Pengo V, Tripodi A, Reber G, Rand JH, Ortel TL, Galli M, De Groot, PG. Update of the guidelines for lupus
anticoagulant detection. J Thromb Haemost 2009 7:1737-1740.19. Vlagea A, Gil A, Cuesta MV, Arribas F, Diez J, Lavilla P, Pascual-Salcedo D. aPS/PT as potential markers of APS.
Clin Appl Thromb Hemost 2012 doi: 10.117/107602961243757820. Scascia S, Sanna G, Murru V, Roccatello D, Khamashta MA, Bertolaccini, ML. aPT and aPS/PT antibodies and
the risk of thrombosis in the APS. J Thromb Haemost. 2014; 111: 354-364.
References
3434
Antiphospholipid Syndrome (continued)
NAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite aPS/PT IgG
Detection of IgG class antibodies to phosphatidylserine/prothrombin complex (PS/PT) in serum or plasma
Native 1 X 96 wells 708835
QUANTA Lite aPS/PT IgM
Detection of IgM class antibodies to phosphatidylserine/prothrombin complex (PS/PT) in serum or plasma
Native 1 X 96 wells 708845
QUANTA Lite Phosphatidylserine IgG
In-vitro measurement of IgG anti-phosphatidylserine antibodies in human serum, as an aid in the diagnosis of anti-phospholipid syndrome (APS)
Native1 X 96 wells
10 X 96 wells704625
704625.10
QUANTA Lite Phosphatidylserine IgM
In-vitro measurement of IgM anti-phosphatidylserine antibodies in human serum, as an aid in the diagnosis of anti-phospholipid syndrome (APS)
Native1 X 96 wells
10 X 96 wells704630
704630.10
QUANTA Lite Phosphatidylserine IgA
In-vitro measurement of IgA anti-phosphatidylserine antibodies in human serum, as an aid in the diagnosis of anti-phospholipid syndrome (APS)
Native1 X 96 wells
10 X 96 wells704635
704635.10
QUANTA Lite® (ELISA)
35
The revised classification criteria issued in 2010 for rheumatoid arthritis (RA) emphasize the need for early and accurate diagnosis. The QUANTA Lite® CCP3.1 IgG/IgA ELISA offers superior detection of early RA compared with CCP21. Clearly defined positive and high positive cut-offs provide results that rheumatologists require.
NAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite CCP3.1 IgG/IgA
Detection of anti-CCP 3.1 IgG and IgA antibodies in patient sera, citrated or EDTA plasma
Synthetic peptide
1 X 96 wells10 X 96 wells
704550704550.10
QUANTA Lite CCP3 IgGDetection of anti-CCP 3 IgG antibodies in patient sera, citrated or EDTA plasma
Synthetic peptide
1 X 96 wells 10 X 96 wells
704535704535.10
QUANTA Lite RF IgGDetection of anti-rheumatoid factor (RF) IgG antibodies in human serum
Native 1 X 96 wells 708685
QUANTA Lite RF IgM Detection of anti-rheumatoid factor (RF) IgM antibodies in human serum
Native 1 X 96 wells 708690
QUANTA Lite RF IgA Detection of anti-rheumatoid factor (RF) IgA antibodies in human serum
Native 1 X 96 wells 708695
Rheumatoid Arthritis
1. Source : QUANTA Lite CCP 3.1 IgG/IgA ELISA direction insert. Early RA defined as detection within 2 years of onset of symptoms.
3636
NAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite ANA Detection of anti-nuclear IgG antibodies (ANA) in human serum
Native, recombinant, extracts from HEp-2 nuclei and nucleoli
1 X 96 wells 708750
QUANTA Lite dsDNA Detection of anti-dsDNA IgG antibodies in human serum Native 1 X 96 wells 708510
QUANTA Lite dsDNA SC (Double Stranded DNA)
In-vitro measurement of specific IgG autoantibodies against dsDNA present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings. Five calibrators allow for creation of standard curve (SC)
Native 1 X 96 wells 704650
QUANTA Lite HA dsDNA
In-vitro measurement of specific high avidity IgG autoantibodies against dsDNA present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings. Five calibrators allow for creation of standard curve
Native 1 X 96 wells 704615
QUANTA Lite Chromatin
Detection of anti-chromatin IgG antibodies in human serum Native 1 X 96 wells 708710
QUANTA Lite C1q CIC
In-vitro measurement of circulating immune complexes (CIC) that bind C1q, present in human serum. It is intended for the determination of CIC in serum of patients with various autoimmune and other CIC-related diseases, and is used in conjunction with other clinical findings
Native 1 X 96 wells 704620
QUANTA Lite Anti-C1q*
Detection of anti-C1q antibodies in human serum Native 1 X 96 wells 704565
QUANTA Lite Centromere
Detection of anti-centromere IgG antibodies specifically reactive to the CENP-A and CENP-B antigens in human serum
Recombinant 1 X 96 wells 708770
* Available Outside The USA Only
Connective Tissue DiseasesLupus and lupus-like diseases present clinicians with a tremendous diagnostic challenge. Tests which stand apart from the rest include the QUANTA Lite® ANA ELISA with a broad array of antigens as well as HEp-2 nuclear extracts, and the QUANTA Lite Chromatin ELISA with excellent performance.
QUANTA Lite® (ELISA)
37
* Available Outside The USA Only
Connective Tissue Diseases (continued)
NAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite HMGCR*
Semi-quantitative detection of IgG anti-HMGCR antibodies in human serum
Native 1 x 96 wells 704760
QUANTA Lite Histone
Detection of anti-histone IgG antibodies in human serum Native 1 X 96 wells 708510
QUANTA Lite Jo-1
Detection of anti-Jo-1 IgG antibodies in human serum Recombinant 1 X 96 wells 708585
QUANTA Lite Ribosome P
Detection of anti-Ribosome P IgG antibodies in human serumSynthetic peptide
1 X 96 wells 708600
QUANTA Lite RNA Pol III
Detection of anti-RNA Polymerase III IgG antibodies in human serum Recombinant 1 X 96 wells 704555
QUANTA Lite RNP
Detection of anti-RNP IgG antibodies in human serum Native 1 X 96 wells 708565
QUANTA Lite Scl-70
Detection of anti-Scl-70 IgG antibodies in human serum Native 1 X 96 wells 708580
QUANTA Lite Sm
Detection of anti-Sm IgG antibodies in human serum Native 1 X 96 wells 708560
QUANTA Lite SS-A
Detection of anti-SS-A (60kDa & 52kDA) IgG antibodies in human serum
SS-A 52 recombinant;
SS-A 60 native
1 X 96 wells 708570
QUANTA Lite SS-A 52
Detection of anti-SS-A 52 IgG antibodies in human serum Recombinant 1 X 96 wells 704505
3838
* Available Outside The USA Only
Connective Tissue Diseases (continued)
NAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite SS-B Detection of anti-SS-B IgG antibodies in human serum Recombinant 1 X 96 wells 708575
QUANTA Lite ssDNA(Single Stranded DNA)
Detection of anti-ssDNA IgG antibodies in human serum. When used in conjunction with QUANTA Lite dsDNA, can aid in the diagnosis of systemic lupus erythematosus (SLE) and certain other rheumatic diseases
Native 1 X 96 wells 708525
QUANTA Lite ENA 4 (Sm, RNP, SS-A and SS-B Screening Test)
Detection of anti-Sm, RNP, SS-A (60kDa and 52kDA) and SS-B IgG antibodies in human serum
SS-A 52 recombinant; SS-A 60 native; SS-B
recombinant; Sm native; RNP native
1 X 96 wells 708555
QUANTA Lite ENA 5 (Sm, RNP, SS-A, SS-B and Scl-70 Screening Test)
This assay is designed for the detection of anti-Sm, RNP, SS-A (60kDa and 52kDa), SS-B and Scl-70 IgG antibodies in human serum
SS-A 52 recombinant; SS-A 60 native; SS-B
recombinant; Sm native; RNP native; Scl-70 native
1 X 96 wells 708610
QUANTA Lite ENA 6 (Sm, RNP, SS-A, SS-B, Scl-70 and Jo-1 Screening Test)
This assay is designed for the detection of anti-Sm, RNP, SS-A (60kDa and 52kDa), SS-B, Scl-70 and Jo-1 IgG antibodies in human serum
SS-A 52 recombinant; SS-A 60 native; SS-B
recombinant; Sm native; RNP native; Scl-70 native;
Jo-1 recombinant
1 X 96 wells 708615
QUANTA Lite ENA Profile EIA*
This kit is designed for the in-vitro qualitative screening of human serum for the presence of specific IgG autoantibodies against extractable nuclear antigens (ENAs) namely; SSA/Ro (60 and 52kD), SSB/La, Sm, Sm/RNP, Scl-70 and Jo-1, as an aid in the diagnosis of certain systemic rheumatic diseases
SS-A 52 recombinant; SS-A 60 native; SS-B
recombinant; Sm native; RNP native; Scl-70 native;
Jo-1 recombinant
1 X 96 wells 704715
QUANTA Lite® (ELISA)
39
Inova Diagnostics' vasculitis menu has expanded with the addition of the QUANTA Lite PR3 SC and QUANTA Lite MPO SC, both offering 5 point standard curve calibration.
Vasculitis
NAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite Thyroid T Detection of anti-thyroglobulin IgG antibodies in human serum
Native 1 X 96 wells 708595
QUANTA Lite TPO Anti-thyroid peroxidase (TPO) IgG antibodies in human serum
Recombinant 1 X 96 wells 708725
Autoimmune Thyroid Disease
NAME DESCRIPTION ANTIGEN PACKAGE PART #
QUANTA Lite MPO IgGDetection of anti-myeloperoxidase (MPO) IgG antibodies in human serum
Native1 X 96 wells
10 X 96 wells708700
708700.10
QUANTA Lite MPO SC
In-vitro measurement of specific IgG autoantibodies against myeloperoxidase (MPO) present in serum, as an aid to the diagnosis of certain types of autoimmune vasculitis. Five calibrators allow for creation of standard curve
Native1 X 96 wells
10 X 96 wells704655
704655.10
QUANTA Lite PR-3 IgG Anti-serine protease 3 (PR-3) IgG antibodies in human serum Native1 X 96 wells
10 X 96 wells708705
708705.10
QUANTA Lite PR3 SC
In-vitro measurement of specific IgG autoantibodies against proteinase 3 (PR3) present in human serum, as an aid in the diagnosis of Wegener's granulomatosis and certain forms of autoimmune vasculitis. Five calibrators allow for creation of standard curve
Native1 X 96 wells
10 X 96 wells704660
704660.10
QUANTA Lite GBMAnti-glomerular basement membrane (GBM) IgG antibodies in human serum
Native1 X 96 wells
10 X 96 wells708740
708740.10
4040
‡ Lead times for delivery may vary, items are manufactured to order
NAME DESCRIPTION PACKAGE PART #
QUANTA ChekANA Panel
Quality control of IFA and ELISA antinuclear antibody procedures. Each serum serves as both a pattern control and a titratable sensitivity control. The staining pattern and intensity for each serum has been calibrated by testing it on NOVA Lite HEp-2 slides and QUANTA Lite ANA kits
10 X 0.15mL 708111
QUANTA ChekANCA Panel
Quality control of IFA and ELISA autoantibody procedures. Each serum serves as both a pattern control and a titratable sensitivity control. The staining pattern and intensity for each serum has been calibrated by testing it on Inova Diagnostics' Neutrophil slides and QUANTA Lite MPO and PR-3 kits
8 X 0.15mL 708112
QUANTA Chek Celiac Panel
Quality control of IFA and ELISA autoantibody procedures. Each serum serves as both a pattern control and a titratable sensitivity control. The staining pattern and intensity for each serum has been calibrated by testing it on NOVA Lite Endomysial slides and QUANTA Lite h-tTG IgA, h-tTG IgG, Gliadin IgG II and Gliadin IgA II kits
8 X 0.15mL 708113
QUANTA Chek Coagulation Panel
Quality control of ACA and β2GPI autoantibody ELISA procedures. Each serum serves as both a sensitivity and specificity control. Each serum has been calibrated by testing it on QUANTA Lite ACA and QUANTA Lite β2GPI kits
8 X 0.15mL 708114
QUANTA ChekENA Panel
Quality control of extractable nuclear antibody (ENA) assay in the QUANTA Lite ENA ELISA procedure. Each serum serves as both a sensitivity and a specificity control. Each serum has been calibrated by testing it on QUANTA Lite ENA ELISA kits
8 X 0.15mL 708115
QUANTA Chek™ Quality Control Panels‡
QUANTA Lite® (ELISA)
41
NAME DESCRIPTION PACKAGE PART #
IgG Sapporo Standard (HCAL)
International standard for the quality control of anti-cardiolipin IgG (aCL) and anti-β2 glycoprotein I (β2GPI) IgG antibody ELISA products. The IgG Sapporo Standard (HCAL) can be serially diluted in order to make a standard curve, or it can be used as a single point control
1 X 0.1mL 508668
IgM Sapporo Standard (EY2C9)
International standard for the quality control of anti-cardiolipin IgM (aCL) and anti-β2glycoprotein I (β2GPI) IgM antibody ELISA products. The IgM Sapporo Standard (EY2C9) can be serially diluted in order to make a standard curve, or it can be used as a single point control
1 X 0.1mL 508673
QUANTA Lite dsDNA Standard Set*
Pre-diluted 5-point standard curve and positive curve to be used in conjunction with QUANTA Lite dsDNA (708510)
5 X 1.2mL 508512
QUANTA Lite Gliadin IgA II Calibrator Set*
Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite Gliadin IgA II ELISA (704525)
6 X 1.2mL 504528
QUANTA Lite Gliadin IgG II Calibrator Set*
Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite Gliadin IgG II ELISA (704520)
6 X 1.2mL 504524
QUANTA Lite h-tTG IgA Calibrator Set*
Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite h-tTG IgA ELISA (708760)
5 X 1.2mL 508763
QUANTA Lite GBM Calibrator Set*
Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite GBM ELISA (708740)
6 X 1.2mL 508744
QUANTA Lite MPO IgG Calibrator Set*
Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite MPO IgG ELISA (708700)
6 X 1.2mL 508703
QUANTA Lite PR3 IgG Calibrator Set*
Pre-diluted 5-point standard curve and positive control to be used in conjunction with QUANTA Lite PR-3 IgG ELISA (708705)
6 X 1.2mL 508708
Calibration and Standard Sets
* Available Outside The USA Only
NOVA Dot®*
42
NOVA Dot® for autoantibody testingNOVA Dot® immunoblots allow for the detection and identification of autoantibodies for up to 12 specific antigens from a single serum sample. The NOVA Dot immunoblot product line was developed with advanced membrane technology and optimized combinations of antigens. NOVA Dot immunoblots provide an alternative approach to autoantibody testing that complements NOVA Lite® IFA, QUANTA Lite® ELISA or QUANTA Flash® chemiluminescent assays.
• Test systems for disease specific antibody profiles
• Up to 12 antigens in a single blot strip
• Simple processing from a single serum sample
• Refined antigen allows for optimized signaling of DFS70 by focusing on core auto-epitopes
* Available Outside The USA Only
43
NAME DESCRIPTION PART #
NOVA Dot Scanner* Scanner for use with NOVA Dot assays DOT1000
NOVA Dot Software License*
Software License to be used with NOVA Dot assays DOT1100
Connective Tissue Disease
Liver Disease
NOVA Dot Common Components
NAME DESCRIPTION ANTIGEN PACKAGE PART #
NOVA Dot CTD Profile*
This immunodot assay allows for the simultaneous detection in human sera of IgG autoantibodies against Nucleosome, Sm, Sm/RNP, SSA/Ro60, Ro52, SSB, Jo-1, Scl-70, CENP-B, PCNA, Ribosome P0 and DFS-70 antigens
Nucleosome native; Sm native; RNP/Sm native; Ro60 native, Ro52 recombinant; SSB recombinant; Jo-1 recombinant; Scl-70 recombinant; CENP-B recombinant; PCNA recombinant; Ribosome P0 recombinant; DFS70 recombinant
24 strips 704800
NOVA Dot Scleroderma Profile In Development
NOVA Dot Myositis Profile In Development
NOVA Dot CTD Confirm
In Development
NAME DESCRIPTION ANTIGEN PACKAGE PART #
NOVA Dot Liver Profile In Development
* Available Outside The USA Only
NOVA Lite®
4444
NOVA Lite IFA Barcoded SlidesAs your partner in autoimmunity testing, Inova Diagnostics is redefining autoimmunity with innovative systems and products. Barcoded slides offer the opportunity to advance your IFA process. Barcoded slides, in combination with QUANTA Link software and QUANTA-Lyser, allow for:
To learn more about NOVA Lite barcoded slides, scan this QR code using your PDA or smartphone or visit barcodedslide.com
� Efficiency by eliminating transcription and related errors � Patient sample traceability
4545
IFA Slide Kits
PR3 positiveMPO positive
Consider microscopic polyangiitis
(60% positive) or granulomatosis with polyangiitis
(Wegener's) (25% positive)
Consider microscopic polyangiitis
(30% positive) or granulomatosis with polyangiitis
(Wegener's) (60% positive)
pANCA / cANCA negative
pANCA or cANCA positive
atypical ANCA positive
Clinical suspicion of autoimmune small vessel
vasculitis low
Order PR3 and MPO ELISA
Clinical suspicion of autoimmune small vessel
vasculitis low; considertesting for ASCA
Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician.
Savige, J. et al, Am J Clin Path 112 (1), 1999
ANCA IFA
Test Associated disease state
AbbreviationsMPO myeloperoxidasePR-3 proteinase 3ANCA anti-neutrophil cytoplasmic antibodiesASCA anti-Saccharomyces cerevisiae antibody
NOVA Lite® has long been synonymous with quality immunofluorescence assays. Inova Diagnostics is commited to customer support and provides training. Proprietary methods used to craft our slides make NOVA Lite assays easy to read and interpret, helping your lab provide the reliable and consistent results demanded by the current healthcare environment.
4646
sp100
Nuclear Dots
Various rheumatic diseases
Spindle
MitoticCytoplasmic staining
gp 210
Nuclear membrane
(rim)
Marker antibody for
SLE
PCNA
CREST variant of Progressive
Systemic Sclerosis
Centromere Coarse
speckledFine
speckledDense �ne speckled
Centromere
CREST
Homogeneous Mitochondrial
Retest on rodent tissue
M2 EP (MIT-3)
Primary Biliary Cirrhosis (PBC)
NEGATIVE
No further follow-up testing indicated. (SS-A testing may be indicated if there is strong clinical evidence of connective tissue disease)
POSITlVE
Con�rmatoryTesting
Nucleolar
Consider Progressive Systemic Sclerosis or
Polymyositis/ Scleroderma overlap (mixed pattern with
positive chromosomes may indicate ScI-70)
Sm
SLE marker antibody
RNP
MCTD or milder SLE
RNA Pol III
Scleroderma, especially
di�use cutaneous form; also associated
with risk of renal crisis
Low % of SLE patients but
highly speci�c
Golgi
PM/DM
Jo-1
Jo-1Ribosomal
Nuclearstaining
Ribosomal P
Immuno�uorescent (IF) major patterns
Re�ex test
Associated disease state
Scl-70
Scleroderma marker
antibodyassociated
with Scleroderma
SS-B
SLE,Sjögren's
Syndrome,Neonatal
SLE
SS-A 60
SLESjögren's
Syndrome, Systemic Sclerosis
,
SS-A 52
SLESjögren's
Syndrome, Systemic Sclerosis, PM/DM
,
dsDNA and/or chromatin
ActiveSLE
Histone
Drug induced SLE
DFS70
When present in isolation,
excludes AARD
HEp-2
Testing strategies provided for informational purposes only. Testing and diagnosis should be determined by a licensed clinician.
AbbreviationsAARDCREST
ANA Associated Rheumatic DiseaseCalcinosis, Raynaud's phenomenon, Esophageal dysmotility, Sclerodactyly, Telangiectasia
ds-DNA Double Stranded DNAENA Extractable Nuclear AntibodyMCTD Mixed Connective Tissue DiseasePBC Primary Biliary CirrhosisPCNA Proliferating Cell Nuclear Antigen
PM/DM Polymyositis/DematomyositisRNP RibonucleoproteinScl-70 Scleroderma antigen (70kD)SS-A Sjögren’s Syndrome A antigenSS-B Sjögren’s Syndrome B antigenSm Smith antigenSLE Systemic Lupus Erythematosus
NOVA Lite® (IFA)
HEp-2Diagnositic Algorithm
4747
sp100
Nuclear Dots
Various rheumatic diseases
Spindle
MitoticCytoplasmic staining
gp 210
Nuclear membrane
(rim)
Marker antibody for
SLE
PCNA
CREST variant of Progressive
Systemic Sclerosis
Centromere Coarse
speckledFine
speckledDense �ne speckled
Centromere
CREST
Homogeneous Mitochondrial
Retest on rodent tissue
M2 EP (MIT-3)
Primary Biliary Cirrhosis (PBC)
NEGATIVE
No further follow-up testing indicated. (SS-A testing may be indicated if there is strong clinical evidence of connective tissue disease)
POSITlVE
Con�rmatoryTesting
Nucleolar
Consider Progressive Systemic Sclerosis or
Polymyositis/ Scleroderma overlap (mixed pattern with
positive chromosomes may indicate ScI-70)
Sm
SLE marker antibody
RNP
MCTD or milder SLE
RNA Pol III
Scleroderma, especially
di�use cutaneous form; also associated
with risk of renal crisis
Low % of SLE patients but
highly speci�c
Golgi
PM/DM
Jo-1
Jo-1Ribosomal
Nuclearstaining
Ribosomal P
Immuno�uorescent (IF) major patterns
Re�ex test
Associated disease state
Scl-70
Scleroderma marker
antibodyassociated
with Scleroderma
SS-B
SLE,Sjögren's
Syndrome,Neonatal
SLE
SS-A 60
SLESjögren's
Syndrome, Systemic Sclerosis
,
SS-A 52
SLESjögren's
Syndrome, Systemic Sclerosis, PM/DM
,
dsDNA and/or chromatin
ActiveSLE
Histone
Drug induced SLE
DFS70
When present in isolation,
excludes AARD
HEp-2
THE HEp-2 DIAGNOSTIC ALGORITHMFor additional information on HEp-2 testing or to view additional images, please visit our website at www.inovadx.com. This diagnostic algorithm was assembled by a panel of experts and is based on years of experience in conjunction with published guidelines. It is provided as a guide to aid in the diagnosis of disease based on laboratory results and is not intended as a definitive diagnosis of any disease condition. Please consider all clinical findings when making diagnostic decisions.
4848
SUBSTRATE
C·ANCA*
P·ANCA*
ATYPICAL P-ANCA*
ANA POSITIVE
NEGATIVE
Granular Cytoplasmic
Granular Cytoplasmic
Negative
Negative
Negative
FORMALIN FIXED SLIDE
Negative
Negative
Negative
Positive
Negative
HEp-2 SLIDE
* Consider confirmatory testing with QUANTA Lite® or QUANTA Flash MPO and PR3.
ANCA ASSOCIATED PATTERN CHART
Perinuclear
Very Perinuclear
Perinuclear or Homogeneous
Negative
ETHANOLFIXED SLIDE
Granular Cytoplasmic
NOVA Lite® (IFA)
ANCA PatternsSubstrate Pattern Chart
4949
Find below a collection of immunfluorescent (IFA) images highlighting a few of the substrate offerings available from Inova Diagnostics. To review our complete product offering and to view additional images please visit our website at www.inovadx.com.
AMA on NOVA Lite ANA Plus
F-Actin antibody on IEC-6 NOVA Lite IgG F-Actin
ASMA on NOVA Lite ANA Plus
GBM antibody on NOVA Lite GBM (Primate Kidney)
Pemphigoid antibody on NOVA Lite Endomysial (Primate Esophagus)
Endomysial antibody on NOVA Lite Monkey Esophagus
AMA on NOVA Lite Rat Kidney/Stomach/Liver
Thyroid antibody on NOVA Lite Thyroid
Pemphigus antibody on NOVA Lite Endomysial (Primate Esophagus)
Additional IFA SubstratesSelected Images
5050
NOVA Lite HEp-2 Immunofluorescence Patterns
HOMOGENEOUS
Uniform, diffuse fluorescence of entire nucleus in interphase cells with pronounced fluorescence of mitotic cells.
SPECKLED
Coarse speckles in interphase cells with nucleolar sparing and negative metaphase mitotic cells.
LAMIN
Homogeneous or fine, ground glass appearance of nuclei in interphase cells associated with staining of
the nuclear rim and negative mitotic cells.
gp210
Rim like staining of the cell nucleus.
RNA POL I
RNA POL I speckling of the nuclei in interphase cells with speckled nucleolar staining.
RIBOSOMAL
Fine, dense granular to homogeneous cytoplasmic staining with weak
nucleolar staining.
Jo-1
Fine cytoplasmic staining concentrated around the nucleus which diminishes towards the periphery of
the cytoplasm.
CENTRIOLE
Metaphase mitotic spindles display discrete fluorescent dots at each pole. Interphase cells adjacent to nucleus display 1 or 2 bright dots.
SS-A
Fine to discrete, uniformly distributed, speckles in the nuclei of the interphase cells. Unstained
metaphase mitotic cells and possible weak cytoplasmic staining.
Scl-70
Homogeneous or dense fine speckling of nuclei with many of these cells having weak
nucleolar staining. Positive mitotic cells.
DFS-70
Dense fine speckling of interphase nuclei with positive mitotic cells.
HEp-2 cell substrate provide a valuable test for the screening and titration of circulating autoantibodies in human serum. The ability to identify key patterns will aid in the laboratory diagnosis of systemic lupus erythematosus (SLE), Sjögren’s Syndrome, Scleroderma and other connective tissue disorders.
NOVA Lite® (IFA)
51
NOVA Lite HEp-2 Immunofluorescence Patterns
CENTROMERE
Discrete speckles throughout the interphase cells. Condensed, speckled
metaphase mitotic cells.
NUCLEOLAR
Large, typically homogeneous clustered granules in nucleoli of interphase cells with surface staining of the
mitotic cells.
.
CENP-F
Fine speckling throughout nucleus in interphase cells; staining of centromeres in prophase and
metaphase; spindle poles in metaphase; spindle and midbody of mitotic cells in anaphase and telophase.
NuMA
Diffuse fine speckled nuclear staining of the interphase cells. Fluorescence of the spindle poles and spindle fibers in metaphase and
anaphase mitotic cells.
PERICENTROSOMES
1-2 large dots at the periphery of the nucleus in interphase cells.
RODS AND RINGS
Multiform cytoplasmic structures. with negative mitotic cells.
GW BODIES
Large, discrete speckles throughout the cytoplasm of interphase cells with negative
mitotic cells.
GOLGI
Speckled polar staining adjacent to one part of the nucleus with negative mitotics.
.
PM-Scl
Homogeneous nucleolar staining associated with weak, diffuse staining of the nuclei and negative
mitotic cells.
PCNA
Highly variable staining in both pattern and intensity of interphase cells. Fine to coarse
speckling in approximately 30-60% of interphase cells (S phase cells).
AMA + sp100
Coarse granular staining throughout the cytoplasm. Multiple nuclear dots throughout the nuclei with
negative metaphase cells.
5252
IFA Slide Kits
NAME DESCRIPTION PACKAGE PART #
NOVA Lite ANCA(Ethanol Fixed)
An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-neutrophil cytoplasmic IgG antibodies (ANCA) in human serum. The presence of these antibodies can aid in the assessment of various systemic vasculitides. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use
10 X 6 wells(new formulation)
(classic formulation)
20 X 12 wells(new formulation)
(classic formulation)
DAPI conjugate#*
708299708290
708298708296
708338
NOVA Lite ANCA (Formalin Fixed)
An indirect immunofluorescent assay for the screening and titration of circulating anti- neutrophil cytoplasmic antibodies (ANCA). These antibodies are markers to aid in the diagnosis and treatment of various systemic vasculitides. Fluorescein labeled IgG conjugate with Evan's Blue - ready to use
10 X 6 wells20 X 12 wells
DAPI conjugate#*
708295 708297708300
NOVA Lite HEp-2 ANA
An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-nuclear IgG antibodies (ANA) in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), or other connective tissue or rheumatic diseases. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use
5 X 12 wells20 X 12 wells
DAPI conjugate#
708101708100704320
NOVA Lite HEp-2 Select®*
An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-HEp-2 IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), or other connective tissue or rheumatic diseases. Fluorscein labeled anti-human IgG conjugate with Evan's blue- ready to use. This kit contains a special specimen diluent, which adsorbs DFS70 antibodies from samples and minimizes their detection during ANA screening
20 x 12 wells 704315
NOVA Lite HEp-2 ANA External EB
An indirect immunofluorescent assay for the screening and titration of circulating antinuclear antibodies by means of an immunofluorescence test. It is to be used as an aid in the diagnosis and treatment of systemic lupus erythematosus (SLE), Sjögren's Syndrome, rheumatoid arthritis and other connective tissue disorders. External Evans blue provided as optional counterstain
10 X 6 wells20 X 12 wells
704230704235
NOVA Lite dsDNA Crithidia luciliae
An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-double stranded DNA (dsDNA) IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE). Fluorescein labeled anti-human IgG conjugate no Evan's Blue - ready to use
10 X 6 wells20 X 12 wells
DAPI conjugate#*
708200708205708210
NOVA Lite ANA KSL
An indirect immunofluorescent assay for the screening and semi-quantitative determination of IgG anti-nuclear antibodies (ANA), anti-mitochondrial (AMA), anti-smooth muscle (ASMA) and gastric parietal antibodies (GPA) in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), or other connective tissue or rheumatic diseases. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use
10 X 4 wells25 X 8 wells
708390708380
# DAPI conjugate does not contain Evan's Blue *Available Outside the USA Only
NOVA Lite® (IFA)
5353
†Monkey and Primate used interchangeably
*Available Outside the USA Only
IFA Slide Kits (continued)
NAME DESCRIPTION PACKAGE PART #
NOVA Lite Rat Liver, Kidney, Stomach
This product is intended for use in the screening and titration of circulating autoantibodies in human serum as an aid in the diagnosis and treatment of various autoimmune diseases. The four major autoantibodies detected are antinuclear antibodies (ANA), antimitochondrial antibodies (AMA), antismooth muscle antibodies (ASMA) and antigastric parietal cell antibodies (AGPCA). Fluorescein labeled anti-human IgG (H&L) conjugate - ready to use
10 X 5 wells 25 X 10 wells
704170704180
NOVA Lite ANA Plus Mouse Kidney & Stomach
An indirect immunofluorescent assay for the screening and semi-quantitative determination of anti-nuclear antibodies (ANA), anti-mitochondrial (AMA), anti-smooth muscle (ASMA) and gastric parietal IgG antibodies (GPA) in human serum. The presence of these antibodies can aid in the diagnosis of systemic lupus erythematosus (SLE), or other connective tissue or rheumatic diseases. Fluorescein labeled anti-human IgG conjugate with Evan's Blue - ready to use
10 X 4 wells20 X 8 wells
708155708150
NOVA Lite IgG F-Actin*
An indirect immunofluorescent assay for the screening and semi quantitative determination of IgG anti-F-Actin antibodies in human serum The presence of IgG anti-F-Actin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC)
5 x 6 wells 708255
NOVA Lite Monkey Esophagus†
(IgG and IgA conjugates)
Monkey esophagus sections are intended for use as a substrate for the screening of antibodies to intra-epidermal antigens or basement membrane zones in human serum, as an aid in the diagnosis of pemphigus and bullous pemphigoid respectively. The sections can also be used for detection of endomysial antibodies as an aid in the diagnosis of celiac disease. Fluorescein labeled anti-human IgG (H&L) conjugate and anti-human IgA conjugate - ready to use
10 X 5 wells 25 X 10 wells
704145704150
NOVA Lite Monkey Esophagus†
(IgA conjugate only)
Monkey esophagus sections are intended for use as a substrate for the detection of endomysial antibodies as an aid in the diagnosis of celiac disease. Includes IgA conjugate only. Fluorescein labeled anti-human IgA conjugate - ready to use
25 X 10 wells 704155
NOVA Lite Monkey Kidney*†
This product is intended for use in the screening of circulating antiglomerular basement membrane (GBM) autoantibodies in human serum. Anti-human IgG (H&L) biotin conjugate and fluorescein labeled-strepavidin conjugate - ready to use
10 X 5 wells 704240
NOVA Lite Thyroid
An indirect immunofluorescent assay for the screening and semi-quantitative determination of antithyroid microsomal and colloid/thyroglobulin IgG antibodies in human serum. The presence of these antibodies can aid in the diagnosis of autoimmune thyroid disease. Fluorescein labeled primate absorbed anti-human IgG conjugate (FC specific) with Evan's Blue - ready to use
10 X 8 wells 708350
5454
‡ Item not part of a kit, analytical and performance characteristics are not established.
NAME DESCRIPTION PACKAGE PART #
NOVA Lite ANCA (Ethanol Fixed)
Ethanol-fixed human neutrophil substrate slide
1 X 6 wells1 X 12 wells10 X 6 wells20 X12 wells
508299508298
508299.10508298.20
NOVA Lite ANCA (Formalin Fixed)
Formalin-fixed human neutrophil substrate slide
1 X 6 wells10 X 6 wells1 X 12 wells
20 X 12 wells
508295508295.10
508297508297.20
NOVA Lite ANCA (Methanol Fixed)*
Methanol-fixed human neutrophil substrate slide 1 X 6 wells 508280
NOVA Lite HEp-2 ANA HEp-2 (human epithelial cell) substrate slide
1 X 6 wells1 X 12 wells10 x 12 wells20 x 12 wells80 x 12 wells 10 X 6 wells
508105508100
508100.10508100.20508100.80508105.10
NOVA Lite ANA(HEp-2 actin)
HEp-2 (human epithelial cell) substrate slide fixed to detect actin fibers1 X 6 wells
1 X 12 wells508095508090
NOVA Lite dsDNA (Crithidia luciliae)
Crithidia luciliae substrate slide
1 X 6 wells1 X 12 wells10 X 6 wells
20 X 12 wells80 X 12 wells
508200508205
508200.10508205.20508205.80
NOVA Lite ANA(Mouse Kidney)
ANA (Mouse Kidney) tissue section slide 1 X 8 wells 508170
NOVA Lite ANA Plus Mouse kidney and stomach tissue substrate slide
1 X 4 wells1 X 8 wells
10 X 4 wells30 X 8 wells
508155508150
508155.10508150.30
NOVA Lite ANA KSL (Mouse Kidney/ Stomach/Liver)
Mouse kidney, stomach and liver tissue substrate slide
1 X 4 well1 X 8 wells
10 X 4 wells30 X 8 wells
508385508380
508385.10508380.30
NOVA Lite Rat Liver/Kidney/Stomach
Rat Liver, Kidney, Stomach IFA slide
1 X 5 wells1 X 10 wells10 X 5 wells
25 X 10 wells
504170504180
504170.10504180.25
IFA Substrate Slides‡
With a comprehensive offering of slide configurations and robust quality standards, Inova stands ready to meet your IFA substrate slide needs.
NOVA Lite® (IFA)
55
* Available Outside The USA Only
‡ Item not part of a kit, analytical and performance characteristics are not established.
NAME DESCRIPTION PACKAGE PART #
NOVA Lite Monkey Esophagus
Monkey esophagus substrate slide
1 X 5 wells1 X 10 wells10 X 5 wells
25 X 10 wells
504145504150
504145.10504150.25
NOVA Lite Monkey Espohagus/Jejunum*
Monkey esophagus/jejunum tissue substrate slide1 X 5 wells
10 X 5 wells504215
504215.10
NOVA Lite Thyroid (Primate)
Primate thyroid tissue substrate slide1 X 4 wells1 X 8 wells
508355*508350
NOVA Lite Adrenal (Primate)*
Primate adrenal tissue substrate slide1 X 4 wells 1 X 8 wells
10 X 4 wells
508375508370
508375.10
NOVA Lite Monkey Cerebellum/Cerebrum Mouse Stomach*
Monkey cerebellum/cerebrum & mouse stomach tissue section slide1 X 5 wells
10 X 5 wells504225
504225.10
NOVA Lite Cerebellum (Primate)*
Primate cerebellum tissue substrate slide1 X 4 wells
10 X 4 wells508357
508357.10
NOVA Lite Cerebrum (Primate)*
Primate cerebrum tissue substrate slide 1 X 4 wells 508362
NOVA Lite Ear (Primate)* Primate ear tissue substrate slide 1 X 4 wells 508358
NOVA Lite GBM (Primate Kidney)*
Primate kidney tissue substrate slide 1 X 4 wells 508345
NOVA Lite Heart (Primate)*
Primate heart tissue substrate slide1 X 4 wells
10 X 4 wells508356
508356.10
NOVA Lite ICA (Primate Pancreas)*
Primate pancreas tissue substrate slide1 X 4 wells1 X 8 wells
10 X 4 wells
508315508310
508315.10
IFA Substrate Slides‡ (continued)
5656
IFA Substrate Slides‡ (continued)
NAME DESCRIPTION PACKAGE PART #
NOVA Lite Lip (Primate)* Primate lip tissue substrate slide 1 X 4 wells 508364
NOVA Lite Liver (Primate)* Primate liver tissue substrate slide 1 X 4 wells 508373
NOVA Lite Monkey Ovary, Testis, Adrenal * Monkey ovary, testis, adrenal tissue section slide1 X 5 wells
10 X 5 wells504220
504220.10
NOVA Lite Ovary (Primate)* Primate ovary tissue substrate slide1 X 4 wells
10 X 4 wells508366
508366.10
NOVA Lite Salivary Gland (Primate)* Primate salivary gland tissue substrate slide1 X 4 wells
10 X 4 wells508367
508367.10
NOVA Lite Sciatic Nerve (Primate)* Primate sciatic nerve tissue substrate slide 1 X 4 wells 508368
NOVA Lite Skeletal Muscle (Primate)* Primate skeletal muscle tissue substrate slide1 X 4 wells
10 X 4 wells508320
508320.10
NOVA Lite Stomach (Primate)* Primate stomach tissue substrate slide 1 X 4 wells 508369
NOVA Lite Testes (Primate)* Primate testes tissue substrate slide 1 X 4 wells 508372
NOVA Lite Urinary Bladder (Primate)* Primate urinary bladder tissue substrate slide 1 X 4 wells 508360
NOVA Lite Peripheral Nerve* Monkey peripheral nerve tissue substrate slide1 X 5 wells
10 X 5 wells504210
504210.10
NOVA Lite Monkey Kidney* Monkey kidney tissue substrate slide1 X 5 wells
10 X 5 wells504240
504240.10
NOVA Lite F-Actin* Rat Intestinal Epithelial Cells
Optimally fixed rat epithelial cell substrate slide 1 X 6 wells 508255
* Available Outside The USA Only
NOVA Lite® (IFA)
‡ Item not part of a kit, analytical and performance characteristics are not established.
57
* Available Outside The USA Only* Available Outside The USA Only
* Available Outside The USA Only** Available upon request with adequate lead time
NAME DESCRIPTION PACKAGE PART #
IFA System Negative Control
IFA System Negative Control - ready to use 1 X 1.0mL 508007
IFA System Negative Control
IFA System Pre-diluted Negative Control - ready to use 1 X 0.5mL 508186
0.5% Evans Blue 0.5% Evan's Blue Stain 1 X 2.5mL 508115
1.0% Evans Blue 1.0% Evan's Blue Stain 1 X 2.5mL 504049
High Contrast Diluent High contrast diluent - ready to use 1 X 25.0mL 508003‡
PBS Concentrate (40X) 40X concentrate of PBS 1 X 25.0mL 508002
PBS II Concentrate (40X) 40X concentrate of PBS (New Formulation) 1 X 25.0mL 508998
Mounting Medium Mounting medium - ready to use1 X 3.0mL 1 X 7.0mL
1 X 10.0mL
508006 508001508005
PVA Mounting Medium Mounting medium polyvinyl alcohol (PVA) - ready to use 1 X 3.0mL1 X10.0mL
504046504047
Urea Buffer* Urea Buffer (as used with the NOVA Lite Monkey Kidney Kit 704240) 1 X 13.0mL 504084
Anti AB Neutralising Reagent *
Anti AB Neutralising Reagent 1 X 5.0mL 504056‡
Coverslips10 coverslips20 coverslips
10 each20 each
508122508112
NAME DESCRIPTION PACKAGE PART #
HEp-2 with DAPI Demonstration Slide
HEp-2 Demonstration Slide. 12 wells/slide pre-stained with antibodies/patterns
1 X 12 wells 518100
HEp-2 Demonstration Slide Actin**
HEp-2 Demonstration Slide. HEp-2 Actin specific 12 wells/slide pre-stained with antibodies/patterns
1 X 12 wells 518090
ANCA with DAPI Demonstration Slide
ANCA Demonstration Slide. 1 Ethanol and 1 Formalin, 2x6 wells 2 X 6 wells 518290
Distal Esophagus Demonstration Slide**
Primate distal esophagus substrate slide pre-stained with antibodies/patterns (pemphigus, pemphigoid, ASMA, endomysial)
1 X 5 wells 518336
NOVA Lite; ANA Plus ** (Mouse Kidney/Stomach)
Mouse kidney/stomach substrate slide pre-stained with antibodies/patterns (ANA homogenous, speckled, nucleolar, dsDNA, negative control, AMA, ASMA, GPA)
1 X 8 wells 518150
Common Components
Demonstration Slides
‡ Item not part of a kit, analytical and performance characteristics are not established.
5858
* Available Outside The USA Only
NAME DESCRIPTION PACKAGE PART #
ANA Homogenous/dsDNA Pattern Control
Pre-diluted human serum antibodies to the cell nucleus and dsDNA 1 X 0.5mL 508181
ANA Speckled Pattern Control Pre-diluted human serum antibodies to the cell nucleus 1 X 0.5mL 508182
ANA Nucleolar Pattern Control Pre-diluted human serum antibodies to the cell nucleus 1 X 0.5mL 508183
ANA Centromere Pattern Control
Pre-diluted human serum antibodies to the cell nucleus1 X 0.5mL1 X 1.0mL
508184504089‡
ANA Scl-70 Pattern Control Pre-diluted human serum antibodies to the cell nucleoli 1 X 0.5mL 508185
ANA Nuclear Dot Pattern Control
Pre-diluted human serum antibodies to the cell nucleus 1 X 0.5mL 508193
ANA PCNA Pattern Control Pre-diluted human serum antibodies to PCNA 1 X 0.5mL 508192
ANA Ribsomal Pattern Control Pre-diluted human serum antibodies to ribosomes in cell cytoplasm 1 X 0.5mL 508195
Autoantibody Control PanelPanel of five vials of pre-diluted controls including ANA Homogeneous/dsDNA Pattern, ANA Speckled Pattern, ANA Nucleolar Pattern, ANA Centromere Pattern and ANA Scl-70 Pattern
5 X 0.5mL 708180
ANA Homogenous Pattern Control
Pre-diluted human serum antibodies to the cell nucleus1 X 0.5mL1 X 1.0mL
508101504054
Homogeneous Pattern ControlPre-diluted homogeneous pattern controls for use with conjugate 504070 or 504088
1 X 1.0mL 504090
ANA Titratable Pattern Pre-diluted human serum antibodies to the cell nucleus 1 X 0.5mL 508171
cANCA Positive Control Pre-diluted human serum antibodies to cANCA antigens1 X 0.5mL1 X 1.0mL
508191 504087
pANCA Positive Control Pre-diluted human serum antibodies to pANCA antigens1 X 0.5mL1 X 1.0mL
508291504086
Atypical ANCA Positive Control Pre-diluted human serum antibodies to aANCA antigens 1 X 0.5mL 508292
Glomerular Basement Membrane Positive Control
Pre-diluted human serum antibodies to GBM1 X 0.5mL1 X 1.0mL
508194504085
dsDNA Positive Control Pre-diluted human serum antibodies to dsDNA 1 X 0.5mL 508211
Gastric Parietal Cell (GPA) Pattern Control
Pre-diluted human serum antibodies to gastric parietal cell 1 X 0.5mL 508190
Yo (Purkinje Cell) Positive Control*
Pre-diluted human serum antibodies to Yo (Purkinje cell) 1 X 0.5mL 504009
Hu ANNA-1 Positive Control* Pre-diluted human ANNA-1 positive control 1 X 0.5mL 504073
IFA Antibody Controls‡
NOVA Lite® antibody controls are designed for use with the NOVA Lite slides. Convenient volumes and ready to use dilutions make these a sensible choice for any laboratory.
NOVA Lite® (IFA)
‡ Item not part of a kit, analytical and performance characteristics are not established.
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* Available Outside The USA Only
NAME DESCRIPTION PACKAGE PART #
IFA System Negative Control Pre-diluted negative control1 X 0.5mL1 X 1.0mL
508186508007
IgG F-Actin Positive Control* Pre-diluted human serum antibodies to F-Actin 1 X 0.5mL 508251
Myelin Associated Glycoprotein Positive Control
Pre-diluted human serum antibodies to MAG (Myelin Associated Glycoprotein)
1 X 0.5mL 504003
Mitochondrial (AMA) Pattern Control
Pre-diluted human serum antibodies to the cell mitochondria1 X 0.5mL1 X 1.0mL
508187504052
Endomysial (Celiac) Positive Control
Pre-diluted human serum antibodies to endomysium1 X 0.5mL1 X 1.0mL
508154504050
Pancreatic Islet Cell Positive Control
Pre-diluted human serum antibodies to pancreatic islet cell 1 X 0.5mL 504005
Skeletal Muscle Positive Control Pre-diluted human serum antibodies to skeletal muscle 1 X 0.5mL 508321
Pemphigoid Positive Control Pre-diluted human serum antibodies to pemphigoid1 X 0.5mL1 x 1.0mL
508331504055
Pemphigus Positive Control Pre-diluted human serum antibodies to pemphigus1 X 0.5mL1 X 1.0mL
508332504051
Smooth Muscle (ASMA) Pattern Control
Pre-diluted human serum antibodies to smooth muscle1 X 0.5mL1 X 1.0mL
508188504053
Thyroid Positive Control Pre-diluted human serum antibodies to thyroid 1 X 0.5mL 508351
IFA Antibody Controls‡ (continued)
‡ Item not part of a kit, analytical and performance characteristics are not established.
6060
NAME DESCRIPTION PACKAGE PART #
FITC IgA Monkey Absorbed Conjugate
Fluorescein labeled anti-human monkey absorbed IgA conjugate 1 X 1.0mL 504016
FITC IgA Conjugate Fluorescein labeled anti-human IgA conjugate 1 X 1.0mL 504034
FITC IgG Conjugate* Fluorescein labeled anti-human IgG conjugate 1 X 1.0mL 504033
FITC IgG Conjugate Primate Absorbed
Fluorescein labeled anti-human monkey absorbed IgG (gamma) conjugate 1 X 1.0mL 504014
FITC IgG (H&L) Monkey Adsorbed Conjugate*
Fluorescein labeled anti-human monkey adsorbed IgG (H&L) conjugate 1 X 1.0mL 504012
FITC IgG (H+L) Conjugate*
Fluorescein labeled anti-human IgG (H+L) conjugate 1 X 1.0mL 504032
FITC IgGAM Conjugate* Fluorescein labeled anti-human IgG, IgA and IgM (H+L) conjugate 1 X 1.0mL 504031
Undiluted Antibody Conjugates
* Available Outside The USA Only
NAME DESCRIPTION PACKAGE PART #
FITC High Sensitivity IgG Conjugate with EB
Fluorescein labeled high sensitivity anti-human IgG conjugate with Evan's Blue
1 X 7.0mL 508126
IgG High Sensitivity Conjugate no EB
Fluorescein labeled high sensitivity anti-human IgG conjugate no Evan's Blue
1 X 15.0mL 504022
FITC IgG (H+L) Conjugate no EB
Fluorescein labeled anti-human IgG (H+L) Conjugate no Evan's Blue 1 X 15.0mL 504021
a HU IgA (Monkey Absorbed) Conjugate
Fluorescein labeled anti-human IgA (Monkey Absorbed) conjugate no Evan's Blue
1 X 7.0mL 504015
FITC IgA Conjugate with EB
Fluorescein labeled anti-human IgA conjugate with Evan's Blue1 X 4.0mL1 X 7.0mL
508152508153
IFA Conjugates‡
Conjugates are arguably the most critical component of the immunofluorescence assay process. The vast menu of NOVA Lite conjugates provides a host of concentrations, specificities and contrast levels to fit individual laboratory needs.
Prediluted Antibody Conjugates
NOVA Lite® (IFA)
‡ Item not part of a kit, analytical and performance characteristics are not established.
61
* Available Outside The USA Only
IFA Conjugates‡ (continued)Prediluted Antibody Conjugates (continued)
NAME DESCRIPTION PACKAGE PART #
FITC IgA Conjugate no EB*
Fluorescein labeled anti-human IgA conjugate no Evan's Blue1 X 7.0mL
1 X 15.0mL504045504023
FITC IgG (H&L) Conjugate
FITC IgG (H&L) chain Conjugate - ready to use 1 X 7.0mL 504072
FITC IgG (H+L) HEp-2 Conjugate no EB
Fluorescein labeled anti-human IgG (H+L) HEp-2 Conjugate no Evan's Blue 1 X 7.0mL 504070
FITC IgG (H+L) Monkey Adsorbed Conjugate no EB
Fluorescein labeled anti-human monkey adsorbed IgG (H+L) conjugate no Evan's Blue
1 X 7.0mL1 X 15.0mL
504011 504071
FITC IgG Conjugate EB Fluorescein labeled anti-human IgG conjugate with Evan's Blue1 X 4.0mL1 X 7.0mL
1 X 15.0mL
508123508125508113
FITC IgG Conjugate no EB Fluorescein labeled anti-human IgG conjugate no Evan's Blue1 X 4.0mL
1 X 15.0mL508124508114
FITC IgG Conjugate Primate Absorbed EB*
Fluorescein labeled primate absorbed anti-human IgG conjugate with Evan's Blue
1 X 7.0mL 508128
FITC IgG (Mky Abs) Conjugate, NEB*
FITC IgG (Monkey Absorbed) Conjugate - ready to use 1 X 7.0mL 504013
FITC IgGAM Conjugate no EB
Fluorescein labeled anti-human IgG, IgA and IgM conjugate no Evan's Blue1 X 4.0mL
1 X 15.0mL508127508117
FITC IgM, no EB FITC IgM Conjugate 1 X 15.0mL 504018
Streptavidin FITC Conjugate*
Streptavidin FITC Conjugate (as used with the NOVA Lite Monkey Kidney Kit 704240)
1 X 3.0mL 504082
a HU IgG (H&L) Monkey Adsorbed Biotin Conjugate
Biotin FITC Conjugate (as used with the NOVA Lite Monkey Kidney Kit 704240)
1 X 3.0mL 504083
‡ Item not part of a kit, analytical and performance characteristics are not established.
62
Conditions of Sale• ORDERS: Orders may be placed by fax or e-mail. Please specify the catalog
number and product description.• SHIPMENTS: All shipping charges will be prepaid FOB San Diego, CA and
added to the invoice. Unless otherwise specified, shipments will be made via Federal Express or UPS. Customers requesting other carriers should specify at the time of order.
• TERMS: All invoices are net 30 days unless otherwise prearranged. All invoices are in U.S. dollars.
• TITLE: Title to the products passes to the customer upon delivery of items ordered to the carrier.
• LOSS OR DAMAGE: Claims for loss or damage of products are the responsibility of the customer and should be reported to Inova at the earliest possible time.
• PARTIAL SHIPMENTS: Inova will make every possible attempt to fill orders promptly and completely. When this cannot be done, we will make partial shipments unless otherwise notified at the time of order confirmation.
• RETURNS: Prior to returning any products, customers must contact Inova technical services for approval. Please provide the reason for the return (ordering error, shipping error, technical problem, etc.). A restocking fee may apply.
• CONDITIONS: Unless otherwise indicated the products listed herein are for ‘in vitro’ diagnostic use only. Nothing disclosed herein is to be construed as a recommendation to use our products in violation of any patents. The information presented is believed to be accurate. However, said information and products are offered without warranty or guarantee since the ultimate conditions of use and the variability of the materials tested are beyond our control. We cannot be responsible for patent infringements or other violations that may occur with the use of these products.
Customer Support
Service is important to us. We believe that we have some of the finest customer service professionals in the industry.
But don't take our word for it – give us a call at +1-800-545-9495 or +1-858-586-9900, email us at [email protected] or visit us at www.inovadx.com for product information.
QUANTA-Lyser, QUANTA Lite, QUANTA Link, QUANTA Flash, NOVA View, NOVA Lite, NOVA Dot are registered trademarks of Inova Diagnostics, Inc. QUANTA CHEK is a trademark of Inova Diagnostics, Inc. BIO-FLASH is a registered trademark of Biokit S.A. DS2 and DSX are registered trademarks of DYNEX Technologies, Inc. © 2016 Inova Diagnostics, Inc. All rights reserved.
63
Technical Assistance/ConsultationOur professional staff is available to answer questions or discuss any aspect regarding the use and interpretation of our products. In addition to our own scientific staff, Inova retains consultants from both the clinical and academic communities. These resources are available to help resolve any unusual cases involving autoimmune disease diagnosis. Email us for assistance at [email protected] or call us at +1-877-829-4745 (U.S. & Canada Only), or + 1-858-805-7950 (Outside the U.S.).
To Order ProductInova Diagnostics, Inc.9900 Old Grove Road San Diego CA, 92131-1638, [email protected] service fax: +1-858-586-9905
US toll free phone: 1-800-545-9495Tel. +1-858-586-9900
Business Hours 6:30 am to 4:00 pm PTMonday thru Friday
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We proudly serve customers in over 90 countries worldwide. For more information on your local distributor please contact Inova Diagnostics at [email protected]
690033 March 2016 Rev. 8
Inova Diagnostics Global Affiliates
Inova Diagnostics, Inc.9900 Old Grove Road • San Diego • CA • 92131-1638Tel. 858-586-9900 • Toll free 800-545-9495 • Fax 858-586-9911www.inovadx.com
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