innovation in immunodiagnostic testing - fujifilm · immunodiagnostic analyzer of high reliability...

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Analyzer Specifications Dimensions (W x D x H) Weight Operating temperature Setup time Required sample volume Data memory Cartridge information 238 x 326 x 310 [mm] Approximately 7 kg 15℃ - 30℃ 59° F - 86° F3 min basic test : 100 μL dilution test : 20 μL 100 tests Information about test parameters is embedded in the QR code attached to the cartridge. Reagent Cartridges Specifications Types of sample Dynamic Range Package Unit Measurement time Reagent Storage v-T4 vc-TSH v-COR v-BA v-T4 vc-TSH v-COR v-BA 10 cartridges/box Approximately 10 min (without dilution) : Canine and Feline Plasma/Serum : Canine Plasma/Serum : Canine Plasma dilution/Serum : Canine and Feline Plasma/Serum : 0.50 - 8.00μg/dL 6.4 - 103.0 nmol/L: 0.25 - 5.00 ng/mL : 1.0 - 30.0 μg/dL 27.6 - 828.0 nmol/L1.0 - 50.0 μg/dL 27.6 - 1380.0 nmol/L)(with dilution: 2.0 - 150.0 μmol/L 2℃ - 8℃ 35.6° F - 46.4° F26-30, NISHIAZABU 2-CHOME, MINATO-KU, TOKYO 106-8620, JAPAN http://www.fujifilm.com/products/medical/ Ref. No. FDCAU10V R(17·11·F1079·F8598) Printed in Japan ©2011 FUJIFILM Corporation This equipment complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice No. 50, dated (June 24, 2007). This equipment is a Class 1 laser product (designed according to IEC60825-1:2014 / EN60825-1:2014) Options Sample barcode reader Printer Automated Fluorescence Immunoassay Analyzer Innovation in Immunodiagnostic Testing Bile Acid Test v-BA Top Front Side IMMUNO AU10V DRI-CHEM analyzers (NX500, FDC4000, FDC7000) FUJI PLAIN/HEPARIN TUBE and FUJI DRI-CHEM AUTO TIPS can be used in both systems. System Configuration Diagram W 238 mm D 326 mm 100 mm 100 mm W 238 mm H 310 mm D 326 mm H 310 mm 100 mm DIMENSIONS NEW

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Analyzer SpecificationsDimensions (W x D x H)

Weight

Operating temperature

Setup time

Required sample volume

Data memory

Cartridge information

238 x 326 x 310 [mm]

Approximately 7 kg

15℃ - 30℃ (59°F - 86°F)3 min

basic test : 100 µLdilution test : 20 µL

100 tests

Information about test parameters is embedded in the QR code attached to the cartridge.

Reagent Cartridges SpecificationsTypes of sample

Dynamic Range

Package Unit

Measurement time

Reagent Storage

v-T4vc-TSHv-CORv-BA

v-T4vc-TSHv-COR

v-BA

10 cartridges/box

Approximately 10 min (without dilution)

: Canine and Feline Plasma/Serum: Canine Plasma/Serum: Canine Plasma(dilution)/Serum: Canine and Feline Plasma/Serum

: 0.50 - 8.00μg/dL(6.4 - 103.0 nmol/L): 0.25 - 5.00 ng/mL: 1.0 - 30.0 μg/dL(27.6 - 828.0 nmol/L) 1.0 - 50.0 μg/dL(27.6 - 1380.0 nmol/L)(with dilution): 2.0 - 150.0 μmol/L

2℃ - 8℃ (35.6°F - 46.4°F)

26-30, NISHIAZABU 2-CHOME, MINATO-KU, TOKYO 106-8620, JAPANhttp://www.fujifilm.com/products/medical/ Ref. No. FDCAU10V R(17·11·F1079·F8598) Printed in Japan ©2011 FUJIFILM Corporation

This equipment complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice No. 50, dated (June 24, 2007).This equipment is a Class 1 laser product (designed according to IEC60825-1:2014 / EN60825-1:2014)

Options

Sample barcode reader Printer

Automated Fluorescence Immunoassay Analyzer

Innovation in Immunodiagnostic Testing

Bile Acid Testv-BA

Top

Front

Side

IMMUNO AU10V DRI-CHEM analyzers (NX500, FDC4000, FDC7000)

FUJI PLAIN/HEPARIN TUBE and FUJI DRI-CHEM AUTO TIPScan be used in both systems.

System Configuration Diagram

W 238 mm

D 326 mm

100 mm

100 mm

W 238 mm

H 310 mm

D 326 mm

H 310 mm100 mm

DIMENSIONS

NEW

Perform automatic measurements simply by inserting a tube (for samples), a tip (for sampling and injection), and a cartridge (reagents), and press the START key!

Simple 2 - step procedure

AU10V has an automatic dilution function for v-COR measurements to accommodate serum samples with high cortisol levels. (Plasma samples are to be measured in dilution mode regardless of cortisol level.)

Automatic Dilution Function

All reagents and materials are already prepared inside the cartridge.

No need to add reagents.

All calibrations and measurements are conducted automatically based on the QR code* attached to the bottom of the cartridge, which eliminates the need for lot calibration.

Automated calibration for reagents using attached QR code

1.5 mL or 0.5 mL sample tube can be used, allowing flexibility when collecting bloodsamples in accordance with the measurement situation.

Flexibility in selecting the most appropriate sample tube (1.5 mL or 0.5 mL)

Top

Bottom

Workflow Time

Measurement completedand results displayed.

Fully automated measurement in approximately 10 min!

Insert materials.1

Press the START key.2

Easy To UseEasy To Use

“QR code” is a registered trademark of DENSO WAVE INC.

FUJI DRI-CHEM IMMUNO AU10VA new in-clinical Immunodiagnostic Analyzer realized by FUJIFILM’s cutting edge technologiesFUJIFILM's new Surface Plasmon enhanced Fluorescence (SPF) technology has brought about a compact sized Fluorometry Immunodiagnostic Analyzer of high reliability and accuracy. Ideal for in-clinic immunodiagnostic testing.

Real time diagnosis and monitoring for endocrineand liver diseases made possible.

Test Parameter

v-T4(Thyroxine (T4) )

vc-TSH(Thyroid-Stimulating Hormone)

v-BA(Bile Acids)

Purpose

Screening and diagnosis for Hypo/Hyperthyroidism

Diagnosis for Hypothyroidism

v-COR(Cortisol)

Diagnosis for Addison’s Disease and Cushing’s Syndrome

Screening for liver diseases and diagnosis for portosystemic shunt

Reagent Cartridges Specifications

v-T4

vc-TSH

v-COR

v-BA

NEW

Principle of the system

TechnologyTechnology

High ReliabilityHigh Reliability

Fluorescent beads

AntigenAntibodyThin gold film

Sample Injection Fluorescence MeasurementLaser Beam IrradiationBinding ReactionThe sample, which is mixed with the reagent, will be dispensed into the sample flow channel of the cartridge.

The analyte binds with the antibody, which will be attached to the thin gold film.

A SPR is generated upon irradiation by the laser beam.

The fluorescent intensity, which is commensurate with the level of analyte concentration, is detected.

Reagent Cup

• The equipment performs fluorometry using Surface Plasmon enhanced Fluorescence(SPF), a technology based on Surface Plasmon Resonance (SPR), within a small cartridge. • SPF has two major advantages which made the realization of a compact sized immunodiagnostic analyzer.• First advantage is it does not require a washing process for surplus fluorescent beads, thus the mechanical process of the equipment is simple. • Second, since the fluorescence is enhanced by SPR, a low power beam is sufficient enough to generate substantial fluorescence intensity for detection.

AU10V Key FeaturesAU10V Key Features

New test parameter: v-BA (canine and feline)

PLASMA samples measurable in all tests

FELINE samples measureable in v-T4

・The only bench top analyzer with TSH test

・Easy to use

・Approximately 10 min measurement

Excellent correlation with standard laboratory analyzerAU10V provides reliable and accurate results. It has excellent correlations with its comparison methods in serum samples.

AU10V can also accurately measure PLASMA samples as shown in the good correlations of serum and plasma.

NEW

NEW

NEW

v-T4 Caniney = 1.034x - 0.002r = 0.967n = 92

CLEIA (µg/dL)

AU10

v-T

4 (µ

g/dL

)

v-T4 Feliney = 0.965x + 0.024r = 0.962n = 90

CLEIA (µg/dL)

AU10

v-T

4 (µ

g/dL

)

v-T4 Caniney = 0.984x - 0.129r = 0.996n = 60

AU10V v-T4 Serum (µg/dL)

AU10

V v-

T4 P

lasm

a (µ

g/dL

)

vc-TSH Caniney = 1.041 x - 0.019 R = 0.991n = 50

AU10V vc-TSH Serum (ng/mL)

AU10

V vc

-TSH

Pla

sma

(ng/

mL)

v-T4 Feliney = 1.005x - 0.003r = 0.997n = 57

AU10V v-T4 Serum (µg/dL)

AU10

V v-

T4 P

lasm

a (µ

g/dL

)

v-COR Caniney = 0.996 x + 0.824 r = 0.994n = 24

AU10V v-COR Serum (µg/dL)

AU10

V v-

CO

R Pl

asm

a (µ

g/dL

)

vc-TSH Caniney = 0.941x + 0.077r = 0.983n = 72

CLEIA (ng/mL)

AU10

V vc

-TSH

(ng/

mL)

v-COR Caniney = 0.999 x + 0.285r = 0.963n = 125

CLEIA (µg/dL)

AU10

V v-

CO

R (µ

g/dL

)

v-BA Caniney = 0.987x - 0.537r = 0.998n = 53

AU10V v-BA Serum (µmol/L)

AU10

V v-

BA P

lasm

a (µ

mol

/L)

v-BA Feliney = 1.039x - 0.714r = 0.999n = 50

AU10V v-BA Serum (µmol/L)

AU10

V v-

BA P

lasm

a (µ

mol

/L)

v-BA Caniney = 0.970x - 0.600r = 0.960n = 53

Enzymatic Method (µmol/L)

AU10

V v-

BA (µ

mol

/L)

v-BA Feliney = 0.933x + 0.643r = 0.967n= 62

Enzymatic Method (µmol/L)

AU10

V v-

BA (µ

mol

/L)