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CD3200 Hematology AnalyzerAttack Pak

COULTER® HmX™ SystemsHematology Flow Cytometer

Competitive Analysis

Abbott DiagnosticsCompany and Product Overview

Abbott Diagnostics Mission: To improve lives by providing cost-effective health care products and services

Abbott Diagnostics Vision: To be the world's primary source of diagnostic tests. Day-to-day efforts are guided by the following four priorities:

Continually improve the quality of patient care Provide exceptional service to the medical community Create a positive working environment for employees Maintain a healthy growing business

Global Presence: Abbott Laboratories is ranked 133 of Fortune 500 companies, has 56,000 employees

in 150 countries worldwide and revenues of $12.5 billion. Greater than $1 billion per year is devoted to the research and development of

innovative health care solutions in the following areas: Pharmaceuticals Diagnostics Hospital Products Nutrition Chemical and Agriculture

Abbott Diagnostics focused on advances in areas of Immunodiagnostics Hematology Blood Glucose Monitoring DNA testing

Positioning Statement: The goal in diagnostics is to help lower the overall cost of health care by developing

tests and systems that provide early, accurate detection and management of medical conditions.

Hematology Strategy against Coulter: Create the perception that Coulter has "old" technology Position optical counting as being more accurate and precise Use the strength of Abbott Diagnostics products by bundling additional laboratory

products - especially immunoassay Use the strength of Abbott Laboratories by bundling hospital and pharmaceutical

products Use national contracts (eg. Premier)

Product Breadth and Depth:Abbott Cell-Dyn hematology portfolio consists of 6 primary instruments (5 platforms):

Cell-Dyn 1700 Cell-Dyn 3200

© Copyright 1999, Beckman Coulter Inc. All rights reserved. of 18


Cell-Dyn 3500R Cell-Dyn 3700 Cell-Dyn 4000 Cell-Dyn SlideMaker/Stainer (SMS)

The only thing consistent about the Cell-Dyn's platform technology is their inconsistency. For example:

CD 4000 is impedance, optical & fluorescence WOC, RIC, ROC, PIC & POC

CD 3000, 3500, 3700 are impedance and optical WOC, RIC, & PIC (3500, 3700 adds WIC, 3700 also has NIC)

CD 3200 is purely optical WOC, NOC, ROC & POC

CD 1400, 1500, 1600 & 1700 are impedance WIC, RIC, & PIC

However, Abbott effectively uses a the derivative product approach The 3700 is an updated 3500

Abbott's Targets:Abbott's primary targets will be every laboratory performing hematology testing. Their overwhelming presence in the hospital as well as in laboratory (especially immunoassay) combined with the shear number of accounts representatives and specialists means that every account is a potential target. However, the aged base of CD3000's and ABC accounts will have a special emphasis.



SWOT Analysis


StrengthsStrengths Diversified business base with Abbott

Laboratories for stable financial resources & large R&D budget

Large global distribution infrastructure leveraged with Pharma business.

Broad product offering in Immunoassay and Hematology.

Highly successful profitable Immunoassay business.

Participates in fast growing and new market segments. E.g., WBG, DNA probes.

License to amplification and DNA probe market entry. (LCx).

Alliance with Toshiba for Chemistry and Systems manufacturing.

Alliance with PSS (Physician’s Sales &

WeaknessesWeaknesses Reputation with customers as arrogant

supplier. Poor service reputation in Hematology. Poor reputation and low market share in

Clinical Chemistry Systems business. Alliance with Toshiba in Chemistry new. No very high volume solution in

Chemistry. No current solution in Sample-Automation. Cannibalization of higher margin IMx units

with AxSYM

ThreatsThreats Loss of Net Realized Price and associated

profits in IA business due to competitive attacks.

Ability to gain significant market share in Diabetology with current entrenched players.

Development of non-invasive glucose methods.

Loss of large national accounts blood processing business. E.g., American Red Cross.

Outsourcing of Abbott’s Next Generation products to Japanese manufacturer.

Re-entry into highly competitive and entrenched chemistry market.

OpportunitiesOpportunities Leverage distribution infrastructure to add

breadth of IVD products. Leverage distribution channels through

PSS (Physician Sales & Service) for cost containment.

Establish dominant position in European market with Prism before competitors enter market.

Leverage Chemistry alliance with Toshiba for additional bundling power with IA and Hematology.

Leverage increase presence in low volume chemistry testing in emerging markets & alternate site testing-Alcyon analyzer.

Murex acquisition gives increased IA presence in microtiter plate market, international blood banking presence in ROW, and opportunity for rapid HIV testing.


The following table is a modification to information originally presented in CAP TODAY, Dec. 1998. Modifications were made to both the HmX and CD3200 information in the interests of completeness.

Instrument Name COULTER® HmX™ Abbott CD3200

First Yr. Sold 1999 HmX A/L1999 HmX CP

1997

Test Menu/Chartable WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, PLT, MPV, lymph #&%, mono #&%, neut #&%, eo #&%, baso #&%, retic #&%, graded RBC morphology* *Not available on the CD3200

WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, PLT, MPV, neut #&%, mono #&%, lymph #&%, eo #&%, baso #&%

Test Menu/Flags Comprehensive high/low, definitive and suspect messages

Band, blast, variant lymph, IG, NRBC, RRBC, NWBC, FWBC

Tests not available but sub for 510K clearance

MRV, IRF **Not available on the CD3200

N/A

Other tests under development

N/A Retic #, %, IRF

Tests used clinically outside US

PCT, PDW PCT, PDW

Differential method(s) Coulter's 3-D VCS technology M.A.P.S.S.b (Multi-angle Polarized Scatter Separation

WBC method(s) Impedance Dual gated optical scatter

Hemoglobin method Modified Cyanmethemoglobin Cyanide-free colorimetric determination

Red blood cell/platelet method Impedance Hydrodynamic focused flow gated optical

Linearity/WBC count (109/L) 0-99.9 0-250

Linearity/RBC count (1012/L) 0-7.0 0-8

Linearity/Hemoglobin (g/dL) 0-25 0-25

Linearity/MCV(fl)or Hct(%) 50-150 (MCV) 35-180 (MCV)

Linearity/Platelet 0-999 0-1750

Precision/WBC count <2.5% <2.7%

Precision/RBC count <2.0% <1.5%

Precision/Hemoglobin <1.5% <1.0%

Precision/MCV or Hct <2.0% (MCV) <1.0% (MCV)

Precision/Platelet <5.0% <4.0%

Accuracy of automated diff compared with manual diff, per NCCLS H-20A

Lymph%=+3.0%, neut%=+2.0%, eo%=+1.0%, baso%=+1.0%

Neut #&%: >.95, lymph #&%: >.94, mono #&%: >.86, eo #&%: >.84, baso #&%: >.73

Interfering substances/WBC Unusual RBC abnormalities that resist lysing, NRBC, fragmented WBC, any unlysed particle >35 fL, very large PLT

NRBCs, lytic-resistant RBCs, PLT clumps, cryoglobulin & cryofibrinogen, fragile WBCs

Interfering substances/RBC count

Very high WBC, high conc. of very large PLT, auto-agglut

Elevated WBC count, increased nos. giant PLTs, auto-agglut, in vitro hemolysis

Interfering substances/Platelet Very small eryth. Or leuk., or cell fragments may cause no-fit. Chemotherapy may affect certain samples.

WBC frags., in vitro hemolysis, microcytic RBCs, cryoglobs, PLT clumping, increased nos. giant PLTs

Interfering substances: differential

High triglycerides may affect lysing N/A

Number normal ranges for sample comparison

1 Patient limit sets: 6

Throughput/max CBCs/hr 75/hr 70/hr

Throughput/max CBCs & 75/hr 70/hr



Instrument Name COULTER® HmX™ Abbott CD3200diff/hr

Throughput Retics/hr 30 /hr N/A

Microsample capability Yes Yes

Recommended average calibration frequency

2 times/yr. 6 mos verification

Modes calibrated Primary Open &/or closed

Parameters calibrated WBC, RBC, Hgb, MCV, PLT, MPV WBC, RBC, Hgb, MCV, PLT

Recommended frequency of blood controls

Once per shift 2 levels every 8 hrs

Frequency of latex controls Once per day N/A

Min specimen volume open/closed

125 µL/185 µL/50 µL predilute 120 µL/250 µL

Sample dead volume closed 0.5 mL 1 mL (sample loader)

Tube sampling supported Yes Yes

Quality control features/Controls

100 runs/file X-B, SD, CV, Westgard, L-J graphs, Cell-Dyn Series Controls

Quality control features/Patient

Any QC control file X-B, MCV, MCH, MCHC, diff-neut & lymph

Quality control features/Method redundancy

Triplicate Counting WBC optical count (WOC)/nucleated optical count (NOC)

Quality control features/Other XB analysis Internal QC programs

Closed vial controls & disk loading assay values

Yes No

Archives patient data for later comparison

Yes Yes

Max archived data accessible when system on line

5,000 results on line, 1,000 numeric results archived to diskette

10,000 samples

# numeric results saved in memory at any time

5,000 with retics 10,000 (all results)

# graphic results saved in memory at any time

5,000 with retics 10,000 results, with scatterplots & histograms

Performs Delta checks No No

Saved results can be recalled and retransmitted

Yes Yes

How long information is retained

5,000 samples, FIFO 10,000 samples, FIFO

Histogram/cytogram results stored

Yes Yes

Saved data can be sorted for reprocessing or report transmission

Yes Yes

Data management capability integrated

Yes Yes

Size of patient medical record field

12 characters 12 characters

Tags and holds result for follow up or confirmatory test or rerun

Yes No

Parameters for flags for User & vendor N/A



Instrument Name COULTER® HmX™ Abbott CD3200holding samples defined by

When results held for follow-up, some can be transmitted others held

Yes, through a selective batch process Yes

Bi-directional interface capability

Yes Yes

Bar code symbologies Codabar, Code 39, Code 128, Interleaved 2 of 5, NW-7

Codabar, Code 39, Interleaved 2 of 5

Scattergram display: Cell-specific color

4 colors/cell types Yes

Histogram display: color with thresholds

Colors without thresholds Yes

Choice of specimen and/or result info displayed

Yes Yes

Prepares micro slides auto or flags problems for slide prep

Yes Yes

Interfaces to auto lab transportation system

No Yes

Accessories available N/A Yes

Units installed in US/outside US/list price

$135,000 A/L/$120,000 CP >250/>400/$155,000-$165,000

Acquisition program based on cost-per-reportable result

Yes Yes

Complexity rating/510(k) status

Moderate/Cleared Moderate/Cleared

Differential sample stability (RT)

Up to 24 hours 8 hours

Auto start load and walkaway Yes - SmartStart™ No

Maintenance Zero daily routine maintenance Extensive

Point of aspiration positive bar code ID

Yes No

Integrated autoloader and bar code reader

Yes No

Immediate STAT Yes No


AbbottSo they say . . . : COULTER® HmX vs. CD3200

What Abbott is saying:

It’s amazing how often people are prepared to accept things at face value from our competitors, but seldom from us. Why is that? It’s probably that we haven’t given you the right information – this section addresses the issue. No claim from a competitor should be left unchallenged. We must place the burden of proof back on them, for if we allow the claim to stand, we ADD to its credibility.

Abbott says… Truth is…Laser technology is new and exciting- Coulter has old technologyTarget: Pathologists, Lab Managers

Yes, the CD3200 is laser based for counting and sizing. However, the Coulter TPS (Two Population Sorter marketed in Europe by Coulter) was the first instrument to utilize laser light scatter. Even Ortho used this technology in the ELT8 back in 1980. So the use of a laser is neither new or exciting. The newest technology introduced to the market was in 1987 - when Coulter introduced the VCS. Coulter has always used advanced and proven technologies to perform CBCs and differentials. The funny thing is, Abbott seems to be just realizing this. How do we know? Just take a look at their new CD3700 brochure - it refers to two advanced technologies, that of proven impedance and high resolution flow cytometry.

Cell-Dyn 3200 has a more accurate WBC count and differential Target: Lab Manager, Technologists

Abbott says their WBC is better because they use two independent laser counts (WOC and NOC). The HmX uses three independent impedance counts (triplicate counting) - the reference method for counting and sizing particles. However, the one thing that is true is that the WBC linearity range on the CD3200 is higher than the HmX. Abbott also states that it has no interference from NRBCs or non WBC (eg. Platelet clumps) and automatically corrects for NRBCs. The reality is that the CD3200 does have interference and flags for NRBCs, NWBCs and RRBCs (see reference material - CD3200 Flags). If the flag is present, the operator is told to Review stained smear. So much for no interference! (By the way - if you have a difficult time finding the flag - it is located next to the MONO%). As for the automatic WBC correction, this is based on the % of cells below the WBC threshold on the 00/100 scatter plot (the region for stroma). (see reference material - CD Scatter Plots) Can you really assume that all cells are NRBCs, or that all fall below the threshold? The obvious potential is for over or under correction of the white count. The phrases "no interference" and automatic correction of NRBCs" sounds good, but if the technologist still has to review the smear and check the histogram - where is the actual time saving or benefit to the customer?

AbbottSo they say . . . : COULTER® HmX vs. CD3200

Coulter has too many flagsTarget: Lab Manager, Technologists

The old technology story isn't working any more, so Abbott has changed tactics. Now they are attacking the flags on the HmX. The reality is that the CD3200 has a multitude of flags - both Suspect Parameter and Suspect Population Flags (see reference material - CD3200 flags). However, the flags show up in interesting places. For example, Platelet flags indicating interference either in the upper or lower threshold region (URI or LRI flags) tell the customer to Review stained smear. However, the flag will be displayed next to the MPV result, not next to the PLT result. Also, watch out for the DFLT flag - this flag will use a default value or threshold to determine the 5-part diff if the CD3200 cannot reliably discriminate between cell clusters.

Of course the CD 3200 performs retic counts.Target: Lab Manager, Technologists

This is an interesting statement that has also recently surfaced. There have been several cases where the Abbott sales reps puts the burden of proof that the CD3200 doesn't do retics back on the Beckman Coulter sales rep. Review their literature - there is no place that documents that the CD3200 can run retics.

You only need 1 box of controls per monthTarget: Lab Manager, COO

Most quotes from Abbott provide for only 1 box of controls per month. The control is packaged 12 x 3 mL. Controls should always be run in the same mode as the patient sample, typically the primary - or the closed vial mode. So if you have a CD3200, you would run the control in the closed vial mode. Abbott states the frequency of controls is 2 levels every 8 hours (see CAP Comparisons). The CD3200 sample loader requires 250 µL of sample and has a 1 mL dead volume. If you work the math, that means each bottle has a maximum of 8 aspirations (3 mL - 1 mL (dead volume) = 2 mL. 2 mL / 250 µL = 8) With 4 bottles of each level that means a maximum of 32 aspirations per level per pack a month. That's only enough to run each level 1x per day, not the two that is required.

The HmX is just another MAXM and if the MAXM is such a reliable instrument, why is it being discontinued.Target: All

The MAXM is, by far, the most successful 5-part diff analyzer ever developed. Why was it so successful? Reliability, ease of use and quality of results to start. The HmX is a proud derivative of the MAXM, built upon that solid platform and made even better! Abbott is just trying to confuse the market once again with their lies, half truths and their lack of knowledge - the MAXM isn't being discontinued!!!

AbbottWinning against Abbott: COULTER® HmX vs. CD3200

Winning Strategies:

FOCUS ON PROVEN TECHNOLOGIES 1. Impedance counting (the Coulter Principle) combined with VCS technology provides the

most accurate CBC and differential. VCS technology uses three simultaneous measurements to examine over 8,000 cells in their near native state to give you the most accurate differential. Abbott also appears to agree with the combination of impedance and flow cytometry as being the best - just look at their CD3700 brochure. They refer to "two advanced technologies" - proven electronic impedance with high resolution flow cytometry - required to produce "accurate results"!

FOCUS ON THE TRUTH 1. Review the CD3200 flags and educate the customer to the reality of no interference from

NRBC,NWBC and RRBC. Point out that these situations do require operator intervention, and will slow down workflow while requiring additional labor.

2. Reinforce that Beckman Coulter is focused on R & D - especially in the area of Cellular Analysis. Three new products have been released this year alone (AcT diff2, HmX and GenS System 2) and our pipeline is full.

3. Put the burden of proof back on the Abbott representative. You have documentation for your products, make them show documentation for their claims.

FOCUS ON APPARENT MISDIRECTION 1. Does the customer think the CD3200 doesn't flag many samples? Maybe they just aren't

looking in the right place! The corrective action for the flags is the same whether it is a suspect parameter or suspect population flag - Review a stained smear. (reference CD3200 flags)

2. Review the PLT flags and point out that they are actually next to the MPV result.3. Review Suspect Parameter Flags and discuss the DFLT (default) flag. If the CD3200 can't

discriminate between abnormal cell clusters it will assign a default value or threshold to determine the 5-part diff. Guess where the flag is located - next to the BASO% result!

4. No interference from NRBC, non WBC or Resistant RBC? Guess again. The flag is located next to the MONO% result, and the corrective action is once again to Review stained smear.

FOCUS ON THE QUALITY 1. The HmX is derived from the most successful selling 5-part diff analyzer ever developed and

retains the qualities that made it ideal for the mid range market. 2. Beckman Coulter service and support is still number one in the industry.

AbbottWinning against Abbott: COULTER® HmX vs. CD3200

FOCUS ON COMPATIBLE PLATFORMS 1. The GenS System 2, HmX, STKS and MAXM all use the same common platform for CBC

and differential analysis - the Coulter principle and VCS technology. Therefore, results will be consistent whether the sample is run at a core laboratory, STAT lab or main lab.

HAVE THE CUSTOMER ASK FOR A COMPLETE CUSTOMER REFERENCE LIST: 1. The number of unsatisfied customers is growing. Lot’s of downtime, performance issues and

growing support issues.

AbbottWinning against Abbott: Maintenance for the Cell-Dyn 3200

At first glance, the Cell-Dyn 3200 doesn't appear to have much in the way of scheduled maintenance (Even though it's more than the HmX with Zero Daily Routine Maintenance):

CELL-DYN 32001

MAINTENANCE LOGDaily Run Auto-Clean

Clean Aspiration NeedleClean Tower

Weekly Clean Sample LoaderClean Exterior of Aspiration ProbeClean Sample Pump Tubing

Monthly Clean Fan FiltersRun Extended Auto-Clean

Semi Annual Clean Printer

Review the "Non Scheduled" maintenance list. If the task is on this log sheet, it must be required with some frequency. Find out what the real recommendations are.

Non Scheduled Clean Shear ValveClean Interior of Aspiration ProbeUnclog Aspiration ProbeClean Interior of Aspiration NeedleUnclog Aspiration NeedleClean Sample Injection SyringeClean WBC Lyse SyringeClean HGB Lyse SyringeClean Diluent/Shealth SyringeClean HGB Flow CellClean Bar Code Reader WindowClean Reagent LinesReplace Aspiration ProbeReplace Aspiration NeedleReplace Tubing in Transfer PumpReplace Tubing in NC ValvesReplace Sample Injection SyringeReplace WBC Lyse SyringeReplace HGC (sic) Lyse SyringeReplace Diluent/Shealth SyringeReplace FusePrepare for Shipping/Non-UseCalibration (we know this is at least twice a year)

1 CELL-DYN® 3200 Operator's Manual November 1997

AbbottWinning against Abbott: Reference Materials

Competitive Quotations

Abbott is being extremely aggressive in their pricing trying to place the CD3200. Typically, there is an additional discount offered on the AxSYM reagents. For Example:

Net Monthly Payment w/ FMV buyout

Service (Extended hours)**

Reagents for 30 CBC/day

(includes 1.5 boxes of

controls/mo)

Total monthly payment

CD 3200 CS* $50,059.00 $959.00 $798.75 $670.20 $2,427.95CD 3200 SL* $60,145.00 $1,175.84 $854.59 $670.20 $2,700.63*with trade-in of CD3000**Extended hours are 8:30 am - 11: pm, 8:30 am - 5:00 pm weekends, holidays

GSA cost = $2200/mo on CD3200 SL, 20 CBC's/day

Net Monthly Instrument Payment

Service Reagents (45 CBC's/day)

Total monthly payment

CD 3200 CS* $45,000 $928.00 $632.00 $623.00 $2,182.00

PLUS: $4,000 in AxSYM reagents (discount applied on a per box basis)

*CS quoted, SL promised

ABBOTT SERVICE DEFINITION

Business Hours Coverage is defined as Monday-Friday 8:30am - 5:00pm excluding holidays. Any service performed outside of the agreement will be billed on a "Time and Material" basis.

Service Agreements include: All travel, labor, and part costs associated with the maintenance and repair of the instrument. These services will be performed within the stated hours of the agreement.

Service Agreements do not include: instrument relocation, shutdown and reinstallations, instrument damage due to customer neglect, acts of God, improper line voltage or power, and improper operating environment. Any services performed for these and related items will be billed on a "Time and Material" basis.

How can you have 1.5 boxes of controls per month?


CD3200 Flags1

Suspect Parameter FlagsThese flags are generated after the instrument evaluates the measured data for a particular parameter or group of parameters. The result may be suspect due to interfering substances or the inability of the instrument to measure a particular parameter due to a sample abnormality.

WBC FlagsFlag Where

displayedCause Interference Action

WBC Next to the WBC result

WBC result exceeds the expected limits and one or both of the following conditions:1. A declining kinetic rate was

detected for WBC (Just like the CD3000!)

2. More than 10% of the WBC count was located in the stroma region

This situation is typically caused by lytic-resistant RBCs interfering w/ the WBC measurement

Repeat the specimen using the resistant RBC lyse cycle to eliminate interference caused by lytic-resistant RBCs. If WBC flag persists, review a stained smear for the presence of NRBCs and verify the LYM and WBC values.

DFLT (NLMEB) (Default - subpopulation)

Next to the BASO%

1. A default value or threshold was used to determine the 5-part diff. This is typically due to the presence of abnormal cell clusters that the instrument cannot reliably discriminate between. Therefore a default threshold is selected. The flag may also be caused by an abnormally low number of cells in a specific population.

2. A declining kinetic rate for WBC

Examine a stained smear to verify the differential values for the subpopulations identified by the descriptive information.


PLT Flags

Flag Where displayed

Cause Interference Action

LRI (Lower region inter-ference)

Next to the MPV result

Interference in the lower threshold region (1-3 fL) is > a predetermined limit

Generally non-biological interference. Debris (Flowcell) Contaminated reagent Microbubbles

Check the background count. If within limits, repeat the specimen. If flags persists, review a stained smear and verify the PLT count.

URI (Upper region inter-ference)

Next to the MPV result

Interference in the upper threshold region (15-35fL) is greater than a predetermined limit.

Generally biologic interference caused by: Microcytic RBCs Schistocytes Giant platelets Sickle cells Platelet clumps

Review the MCV and the PLT histogram. If the MCV is low and/or the histogram indicates an overlap in the RBC and PLT populations, review a stained smear to determine the cause and confirm the PLT count.

Suspect Population FlagsThese flags are generated when the instrument's evaluation of the measured data for a particular parameter or group of parameters indicates the possible presence of an abnormal subpopulation

A stained smear should be reviewed whenever a suspect population is present

WBC FlagsFlag Where


Band

Next to the NEU%

1. Count in region of scatter (on the 00/100 plot) where bands are typically located is >12.5% of the total WBC count

2. Ratio of suspected bands to mature neutrophils in >50%

3. CV of neutrophil cluster on the 00 axis exceeds expected criteria

Bands

Review stained smear

IG Next to the NEU%

Count in region of scatter (on the 00/100 plot) where immature

Immature Granulocytes



WBC FlagsFlag Where


granulocytes are typically located is >3% of the total WBC count

Blast

Next to the LYM%

1. The count in the region of scatter (on the 900/00 plot) where blasts are typically located is >1% of the total WBC count

2. The MONO% is >20% of the total WBC count

3. The MONO% is >3% of the total WBC count and the S.D. of the monocytes on the 00 axis exceeds expected criteria

Blast


Variant LYM

Next to the LYM%

The position, density or CV of the lymphocyte cluster on the 00/100 scatter plot exceeds expected criteria

Variant Lymphs Review stained smear

NWBC (Non-White Blood Cells

Next to the MONO%

1. A non-WBC population is present in the N1 region below the dynamic WBC threshold on the 00/100 scatter plot

2. The count in the N1 region is > 2.9% of the total WBC

Low levels of NRBCs Unlysed RBCs PLT clumps Giant PLTs


FWBC (Fragile WBC)

Next to the MONO%

Presence of fragile WBCs is suspected

Fragile WBCs Rerun sample w/ Fragile WBC selected as sample type Review stained smear

NRBC (nucle-ated RBC)

Next to the MONO%

1. WBC result exceeds expected limit

2. The count in the area below the WBC threshold on the 00/100 scatter plot is >2.9% of the total WBC

Nucleated RBCs

Review stained smear. If NRBCs are present, they should be quantified. Correction is not necessary.If WBC flag is displayed with NRBC flag, rerun specimen using Resistant RBC cycle

RRBC (Resis-tant

Next to the MONO%

The presence of lyse-resistant RBCs is suspected

Lyse resistant RBCs

Rerun specimen using Resistant RBC cycle.


WBC FlagsFlag Where


RBCS)

If WBC flag is displayed review a stained smearVerify WBC value by an alternate method

RBC Flags



RBC MORPH

Next to the HCT result

One or more of the following parameters exceeds expected limits:MCV < 80 fL or > 100fLMCH < 25 pg or > 34 pgMCHC < 29 g/dL or > 37 g/dLRDW > 18.5%

Review a stained smear for abnormal RBC or PLT morphology

PLT Flags



No MPV result displayed (data suppressed)

The PLT histogram did not meet expected criteria (non-log normal distribution)

Review a stained smear for abnormal PLT morphology or presence of PLT aggregates. Verify the platelet count.

1 CELL-DYN® 3200 Operator's Manual November 1997


CELL-DYN Scatter Plots

This is the typically scatter plot displayed and printed showing "size vs complexity"- It's easy to see why the scatter plot is in color- Cell separation details are lost in black and white

Scatter plot with thresholds lines for cell types. Notice "stroma" area where all NRBCs, NWBCs and RRBC are supposed to be.

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