Westergren: The gold standard or not to be - Sysmex UK...

Sysmex Customer User Days:

Westergren: The gold standard or

not to be

Whittlebury Hall, November 2016Joost Spelt +31615892659 [email protected]

Copyright © 2016 RR Mechatronics 1

Masters of Measurement

RR Mechatronics Profile

Copyright © 2014 RR Mechatronics 217-2-2016 RR Mechatronics :only for Internal Use

RR Mechatronics

• RR Mechatronics established 1986– Zwaag Amsterdam, (The Netherlands), Warwick (RI, USA)

– 60+ employees, 250 associates

• Medical Technology company with focus on hematology– ESR, RBC-analyzer, hematology related instruments (RPU/RPI)

• R&D, assembly & testing in house– 25% of employees R&D Engineers

– Strong focus on innovation

– Important research & industry cooperations

• Worldwide sales & service– Exclusive distributors

– Certified service engineers

– +250 associates


http://rrmechatronics.com/rr-mechatronics/news-events/gazellenawards

http://rrmechatronics.com/rr-mechatronics/news-events/gazellenawards

Product Developments


Starrsed TL

17-2-2016 RR Mechatronics :only for Internal Use

Starrsed Control & EQAS

The defined gold standard

Westergren ESR without compromise



Erythrocyte Sedimentation Rate

Measurement of erythrocytes settlement over a course of time

• General condition indicator

• Non-specific marker of inflammation

• Serves as a guide to diagnosis

• Sedimentation influenced by plasma proteins

Normal Erythrocytes Inflammation



Sedimentation process

Sedimentation process divided in 3 stages

1. Lag stage-rouleaux formation 10 min

2. Decantation stage sedimentation 40 min

3. Packaging stage 10 min

Start ESR Lag stage-rouleaux Decantation stage Packing stage


ESR Measurement


Westergren = ESR Gold standard

• 2011 confirmation & definition Reference Method for ESR being

Westergren

• 1897 principle invention by Edmund Biernacki

• 1918 Fåhræus & Westergren added sodium citrate-anti-coagulation (minimizing Hct influence)

• 1987-to date: Starrsed uniquely offers automated ESR according

Westergren gold standard


Westergren:

The gold standard that other ESR techniques are

evaluated against!


Reference Method ESR


Confirmation and definition Reference Method¹ for ESR being

Westergren:

•Glass pipette with a bore of 2.55 mm

•Blood column of 200 mm

•Blood diluted in a ratio of 4:1

•Glass pipette perfectly vertical placed

•No direct sunlight , drafts and vibrations

•18ºC - 25ºC during sedimentation

•Westergren test performed in 30/60 minutes

CLSI Procedures for the Erythrocyte Sedimentation Rate Test: Approved Standard-Fifth Edition; CLSI document H02-A5, Wayne PA:, Clinical and Laboratory Standards Institute; 2011ICSH review of the measurement of the erythocyte sedimentation rate, 2011 International Journal of Laboratory Hematology


ESR is a useful test!

ESR is a screening test plus a very useful test in all hereafter

mentioned disorders.

• Diagnostic tool

– Elevated ESR supports the diagnosis

• Monitoring disease activity

– Clinical improvement

– Referral to specialist

• Response to therapy

– Change in dosage

• Prognostic factor

– Unfavorable prognostic sign


The defined gold standard

Fully automated ESR instruments (EDTA)



Instruments

Working directly with standard EDTA tubes

•Image comparison: – working principle: image comparison

• Sudden stop: – working principle: aggregation sudden stop

• RR Mechatronics Starrsed instrument range–working principle: Westergren “Gold Standard”



Correlation Image Comparison

Conclusion:Ves-Matic Cube 200 method showed a higher correlation and a lower bias than the iSED device when compared with Westergren

reference method These instruments should be carefully monitored. Journal of Clinical Laboratory Analysis 00: 1–6 (2014) Nihal Bogdaycioglu

et al

False Positives

False Negatives


Correlation 3/3


Conclusion:There is a weaker correlation shown with the Alifax, which might be

caused by the fact that the Alifax method for determination of the

ESR is based on capillary photometry technology in which data are

converted into Westergren values (5).

Ned Tijdschr Klin Chem Labgeneesk 2013; 38: 149-150 Mg Schoorl

Conclusion:

iSED sedimentation showed a poor correlation and a high bias (>10%)

with the Westergren method. These instruments should be

carefully monitored Journal of Clinical Laboratory Analysis 00: 1–6 (2014)

Nihal Bogdaycioglu et al

False Negatives

False Positives

False Negatives

False Positives


ESR Method Comparisons

ESR standards Starrsed Diesse:Image

Comparison

Alcor:Sudden Stop & Yth

Alifax:Sudden Stop

ESR Westergren ✔ ✖Calculated

✖Calculated

✖Calculated

EDTA - tube blood ✔ ✔ ✔ ✔

Blood dilution 4:1 ✔ ✖ ✖(Hct correction)

✖(Hct correction)

Glass pipette ✔ ✖ ✖ ✖

Correlation with Westergren

✔ ✖ ✖ ✖

Kahler / Multiple myeloma

✔ ✔ ✖ ✖


¹ Procedures for the Eryhrocyte Sedimentation Rate Test: H02-A5 vol. 31 No. 11² ICSH review of the measurement of the erythocyte sedimentation rate december 2010


Non Westergren risks:

In case the ESR is not determined using the Westergren gold

standard, risks increase:

False Positives: A too high sedimentation rate is reported

• Unnecessary time and money is spent to confirm diagnosis

of healthy patient.

False negatives: A too low sedimentation rate is reported

• Medical personnel is not receiving the right information for

diagnostic - and treatment purposes. Patient is

unnecessarily at risk.


The Gold standard or not to be

• Westergren is by far the largest volume of ESR tests, and is a

very affordable marker for inflammation

• In no instance a test method should be misguiding

• Results should be commutable with the gold standard


Whitepaper Westergren

• Reference method

• CLSI& ICSH

• Always clarity interpretation of

measurements

• No false positives

• No false negatives

• RR Mechatronics Starrsed

– Single tube Starrsed ST

– Rack Starrsed RS

– Track Starrsed TL

Starrsed Interliner


Gold Standard ESR

Starrsed Range


Starrsed RL / Interrliner

• Westergren gold standard

• Max. load 200 samples or integrated in Sysmex-XN

• Lowest TCO

• EDTA blood. No disposables.

• Max. cap/hour 140/240/375

• Sample stability 24 hours

• Fully automated daily maintenance

• Bi-directional LIMS communication


Starrsed TL


• Lowest TCO

• EDTA blood; no disposables

• TLA track connected (all brands)

• All functions integrated

• Max. capacity/hour 140

• Hazy sample reporting





Starrsed RS


• Lowest TCO


• Max. load 60 samples

• Table top







Starrsed ST


• Lowest TCO


• Small footprint

• Table top






Lorrca MaxSis Ektacytometer


RBC analyzer used for

•Deformability

•Osmotic stress

•Aggregation

Research & Diagnosis

• Hereditary membrane disorders• Ovaloctosis, Stomacytosis

• Hereditary hemoglobin disorders• Sickle cell anemia, Thalassemia

• Predictive organ failure• Sepsis, Diabetes, Obesities

• Blood storage and treatment

• Medicine development


Thank you very much for your attention!

We are here to partner with you.


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Westergren: The gold standard or not to be - Sysmex UK...

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