Sysmex Customer User Days:
Westergren: The gold standard or
not to be
Whittlebury Hall, November 2016Joost Spelt +31615892659 [email protected]
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Masters of Measurement
RR Mechatronics Profile
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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
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Product Developments
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Starrsed TL
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Starrsed Control & EQAS
The defined gold standard
Westergren ESR without compromise
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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
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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
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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
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Westergren:
The gold standard that other ESR techniques are
evaluated against!
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Reference Method ESR
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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
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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
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The defined gold standard
Fully automated ESR instruments (EDTA)
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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”
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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
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Correlation 3/3
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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
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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
✔ ✔ ✖ ✖
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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
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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.
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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
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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
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Gold Standard ESR
Starrsed Range
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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
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Starrsed TL
• Westergren gold standard
• Lowest TCO
• EDTA blood; no disposables
• TLA track connected (all brands)
• All functions integrated
• Max. capacity/hour 140
• Hazy sample reporting
• Sample stability 24 hours
• Fully automated daily maintenance
• Bi-directional LIMS communication
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Starrsed RS
• Westergren gold standard
• Lowest TCO
• EDTA blood; no disposables
• Max. load 60 samples
• Table top
• Max. capacity/hour 135
• Hazy sample reporting
• Sample stability 24 hours
• Fully automated daily maintenance
• Bi-directional LIMS communication
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Starrsed ST
• Westergren gold standard
• Lowest TCO
• EDTA blood; no disposables
• Small footprint
• Table top
• Max. capacity/hour 36
• Hazy sample reporting
• Sample stability 24 hours
• Fully automated daily maintenance
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Lorrca MaxSis Ektacytometer
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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
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Lorrca User Group
Linking researchers and publications
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