Evaluating the analytical performance of five new coagulation assays for the measurement of prothrombin time and activated thromboplastin time

Steve Kitchen, Ulrich Geisen, J. Kappelmayer, Peter Quehenberger, Julia Drieß, Anna Lowe, Robert Jones, Jana G. Boehm, Gabrielle Miles, Gergely Rozsnyai

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Introduction: New methods for coagulation tests require careful assessment before routine use. We evaluated the analytical performance of five new coagulation assays for measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT). Methods: PT Rec, PT Owren, aPTT, aPTT Lupus and aPTT Screen assays (Roche Diagnostics) were evaluated on cobas t 711 and cobas t 511 analysers (Roche Diagnostics) at four European centres. Analytical performance and method comparisons with relevant commercially available assays were performed to Clinical Laboratory Standards Institute guidelines using residual anonymized samples. Lot-to-lot comparison and equivalency of the cobas t analysers were also assessed; reference ranges were determined using samples from apparently healthy volunteers. Results: Overall, coefficients of variation were ≤1.3% for within-run precision and ≤6.3% for total reproducibility across all sites. Deming regression analyses showed good agreement between each assay (cobas t 711) and respective comparator method (Pearson's r: 0.964-0.999, n > 120 samples/assay/site). Passing-Bablok regression analyses demonstrated equivalence of the two cobas t platforms for use with each assay (Pearson's r ≥ 0.995). Lot-to-lot consistency was high for all assays and comparisons (Pearson's r ≥ 0.998). Reference ranges (2.5th-97.5th percentiles; n = 200 samples/assay) in seconds were 8.4-10.6 (PT Rec), 18.2-27.2 (PT Owren), 23.6-30.6 (aPTT), 24.1-31.7 (aPTT Lupus) and 23.9-33.2 (aPTT Screen). Conclusion: Based on the excellent analytical performance and good agreement with relevant comparator methods, the five coagulation assays on the novel cobas t 711 and cobas t 511 analysers are suitable for routine use in core laboratories.

Original languageEnglish
JournalInternational Journal of Laboratory Hematology
DOIs
Publication statusAccepted/In press - Jan 1 2018

Fingerprint

Partial Thromboplastin Time
Prothrombin Time
Thromboplastin
Prothrombin
Coagulation
Assays
Reference Values
Regression Analysis
Clinical laboratories
Healthy Volunteers
Guidelines

Keywords

  • Activated partial thromboplastin time
  • Coagulation analyser
  • Prothrombin time

ASJC Scopus subject areas

  • Hematology
  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

Evaluating the analytical performance of five new coagulation assays for the measurement of prothrombin time and activated thromboplastin time. / Kitchen, Steve; Geisen, Ulrich; Kappelmayer, J.; Quehenberger, Peter; Drieß, Julia; Lowe, Anna; Jones, Robert; Boehm, Jana G.; Miles, Gabrielle; Rozsnyai, Gergely.

In: International Journal of Laboratory Hematology, 01.01.2018.

Research output: Contribution to journalArticle

Kitchen, Steve ; Geisen, Ulrich ; Kappelmayer, J. ; Quehenberger, Peter ; Drieß, Julia ; Lowe, Anna ; Jones, Robert ; Boehm, Jana G. ; Miles, Gabrielle ; Rozsnyai, Gergely. / Evaluating the analytical performance of five new coagulation assays for the measurement of prothrombin time and activated thromboplastin time. In: International Journal of Laboratory Hematology. 2018.
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AU - Geisen, Ulrich

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AU - Quehenberger, Peter

AU - Drieß, Julia

AU - Lowe, Anna

AU - Jones, Robert

AU - Boehm, Jana G.

AU - Miles, Gabrielle

AU - Rozsnyai, Gergely

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N2 - Introduction: New methods for coagulation tests require careful assessment before routine use. We evaluated the analytical performance of five new coagulation assays for measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT). Methods: PT Rec, PT Owren, aPTT, aPTT Lupus and aPTT Screen assays (Roche Diagnostics) were evaluated on cobas t 711 and cobas t 511 analysers (Roche Diagnostics) at four European centres. Analytical performance and method comparisons with relevant commercially available assays were performed to Clinical Laboratory Standards Institute guidelines using residual anonymized samples. Lot-to-lot comparison and equivalency of the cobas t analysers were also assessed; reference ranges were determined using samples from apparently healthy volunteers. Results: Overall, coefficients of variation were ≤1.3% for within-run precision and ≤6.3% for total reproducibility across all sites. Deming regression analyses showed good agreement between each assay (cobas t 711) and respective comparator method (Pearson's r: 0.964-0.999, n > 120 samples/assay/site). Passing-Bablok regression analyses demonstrated equivalence of the two cobas t platforms for use with each assay (Pearson's r ≥ 0.995). Lot-to-lot consistency was high for all assays and comparisons (Pearson's r ≥ 0.998). Reference ranges (2.5th-97.5th percentiles; n = 200 samples/assay) in seconds were 8.4-10.6 (PT Rec), 18.2-27.2 (PT Owren), 23.6-30.6 (aPTT), 24.1-31.7 (aPTT Lupus) and 23.9-33.2 (aPTT Screen). Conclusion: Based on the excellent analytical performance and good agreement with relevant comparator methods, the five coagulation assays on the novel cobas t 711 and cobas t 511 analysers are suitable for routine use in core laboratories.

AB - Introduction: New methods for coagulation tests require careful assessment before routine use. We evaluated the analytical performance of five new coagulation assays for measuring prothrombin time (PT) and activated partial thromboplastin time (aPTT). Methods: PT Rec, PT Owren, aPTT, aPTT Lupus and aPTT Screen assays (Roche Diagnostics) were evaluated on cobas t 711 and cobas t 511 analysers (Roche Diagnostics) at four European centres. Analytical performance and method comparisons with relevant commercially available assays were performed to Clinical Laboratory Standards Institute guidelines using residual anonymized samples. Lot-to-lot comparison and equivalency of the cobas t analysers were also assessed; reference ranges were determined using samples from apparently healthy volunteers. Results: Overall, coefficients of variation were ≤1.3% for within-run precision and ≤6.3% for total reproducibility across all sites. Deming regression analyses showed good agreement between each assay (cobas t 711) and respective comparator method (Pearson's r: 0.964-0.999, n > 120 samples/assay/site). Passing-Bablok regression analyses demonstrated equivalence of the two cobas t platforms for use with each assay (Pearson's r ≥ 0.995). Lot-to-lot consistency was high for all assays and comparisons (Pearson's r ≥ 0.998). Reference ranges (2.5th-97.5th percentiles; n = 200 samples/assay) in seconds were 8.4-10.6 (PT Rec), 18.2-27.2 (PT Owren), 23.6-30.6 (aPTT), 24.1-31.7 (aPTT Lupus) and 23.9-33.2 (aPTT Screen). Conclusion: Based on the excellent analytical performance and good agreement with relevant comparator methods, the five coagulation assays on the novel cobas t 711 and cobas t 511 analysers are suitable for routine use in core laboratories.

KW - Activated partial thromboplastin time

KW - Coagulation analyser

KW - Prothrombin time

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