High level of agreement between CP3000 and five other coagulation analyzers for INR in a multicenter study

Transcription

1 DIAGNOSTICS Gabriella Lakos, MD, PhD. Sr. Associate Medical Director Medical & Scientific Affairs Abbott Diagnostics Larry Smith, PhD. Medical & Scientific Affairs Manager Abbott Diagnostics High level of agreement between CP000 and five other coagulation analyzers for INR in a multicenter study July 07 Sarah Just South West Area Pathology Service Liverpool Hospital Sydney, Australia Stephen So Shing Chau Clinical & Histopathology Laboratory St. Teresa s Hospital Kowloon, Hong Kong Ivana Malikova General University Hospital (Všeobecná Fakultní Nemocnice v Praze) Prague, Czech Republic Volker Drescher Medizinisches Labor Westsachsen Fachlabor Zwickau, Germany 5 Peter Reichardt Medizinisches Labor Westsachsen Fachlabor Zwickau, Germany Neda Razavi Marketing Manager Abbott Laboratories, Santa Clara, CA USA Abbott Diagnostics, Abbott Park, Illinois 600. Authors contributed equally to this document. Page of 7

2 Objectives In this multicenter study, the performance of the Sekisui CP000 Coagulation System (with Coagpia PT-N reagent) was assessed for prothrombin time (PT) and International Normalized Ratio (INR) in comparison with that of the ACL TOP-00 (Instrumentation Laboratories), Cobas t (Roche), Siemens BCS (Siemens), Sysmex CA-7000 (Siemens) and STAGO STA-R Evolution (Diagnostica STAGO) in routine laboratory settings. Methods A total of 95 samples (up to 0 patient samples per comparative instrument) were assayed by the CP000. Results were compared using regression statistics, Pearson correlation and qualitative agreement methods. Results The overall tested range spanned from 9.9 to 77. seconds. PT results obtained with the CP000 analyzer showed excellent correlation with those obtained with each comparative system: the Pearson correlation coefficient ranged from 0.96 (ACL TOP-00 and Cobas) to 0.99 (Siemens BCS) (Table ). Correlation coefficients for INR results ranged from 0.95 (Cobas) to.0 (Siemens BCS and STA-R Evolution) (Table ). Passing and Bablok regression analysis resulted in slopes of.0 (Siemens BCS) to. (Cobas) for INR. The percentage of samples in the INR range of.0 to.0 with < 0.5 difference in pairwise comparison (CLSI H57-A criteria) ranged from 50% (in comparison with ACL TOP-00) to 00% (in comparison with Siemens BCS). The mean difference in the therapeutic range (.0-.0 INR) ranged from (STA-R Evolution) to 0. (Roche t). Formal throughput testing with routine samples containing 7% specimens with prolonged PT resulted in 55 PT/hour performances. Based on 5 individual tests, average time to first (PT) result was minutes and seconds, and for a panel of PT, activated partial thromboplastin time (APTT) and fibrinogen concentration was 5 minutes and 7 seconds. Conclusion INR results obtained with the CP000 analyzer showed high level of agreement with those generated with the Siemens BCS, Sysmex CA-7000, STAGO STA-R Evolution, ACL TOP-00 and Cobas t instruments. Page of 7

3 Objectives This multicenter study compared prothrombin time (PT) and International Normalized Ratio (INR) results obtained with the CP000 Coagulation System (Sekisui Medical Co. Ltd, Tokyo) and Coagpia PT-N (Sekisui) reagent to those obtained with five different coagulation platforms: ACL TOP-00 (Instrumentation Laboratories), Cobas t (Roche), BCS (Siemens), CA-7000 (Sysmex/Siemens), and STA-R Evolution (Diagnostica STAGO). In addition, the study assessed the throughput and turnaround time of STAT results on CP000. Methods A total of 99 samples (up to 0 samples per comparative instrument) were assayed in four clinical laboratories with the CP000 and the comparative instruments. The following calculations were performed on these data: ) Passing-Bablok regression analysis ) Pearson correlation ) Predicted bias calculation at medical decision levels ) Percent of samples in the INR range of.0-.0 with <0.5 difference according to CLSI H57-A guideline 5) Mean difference between INR values in the INR range of.0-.0 Throughput was assessed for PT with normal and abnormal samples, and time to first result was measured for PT alone processed as a STAT sample, and for a panel of PT, activated partial thromboplastin time (APTT), and fibrinogen assays. Results Pearson correlation coefficients were 0.95 for PT and INR (Table and Figure A-E) in all comparisons. The slope and intercept of the regression line suggested the strongest concordance of CP000 results with those obtained with Siemens BCS and Sysmex CA-7000 (both with Thromborel S reagent), and the least amount of concordance with those obtained with Cobas t and STA-R Evolution. Slope and intercept values, however, significantly improved in these two comparisons when INR was considered instead of PT (Table ). Page of 7

4 INR - CP000 INR - CP000 Table. Correlation results according to comparative instrument. Reagents are shown in parenthesis. Comparative system n Range tested Passing-Bablok regression Pearson s r ACL TOP-00 (RecombiPlastin G) Roche Cobas t (Coasys thromboplastin) Siemens BCS (Thromborel S) Sysmex CA-7000 (Thromborel S) STAGO STA-R Evolution (Neoplastine CI Plus) Slope Intercept PT (sec) INR PT (sec) INR PT (sec) INR PT (sec) INR PT (sec) INR INR - ACL TOP INR - Roche Cobas t Page of 7

5 INR - CP000 INR - CP000 INR - CP INR - BCS INR - CA INR - STAGO STA-R-Evolution Figure. INR correlation across platforms. Predicted bias at medical decision levels was the smallest in comparison with Siemens BCS, STA- R Evolution and Sysmex CA-7000 (Table ). Table. Predicted bias Predicted bias according to comparator system INR medical decision levels ACL TOP-00 Roche Cobas t Siemens BCS Sysmex CA-7000 STAGO STA-R Evolution Page 5 of 7

6 The average difference between INR values in the INR range of.0-.0 was <0.5 in each comparison (Table ). CLSI guideline H57-A considers two PT methods equivalent if at least 85% of the samples in the INR range of.0-.0 exhibit < 0.5 difference. This criterion was fulfilled in comparison with Siemens BCS and STAGO STA-R Evolution, and it was not fulfilled in comparison with Cobas t. The number of samples in the INR range of.0-.0 was and 6 for ACL TOP-00 and Sysmex CA-7000, respectively, so the results are inconclusive (Table ). Table. Average and pair-wise differences Comparative system CP000 vs comparative instrument n samples in INR range of.0-.0 % samples in INR range of.0-.0 with < 0.5 difference Average difference in INR range of ACL TOP % 0.7 Roche Cobas t 8.6% 0. Siemens BCS % 0.0 Sysmex CA % 0.5 STAGO STA-R Evolution % Formal throughput testing with routine samples containing 7% specimens with prolonged PT resulted in 55 PT/hour performance. Based on 5 individual tests, average time to first PT result was minutes and seconds, and for a panel of PT, APTT and fibrinogen concentration was 5 minutes and 7 seconds. Conclusion Results obtained from these studies demonstrate that INR values generated on the CP000 with Coagpia PT-N reagent show strong concordance with those obtained with five other coagulation analyzers. INR equivalency was successfully demonstrated in comparison with Siemens BCS and STAGO STA-R Evolution. Throughput was in line with the manufacturer s claim and time to first results was rapid. Page 6 of 7

7 REFERENCES Sara Just, Larry Smith, Gabriella Lakos. CP000 vs STA-R Evolution. Study ID: C-6-06; Haematology Department, Sydney South West Pathology Service, New South Wales Health Pathology, Liverpool Hospital, Sydney, Australia. Stephen So Shing Chau, Larry Smith, Gabriella Lakos. CP000 vs. ACL TOP-00. Study ID: C- 6-0; Clinical & Histopathology Laboratories, St. Teresa s Hospital, Kowloon, Hong Kong. Ivana Malikova, Larry Smith, Gabriella Lakos. CP000 vs BCS and CA Study ID: C-6-0; General University Hospital (Všeobecná Fakultní Nemocnice v Praze), Prague, Czech Republic. & 5 Volker Drescher, Peter Reichardt, Larry Smith, Gabriella Lakos. CP000 vs t. Study ID: C-6-0; Medizinschces Labor Westsachsen Fachlabor, Zwickau, Germany Presented at XXXth International Symposium on Technical Innovations in Laboratory Hematology, Honolulu, HI, May -6, 07, Abstract Number. ISLH 07, Honolulu, HA. CP000 is manufactured by Sekisui Medical Co., Ltd. Distributed by Abbott Laboratories. CP000 is a mark of Sekisui Medical Co., Ltd. Coagpia is a registered trademark of Sekisui Medical Co., Ltd. All other trademarks are the property of their respective owners ADD Abbott Laboratories. Page 7 of 7