Analytical Performance Assessment of the Prothrombin Time and Activated Partial Thromboplastin Time Tests by Roche Cobas t511 Coagulation Analyzer
Murat CAN, Berrak Guven, Abdulkadir Tekin
Activated partial thromboplastin time, Analytic performance, Coagulation analyzer, Prothrombin time, Roche t511
Citation Information :
CAN M, Guven B, Tekin A. Analytical Performance Assessment of the Prothrombin Time and Activated Partial Thromboplastin Time Tests by Roche Cobas t511 Coagulation Analyzer. Indian J Med Biochem 2021; 25 (2):71-75.
Aim and objective: The study aims to evaluate the performance of a newly installed fully automatic coagulation analyzer Roche t511.
Materials and methods: The prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR) values obtained from 150 patients by a Roche t511 were compared with those obtained by Siemens Sysmex CS 2000i. Coagulation assays were performed under routine conditions using standard reagents and an analyzer. Reference intervals were established using 2.5th and 97.5th percentiles for hematologic analytes and minimum and maximum values for coagulation tests.
Results: In our study, within- and between-run precision CVs for PT and aPTT in Cobas t511 analyzer were excellent according to the criteria for acceptance. Reference intervals are reported.
Conclusion: The data reported here show that the PT and aPTT assay on the t511 fully automated analyzer is highly sensitive, accurate, and specific for the measurement of hemostasis.
Woodward M, Lowe GDO, Rumley A, et al. Epidemiology of coagulation factors, inhibitors and activation markers: the third Glasgow MONICA survey. II. Relationships to cardiovascular risk factors and prevalent cardiovascular disease. Br J Haematol 1997;97(4):785–797. DOI: 10.1046/j.1365-2141.1997.1232935.x.
Samuelson BT, Cuker A, Siegal DM, et al. Laboratory assessment of the anticoagulant activity of direct oral anticoagulants: a systematic review. Chest 2017;151(1):127–138. DOI: 10.1016/j.chest.2016.08.1462.
Clinical and Laboratory Standards Institute (CLSI). Evaluation of precision performance of quantitative measurement methods; approved guideline 3rd ed. CLSI document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
Clinical and Laboratory Standards Institute (CLSI). Measurement procedure comparison and bias estimation using patient samples; approved guideline 3rd ed. CLSI Document EP09-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2013.
Clinical and Laboratory Standards Institute (CLSI). One-stage prothrombin time (PT) test and activated partial thromboplastin time (APTT) test; approved guideline. CLSI Document H48-A. Wayne, PA: Clinical and Laboratory Standards Institute; 1996.
WHO Expert Committee on Biological Standardization. Annex 3: guidelines for thromboplastins and plasma used to control oral anticoagulant therapy. In: World Health Organization Technical Report Series. 48th report. No. 889. Geneva, Switzerland: World Health Organization; 1999. pp. 64–93.
Bilic-Zulle L. Comparison of methods: passing and bablok regression. Biochem Med 2011;21(1):49–52. DOI: 10.11613/bm.2011.010.
Bland JM, Altmann DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;i(8476):307–310. DOI: 10.1016/S0140-6736(86)90837-8.
Lippi G, Salvagno GL, Gelati M, et al. Analytical assessment of the new roche cobas t 711 fully automated coagulation analyzer. Semin Thromb Hemost 2019;45(3):308–314. DOI: 10.1055/s-0038-1676578.
Kitchen S, Geisen U, Kappelmayer J, et al. Evaluating the analytical performance of five new coagulation assays for the measurement of prothrombin time and activated thromboplastin time. Int J Lab Hematol 2018;40(6):645–654. DOI: 10.1111/ijlh.12897.