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Application of EP15A3 and EP15A2 Protocols to Verify the Performance of a Coagulometer in the Coagulation Laboratory of the National Institute of Respiratory Diseases in Mexico City

1Instituto Nacional de Enfermedades Respiratorias, Laboratorio de Trombosis, Mexico, Mexico, 2Instituto Nacional de Enfermedades Respiratorias, Consulta Externa Servicio de Cardiologia, Mexico, Mexico

Abstract Number: PB0585

Meeting: ISTH 2020 Congress

Theme: Diagnostics and OMICs » Laboratory Diagnostics

Background: The culture of quality among clinical laboratories has increased the need to evaluate the performance of the analytical methods used for the tests offered to the patient.

Aims: To verify the performance of a coagulometer under the conditions of the INER clinical laboratory based on the verification protocol EP15-A3 User Verification of Performance for Precision and Trueness, proposed by CLSI (Clinical and Laboratory Standards Institute).

Methods: The coagulometer with viscosimetric (mechanical) detection principle: accurately evaluates weak instrument clots of the STA® range.
20 samples of blood bank donors are used; Global coagulation tests were determined (PT, PTT TT, Fibrinogen and D-dimer). With the results obtained, precision, veracity, method comparison, verification of reference ranges 6, linearity 7, total error 8 and Sigma metric were calculated. A statistical analysis was performed where the following programs were used: GMigliarino SC version 4.8; EP Evaluator version 8.0.0.172.

Results: It was observed that the coefficients of variation obtained are lower than estimated by the manufacturer. The verification of the instrument is acceptable. Perform a verification of methods in an analyte measurement laboratory, it is very important since the data provided by the manufacturer are compared in their own conditions, allowing the results generated by the instruments to be useful in the diagnosis, prognosis and treatment of a large number of diseases.

Conclusions: The coagulometer at the height of Mexico City (2250 meters above sea level), is able of work above the minimum acceptance specifications established by the manufacturer, complying with the CLSI international verification recommendations.

Analyte Level 1 control PT PTT Fibrinogen D-dimer Analyte Level 2 control PT PTT Fibrinogen D-dimer
Sr 0.17 0.22 6.71 0.0502 Sr 0.152 0.259 5.22 0.0554
CVr 1.2 0.6 2.5 4.7 CVr 0.8 0.5 3.3 9.1
CVr-Fab 1.5 1.5 4.0 17.5 CVr-Fab 2.0 2.0 5.0 15.2
UVL CVr Fab 2.0 2 5.2 22.9 UVL CVr Fab 2.6 2.6 6.6 19.9
Interpretation ACCEPTED ACCEPTED ACCEPTED ACCEPTED Interpretation ACCEPTED ACCEPTED ACCEPTED ACCEPTED

[Table 1. Precision results for level 1 and level 2 control. Where: Sr (Deviated standard in repeatability conditions); CVr (Coefficient of variation)]

Analyte level 1 control PT PTT Fibrinogen D-dimer Analyte level 2 control PT PTT Fibrinogen D-dimer
Swl 0.205 0.782 8.79 0.0502 Swl 0.314 0.767 6.01 0.0581
CVwl 1.4 2.2 3.2 4.7 CVwl 1.7 1.6 3.9 9.5
CVwl-Fab 5.0 5.0 6.0 26.3 CVwl-Fab 5.0 5.0 6.0 30.3
UVL CVwl Fab 8.0 8.0 8.7 38.1 UVL CVwl Fab 8.0 8.0 8.1 47
Interpretation Accepted Accepted Accepted Accepted Interpretation Accepted Accepted Accepted Accepted

[Intermediate precision results, where: Swl (Standard deviation in intermediate precision conditions); CVwl (Coefficient of variation in intermediate p]

To cite this abstract in AMA style:

Zuñiga Ascencio BS, Vidal Martinez F, Castillejos López MJ, Lira Mendoza BA, Jaime Capetillo ME, Juárez Silva E, Rodríguez Ventura MA, Guevara Gutiérrez R. Application of EP15A3 and EP15A2 Protocols to Verify the Performance of a Coagulometer in the Coagulation Laboratory of the National Institute of Respiratory Diseases in Mexico City [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/application-of-ep15a3-and-ep15a2-protocols-to-verify-the-performance-of-a-coagulometer-in-the-coagulation-laboratory-of-the-national-institute-of-respiratory-diseases-in-mexico-city/. Accessed October 1, 2023.

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