External Quality Assessment of Transfusion-transmissible Infections Testing
Tatjana Makarovska Bojadzieva *
Institute of Transfusion Medicine, Saints Cyril and Methodius University, Skopje, Macedonia
Lolita Mitevska
Institute of Transfusion Medicine, Saints Cyril and Methodius University, Skopje, Macedonia
Jasmina Trojacanec
Institute of Pharmacology, Saints Cyril and Methodius University, Skopje, Macedonia
*Author to whom correspondence should be addressed.
Abstract
Aims: To assess the overall performance of the transfusion-transmissible infection testing laboratory through the evaluation of the results obtained from the participation in a blood proficiency testing study (B-PTS).
Study Design: The B-PTS study was designed, organized and conducted by European directorate for the quality of medicines (EDQM). We were requested to test the B-PTS samples and to report the results on the online result data sheet.
Place and Duration of Study: The 3 blood testing laboratories of the Institute of transfusion medicine in Macedonia; July 2017.
Methodology: Each set of B-PTS-samples contained 4 panels: Anti-HCV (032), anti-HIV/p24 (033), anti-Treponema (034) and HBsAg panel (035). The samples were subjected to serological testing with two assays: Enzyme immunoassay with Enzygnost system, Siemens using BEP2000 and chemiluminescent microparticle immunoassay with Architect system, Abbott using Architect i2000.
Results: The laboratories were classified as “satisfactory” for B-PTS032 and B-PTS034. For B-PTS033 the classification was “non evaluable” because the results were not properly submitted. The B-PTS035 results were classified as “unsatisfactory” because two laboratories reported the reactive sample number 3 as “Not Reactive” with the Enzygnost assay and one laboratory reported it as “Not Reactive” with the Architect assay. The single observed non-conformity was that the S/Co (1.22) of the positive control for the Architect HBsAg assay was out of rang (1.65-4.96) for the corresponding reagent lot.
Conclusion: The participation in a B-PTS study provides an objective and independent evaluation of the overall performance of the laboratory. The management of the non-satisfactory PTS results should be documented and performed in a controlled manner. Appropriate corrective and preventive measures should be taken in order non-conformities not to repeat.
Keywords: Transfusion-transmissible infection, external quality assessment, blood proficiency testing