ABSTRACT
Introduction: EQAS program at New Delhi under IAMM was started in January 2014 across North and North east regions of India with 217 participants, which grew up to 540 by 2018. Materials and Methods: In 2014, 4 analytes per year were sent for 3 exercises, i.e. smear culture and serology. 2018 onwards PT analytes were increased from 4 to 12 and comparative performance of techniques analysed. Results: Out of the 22 smears sent for gram staining, ZN staining, Kinyoun staining and Albert staining, completely correct results ranged between 29.55% - 79.9%, 94.3% - 99.2%, 35.5% & 93.8%, respectively. Correct results for culture isolate identification & susceptibility testing and serology exercises varied between 70 & 92.4% and 73.1 & 98.59%, respectively. In the year 2018, 470 responses were received for bacterial culture identification & antibiotic susceptibility testing out of which manual and automated systems were used by 54% & 46% and 52.5% & 47.5% participants, respectively. Techniques used in BBV assays for HBsAg, HCV & HIV found all methods like ELISA, ELFA, CLIA and Card Test performing similarly. The major challenges in running the EQA program included requirement of large amount of specimens for PT item preparation, stability in hot and humid conditions and timely delivery of PT challenges in remote parts of the country. Conclusion: A large number of the participating laboratories (77%) had an overall score of >80% for all exercises, demonstrating acceptable baseline performance of EQAS registered laboratories. However, continued EQAS participation could further improve the quality of results.
ABSTRACT
BACKGROUND: HIV serologic testing is essential for blood donor screening, and the test results should be accurate. It is important that clinical laboratories perform quality control, quality management and standardization for obtaining accurate laboratory results. The Korean National Institute of Health, the Division of AIDS and the Center for Immunology and Pathology have all performed annual external quality surveillance assessment (EQS, EQA) with using a 5 sera panel for all the Korean HIV testing laboratories that have collaborated with the Quality Assurance Committee of the Korean Society of Laboratory Medicine since 2005. The results of HIV testing in the clinical laboratories during the year 2007 were analyzed. METHODS: The results for the clinical laboratories that participated in the HIV EQAS during 2007 were collected and analyzed. The HIV test results and questionnaire data were sent to the web site "http://hivqa.nih.go.kr". Three hundred thirty two results from 303 institutions in 2007 were analyzed. RESULTS: The most widely used HIV testing method was an automated chemiluminescent immunoassay, such as the Abbott AxSym and the Architect system or the Roche Elecsys. About 5% of erroneous results were reported among 332 results. The causes of error were mostly clerical errors and specimen errors. CONCLUSION: The current status for HIV testing in Korean clinical laboratories was that fully automated immunoassay analyzers were used along with manual POCT tests.