Improvement of laboratory testing services by implementation of quality assurance scheme

Abstract

Introduction: The National AIDS Control Organization (NACO), Government of India and the Uttar Pradesh State AIDS Control Society (UPSACS) established the State Referral Laboratory (SRL) in the Department of Microbiology, Motilal Nehru Medical College, Prayagraj for HIV testing and monitoring of linked HIV Counselling and Testing Services (HCTS) in Uttar Pradesh.Methods: This is a retrospective study conducted from 2008 to 2021. In this evaluation period 10144 serum samples (9580 HIV negative, 555 HIV positive and 9 discordant) were received for retesting at SRL. The Quality Control serum samples received from testing sites consisted of 5% negative and 20% positive from all tested samples collected in the first seven days in the External Quality Assurance Scheme (EQAS) quarter month i.e. January, April, July and October. All samples were tested using rapid diagnostic kits procured by NACO/UPSACS with NACO testing strategy. All linked centres with SRL received 4 coded serum samples for proficiency testing (PT) which were tested similarly.Results: Of 10144 serum samples, 99.92% reported correct results and 0.08% reported discrepancy due to various issues. Similarly in the proficiency testing programme, of 4072 samples tested between 2010 to 2021 by testing sites, 4061 (99.07%) reported concordant results and the remaining14 (0.34%) samples reported indeterminate results. Of the 4072 samples, 14 shows discordant results by three different rapid tests based on different principles. Hands on training were provided for technicians who reported indeterminate results in PT or retesting.Conclusion: The tremendous increase in quality testing at peripheral centrally linked centres increase the reliability of HIV diagnosis at ground level. The study also concluded that continuous monitoring and mentoring of technicians of the diagnostic laboratories under EQAS improves their quality for HIV diagnosis.