External quality assessment of COVID-19 real time reverse transcription PCR laboratories in India

Abstract

Sudden emergence and rapid spread of COVID-19 created an inevitable need for expansion of the COVID-19 laboratory testing network across the world. The strategy to test-track-treat was advocated for quick detection and containment of the disease. Being the second most populous country in the world, India was challenged to make COVID-19 testing available and accessible in all parts of the country. The molecular laboratory testing network was augmented expeditiously, and number of laboratories was increased from one in January 2020 to 2951 till mid-September, 2021. This rapid expansion warranted the need to have inbuilt systems of quality control/ quality assurance. In addition to the ongoing inter-laboratory quality control (ILQC), India implemented an External Quality Assurance Program (EQAP) with assistance from World Health Organization (WHO) and Royal College of Pathologists, Australasia. Out of the 953 open system rRTPCR laboratories in both public and private sector who participated in the first round of EQAP, 891(93.4%) laboratories obtained a passing score of > = 80%. The satisfactory performance of Indian COVID-19 testing laboratories has boosted the confidence of the public and policy makers in the quality of testing. ILQC and EQAP need to continue to ensure adherence of the testing laboratories to the desired quality standards.

Design of external quality assessment (EQA) schemes and definition of the roles of their providers in future epidemics

“…Among the 17 publications reviewed, three reported on international [25,26,33], one on a bi-national (Australia, New Zealand) [31] and ten on national EQA schemes or rounds, including Austria [11-14,17], China [28,32,36], India [30], Japan [20,29] and Korea [34,35]. Counts of test facilities enrolled per round were 32 to 953, and test systems were 32 to 953.…”

“…Literature on EQA is generally rare. We identi ed a total of 17 publications on EQA of SARS-CoV-2 in PubMed with the search terms "EQA" or "external quality assessment" or "pro ciency testing" or "PT" and "SARS-CoV-2" or "Covid-19" (search performed July 2022, period searched 01/2020 to 07/2022, see Table 1) [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36]. Information from each publication was aggregated (Table 1) and the subject criteria were derived from this.…”

“…Two publications reported that performance depended on laboratory category [20,29]. Two publications reported on unequal performance of different batches of the same reagent, and the same two publications reported on the relation of performance to the extraction method [29,36]; however, one publication found no such relation [30]. One publication reported on the loss of relative sensitivity of assays when EQA samples were pooled and that most assays met speci cations for sensitivity as stated by the manufacturer and many detected even lower concentrations than speci ed [23].…”

Design of external quality assessment schemes and definition of the roles of their providers in future epidemics

“…We searched PubMed using the terms “EQA” or “external quality assessment” or “proficiency testing” or “PT” and “SARS-CoV-2” or “COVID-19” for full-text articles published between January, 2020, and July, 2022 and identified 17 publications on EQA of SARS-CoV-2 ( appendix p 1 ). 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 Each publication was evaluated for general information on the EQA scheme, performance indicators of participant assays and laboratories, specifications and features of assays, specifications of samples used, and any additional noticeable information provided ( panel 1 ). From this aggregated information we derived the subjects and sorted them into two categories.…”

“…Among the 17 publications reviewed, three reported on international EQA schemes or rounds, 32 , 33 , 40 one on a binational (Australia and New Zealand) EQA scheme or round, 38 and 13 on national EQA schemes or rounds (Austria, 28 , 29 , 30 , 31 , 34 China, 35 , 39 , 43 India, 37 Japan, 27 , 36 and South Korea). 41 , 42 None of the publications 32 , 33 , 38 , 40 on international schemes reported any difficulties shipping EQA sample panels to any countries with import restrictions in place.…”