Quality assurance of SARS-CoV-2 testing laboratories during the pandemic period in India - An experience from a designated provider laboratory

Vikas Manchanda; Oves Siddiqui; Kavita Meena; Anju Sharma; Sonal Saxena

doi:10.1016/j.ijmmb.2024.100577

Quality assurance of SARS-CoV-2 testing laboratories during the pandemic period in India - An experience from a designated provider laboratory

Indian J Med Microbiol. 2024 Apr 13:49:100577. doi: 10.1016/j.ijmmb.2024.100577. Online ahead of print.

Authors

Vikas Manchanda¹, Oves Siddiqui², Kavita Meena³, Anju Sharma⁴, Sonal Saxena⁵

Affiliations

¹ Department of Microbiology, Maulana Azad Medical College & Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi, 110002, India; State Level -Viral Research and Diagnostic Laboratory (VRDL), Department of Microbiology, Maulana Azad Medical College & Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi, 110002, India. Electronic address: micromamc@gmail.com.
² Department of Microbiology, Maulana Azad Medical College & Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi, 110002, India; State Level -Viral Research and Diagnostic Laboratory (VRDL), Department of Microbiology, Maulana Azad Medical College & Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi, 110002, India. Electronic address: oves16@gmail.com.
³ Department of Microbiology, Maulana Azad Medical College & Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi, 110002, India. Electronic address: kavitachirawat@gmail.com.
⁴ State Level -Viral Research and Diagnostic Laboratory (VRDL), Department of Microbiology, Maulana Azad Medical College & Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi, 110002, India. Electronic address: anjusharma10783@gmail.com.
⁵ Department of Microbiology, Maulana Azad Medical College & Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi, 110002, India; State Level -Viral Research and Diagnostic Laboratory (VRDL), Department of Microbiology, Maulana Azad Medical College & Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi, 110002, India. Electronic address: sonalsaxena@gmail.com.

PMID: 38588879
DOI: 10.1016/j.ijmmb.2024.100577

Abstract

Purpose: Indian Council of Medical Research (ICMR) initiated an Inter-Laboratory Quality Control testing (ILQC) program for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing. Under this program, SARS-CoV-2 testing laboratories across the country submit specimens to the assigned State Quality Control (SQCs) laboratories for ILQC testing. This study aimed to investigate the performance of public and private SARS-CoV-2 testing laboratories in Delhi and highlights the country's effort in ramping up testing facility with close monitoring of the quality of Covid-19 testing results.

Methods: In the present study, two-years of SARS-CoV-2 testing data is included. During July 2020 through February 2022, a total of 1791 anonymised specimens were received from 56 public and private laboratories. These specimens were processed by reverse transcriptase - polymerase chain reaction (RT-PCR) tests as per National Institute of Virology (NIV) protocol and the results were uploaded on the ICMR quality control/quality assurance (QC/QA) portal without directly conveying the results to respective participating laboratories. This portal generated a final report stating concordance and intimate results to individual laboratories.

Results: Among the 1791 specimens, 25 were rejected and the remaining 1766 were tested. Among these specimens 1691 (95.75%) revealed concordance, and 75 (4.24%) were discordant. A total of 29 laboratories had 100% concordance, 21 laboratories had over 90% concordance and six laboratories had over 80% concordance.

Conclusions: The study demonstrates that the establishment of an inter-laboratory comparison program for SARS-CoV-2 testing helped in monitoring quality of SARS-CoV-2 testing in the country.

Keywords: ICMR-NIV; ILQC; QC/QA; SARS-CoV-2; SQC.