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

Copyright © 2024 Indian Association of Medical Microbiologists. Published by Elsevier B.V. All rights reserved..

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.

Medienart:

E-Artikel

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

Zur Gesamtaufnahme - volume:49

Enthalten in:

Indian journal of medical microbiology - 49(2024) vom: 13. Apr., Seite 100577

Sprache:

Englisch

Beteiligte Personen:

Manchanda, Vikas [VerfasserIn]
Siddiqui, Oves [VerfasserIn]
Meena, Kavita [VerfasserIn]
Sharma, Anju [VerfasserIn]
Saxena, Sonal [VerfasserIn]

Links:

Volltext

Themen:

ICMR-NIV
ILQC
Journal Article
QC/QA
SARS-CoV-2
SQC

Anmerkungen:

Date Revised 14.04.2024

published: Print-Electronic

Citation Status Publisher

doi:

10.1016/j.ijmmb.2024.100577

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM370782275