Laboratory preparedness for SARS-CoV-2 testing in India: Harnessing a network of Virus Research & Diagnostic Laboratories.

Background & objectives: An outbreak of respiratory illness of unknown aetiology was reported from Hubei province of Wuhan, People's Republic of China, in December 2019. The outbreak was attributed to a novel coronavirus (CoV), named as severe acute respiratory syndrome (SARS)-CoV-2 and the disease as COVID-19. Within one month, cases were reported from 25 countries. In view of the novel viral strain with reported high morbidity, establishing early countrywide diagnosis to detect imported cases became critical. Here we describe the role of a countrywide network of VRDLs in early diagnosis of COVID-19. Methods: The Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV), Pune, established screening as well as confirmatory assays for SARS-CoV-2. A total of 13 VRDLs were provided with the E gene screening real-time reverse transcription-polymerase chain reaction (rRT-PCR) assay. VRDLs were selected on the basis of their presence near an international airport/seaport and their past performance. The case definition for testing included all individuals with travel history to Wuhan and symptomatic individuals with travel history to other parts of China. This was later expanded to include symptomatic individuals returning from Singapore, Japan, Hong Kong, Thailand and South Korea. Results: Within a week of standardization of the test at NIV, all VRDLs could initiate testing for SARS-CoV-2. Till February 29, 2020, a total of 2,913 samples were tested. This included both 654 individuals quarantined in the two camps and others fitting within the case definition. The quarantined individuals were tested twice - at days 0 and 14. All tested negative on both occasions. Only three individuals belonging to different districts in Kerala were found to be positive. Interpretation & conclusions: Sudden emergence of SARS-CoV-2 and its potential to cause a pandemic posed an unsurmountable challenge to the public health system of India. However, concerted efforts of various arms of the Government of India resulted in a well-coordinated action at each level. India has successfully demonstrated its ability to establish quick diagnosis of SARS-CoV-2 at NIV, Pune, and the testing VRDLs.

Impact of the RNTCPIRL-EQA-OSE visits on quality of sputum smear microscopy services of Gujarat, India.

OBJECTIVE: On-site evaluation of laboratories with standard checklist is a first step to promote effective and consistent supervision. The present study was carried out to evaluate the impact of the RNTCP- Intermediate Reference Laboratory External Quality Assessment- On-Site Evaluation visits on quality of sputum smear microscopy services of Gujarat, India. Data of three IRL-EQA-OSE visit rounds, carried out between January 2005 and December 2010 are presented here. MATERIAL AND METHODS: Within the Revised National Tuberculosis Control Programme EQA framework, the IRL, Ahmedabad visited all Gujarat District Tuberculosis Centres, and evaluated their sputum smear microscopy services. The study covered a cohort of 29 DTCs during each of the three IRL-EQA-OSE visits. The authors focused on section III of Annexure A to study and analyse the said impact. In order to convert qualitative data into quantitative one, the authors denoted a score of 1 to "Acceptable" (No Error) remark and 0 to "Not-Acceptable" (Error) one. RESULTS: A larger degree of improvement was noted in Standard Operating Procedure practices, Disinfection practices, and Internal Quality Control practices. Many DTCs did not retrain their laboratory staff in EQA methodology. The Gujarat DTCs achieved an overall score of (820/957) 86% during the initial OSE visits which consistently improved to (842/957) 88% and (885/957) 92% during the two follow-up OSE visits along with sustenance and improvement in many important laboratory parameters. CONCLUSION: The co-sponsoring organisation (IRL) recognises the challenges and therefore, is committed to supporting state-level implementation of EQA through additional training, technical assistance to districts, and improving this technical guidance. By periodic IRL-EQA-OSE visits, sputum smear microscopy services can be sustained and improved at field level.