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

Abstract

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

COVID 19 pandemic testing time – Crisis or opportunity in disguise for India?

“…Virus isolate is the gold standard for establishment and standardization of assay performance. Since SARS-CoV-2 virus isolate was not available earlier, based on the genetic sequence of SARS-CoV-2 and closely related SARS-CoV (2002-2003), the World Health Organization (WHO) shared protocols (E, N, RdRp, and S genes) for screening and confirmation of probable cases, and RT PCR was considered as the gold standard for rapid nucleic acid amplification of the SARS-COV-2 [5 ].…”

“…Several laboratories resorted to amalgamation and repurposing of resources to cover the need for testing with microbiologist joining hands with molecular pathologist and/or basic researchers. The interventions ranged from optimizing the existing capacity of manual qRT-PCR instruments through multiple shifts and reduction in laboratory-level manual RNA extraction effort; deploying additional manual and automated machines from other public institutes and research organizations and procuring automated high-throughput instruments [5 , 19] .…”

Diagnosis of SARS-CoV-2: A Review on the Current Scenario and Future Outlook

“…Many commercial diagnostic kits have also been validated by the ICMR-NIV such as Altona diagnostics based on the E and S genes; KILPEST based on the E, RdRp and N genes; MY LAB Patho detect kit (make-in-India product); SD Biosensor kits based on the (Gupta et al, 2019). The IIT, New Delhi has also designed a probe-free kit aimed at easier and cheaper diagnosis with lesser turnaround time (Gupta et al, 2020b;Vashisht, 2020). Due to the worldwide efforts of the research community, prominent advances are being made for the prompt diagnosis of SARS-CoV-2.…”

Measures of Preventing Covid-19 Transmission

“…Close contact with the infected patient is the inclusion criteria. Affected countries instituted various case-inding activities using WHO case de inition or a modi ied version, Malaysia, South Korea & UK incorporated COVID-19 testing for SAR1 & IL1 (in luenza-like illness) surveillance (Abraham et al, 2020).…”

“…Testing NCDC (National Centre for Disease Control) Delhi has a testing facility with an RT-PCR Corona kit. (NIV) National Institute of Virology, Pune has testing facilities all across India, increasing the number of laboratories (Abraham et al, 2020). Apart from RT-PCR National Institute of Virology (NIV), also introduced serology based rapid detection test like Enzyme-Linked Immunosorbents Assay (ELISA) with a capacity to give results within two and a half hours with 90 samples being processed at a time.-Initially testing was done only for those who have Travel History or High-risk groups or those who had contact with covid-19 lab-con irmed case.…”