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Insights from establishing a high throughput viral diagnostic laboratory for SARS-CoV-2 RT-PCR testing facility:
Sanchita Roy Pradhan1, M H Yashavarddhan1, Ashish Gupta1
1High-Throughput Viral Diagnostic Laboratory (HTVDL), ICMR - National Institute of Cancer Prevention and Research (NICPR), Ministry of Health and Family Welfare, Government of India, Noida, Uttar Pradesh, India.
Insights
India established a high-throughput viral diagnostic laboratory (HTVDL) for COVID-19 testing during the pandemic. This initiative expanded testing capacity and developed rapid diagnostic procedures to control viral spread.
Area of Science:
- Virology
- Public Health
- Laboratory Science
Background:
- The COVID-19 pandemic necessitated rapid identification and isolation of infected individuals due to the lack of immediate treatments.
- India, facing a dense population, required scalable diagnostic capabilities to manage the viral spread.
- The Indian Council of Medical Research (ICMR) played a crucial role in policy development and establishing testing infrastructure.
Purpose of the Study:
- To detail the establishment of a high-throughput viral diagnostic laboratory (HTVDL) at the National Institute of Cancer Prevention and Research (NICPR).
- To describe the development and implementation of rapid testing procedures for SARS-CoV-2 using Real-Time PCR.
- To share experiences and challenges faced in establishing a large-scale diagnostic facility in a developing country during a global health crisis.
Main Methods:
- Establishment of a high-throughput viral diagnostic laboratory (HTVDL) equipped for RT-PCR based diagnosis of SARS-CoV-2.
- Development and implementation of standard operating procedures (SOPs) for rapid testing.
- Scaling up testing capacity to 6000 samples per day to serve Delhi and western Uttar Pradesh.
Main Results:
- Successful establishment of an HTVDL during the initial phase of the COVID-19 lockdown.
- Expansion of SARS-CoV-2 testing capacity in the National Capital Region and surrounding areas.
- Development of a model for rapid laboratory setup and operation applicable in pandemic scenarios.
Conclusions:
- The establishment of the HTVDL demonstrated the feasibility of rapidly scaling up diagnostic capacity in response to a pandemic.
- The experience provides valuable insights for establishing similar high-throughput laboratories globally, even outside of pandemic emergencies.
- Effective public health strategies, supported by robust laboratory infrastructure, are critical for controlling infectious disease outbreaks.
Abstract:
Background: The World Health Organization declared the coronavirus disease 2019 (COVID-19) a global pandemic on 11 March 2020. Identifying the infected people and isolating them was the only measure that was available to control the viral spread, as there were no standardized treatment interventions available. Various public health measures, including vaccination, have been implemented to control the spread of the virus worldwide. India, being a densely populated country, required laboratories in different zones of the country with the capacity to test a large number of samples and report test results at the earliest. The Indian Council of Medical Research (ICMR) took the lead role in developing policies, generating advisories, formulating guidelines, and establishing and approving testing centers for COVID-19 testing. With advisories of ICMR, the National Institute of Cancer Prevention and Research (NICPR) established a high-throughput viral diagnostic laboratory (HTVDL) for RT-PCR-based diagnosis of SARS-CoV-2 in April 2020. HTVDL was established during the first lockdown to serve the nation in developing and adopting rapid testing procedures and to expand the testing capacity using "Real-Time PCR." The HTVDL provided its testing support to the national capital territory of Delhi and western Uttar Pradesh, with a testing capacity of 6000 tests per day. The experience of establishing a high-throughput laboratory with all standard operating procedures against varied challenges in a developing country such as India is explained in the current manuscript which will be useful globally to enhance the knowledge on establishing an HTVDL in pandemic or non-pandemic times.
