Testing is a critical component of the pandemic response. It serves two purposes; for
clinical purposes, it focuses on identifying disease in symptomatic patients, while
testing for epidemiological purposes, spread in the population is also assessed. India
uses a mix of both Reverse Transcriptase Polymerase Chain Reaction (RT PCR) and Antigen
Rapid Diagnostic Tests (Ag RDTs) for COVID-19 testing. RT PCR is the reference standard
test for detection of the virus. However, not all facilities have RT PCR, and many
communities have poor access. This leads to a long turn-around time (TAT) for the results
to be obtained and a high load on RT PCR facilities. Hence, to prevent the spread of the
virus, cases must get detected early. At the peak of the first wave of the pandemic in
the country, Ag RDTs constituted close to 50% of all the tests conducted in the country.
Self-testing for COVID-19 has emerged as a viable complementary testing modality. The use
of self-testing kits while ensuring the availability of other COVID-19 tests at the
nearest point of care addresses many of the usual barriers to uptake of services, leading
to timely testing of individuals, diagnosis, and access to care. It can also reduce the
burden on existing testing infrastructure especially during a surge in the cases. It also
reduces overcrowding at testing facilities thereby reducing the risk of disease
transmission. To improve access to testing and prevent overreliance on RT PCR
laboratories, the Indian Council of Medical Research (ICMR) approved and validated the
use of COVID-19 self-testing kits. As of March 2022, sixteen self-testing kits have been
validated in India of which 10 are found to be satisfactory. While there are many
benefits to self-testing, it is also essential to understand the utilization of the
self-testing strategy, including whether or not the community can follow the steps for
self-testing and what support, if any, the community may require to use self-test kits.

The present study proposes the demonstration of ICMR and US-FDA (United States Food &
Drug Administration) approved SURE STATUS self-testing kit in the healthcare workers and
educational institution setting in Mizoram for a period of 5 months. With the ease of
lockdown and movement restrictions, workplaces and educational institutes are gradually
opening up. However, with the threat of the pandemic still looming large, it is prudent
to put in place systems for regular screening within these settings to promote early
diagnosis and care and prevent outbreaks. COVID-19 self-test has been identified as one
way any institution can scale up COVID-19 testing to improve COVID-19 status awareness by
reaching out to as many people as possible at a given point of time.

While COVID-19 self-tests are available and widely used in India, these kits are largely
used within the confines of individual homes. It is learnt that the reporting of the
results of the self-test is poor as compared to the utilization of the self-test kits. To
the investigator's knowledge, no study has been conducted in India to assess the
utilization of self-testing as a routine procedure in places of mass indoor gathering,
like workplaces and educational institutions. To address this gap, the investigators will
conduct a study to evaluate the utilization, adherence, and acceptability of routine
COVID-19 self-testing among students, employees and healthcare workers in two congregate
settings: one University College and one Medical College and Hospital in Mizoram, India.
The proposed study will document challenges, if any, in reporting of self-test results
and document the key processes in operationalizing routine COVID-19 self-testing among
students, employees and healthcare workers and provide learning and recommendations for
systematic use of self-tests for future models of institution based COVID-19 self-testing
in congregate settings.