Testing if one is COVID positive has been a long process, and at times, inconvenient. Now a home testing kit named CoviSelf, claims to make it hassle-free to know within minutes if someone is COVID positive. This invention may be a great leap in the world of medicine. 

For our comprehensive coverage and latest updates on COVID-19 click here.

What is the CoviSelf COVID-19 rapid antigen test?

Pune-based Mylab Discovery Solutions recently set a landmark by delivering the self-use COVID-19 test kit, CoviSelf, in India for Rs 250 per pack. The CoviSelf COVID-19 Rapid Antigen Test is an immunochromatographic nitrocellulose membrane test that detects COVID-19 nucleocapsid protein from nasal swab specimens using very sensitive antibodies. Coviself's (PathoCatch) COVID-19 OTC Antigen LF gadget is based on the rapid antigen test concept, in which a nasal swab sample is analysed for virus and findings are provided within minutes.

Mylab posted announcing the debut of the crucial product, "Today, Mylab took a critical and necessary step in assisting India and the rest of the globe in combating the greatest epidemic in human history. A move that will provide every Indian with the tools necessary to combat the epidemic. We are honoured to present India with the world's first self-use COVID-19 test kit, CoviSelf. The test takes two minutes to complete and 15 minutes to receive the results. It will be available in over 7 lakh pharmacies and our online pharmacy partners across India by the end of next week. Our goal is to reach 90% of India's pin codes."

RAT test kit

Meanwhile, the Indian Council of Medical Research has given its approval to a home-based Rapid Antigen Test (RAT) kit (ICMR). The apex scientific organisation has declared unequivocally that, "Only symptomatic persons and immediate contacts of laboratory-confirmed positive cases should undergo RAT testing at home. The use of indiscriminate testing is not recommended". A pre-filled extraction tube, a sterile nose swab, one test card, and a biohazard bag are included in each package. To minimise pain, the test is designed to be performed using a nose swab rather than a deep nasopharyngeal swab.

Local pharmacies and internet channel partners sell the test kits without requiring a prescription. It is approved for non-prescription home usage using self-collected nasal swab specimens from people aged 18 and up, as well as adult-collected samples from people aged 2 and up.

COVID-19 antibodies immobilised on the membrane as a Test line (T) and control solution specific antibodies immobilised on the membrane as a Control line (C) make up the test assembly (C). A buffered sample pad containing COVID-19 colloidal gold conjugated antibodies is also included with the test strip. The sample (specimen + lysis buffer combination) migrates with the colloidal gold nanoparticles when placed on the sample pad of the test equipment.

If a sample has detectable amounts of COVID-19 antigen, it will react with colloidal gold conjugated antibodies from the Ag-Ab complex. This complex subsequently migrates to the membrane and forms a test band when it interacts with the coated COVID-19 monoclonal antibodies on the test line (Test Line). Regardless of the presence of COVID-19 antigen, the procedural control line is formed by a colloidal gold conjugate antibody from the sample pad forming a complex with control solution-specific antibodies.

How to use the kit?

According to the ICMR guidelines, symptomatic persons identified as negative by RAT should be connected to the RT-PCR test facility and then tested by RT-PCR to rule out COVID-19 infection. In the meanwhile, such individuals will be encouraged to adhere to home isolation and treatment, as a negative RAT report may not be a real negative in some cases.

A positive result should be regarded as a true positive and does not require reconfirmation by the RT-PCR test. Furthermore, it is stated in the recommendations that before beginning the exam, carefully read the instructions. Individuals should do any tests with their own consent and entirely at their own risk, cost, and consequences.

In terms of storage, it is advised that it be stored at room temperature, out of direct sunlight, and out of reach of children, and that no test kit components be frozen or used beyond the expiration date. The ICMR further urged that home testing be carried out in accordance with the protocol outlined by the manufacturer in the user manual.

The ICMR has also informed consumers that the home testing mobile app is available on Google Play and Apple stores and must be downloaded by all users. According to the company, the mobile app offers a thorough guide to the testing method and will present the patient with a positive or negative test result. Data from the phone will be centralised recorded in a secure server linked to the ICMR's COVID-19 testing site, where all data will finally be saved.

Recommendations

The recommendation further said, 'All users are recommended to take a photograph of the test strip after finishing the test procedure with the same mobile phone that was used for downloading the mobile app and user registration'.

1. Data from your mobile phone's app will be centrally gathered on a secure server linked to the ICMR COVID-19 testing site, where all data will finally be archived. The patient's confidentiality will be totally protected.
2. Individuals who test positive may be regarded as genuine positives, and no further testing is necessary.
3. All symptomatic persons who test negative for RAT should be tested for RTPCR as away. This is especially essential because RATs are prone to missing a small number of positive cases with a low viral load.
4. All RAT negative symptomatic patients should be regarded as suspect COVID-19 cases and should adhere to the ICMR/MoH&FW home isolation guidelines while waiting for the RTPCR test result.
5. All findings should be interpreted in accordance with the procedure outlined by the manufacturer in the user manual (a picture and video link to the user manual is provided below next to the name of the authorised test kit).
6. The manufacturer's instructions for disposing of the test kit, swab, and other items must be meticulously followed.

In the meantime, the Managing Director of Mylab Discovery Solutions, said "We are sharing the power of early testing with citizens through CoviSelf. Thousands of lives will be saved as a result. We will make millions of kits available in India at a tenth of the cost of similar kits in the United States."

Most Western nations have made self-testing available to their citizens and regard it as a strong weapon for breaking the chain. This simple test, when combined with Mylab's AI-powered mobile app, allows a user to determine his or her positive status, send the result immediately to ICMR for traceability, and know what to do next in either event of the outcome. "We are certain that this minor move will be a significant step in minimising the second and following waves," the Director at Mylab commented. Mylab's current production capacity is 70 lakh tests per week, with ambitions to rise to 1 crore tests per week in 14 days.

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.