As India's testing capacity continues to reel under the mounting number of COVID-19 cases, the Indian Council of Medical Research (ICMR), on Tuesday, issued an advisory for the home testing of COVID-19 using Rapid Antigen Tests (RATs). CoviSelf—developed by Pune-based Mylab Discovery Solutions— is the first self-use Rapid test for COVID-19 to receive the ICMR's approval.
The advisory also recommended that only symptomatic individuals and immediate contacts of laboratory-confirmed positive cases avail home testing; discouraging indiscriminate testing. A mobile application called CoviSelf—which will be available on Google Play Store and Apple store—will serve as the primary platform for the testing process.
What is CoviSelf?
It is a completely self-administered COVID-19 diagnostic test that requires no sample collection training; thereby, eliminating the need for a healthcare professional. CoviSelf, which is priced at Rs.250, can be purchased at local pharmacies without a prescription, and through select online channels.
The test must be performed after downloading the app and completing the registration process. A QR code will be present inside the package, which must be scanned through the app.
Every kit will come with all the materials required for testing along with an IFU (instruction for use) leaflet. A pre-filled buffer tube with an antigen reagent and a swab will be available in the kit. The test uses a nasal swab, unlike the currently employed RT-PCR test that uses a nasopharyngeal swab which may cause discomfort.
After opening the tube, the individual must collect a nasal sample, and follow the instruction to safely deposit the sample inside the tube and prepare the testing solution. Next, a few drops of the solution must be transferred to a strip (similar to those in pregnancy kits) that comes with the kit.
After waiting for 10-15 minutes, a photograph of the strip must be uploaded to the app for analysis and results. A biohazard bag for safe disposal following testing will also be provided with the testing kit. According to Mylab, CoviSelf will provide results in only 15 minutes.
IMCR's Advisory for Home testing
In its advisory, the IMCR also issued other post-test guidelines. They are as follows:
- The picture of every individual test must be uploaded using only the phone on which the app has been downloaded and registered.
- Individuals who test positive will be considered as true positives and there will be no need for repeat testing.
- Those who test positive must adhere to all home isolation and care instructions according to the ones laid down by the ICMR & Ministry of Health.
- Symptomatic individuals, who test negative using RAT, must immediately undergo conventional RT-PCR testing. This is because RAT is likely to miss identifying a handful of positive cases if the viral load is very low.
- All RAT negative symptomatic individuals must be treated as suspected COVID-19 cases and must follow all isolation protocols while they await the results of the RT-PCR test.
- Instructions of the manufacturer for the disposal of the test kit, swab, and other materials must be adhered to strictly.
Safety and Confidentiality
The circular also added that all test results must be interpreted according to the protocol laid down by the manufacturer in the user manual. Data from the app will be captured centrally in a secure server that is connected to the COVID-19 testing portal.
Eventually, all data will be stored on the server. With concerns over privacy and identity still prevalent among COVID-19 patients, the advisory addressed them as well. "Patient confidentiality will be fully maintained," read a portion of the document.
Stressing on the potential of the test, Hasmukh Rawal, Managing Director of Mylab Discovery Solutions, said in a press release: "This is the biggest crisis our country has ever faced. Time and again, we have tried to observe carefully what our country needs and developed solutions with social benefit at the core. With CoviSelf, we are sharing the power of testing early with the citizens. It will save thousands of lives. For India, we will make millions of kits available at fraction of the cost of such kits in the US."