India on Wednesday approved the first home-based testing kit for coronavirus, reported the Hindustan Times. Residents can buy the kit at Rs 250 and it will provide results within 15 minutes.
The Indian Council of Medical Research said it has approved a rapid antigen test kit manufactured by Pune-based Mylab Discovery Solutions. In a statement, the medical research body said that the testing is advised for use only on symptomatic individuals and immediate contacts of laboratory-confirmed positive cases.
“All symptomatic individuals who test negative by RAT should get themselves immediately tested by RT-PCR,” the statement said. “This is especially important as the RATs are likely to miss few positive cases presenting with a low viral load.”
Rapid antigen tests are considered less sensitive than lab-based RT-PCR tests. This means that some results from the RAT may show false negatives – wrongly indicating that the infection is absent. However, experts believe that their accuracy of the tests increase when the viral load is high.
The ICMR asked users to download the home testing mobile application available on Google Play Store and Apple store. “The mobile app is a comprehensive guide of the testing procedure and will provide a positive or negative test result to the patient,” it said. “All users are advised to click a picture of the test strip after completing the test procedure with the same mobile phone, which has been used for downloading the mobile app and user registration.”
The research body also asked residents to take the test according to the user manual provided by the manufacturer and strictly follow the guidelines on the disposal of the kits. Users can download the manual for Mylab Discovery Solutions test kits, CoviSelf, here.
The testing kit comes with a pre-filled extraction tube, a sterile nasal swab, one test card, and a biohazard bag.
“Insert the nasal swab in both the nostrils up to 2 to 4 cm or until resistance is met” the user manual says. “Roll the swab five times inside both your nostrils. Immerse the swab in the pre-filled tube and break the remaining swab; close the cap of the tube.”
The manual then says to put two drops, one after the other, on the test card by pressing the tube and wait for 15 minutes for the result. “Any result taking more than 20 minutes to appear is considered invalid,” it says.
The test card has two sections, according to the manual. If the bar shows up only to the control section “C”, the result is negative. If the bar can be seen on both the control section and test section “T”, the test is positive.
Mylab Discovery Solutions Managing Director Hasmukh Rawal said that a positive test will take five to seven minutes and a negative result will take maximum 15 minutes.
At a press briefing on Thursday evening, Indian Council of Medical Research Director General Balram Bhargava said that applications of three more companies making home-testing kits were in the process, ANI reported.
India has conducted 32,03,01,177 Covid-19 tests as of Tuesday, ICMR data showed. The home-based testing kits are expected to take off the pressure from testing laboratories.
However, the figures show that India is not conducting tests at its full capacity, according to NDTV. India has a capacity of conducting 33 lakh tests a day, but the daily average is 18 lakh, which has increased from 10 lakh on April 1. This means that 45% of the country’s testing capacity is unused.
On Wednesday, India registered 2,67,334 new coronavirus cases, taking the total count of infections to 2,54,96,330 since the pandemic broke out in January 2020. The country reported 4,529 deaths, its highest single-day toll. This pushed the overall fatality count to 2,83,248.