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Explainer: What you need to know about the new COVID-19 Home Testing kit?

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To enable a greater number of COVID-19 tests and reduce the burden on laboratories, the ICMR has recently approved a COVID-19 home testing kit which can be used by all adults at home. The test kit is called ‘CoviSelf’ and is designed to give results within 15 minutes of taking the test. Here is everything you need to know about ‘Home Testing’ kits.

With the rise in COVID-19 cases across the country, there is a need to scale up the testing. India has been conducting more than 20 lakh tests a day since 18 May 2021 and has been setting a new record for the highest number of tests conducted in a day. The increased burden on laboratories has resulted in delayed results, especially in the case of RT-PCR tests which further delays treatment and isolation. Quick testing and isolation are key to controlling the spread of infection, as noted time & again by various agencies. To address this issue, the Indian Council of Medical Research (ICMR) recently approved a self-use rapid antigen test (RAT) kit developed by Pune-based Mylab Discovery Solutions. CoviSelf is India’s first self-use kit for testing for COVID-19 at home that will give results in 15 minutes.  

The CoviSelf kit approved by ICMR consists of a pre-filled extraction tube, a sterile nasal swab, a test card, and a biohazard bag. The kit also comes with a user manual. To use the kit, people should first download the CoviSelf application on their phones, which is available in Google Play Store and Apple Store, and fill in their details. The application connects the data with the ICMR portal which will give the government access to the data for monitoring purposes. 

Source: CoviSelf

How to take the test?

Prior to taking the test, users must sanitize their hands. It should also be ensured that the surface on which the kit is placed for the test is clean. The nasal swab should be held by the tail-end and the other end should be inserted into the nose by 2-4 cm or until it touches the back of the nasal tract and rub it. Now that the specimen has been collected, the swab must be swirled inside the extraction tube filled with the liquid and closed tightly. Once the specimen mixes with the liquid, two drops should be dropped onto the testing card. The testing card displays the result in about 15 minutes and the result can be inferred as follows;

  • If two lines appear on the test card, one in front of the ‘t’ marker and the other in front of ‘c’ marker, it means the test is positive. That is, the person is COVID-19 positive. 
  • If only one line appears in front of the ‘c’ marker, it means that the test is negative.
  • If the test is invalid, no line will appear. 

Those with symptoms but test negative through RAT tests should be considered suspect COVID-19 cases and must take the RT-PCR test immediately. However, no test is required if the user tests positive in the RAT test. If positive, in either case, home isolation must be followed, or a doctor must be consulted based on the condition of the person. 

Once the test is done, the tube and swab should be sealed inside the biohazard bag and carefully disposed as biomedical waste. ICMR also advises users 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.

Who can use the self-test?

According to the advisory released by ICMR, it is advised that home testing be used only by symptomatic individuals and immediate contacts of laboratory-confirmed positive cases. Indiscriminate testing should be avoided. Individuals aged 18 years and older can take this test. For kids between the ages of 2 and 17, an adult member is to collect the sample. The self-test does not require a prescription. 

How to store the kit?

The test kit can be at room temperature in a place without direct sunlight and out of reach of children. It should not be frozen. Further, the test kit should not be used after the expiry date. If the Test Card has been outside of the sealed kit for more than 10 minutes, it should be discarded.

Where will the kit be available and what is the cost?

According to CoviSelf’s press release, the kit would cost Rs. 250 and will be available in an affordable pack of one across the country. According to PTI, the company is aiming to stock as many as one crore testing kits before it is rolled out for people to use by 01 June 2021. Mylab’s current production capacity is 70 lakh test kits per week and plans are in place to increase its capacity to 1 Crore test kits per week soon. The company’s target is to reach 90% of the pin codes in India.

How does home testing help during the pandemic?

Home testing is an important tool to test & isolate as laboratories are overburdened with samples, and results are taking much longer than usual. People can avoid the stress of booking appointments and visits to high transmission settings such as hospitals and diagnostic centres. The price of the kit is also relatively low, as compared to RAT tests which can cost at least Rs. 700, and RT-PCR tests which can cost around Rs. 1,200. Overall, these self-test kits help in saving time, money, and reduce the risk of transmission. The quick result will also the user take necessary precautions and treatment without delay. 

Is home testing really effective?

The effectiveness of home testing depends on a few factors including the person using the kit. One cannot rule out the possibility of incorrect collection of the sample, or contamination of the swab stick. There is even possibility that one may take the test too early. Another factor that affects the effectiveness of the test is the data being fed in the mobile application. It needs to be ensured that the users feed the correct details. In addition, users may also be careless while disposing the kit leading to dangerous biowaste.

The European Centre for Disease Prevention and Control in its report in March 2021 stated that “Shifting the responsibility of reporting test results from health professionals and laboratories to individuals could lead to underreporting and make response measures such as contact tracing and quarantine of contacts even more challenging”. Furthermore, “The reliability of the test result depends on a few factors: the ability of the person taking the sample and performing the test to follow instructions, the viral load at the time of the sampling, and the disease prevalence in the population when the test is taken.”, it stated. ECDC added that samples from self-testing would not be available for sequencing and monitoring variants of concern, which is an additional challenge. 

Source: ECDC

It is already known that the accuracy of RAT tests is lower than RT-PCR tests. RT-PCR tests are molecular tests that detect the genetic material of the virus while Antigen tests detect proteins in the virus. There is a high probability of a person who tested negative in the RAT test is COVID-19 positive. 

Have other countries authorized home-testing kits?

Other countries including the US, UK, and Canada have authorized home-testing. US’s FDA issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home in November 2020. ‘Lucira COVID-19 All-In-One Test Kit’ was authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. The kit could also be used in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test was initially authorized for prescription use only. However, a month later, FDA gave authorization for ‘Over-the-Counter’ home testing kits. 

Featured Image: COVID-19 Home Testing kit

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