As the COVID-19 pandemic continues to impinge upon our everyday lives, the high demand for diagnostic testing has overwhelmed molecular laboratory capacities. Although RT-PCR test remains the gold standard for detecting SARS-CoV-2, few challenges such as awaiting sampling, travelling to testing centres, and long waiting for the reports have increased the demand for safe and rapid testing alternatives. To accommodate the growing need of mass population for COVID testing, government and medical agencies of different countries have approved the distribution of self-diagnostic testing kits. At-home COVID testing kits can empower the general population to pursue diagnostic testing at the convenience of their home, rather than being subjected to frustrating and inadequate testing facilities.  

Self-testing kits can be a potential gamechanger for low-and middle-income countries where healthcare infrastructure is already under a lot of stress as they can dissipate the burden on existing manpower for collecting samples from home. Rather than waiting for the RT-PCR report to detect the virus, one can take the test and get the results within a few minutes or even seconds with self-diagnostic kit. If any person comes out to be positive, he/she can immediately quarantine themselves or seek medical help to prevent the transmission of the virus. Prevention at an early stage can greatly help to reduce the virus contamination within family groups, cohabitating individuals, or community at large, therefore self-diagnostic kits are essential in our fight against the deadly pathogen. 

Here are some of the popular self-diagnostic kits for COVID-19 testing. 

Lucira COVID-19 All-In-One Test 

Developed by Emeryville Biotech, Lucira COVID-19 All-In-One is one of the first molecular single-use self-diagnostic kits approved by the FDA. The kit intends to detect novel coronavirus SARS-CoV-2 among individuals aged 14 and older. The test kit is also authorized for use in point-of-care (POC) settings such as doctor’s offices, hospitals, emergency rooms, etc. During the test, a person requires to rotate the swab in each nostril five times, stir it in a sample vial, and then gently press it into the test unit. Within 30 minutes, the test unit’s light-up display shows the infection status of the person whether he/she is positive or negative. If the individual tests negative but continues to experience symptoms, then they should opt for the RT-PCR test. Lucira test kits employ targeted molecular amplification, that makes it reactive to more than 99.9% of Covid-19 viral sequences. 

Ellume COVID-19 Home Test

The Ellume COVID-19 Home Test is a rapid at-home lateral flow antigen test that can detect proteins of the SARS-CoV-2 virus among individuals aged two and above. The test kit can be bought without a prescription, which allows symptomatic as well as asymptomatic individuals to test themselves for the infection. The test kit includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer. The user requires to collect a mid-turbinate swab (further back than usual nasal swabs but not as far as nasopharyngeal swab), put it into the processing fluid, and check the infection status within 20 minutes. The results are automatically transmitted to the user’s smartphone via Bluetooth connected with a software application, that provides real-time reporting to health authorities and government bodies for further mapping. Ellume’s COVID-19 home test shows an overall sensitivity of 95% and specificity of 97% in a US clinical study. 

PanBio Covid-19 Antigen Test 

The CE-marked rapid antigen test kit launched by Abbott, PanBio^TM supports the detection of the SARS-CoV-2 virus in the asymptomatic population through nasopharyngeal samples. The patient-friendly and minimally invasive nasal swab enhances patient comfort and delivers real-time results on a smartphone. The rapid antigen testing kits are highly portable, reliable, affordable, and eliminate the risks of repeat testing in people who test positive. PanBio consists of a membrane strip precoated with the immobilized anti-SARS-CoV-2 antibody on the test line whereas the control line is coated with mouse monoclonal anti-chicken IgY conjugate. After completion of the procedure, the user needs to take a picture of the test strip and upload it on the registered home testing mobile app. The PanBio testing kit is available at Rs. 250/-.

CoviSelf 

CoviSelf is India’s first ICMR-approved self-testing kit developed by MyLab Discovery Solutions. The self-testing kit comes with a pre-filled extraction tube, sterile nasal swab, biohazard bag, and a testing card. After cleaning hands and disinfecting the surface where the kit needs to be placed, the user inserts a swab into the nose until it reaches into the back of the nasal tract. Then, the user has to swirl the tube into the extraction tube to mix it with the liquid inside, and then the tube is tightly closed. Only two drops of drops from the extraction tube are spilled into the testing card to detect the virus. Usually, two lines on the ‘t’ mark shows mean the person is positive whereas one line on ‘c’ mark shows that he/she is negative. The test is regarded as invalid if the no line shows within 20 minutes. The user needs to register himself at the CoviSelf app, enter all the required information, and provide test results, which would be further sent to the ICMR portal. Make sure to place the tube in a biohazard bag and dispose it off post testing. The CoviSelf self-testing kit is available at the price of Rs. 250/-.

Covi Direct 

Hyderabad-based Lorven Biologics in collaboration with the University of Mysore (UoM) have developed a COVID-19 self-testing kit, Covi Direct with an accuracy rate of more than 90%. The kit has been develoed utilizing the latest technologies in molecular biology, nanotechnology, and artificial intelligence. For testing, the individual can use body fluids such as sputum, nasal secretions, and saliva and detect infection status within 10 minutes. Whether a person has tested negative or positive, he needs to scan the barcode strip that is linked to an app, which informs the government agencies to monitor the cases immediately. During the second wave of coronavirus, unfortunately, 40% of RT-PCR tests were found to be negative as the virus continuously manipulate its genome. But the developers of the new kit claim that Covi Direct can detect many types of COVID-19 variants, that other testing kits fail to do. The testing kit has been sent to the Indian Council of Medical Research for emergency approval. Once approved, the price of the kit is expected to be only Rs. 100/-. 

Limitations of Self-diagnostic COVID-19 Testing Kits

·       Insensitive testing kits

Some types of rapid antigen tests cannot detect the virus until the infection has reached a high level in a person’s body, almost thousands or millions of viral copies per millilitre of the sample. When the infection reaches the highest levels then the person can become most contagious. On the contrary, PCR-based tests can pick up even small amounts of genetic materials during incubation and post-infectious period.

·       Inaccuracy 

People who are symptomatic and test negative on the self-diagnostic kit have to opt for RT-PCR to confirm the results. In a way, the rapid test kits are somewhat thought of as tests that determine infectiousness and not the infection. Most of the kits can detect only high viral loads so people with low viral loads can miss identification of SARS-CoV-2 virus in their nasal swabs. Confirmatory testing could lead to an increased burden on healthcare infrastructure. 

·       Fake Results

Many people who may be asymptomatic and test negative in self-diagnostic tests might not care for taking another test or opt for RT-PCR. But these people can become carriers of the virus and lead to further contamination within families and communities. Also, if the test shows a fake positive result, then the person would have to remain in isolation and follow other measures. 

·       High Risk of Contamination

The user is solely responsible for the management of the testing device, from testing to interpretation of the result without any medical assistance. People are not trained to perform the COVID-19 test responsibly and only rely on instructions provided on the test kit, so they might not be able to take the sample properly or use the kit as it is supposed to be. Also, negligence while disposing off the testing kit could result in the spread of infections.

However, the government can take some measures to reduce the limitations associated with self-testing such as providing clear and simple instructions for testing, detecting, and reporting results as well as incorporating results in national surveillance systems via software and application for proper mapping. 

Conclusion 

The self-testing kits are fundamental for Covid-19 management in India as they can help to cut queues in laboratories, reduce costs, provide quick results, and lead to prompt treatment and isolation. Early detection can help to contain the spread of infection and thus reduce community transmission and warrants consideration as part of a national containment strategy. Besides, the testing kit is affordable, simple, and quick, that reduces the overall expenditure and stress of booking appointments. On the contrary, reliability always remains a concern as the self-diagnosing kits increase chances of false negatives. However, self-testing methods can complement the sampling and testing methods in times of high pressure on healthcare and laboratories, but individuals must be provided with clear instructions for performing testing, interpreting results, and reporting to the government authorities to make testing kits a great success!

According to TechSci research report on “Global Coronavirus Testing Kits Market By Type of Test (Molecular v/s Serological), By Use (Multiple Test v/s Single Test), By Full Test Time (5 Hours-12Hours, 1 Hours-5 Hours, 15-60 Minutes, Less than 15 Minutes, 12 Hours-24Hours, More Than 1 Day), By Technology (RT-PCR, Rapid Diagnostic Test, ELISA Tests, Others), By Specimen Type (Nasopharyngeal specimen, Oropharyngeal specimen, Blood, Sputum, Others), By Mobility (Stationary v/s Mobile), By End Use (Public Health Labs, Hospitals, Private or Commercial Labs, Physician Labs, Others), By Region, Competition Forecast & Opportunities, 2026”, global coronavirus testing kits is expected to grow at a formidable CAGR during the forecast period. The growth can be attributed to the rising incidences of coronavirus cases as well as surge in demand for early diagnostic requests.

According to another TechSci research report on “Global Coronavirus Diagnostics Market By Type of Test (Molecular v/s Serology), By User (Multiple v/s Single), By Full Test Time (1 Hour - 12 Hours, Less Than 60 Minutes, 13 Hours - 24 Hours, More Than 1 Day), By End User (Hospitals, Public Health Labs, Private or Commercial Labs, Physician Labs, Others), By Region, Competition Forecast & Opportunities, 2026”, the global coronavirus diagnostics market is anticipated to reach USD15.57 million by 2026. The growth can be attributed to the rising incidences of the disease as well as introduction of self-diagnosing testing kits across different parts of the globe.