ICMR has approved India’s COVID-19 self-testing kit
Indian council of medical research (ICMR) on Wednesday approved the country’s first COVID-19 self-testing kit for home use. That means anyone may collect a nose sample and have it tested for SARS-CoV-2.
The gold standard for COVID-19 testing, the RT- PCR test takes 3-4 days to get results, Which delaying hospitalisation and treatment. Self- test kit has the potential to revolutionise COVID-19 management in India. These can shorten lab lines, save money, relieve existing manpower from collecting samples from homes and deliver speedy result within 15 minutes, allowing for faster treatment and isolation.
MyLab Discovery Solutions, a molecular firm based in Pune, Invented CoviSelf. It employs a fast antigen test, which analyses a nasal swab sample for the virus and provide resulting 15 minutes. it takes less than two minutes to complete the test.
This test kit costs INR250, while an RT-PCR test cost between INR400 and INR1500, and fast antigen test in a lab cost between INR300 and INR900 depending on the state.
MyLab’s current weekly production capacity is 70 Lac kits, with ambition to increases to 1,00,00,000 kit in next two weeks. At India the kits would be offered in at least seven Lakh pharmacies and e-pharmacy portals.
“This simple test pairs with MyLab’s AI-powered mobile app so that a user may determine if he or she is positive, submit the result immediately to the ICMR for traceability, and know what to do next in either case.
Covid-19 Rapid Antigen Tests, home testing kit recommendation
Only symptomatic persons and close relatives of laboratory-confirmed positive cases should undergo RAT testing at home. The use of indiscriminate testing is not recommended. Home testing should be done according to manufacturer’s instructions in the user Handbook. All users must download the home testing mobile app, which is accessible in Google Play and Apple stores.
The mobile app is a comprehensive guide to testing procedures and will provide a positive or negative test result to the patient. 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 to downloading the mobile app and user registration. Data from your mobile Phone’s app will be centralised on a secure server linked to the ICMR Covid-19 testing portal, where all the data will finally be saved. Patient privacy shall be protected to fullest extent possible.
All people who tested positive are deemed true positives, and no further testing is necessary. All test positive individuals are encouraged to follow the ICMR and Ministry of Health and family welfare (MOH & FW) guideline for home isolation and care, which may be found at https://www.icmr.gov.in/chromecare.html.
All symptomatic people whose test negative for RAT should get an RT-PCR test done right away. This is especially essential because RAT is likely to miss a small number of positive cases with low virus loads. While waiting for the RTPCR test result, all RAT negative symptomatic person should be regarded as a suspect COVID-19 cases and should follow the ICMR/MOH & FW home isolation policy. All results should be interpreted according to the manufacturer protocol in user Handbook. The test kit, swab, and other materials must be disposed of according to the manufacturer recommendations.
KIT STORAGE AND STABILITY
- You can store the testing kit at a room temperature in a place out of direct sunlight and out of reach of children.
- Do not freeze any of the kit components.
- Do not use the device under reagents after the expiration date.
PRINCIPLES OF THE TEST
The CoviSelf COVID-19 Rapid Antigen Test is an immunochromatographic nitrocellulose membrane assay that detects COVID-19 nucleocapsid protein from nasal swab specimens using highly sensitive antibodies.
COVID-19 antibodies immobilised on the membrane as the tested line(T) and control solution specific antibodies immobilised on the membrane as control line make up the test assembly (C). A buffered sample pad containing COVID-19 colloidal gold conjugated antibodies is also included with the test strip. When the sample is placed on the test device sample pad, it migrates with colloidal gold nanoparticles.
If COVID-19 antigen is present in the sample, it combines with colloidal gold conjugated antibodies to form the Ag-Ab complex. The complex subsequently migrates to the membrane, where it reacts with the coated COVID-19 monoclonal antibodies on the test line, forming the test band (This Line). Even if COVID-19 antigen is present, a colloidal gold conjugate antibody from the sample pad travels forward and former a complex control solutions-specific antibodies to generate the procedural control line.
Source: ICMR/MyLab Discovery Solutions/twitter