Mylab Discovery Solutions has today announced that it has received ICMR's approval for India's first self-use Rapid test for Covid-19. The test is developed in India and is named as CoviSelfTM. The self-use test can be used by the Individuals themselves and will not need sample collection by a healthcare professional.
Mylab CoviSelf COVID-19 Rapid Antigen Self Test Kit is designed to assist you in taking a safe rapid antigen test easily at the comfort of your home. Get your and your family's immediate COVID-19 Rapid Antigen test done quickly and hassle-free with this self-assessing kit. Now you can get tested for COVID-19 in just 15 minutes with this test kit.
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The CoviSelf COVID-19 Rapid Antigen Test is an in vitro diagnostic test for the qualitative detection of COVID-19 antigen in nasal swab specimens directly from individuals with or without symptoms or with other epidemiological reasons to suspect COVID-19. The test is authorized for non-prescription home use with self-collected nasal swab specimens from individuals aged 18 years and older or with adult collected samples from individuals aged 2 years or older.
Each pack contains
The CoviSelf COVID-19 Antigen Test is a self-test kit for the detection of protein antigen from SARS-CoV-2 in direct nasal swab samples from individuals with or without symptoms of COVID-19.
Yes. This test is authorized for non-prescription home use with self-collected nasal swab specimens from individuals aged 18 years and older or with adult-collected nasal swab samples from individuals aged 2 years or older.
For positive results, if both the quality control line C and the test line T appears, novel coronavirus antigen has been detected and the result is positive. This takes up to 10-15 minutes for the results to appear.
Positive results indicate the presence of viral antigens. Individuals who test positive with CoviSelf COVID-19 Antigen Test should self-isolate and seek follow up care with their physician or healthcare provider as additional testing may be necessary.
For Positive Test:
A positive test should be considered as true positive and does not need reconfirmation by the RT-PCR test.
For negative results, if there is only a quality control line C and the test line T does not appear, this indicates that novel coronavirus antigen has not been detected and the result is negative. This usually takes up to 15-20 minutes to confirm the negative result.
For Negative test:
Symptomatic individuals identified negative by Rapid Antigen Test should be linked with RT-PCR test facility and subsequently get tested by RT-PCR to rule out infection. In the meantime, such individuals will be urged to follow home isolation and treatment as a negative report on Rapid Antigen Test may not be true negative in some cases.
No potential hazard or side effects are associated with the test, however there might be
The results from the CoviSelf COVID-19 Antigen Test along with any medical history can help your healthcare provider make informed recommendations about your care. The results of this test may help limit the spread of COVID-19 to your family and others in your community if you take the necessary precautions.
No, the nasal swab (called the Safe Swab) is specially designed by Mylab which is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, please stop the test and seek advice from a healthcare provider.
Molecular test (also known as RT-PCR tests) detect the genetic material of the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus, but are not as sensitive as molecular tests.
This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test would help with your care, and when you should discontinue home isolation.
Each CoviSelf COVID-19 Antigen Test pouch contains:
The following are the test preparations before the test:
The liquid in the tube is a virus inactivating solution which does not cause any spread or contamination to the environment.
All contents of the kit should be discarded in the disposal bag into the household waste
Yes. Before starting the test, please download the Mylab CoviSelf App on Google Play or App Store. It is important to fill in your credentials and proceed with the test.
You can store the test kit at room temperature in a place out of direct sunlight and out of reach of children. Do not freeze any of the test kit contents. Do not use test kit after the expiration date.
Make sure all tests reagents are at room temperature before use.
For invalid results, if the quality control line C is not observed, it will be invalid regardless of whether there is a test line T. In this case, the test shall be conducted again.
If you are experiencing any congestion in your nostrils, you must first decongest your nostrils by removing the mucous/congestion.
You need to insert the nasal swab up to 2-4 cms until resistance is met.
Yes, please put all the components of the test in the disposal bag and discard the entire bag in the house hold waste bin.
No
Once the test is performed, the nasal swab cannot be reused. It must be discarded along with the other contents of the kits into the disposal bag provided.
It is important you do not touch the head of the swab as it will lead to contamination and improper results.
No. Please check the contents of the kit before performing the test.
Any results appearing after 20 minutes are considered invalid.
Antigen tests provide an additional layer of protection. These tests don't provide guaranteed security against the COVID-19 infection but they help reduce the spread. A good level of protection can be achieved when rapid tests, masks, social distancing, and better ventilation are added together.
ICMR is the regulatory body in India which is responsible for the curb of COVID-19 pandemic along with other important regulatory bodies. Reporting the results helps the body and authorities curb the spread of the disease. It thus becomes our moral obligation to help ICMR by reporting our test result data.
The results from the CoviSelf COVID-19 Antigen Test along with any medical history can help your healthcare provider make informed recommendations about your care.
The results of this test may help limit the spread of COVID-19 to your family and others in your community if you take the necessary precautions.
The home test results are quick, accurate and can be taken frequently with almost immediate results.
The test is authorized for non-prescription home use with self-collected nasal swab specimens.
Currently, Home testing by Rapid Antigen Test (RAT) is advised in symptomatic individuals and immediate contacts of confirmed positive cases.
Yes. You can perform the antigen home test to check if the results are positive or negative and seek follow-up care with your physician and healthcare provider. Also please follow ICMR guidelines.