CoviSelf - COVID-19 Self Test Kit from Mylab

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.

Key Benefits

Description

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Intended Use

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.

Kit Storage and Stability

User Instructions

Kit Components

Each pack contains

Rapid Antigen Self Test Kit FAQ

What is the intended use of CoviSelf COVID-19 Antigen Test?

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.

Is the test authorized for home use?

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.

How do you know when the result is positive?

Positive Cassette

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.

What do positive results indicate?

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.

How do you know when the result is negative?

Negative Cassette

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.

What do negative results indicate?

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.

What are the known and potential hazards of this test?

No potential hazard or side effects are associated with the test, however there might be

  • Possible discomfort during sample collection.
  • Possibility to interpret incorrect test results.

What are the benefits of this test?

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.

Will this test hurt me in the nose?

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.

What is the difference between an antigen and molecular test?

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.

What are the contents in a CoviSelf COVID-19 Antigen Test kit?

Each CoviSelf COVID-19 Antigen Test pouch contains:

  • One pre-filled extraction tube
  • One sterile nasal safe swab
  • One instruction manual
  • One test card
  • One Disposal bag

What are the test preparations before the test?

The following are the test preparations before the test:

  • First, it is important that you find a clean place to do the test.
  • Identify a table and sanitize the surface thoroughly.
  • Wash your hands with soap and make sure that your hands are dry before you perform the test.
  • Tear the pouch and lay the contents of the kit on the table.
    You have:
    • One instruction manual
    • One pre-filled extraction tube
    • One sterile nasal safe swab
    • One test card
    • One Disposal bag
  • Before you proceed with the test, please download the MylabCoviSelf App either on Google Play or App Store. Fill in the credentials and proceed with the test.

Is the liquid (knows as extraction lysis buffer) in the pre-filled extraction tube safe?

The liquid in the tube is a virus inactivating solution which does not cause any spread or contamination to the environment.

How to discard the contents of the kit after the test results?

All contents of the kit should be discarded in the disposal bag into the household waste

Is it important to fill in your credentials before the test?

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.

What are the precautions for kit storage?

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.

Is it necessary to maintain room temperature for all test reagents in the kit?

Make sure all tests reagents are at room temperature before use.

How do you know when the result is invalid?

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.

What if you experience congestion in either of the nostrils, can you still perform the test?

If you are experiencing any congestion in your nostrils, you must first decongest your nostrils by removing the mucous/congestion.

How far back must you insert the nasal swab in your nostrils?

You need to insert the nasal swab up to 2-4 cms until resistance is met.

Can we discard the test components in a regular bin?

Yes, please put all the components of the test in the disposal bag and discard the entire bag in the house hold waste bin.

Can we use the test kit after expiry date?

No

Can we reuse the swab?

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.

What will happen if I touch the head of the swab?

It is important you do not touch the head of the swab as it will lead to contamination and improper results.

Can we use a damaged kit?

No. Please check the contents of the kit before performing the test.

Can the test line form after 20 minutes? What happens if the test results come positive after 20 minutes?

Any results appearing after 20 minutes are considered invalid.

If my antigen test comes out to be negative, does it mean that I am immune against the COVID-19 infection?

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.

What are the benefits of reporting the results to ICMR?

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.

What are the benefits of home use test?

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.

When should I take an antigen test?

Currently, Home testing by Rapid Antigen Test (RAT) is advised in symptomatic individuals and immediate contacts of confirmed positive cases.

Should I undertake an antigen test if any of my family members have tested positive?

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.

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