Description
- Technical Product Name: Covid-19 Antigen lateral flow test device
- Generic Name: Covid-19 Self Test Kit
- Brand Name: CoviSelf™
- Use: For single use only | Not for Internal or medicinal use | OTC Home Test
- Safety: Keep out of reach of children
- Expiry: 2 years from the manufacturing date.
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
- Store between 2°C – 30°C.
- Store in a dry place, away from direct sunlight and humidity.
- Do not use the contents beyond the expiration date printed on the label.
- The expiration date is 24 months from manufacturing date.
User Instructions
- Use only the accessories available with the kit. Single Use Only.
- Do not re-use the Kit Components.
- Do not use the product if the package is damaged.
- Refer the User Manual provided with Kit before conducting the test.
- Must be age 18+ to use this kit. Suitable for age 2+ years.
Kit Components
Net Quantity: 5 packs
Each pack contains
- Pre-filled Extraction Tube – 1 N
- Test Card – 1 N
- Instruction For Use- 1 N
- Sterile Nasal Swab – 1 N
- Disposal Bag – 1 N
Manufactured By
Marketed By
Mylab Discovery Solutions Private Limited Plot No. 99-B, Lonavala, Industrial Co-operative Estate Ltd., Nangargaon, Lonavala, Pune, Maharashtra 410401, India.
Email: care@mylabglobal.com, Contact Customer Care at 1800-121-8684 website: www.coviself.com
Disclaimer
ICMR Advisory: Currently, Home testing by Rapid Antigen Test (RAT) is advised in symptomatic individuals and immediate contacts of confirmed positive cases.
For Negative Test: Symptomatic individuals identified negative by RAT should be linked with RT-PCR test facility and subsequently get tested by RT-PCR to rule out infection. In the meantime, such individual will be urged to follow home isolation and treatment as a negative report on RAT may not be true negative in some cases
For Positive Test: A positive test should be considered as a true positive and does not need reconfirmation by the RT-PCR test.
Read the instructions before performing the test. All tests should be conducted by the individuals with their own consent and completely at their own risk, cost and consequences, and the test results should be uploaded at the ICMR site using the Mylab CoviSelf App.