CoviSelf Covid 19 Rapid Antigen Self Test Kit

COVID-19 Rapid AntigenSelf Test Kit(RAT) is the first COVID-19 self-test kit in India. It is an in vitro diagnostic test for the qualitative detection of COVID-19 antigen in nasal swab specimen directly from individuals with or without symptoms or with other epidemiological reasons to suspect COVID-19.

The user will get the test results within 20 minutes from the safety of their own house. The test reports can be checked using the MyLab app. Both testing materials, a guidelines for use (IFU) leaflet, and a biohazard bag to properly dispose of test materials will be included with each package. To minimise pain, the procedure is intended to be performed using a nasal swab rather than a deep nasopharyngeal swab.

Uses:
The Rapid Antigen Self Test kit allows the user to get himself/herself tested at home without any discomfort.

Product Specifications and Features:

• Intelligently Designed Tube: Filled with a solution that inactivates the virus and it has been designed in the manner to control and contain biohazard

• Unique QR Code: For accurate report generation

• Biohazard Bag: Biohazard bag for easy and safe disposable

• Safe Swab: Swab is designed intelligently for bio containment

How to check positive/negative result:

• If both the quality control line “C” and the detection line appear, the novel coronavirus antigen has been detected and the result is negative for the antigen. (Look very closely, as the bottom line can be very faint. Any pink/purple line visible indicates a positive result)

• If there is only a quality control line “C” and no test line “T”, it indicates that the result is negative

Directions For Use:
Test preparation:

• Wash your hands and make sure they are dry before starting the test procedure

• Tear the pouch and keep the individual components ready for testing

• Open the MyLab Coviself app and fill in the credentials (All fields are mandatory as per ICMR)

• Open the pouch containing the test device(cassette)

• Scan the OR code on the cassette to link the code with your credentials

How To Use:

• Find the pre-filled buffer tube and remove it out of the pouch and tap vertically on the horizontal surface, to make sure the extraction buffer settles at the bottom of the tube

• Unscrew the cap and hold the tube in your hand. Do not spill the content of the tube

Step 1:Open the swab package from the tail end and take the swab out (Do not touch the swab head)

Sampling with a nasal swab:

• Using the sterile swab provided in the kit, carefully insert the swab into one nostril. The swab tip should be inserted up to 2-4cm or until resistance is met

• Roll the swab 5 times inside the nostril to ensure that cells are collected

• Using the same swab, repeat this process for the other nostril to ensure that an adequate sample is collected from both the nasal cavities

• Withdraw the swab from the nasal cavity. The specimen is now ready for testing using the extraction buffer provided in the test kit

Step 2:

• Take the nasal swab and dip in the pre-filled extraction tube. Pinch the tube at the bottom and swirl the nasal swab 10 times ensuring the swab is immersed well in the extraction buffer

• Find the breakpoint of the swab. Break the swab at the breakpoint. Discard the remainder of the swab. Mix well

Step 3:

• Do not leave the test device unused once opened for more than 5 minutes. Add 2 full drops of extracted antigen buffer mixture into the sample well of the test device, by pressing the tube and wait for 10-15min for the results to appear

• Read the results within 20 minutes. Strong positive results can be reported within 10-15 minutes. Results that appear after 20 minutes are not valid (Phone will give you the alarm to capture the test results)

Step 4:

• Take the test device and click a picture (Wait for the app to analyse and display your COVID-19 test results)

• The swab is inserted in the lysis buffer which destroys the COVID-19/respiratory viruses. This tube (with swab head inside), is to be put inside the waste disposal bag and this bag can be thrown in the household waste

Kit Storage and Stability:

• You can store the testing kit at room temperature in a place out of direct sunlight and out of reach of the children

• Do not freeze any of the test kit components

• Do not use test device and reagents after the expiration date

Safety Information:

• Read the label carefully before use

• The test is authorized for non-prescription home use with self-collected nasal swab specimen from individuals aged 18 years and older with adult

• 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

FAQs:
Q. Is the test authorized for home use?
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.

Q. How do you know when the result is positive?
If both Control Line C and the Test Line T appears in the cartridge, the presence of novel coronavirus antigen is confirmed and the result is positive. This takes up to 10-15 minutes for results to appear.

Q. 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 for further action.