Roche COVID-19 Rapid Antigen Self-Test User Guide

COVID – 19
At-Home Test
COVID-19 Rapid Antigen self-test quick guide
Use Nasal Swab

Before performing the test, read the complete quick guide properly.

OVERVIEW AND DESCRIPTION

Common signs of a person infected with a SARS COV-2 include respiratory symptoms, fever, cough, shortness of breath, diarrhea, running nose, congestion, fatigue, loss of smell, loss of taste. It may take upto 14 days for a person to develop the signs & symptoms after exposure to SARS COV-2. Some patients may remain asymptomatic while others may have the severe disease even leading to death.
COVID-19 Rapid Antigen Self testing kits are helpful for the auxiliary diagnosis of SARS COV-2 infection. Please note that the test results are for clinical reference only and cannot be used alone as a basis for confirming or excluding cases.

PURPOSE OF USE

Intended to be used in individuals with symptoms suggestive of COVID-19. The test is used for the qualitative detection of SARS CoV-2 antigens in a nasal specimen by immunochromatography. It is an in vitro diagnostic medical device.

TEST PRINCIPLE

COVID-19 At-Home Test has two pre-coated lines, Control line (C) and Test line (T) on the surface of the nitrocellulose membrane. Both the control line and test line in the result window are not visible before applying any specimen. During the test, COVID-19 antigen in the specimen interacts with monoclonal gold conjugate making antigen-antibody color particle complex. This complex migrates on the membrane via capillary action until the test line, where it will be captured by the highly specific antibody. A colored test line would be visible in the result window if COVID-19 antigens are present in the specimen. If COVID-19 antigens are not present in the specimen, then no color appears in the test line. The control line is used for procedural control, and should always appear if the test procedure is performed properly and the test reagents are working.

KIT STORAGE AND STABILITY

Store the test kit at room temperature, 2-40°C out of direct sunlight. The materials provided are stable until the expiration date is printed on the box. DO NOT FREEZE.

Kit Content

STEP 1 Preparation for the test

1. Wash your hands thoroughly with soap before testing.

 When using the product, wear disposable plastic gloves, etc.

Scan the QR Code on the package to download the App

Open the QR code scanner (Google lens app.*) on android or camera app in iOS

Scan the respective QR code (either Android or iOS) mentioned on the outer box to download App.

Fill all the details in the app.
All fields are mandatory.

Check the expiry date at the back of the cassette package.

Open the cassette package to take out the cassette.

Scan the QR code on the cassette to link the code with your credentials.

Perform the test immediately after opening the cassette package.

2. Open the extraction buffer tube & nozzle cap pouch. Remove the lid of the extraction buffer tube. Place the extraction buffer tube into the extraction buffer tube holder in the package.

STEP 2 Specimen collection

3 Open the sterile swab pouch and take it out.

Be careful not to touch the swab head.

4 Before collecting the specimen, the individual has to blow his/her nose 3 times. Insert the same sterile swab up to 2 cm in both nostrils one by one and rub at least 5 times.

STEP 3 Test procedure

5. Put the swab removed from the inside of the nose into the extraction buffer tube. Stir it 10 times or more. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab and then close the nozzle cap by pressing it.

• Do not swallow or allow the solution to come into contact with your eyes mouth or any open wound.
• Keep it away from the reach of children.

6. Apply 3 drops of the extracted specimen to the specimen well of the cassette.

Adding incorrect volumes of the specimen may give false or invalid results.

After adding the specimen, start the timer in the app.

7. The mobile phone will give an alarm at the end of 15 minutes. Click the picture of the test card at 15 minutes.

Do not read the test result after 30 minutes. It may give false results.
Wait for the App to analyze and display your COVID-19 test result.

STEP 4 Interpretation of the test result

Positive Result

If both the Control line “C” and the Test line “T” are visible, the result is Positive. Even if the test band is faint, it should be considered as positive.

Note: All Individuals who test positive may be considered as true positives and no-repeat testing is required. All positive individuals are advised to follow home isolation & care as per the ICMR & Ministry of Health & Family Welfare (MoH&FW) protocol which can be accessed at: https://www.icmr.gov.in/chomecare.html

Negative Result
If only control line “C” and no test line “T” is visible, the result is Negative.

Note: All symptomatic individuals who test negative by Rapid antigen test should get themselves tested by RT-PCR.
This is especially important as the Rapid antigen test is likely to miss a few positive cases presenting with a low viral load. All Rapid antigen test negative symptomatic individuals may be treated as suspect COVID-19 cases and are advised to follow ICMR/ MoH&FW home isolation protocol while awaiting the RT-PCR test result.

Invalid Result
If the control line “C” is not visible, the result will be invalid.

STEP 5 Discarding the used components

The swab inserted in the Extraction buffer tube neutralizes SARS-CoV-2 & other viruses. All used components of the test should be put inside the waste disposal bag and discarded as Bio-Medical Waste in accordance with the facilities arranged by Local Urban Bodies. Disinfect all surfaces that the specimen may have touched and wash your hands after disposal.

*Disclaimer: GOOGLE LENS is a trademark of GOOGLE LLC. & is the property of GOOGLE LLC.
It has been used in this IFU for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

| Catalog number
---|---
| in vitro Diagnostics
| Consult Instructions for Use
| Contains Sufficient for Tests
****| Caution
| To indicate the temperature limitations in which the transport package has to be kept and handled.
| Do not re-use.
| Use by
| Batch code
| Manufacturer
| Date of manufacture
| Indicate that you should keep the product dry
| Keep away from sunlight
| Do not use if the packaging is damaged
| This way up

Manufactured by :
Roche Diagnostics India Pvt. Ltd.,
Manufacturing site: Plot No. 38, Sector – 4,
IMT Manesar, Gurugram, Haryana – 122 052, India

Marketed by :
Roche Diagnostics India Pvt. Ltd.,
501B, Cabin no. 1 601B, Silver Utopia, Cardinal Gracious Road,
Chakala, Andheri (East), Mumbai – 400 069, Maharashtra (INDIA)

For Complaints contact Customer Care Executive at:
Roche Diagnostic India Pvt. Ltd,
4th New No 48 and 50, Old No. 17 and 18, SKCL Harmony Square,
Prakasam Street, T.Nagar, Chennai – 600 017, Tamil Nadu, India.
Call: 1800 1237 599 (Toll-Free)
(Mon-Sat, 08:00 am to 08:00 pm)
Email: rps.online@roche.com. For Sale In India Only

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