INDICAID COVID-19 Antigen Rapid Test Instruction Manual

1. Introduksjon

This manual provides detailed instructions for the proper use of the INDICAID COVID-19 Antigen Rapid Test. This test is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen from direct anterior nasal swab specimens. It is intended for self-administration by individuals aged 15 years or older, or by an adult for children aged 2-14 years.

The INDICAID COVID-19 Antigen Rapid Test is authorized for emergency use by the FDA for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.

Image 1.1: INDICAID COVID-19 Antigen Rapid Test Kit Packaging.

2. Produktkomponenter

Each INDICAID COVID-19 Antigen Rapid Test kit contains the following components:

Image 2.1: Contents of the INDICAID COVID-19 Antigen Rapid Test Kit.

• Testenhet: Individually sealed pouch containing a test cassette.
• Buffer Solution Vial: Pre-filled tube with extraction buffer.
• Neseprøve: Sterile swab for specimen collection.
• Bruksanvisning: Denne håndboken.

Ensure all components are present and undamaged before proceeding with the test.

3. Oppsett og forberedelse

Before starting the test, please follow these preparation steps:

1. Read the entire instruction manual carefully before performing the test.
2. Vask hendene grundig med såpe og vann i minst 20 sekunder, og tørk dem deretter helt.
3. Open the kit box and place all components on a clean, flat surface.
4. Check the expiration date on the kit box and individual component packaging. Do not use expired tests.
5. Ensure the test device pouch is intact and open it just before use.

4. Bruksanvisning

Follow these steps precisely to perform the INDICAID COVID-19 Antigen Rapid Test:

1. Step 1: Collect Nasal Swab Sample

   Carefully open the sterile nasal swab package. Insert the entire soft tip of the swab into one nostril about 1/2 to 3/4 inch (1 to 1.5 cm) until resistance is met. Rotate the swab 5 times against the nasal wall. Using the same swab, repeat the process in the other nostril. Withdraw the swab from the nostril.

   

   Image 4.1: Proper nasal swab collection technique.

2. Trinn 2: Forbered Sample

   Unscrew the cap of the buffer solution vial. Insert the swab tip into the buffer solution vial. Swirl the swab vigorously in the solution 10 times, pressing the tip against the bottom and sides of the vial to ensure the sample is thoroughly mixed with the buffer. Remove the swab while squeezing the sides of the vial to extract as much liquid as possible from the swab tip. Dispose of the swab in a biohazard bag or household waste.

3. Step 3: Apply Sample to Test Device

   Place the dropper cap firmly onto the buffer solution vial. Invert the vial and add three (3) drops of the solution into the sample well (S) of the test device. Do not touch the test device with the dropper tip.

   

   Image 4.2: Applying sample to the test device (left side of image) and result interpretations (right side).

4. Trinn 4: Vent på resultater

   Still inn en timer på 20 minutter. Les av resultatene nøyaktig etter 20 minutter. Ikke les av resultatene før 20 minutter eller etter 25 minutter, da dette kan føre til unøyaktige avlesninger.

5. Tolke resultater

Refer to Image 4.2 for visual examples of result interpretations. The test device has two lines: a Control Line (C) and a Test Line (T).

• Positivt resultat: Two colored lines appear. One colored line appears at the Control Line (C) region and another colored line appears at the Test Line (T) region. Any faint line at the T region should be considered positive. A positive result indicates the presence of SARS-CoV-2 antigens.
• Negativt resultat: One colored line appears at the Control Line (C) region. No colored line appears at the Test Line (T) region. A negative result indicates that SARS-CoV-2 antigens were not detected.
• Ugyldig resultat: No colored line appears at the Control Line (C) region, or only a colored line appears at the Test Line (T) region. An invalid result indicates that the test did not work correctly. In this case, discard the test and repeat with a new test kit. If the issue persists, contact customer support.

A positive result does not rule out co-infections with other pathogens. A negative result does not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions.

6. Vedlikehold og lagring

Proper handling and storage ensure the reliability of the test kit.

• Lagring: Store the test kit at room temperature, between 2°C to 30°C (36°F to 86°F), away from direct sunlight and moisture.
• Utløp: Do not use the test kit beyond the expiration date printed on the packaging. The FDA has granted a shelf-life extension for this product, increasing its shelf life from 6 months to 15 months. Always check the updated expiration date if available.
• Avhending: After use, place all test components in a sealed plastic bag and dispose of them with household waste according to local regulations.

Bilde 6.1: Eks.ample of Lot Number and Expiration Date on product packaging.

7. Feilsøking

Hvis du støter på problemer under testing, kan du se følgende vanlige problemer og løsninger:

For ytterligere hjelp, vennligst kontakt kundestøtte.

8. Spesifikasjoner

• Produktnavn: INDICAID COVID-19 Antigen Rapid Test
• Modell: Covid-19 antigen rask test
• Produsent: Indicaid
• Pakkedimensjoner: 7.99 x 2.6 x 1.06 tommer
• Vekt: 1.76 unser
• Dato først tilgjengelig: 18. juli 2022
• Holdbarhet: Up to 15 months (check specific expiration date on packaging)
• Testtid: 20 minutter

9. Garanti og støtte

For information regarding product warranty, please refer to the official INDICAID website or contact their customer support directly. If you have questions or require assistance with your INDICAID COVID-19 Antigen Rapid Test, please reach out to the manufacturer's customer service.

Du finner mer informasjon og støtteressurser på INDICAID Brand Store.