Manual de instrucțiuni pentru testul rapid INDICAID COVID-19 Antigen

1. Introducere

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. Componentele produsului

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.

• Dispozitiv de testare: Individually sealed pouch containing a test cassette.
• Buffer Solution Vial: Pre-filled tube with extraction buffer.
• Tampon nazal: Sterile swab for specimen collection.
• Instructiuni de utilizare: Acest manual.

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

3. Configurare și pregătire

Before starting the test, please follow these preparation steps:

1. Read the entire instruction manual carefully before performing the test.
2. Wash your hands thoroughly with soap and water for at least 20 seconds, then dry them completely.
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. Instrucțiuni de utilizare

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. Pasul 2: Pregătiți 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. Pasul 4: Așteptați rezultatele

   Set a timer for 20 minutes. Read the results at exactly 20 minutes. Do not read the results before 20 minutes or after 25 minutes, as this may lead to inaccurate readings.

5. Interpretarea rezultatelor

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).

• Rezultat pozitiv: 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.
• Rezultat negativ: 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.
• Rezultat nevalid: 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. Întreținere și depozitare

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

• Depozitare: Store the test kit at room temperature, between 2°C to 30°C (36°F to 86°F), away from direct sunlight and moisture.
• Expirare: 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.
• Eliminare: After use, place all test components in a sealed plastic bag and dispose of them with household waste according to local regulations.

Imaginea 6.1: Example of Lot Number and Expiration Date on product packaging.

7. Depanare

If you encounter issues during testing, refer to the following common problems and solutions:

Pentru asistență suplimentară, vă rugăm să contactați serviciul de asistență pentru clienți.

8. Specificații

• Nume produs: INDICAID COVID-19 Antigen Rapid Test
• Model: Test rapid antigen COVID-19
• Producător: Indicaid
• Dimensiuni pachet: 7.99 x 2.6 x 1.06 inci
• Greutate: 1.76 uncii
• Data primului disponibil: 18 iulie 2022
• Perioada de valabilitate: Up to 15 months (check specific expiration date on packaging)
• Timpul testului: 20 minute

9. Garanție și asistență

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.

Puteți găsi mai multe informații și resurse de asistență pe INDICAID Brand Store.