Bhuku reMirayiridzo yeKuedza Kukurumidza kweCOVID-19 Antigen

1. Nhanganyaya

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.

INDICAID COVID-19 Antigen Rapid Test kit box

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

2. Zvigadzirwa zveChigadzirwa

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.

Yedza mudziyo: Individually sealed pouch containing a test cassette.
Buffer Solution Vial: Pre-filled tube with extraction buffer.
Nasal Swab: Sterile swab for specimen collection.
Mirayiridzo Yekushandisa: Iri bhuku.

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

3. Setup uye Kugadzirira

Before starting the test, please follow these preparation steps:

Read the entire instruction manual carefully before performing the test.
Wash your hands thoroughly with soap and water for at least 20 seconds, then dry them completely.
Open the kit box and place all components on a clean, flat surface.
Check the expiration date on the kit box and individual component packaging. Do not use expired tests.
Ensure the test device pouch is intact and open it just before use.

4. Operating Instructions

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

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.
Danho 2: Gadzirira 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.
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).
Danho rechina: Mirira Mibairo
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. Kuturikira Migumisiro

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).

Positive Result: 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.
Negative Result: 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.
Mhedzisiro Isiriyo: 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. Kuchengetedza nekuchengetedza

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

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

Side of INDICAID COVID-19 test box showing lot number and expiration date

Mufananidzo 6.1: Eksample of Lot Number and Expiration Date on product packaging.

7. Kugadzirisa matambudziko

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

Dambudziko	Zvinogona Kukonzera	Solution
No Control Line (C) appears.	Test device malfunction or insufficient sample vhoriyamu.	The result is invalid. Repeat the test with a new kit. Ensure 3 drops of solution are added to the sampzvakanaka.
Test Line (T) is very faint.	Low concentration of antigen or early stage yehutachiona.	Any visible line at the T region, no matter how faint, should be considered a positive result. Consult a healthcare professional.
Results read after 25 minutes.	Delayed reading can lead to inaccurate results (false positives or negatives).	The result may be unreliable. Repeat the test with a new kit, ensuring results are read at exactly 20 minutes.

Kuti uwane rumwe rubatsiro, ndapota taura nerutsigiro rwevatengi.

8. Zvinotsanangurwa

Product Name: INDICAID COVID-19 Antigen Rapid Test
Muenzaniso: COVID-19 Antigen Rapid Test
Mugadziri: Indicaid
Package Dimensions: 7.99 x 2.6 x 1.06 inches
Kurema 1.76 ounces
Zuva Rokutanga Kuwanikwa: Chikunguru 18, 2022
Sherufu Hupenyu: Up to 15 months (check specific expiration date on packaging)
Nguva Yekuedza: 20 kwemaminitsi

9. Warranty uye Tsigiro

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.

Unogona kuwana rumwe ruzivo uye zviwanikwa zvekutsigira pa INDICAID Brand Store.

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INDICAID COVID-19 Antigen Rapid Test