INDICAID COVID-19 -antigeenin pikatestin käyttöohje

1. Johdanto

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. Tuotteen osat

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.

Testilaite: Individually sealed pouch containing a test cassette.
Buffer Solution Vial: Pre-filled tube with extraction buffer.
Nenäpuikko: Sterile swab for specimen collection.
Käyttöohjeet: Tämä opas.

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

3. Asennus ja valmistelu

Before starting the test, please follow these preparation steps:

Read the entire instruction manual carefully before performing the test.
Pese kätesi huolellisesti saippualla ja vedellä vähintään 20 sekunnin ajan ja kuivaa ne sitten kokonaan.
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. Käyttöohjeet

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.
Vaihe 2: Valmista 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).
Vaihe 4: Odota tuloksia
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. Tulosten tulkitseminen

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).

Positiivinen tulos: 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.
Negatiivinen tulos: 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.
Virheellinen tulos: 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. Huolto ja varastointi

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

Varastointi: Store the test kit at room temperature, between 2°C to 30°C (36°F to 86°F), away from direct sunlight and moisture.
Vanheneminen: 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.
Hävittäminen: 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

Kuva 6.1: Esim.ample of Lot Number and Expiration Date on product packaging.

7. Vianmääritys

Jos kohtaat ongelmia testauksen aikana, tutustu seuraaviin yleisiin ongelmiin ja ratkaisuihin:

Ongelma	Mahdollinen syy	Ratkaisu
No Control Line (C) appears.	Test device malfunction or insufficient sampäänenvoimakkuus.	The result is invalid. Repeat the test with a new kit. Ensure 3 drops of solution are added to the sampno hyvin.
Test Line (T) is very faint.	Low concentration of antigen or early stage infektiosta.	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.

Jos tarvitset lisäapua, ota yhteyttä asiakastukeen.

8. Tekniset tiedot

Tuotteen nimi: INDICAID COVID-19 Antigen Rapid Test
Malli: COVID-19-antigeenin pikatesti
Valmistaja: Indicaid
Paketin mitat: 7.99 x 2.6 x 1.06 tuumaa
Paino: 1.76 unssia
Päivämäärä, kun ensimmäinen saatavilla: 18. heinäkuuta 2022
Säilyvyys: Up to 15 months (check specific expiration date on packaging)
Testiaika: 20 minuuttia

9. Takuu ja tuki

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.

Lisätietoja ja tukiresursseja löydät osoitteesta INDICAID Brand Store.

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