INDICAID COVID-19 Antigen Rapid Test Instruction Manual

1. Introduzione

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. Componenti del prodotto

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.

Dispositivo di prova: Individually sealed pouch containing a test cassette.
Buffer Solution Vial: Pre-filled tube with extraction buffer.
Tampone nasale: Sterile swab for specimen collection.
Istruzioni per l'uso: Questo manuale.

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

3. Impostazione e preparazione

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. Istruzioni per l'uso

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.
Passaggio 2: preparare la 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).
Passaggio 4: attendere i risultati
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. Interpretazione dei risultati

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).

Risultato positivo: 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.
Risultato negativo: 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.
Risultato non valido: 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. Manutenzione e conservazione

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

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

Immagine 6.1: Es.ample of Lot Number and Expiration Date on product packaging.

7. Risoluzione Dei Problemi

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

Problema	Possibile causa	Soluzione
No Control Line (C) appears.	Test device malfunction or insufficient sampvolume.	The result is invalid. Repeat the test with a new kit. Ensure 3 drops of solution are added to the sampbene.
Test Line (T) is very faint.	Low concentration of antigen or early stage di infezione.	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.

Per ulteriore assistenza, contattare l'assistenza clienti.

8. Specifiche

Nome del prodotto: INDICAID COVID-19 Antigen Rapid Test
Modello: Test rapido per l'antigene COVID-19
Produttore: Indicaid
Dimensioni della confezione: 7.99 x 2.6 x 1.06 pollici
Peso: 1.76 once
Data prima disponibilità: 18 luglio 2022
Durata di conservazione: Up to 15 months (check specific expiration date on packaging)
Tempo di prova: 20 minuti

9. Garanzia e supporto

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.

Puoi trovare maggiori informazioni e risorse di supporto su INDICAID Brand Store.

	Test rapido antigenico COVID-19 INDICAID a domicilio: istruzioni e guida Istruzioni e linee guida complete per l'utilizzo del test rapido antigenico COVID-19 INDICAID da utilizzare a casa, tra cui come eseguire il test, interpretare i risultati e comprenderne le limitazioni.
	Test rapido antigenico INDICAID COVID-19: Guida alle istruzioni Guida completa alle istruzioni per il test rapido antigenico INDICAID® COVID-19, che descrive in dettaglio l'uso previsto, come eseguire il test, interpretare i risultati, importanti informazioni sulla sicurezza, limitazioni, domande frequenti e dati di accuratezza. Include informazioni sull'app mobile INDICAID®.
	Istruzioni per l'uso del test antigenico INDICAID COVID-19 / Influenza A&B Questo documento fornisce istruzioni per il test antigenico INDICAID COVID-19 / Influenza A&B, un test diagnostico rapido per il rilevamento qualitativo e la differenziazione degli antigeni dell'influenza A, dell'influenza B e SARS-CoV-2 dai tamponi nasali anteriori.amples. Include l'uso previsto, la procedura di prova, l'interpretazione dei risultati, le limitazioni e le caratteristiche delle prestazioni.
	Test antigenico INDICAID COVID-19/Influenza A&B: istruzioni di riferimento rapido Questo documento fornisce istruzioni di riferimento rapido per il test antigenico INDICAID COVID-19/Influenza A&B, inclusi materiali, preparazione, sampRaccolta dati, procedura di test, interpretazione dei risultati, domande frequenti e informazioni tecniche. Progettato per uso professionale e per l'auto-raccolta da parte di persone dai 14 anni in su.
	Striscia reattiva rapida per il test delle infezioni delle vie urinarie INDICAID: istruzioni per l'uso e l'interpretazione Istruzioni per l'uso e l'interpretazione del test rapido a strisce INDICAID™ UTI Test. Questo kit per test domiciliare da banco (OTC) rileva qualitativamente leucociti e nitriti nelle urine, facilitando lo screening delle infezioni del tratto urinario (UTI). Include istruzioni, interpretazione dei risultati, limitazioni e domande frequenti.
	Test domiciliare INDICAID COVID-19/Influenza A&B: istruzioni per l'uso e dati sulle prestazioni Istruzioni complete per il test domiciliare INDICAID COVID-19/Influenza A&B, inclusi uso previsto, procedura, interpretazione dei risultati e caratteristiche prestazionali. Rileva SARS-CoV-2, Influenza A e Influenza B.