# OnGo COVID-19 Antigen Rapid Self-Test

## Product Overview
The OnGo COVID-19 Antigen Rapid Self-Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from anterior nasal swab specimens. It is intended for self-testing at home or other locations by individuals aged 14 years and older, or for adult-collected testing for individuals aged 2 years and older.

## Key Features
*   **Rapid Results:** Results in 15 minutes.
*   **Easy to Use:** Simple self-test with clear instructions.
*   **No Prescription Needed:** Available for over-the-counter (OTC) home use.
*   **FDA Authorized:** Authorized under an FDA Emergency Use Authorization (EUA).
*   **For Symptomatic and Asymptomatic Use:** Can be used with or without symptoms.

## Intended Use
*   For the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
*   For individuals aged 2 years and older when samples are collected by an adult, or for individuals aged 14 years and older for self-collection.
*   For use with direct anterior nasal swab specimens.

## Contents
*   1 Test Device (in a foil pouch)
*   1 Extraction Tube (pre-filled with extraction buffer)
*   1 Tube Cap (with nozzle)
*   1 Sterile Nasal Swab
*   1 Quick Reference Instruction Card
*   1 Full Instructions for Use

## How to Use
1.  **Prepare:** Wash hands and place all components on a clean surface.
2.  **Collect Sample:** Insert the sterile swab into one nostril (about 1/2 to 3/4 of an inch). Gently swirl the swab against the inside of your nostril at least 5 times. Repeat in the other nostril using the same swab.
3.  **Process Sample:** Insert the swab into the extraction tube. Pinch and swirl the swab in the buffer for 15 seconds. Remove the swab while squeezing the sides of the tube. Attach the nozzle cap.
4.  **Test:** Place the test device on a flat surface. Add 4 drops of the extracted sample to the sample well (S) on the test device.
5.  **Read Results:** Wait 15 minutes and read the results. Do not read results after 20 minutes.

## Reading Results
*   **Positive:** Two colored lines appear. One line at the Control line (C) and one line at the Test line (T). A positive result means SARS-CoV-2 antigens were detected.
*   **Negative:** Only one colored line appears at the Control line (C). No visible line at the Test line (T). A negative result means SARS-CoV-2 antigens were not detected.
*   **Invalid:** The Control line (C) does not appear. The test is invalid and must be repeated with a new test kit.

## Important Notes
*   This test is for in vitro diagnostic use only.
*   Read all instructions before performing the test.
*   Store the test kit between 36-86°F (2-30°C). Do not freeze.
*   For the most up-to-date information on COVID-19, visit the [CDC website](https://www.cdc.gov) and [FDA website](https://www.fda.gov).
*   Negative results do not rule out SARS-CoV-2 infection and should be confirmed with a molecular test if necessary.
*   Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary.

## Warnings & Precautions
*   For external use only. Do not swallow any kit components.
*   The extraction buffer contains a harmful chemical. If solution contacts skin or eyes, flush with plenty of water. If swallowed, contact a Poison Control Center immediately.
*   Keep away from children and pets before and after use.
*   Use the test kit contents before the expiration date.
*   Do not use if the pouch is damaged or open.
*   Disposal: Dispose of all used kit components in household trash.

## Support
For product support or to report an adverse event, please contact the manufacturer using the information provided in the Instructions for Use.