Intended Use
The Health COVID-19 Antigen Rapid Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 6 days from symptom onset. This test is for non-prescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.
The Health COVID-19 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.
- For over the counter use.
- For in vitro diagnostic use.
- For use with anterior nasal swab specimens.
** For a full list of warnings and precautions, please read the quick start guide included in the box.
BEFORE GETTING STARTED
- Check the expiration date on the outside of the box.
Do not use beyond the expiration date. do not use if any of the test kit contents or packaging is damaged.
(Note: The GTIN and Lot No. will be specific to your test)
Occasionally, expiration date extensions may be granted by the FDA. Click here to see if there has been any extensions granted for your particular test lot number.
- Wash your hands with soap and water for 20 seconds and dry them thoroughly before testing and use hand sanitizer.
PREPARE THE MATERIALS
- Open the package, take out the COVID-19 Test Card in Pouch, the Tube and the Swab. When you are ready to proceed with the test, open the foil pouch of the COVID-19 Test Card.
- Hold the tube upright and tap the tube on the table. After that, gently peel off the foil seal.
- Place the tube in the front of the box labeled "Insert Tube Here".
Collect Sample
- Remove the swab from its package, being careful not to touch the tip of the swab. Please keep the swab package for later use.
- Gently insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into your nostril.
Note: With children, the maximum depth of insertion may be less than 3/4 of an inch, and you may need a second person to hold the child's head while swabbing.
- Firmly and slowly brush against insides of nostril in a circular motion against the nasal wall at least 5 times. Take at least 15 seconds to collect the specimen and be sure to collect any nasal drainage on the swab. Using the same swab, repeat the same sample collection procedure for the other nostril. Be sure to brush BOTH nostrils with the SAME SWAB.
Note: Failure to swab properly in both nostrils may cause false negative results.
Process Sample
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insert the swab into the tube, touch the bottom of the tube with the swab tip, and stir at least 15 times.
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Squeeze the sides of the tube to express as much liquid as possible from the swab, and then remove the swab.
Note: If you don't squeeze the swab, there may not be sufficient sample material to perform the test properly and you may obtain a false negative result.
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Close the tube by pushing the cap firmly into the tube
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Put the swab back into the package, safely dispose of the swab and the package.
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Add Sample
Place the Test Card on a FLAT surface and add 3 drops of samples into the Sample Port of the test card.
Note: A false negative or invalid result may occur if too little solution is added to the test card
Wait 15 minutes
Immediately after adding sample to the Sample Port, start a 15-minute timer. For users of the App, click the "Start Timer" button on the App. The result will be ready in 15 minutes.
Note: Do NOT interpret your test result until after your 15-min timer has completed, as the T line may take as long as 15 minutes to appear.
Read Result
Results should be read between 15 and 30 minutes (Result shown at 2x magnification).
Note: A false negative or false positive result may occur if the test result is read before 15 minutes or after 30 minutes.
Note: The T line can be extremely faint. Any faint T line is positive
Test Interpretation
Repeat testing is needed to improve test accuracy. Please follow the table below when interpreting test results for COVID-19.
| First Result Day 1 | Second Result Day 3 | Third Result Day 5 | Interpretation |
| Positive | N/A | N/A | Positive for COVID-19 |
| Negative | Positive | N/A | Positive for COVID-19 |
| Negative | Negative | N/A | Negative for COVID-19 |
Results should be considered in the context of an individual's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19
COVID-19 Positive (+)
If the Control (C) line and the Test (T) line are visible, the test is positive.
Below are photos of actual positive tests. Any faint visible pink-to-purple test (T) line with the control line (C) should be read as positive.
You do not need to perform repeat testing if you have a positive result at any time.
A positive test result means that the virus that causes COVID-19 was detected in your sample and it is very likely you have COVID-19 and are contagious. Please contact your doctor/primary care physician and adhere to the local guidelines regarding self-isolation. There is a very small chance that this test can give a positive result that is incorrect (a false positive).
COVID-19 Negative (-)
If the Control (C) line is visible, but the Test (T) line is not visible, the test is negative.
To increase the chance that the negative result for
COVID-19 is accurate, you should:
- Test again in 48 hours if you have symptoms on the first day of testing.
A negative test result indicates that the virus that causes COVID-19 was not detected in your sample. A negative result is presumptive, meaning it is not certain that you do not have COVID-19. You may still have COVID-19 and you may still be contagious. There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR. If you test negative and continue to experience COVID-19-like symptoms, (e.g., fever, cough, and/or shortness of breath) you should seek follow up care with your healthcare provider.
Invalid
If the control (C) line is not visible, the test is invalid. Re-test with a new swab and new test kit. An invalid result does not indicate if the individual does or does not have COVID-19 and the test should be repeated.
Dispose the Test Kit
After test is complete, dispose the kit components in trach