Sense of Security

With the Healgen® Rapid COVID‑19 Antigen Self‑Test, a fast and accurate COVID‑19 test result is only 15 minutes away. The overall accuracy of the product is 98.73%.

What is COVID-19?

Coronavirus disease (COVID‑19) is an infectious disease caused by the SARS‑CoV‑2 virus.

Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment. However, some will become seriously ill and require medical attention. Older people and those with underlying medical conditions like cardiovascular disease, diabetes, chronic respiratory disease, or cancer are more likely to develop serious illness. Anyone can get sick with COVID-19 and become seriously ill or die at any age.


 

The virus can spread from an infected person’s mouth or nose in small liquid particles when they cough, sneeze, speak, sing or breathe. These particles range from larger respiratory droplets to smaller aerosols. It is important to practice respiratory etiquette, for example by coughing into a flexed elbow, and to stay home and self‑isolate until you recover if you feel unwell.

 

Source: World Health Organization

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Please follow local government and global health guidance and regulations with respect to COVID‑19 health and safety.

 

For In Vitro diagnosis COVID-19 Products visit www.healgen.com

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Rapid COVID-19 Antigen Self-Test


● Read the instructions carefully before starting the test.

● Test setup is about 5 minutes. The result must be read at 15 minutes.

● Take appropriate safety measures when testing other people.

Kit contents

 

For Kit Sizes of 1, 2, 3 or 5 Tests

For Kit Sizes of 7, 8, 10, 15, 20 or 25 Tests

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Step 1

Buffer tube preparation

  1. Insert the buffer tube into the outlined hole located on the front of the test kit.

  2. Remove the protective foil from the top of the buffer tube.

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Step 2

Nasal specimen collection

  1. Open sterile swab pouch by peeling back the pouch cover. Grab the plastic end of the swab and remove from pouch. Do not touch the swab tip.

  2. Carefully insert swab tip into one nostril until you meet resistance.

  3. Rub the insides of the nostril in a complete circle at least 5 times. Make sure you are rubbing the inside of the nostril.

  4. Using the same swab, insert the swab inside the other nostril and repeat steps 2 and 3.

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Step 3

Roll swab

  1. Withdraw the swab from the nasal cavity and insert into the tube.

  2. Roll swab 6 times against the inside of tube. Ensure swab tip touches bottom and sides of tube.

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Step 4

Let swab stand for one minute
  1. Start timer for one minute.

  2. After 1 minute take the tube out of the tube holder. As you remove the swab from tube, squeeze swab tip several times from outside of the tube. Try to release as much liquid from the swab as possible.

  3. Place swab in a disposal bag.

  4. Insert provided dropper tip into the opening of the buffer tube.

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Step 5

Add sample to cassette

  1. Place test cassette on a clean, flat surface.

  2. Add 4 drops of the prepared specimen into the sample well.

  3. Start timer for 15 minutes.

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Step 6

Add sample to cassette

Wait 15 minutes for results

Important Note:

Do not read result after 20 minutes.

Interpretation of Results

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Positive

The presence of two lines, a control line (C) and a test line (T), even a faint line, within the result window indicates the test is positive.

*Please call your doctor or local health department to ensure you adhere to local health regulations and guidelines.

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Negative

The presence of only a control line (C) within the result window indicates the test is negative.

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Invalid

If there is no line visible, or only 1 line at “T”. The result is invalid. Review the procedure and repeat the test with a new test cassette.

Detailed results explanation

Positive Results Indicates:

● If the test device looks like either of the positive result windows as shown on the left, you have a current COVID‑19 infection. Please call your doctor or your local health department and make sure you adhere to local guidelines for self‑isolation. Re‑testing with other test methods such as a PCR test may be required.

Negative Result Indicates:

● If the test device looks like the negative result window as shown in the middle, no COVID‑19 infection could be detected. In a suspected case, repeat the test after 1‑2 days since the virus cannot be accurately detected in all phases of an infection. Despite a negative test result, you still have to comply with all applicable rules regarding contact with others and protective measures.

Invalid Results Indicates:

● If your test result shows no lines visible or only one line at T, the result is invalid. This may be a result of the test execution, and the test should be repeated. If invalid test results continue, please contact your doctor or a COVID test center.