OHC - osang healthcare

GeneFinder
COVID-19 Ag Home Test

INSTRUCTION FOR USE(IFU)

Steps to use the test, FAQs and safety information.

Access IFU here

Seven Easy Steps to Run a Test

OPEN TUBE &
PLACE TUBE IN TUBE HOLDER

Open the pouch that contains the extraction buffer tube & filter cap.

Open the seal of the tube carefully without spilling the liquid inside the tube.

Punch a hole in the box to hold the tube.

OPEN TUBE & PLACE TUBE IN TUBE HOLDER
OPEN SWAB

Remove the swab from the packaging.

Ensure that you only touch the handle of the swab and not the soft pad at the tip.

OPEN SWAB
SWAB BOTH NOSTRILS

Holding the stick end of the swab, gently insert the foam end of the swab into the nostril approximately ¾ inch.

**Swab Both Nostrils**

Firmly and slowly rotate the swab at least 5 times, brushing against the inside walls of the nostril at least 5 times for a total of 15 seconds.

SWAB BOTH NOSTRILS
PLACE SWAB IN TUBE &
REMOVE SWAB FROM THE TUBE

Directly Insert the sterile swab taken from the nostril into the extraction buffer tube and stir it more than 10 times. Take out the swab from the extraction buffer tube by squeezing and applying pressure on both sides of the tube.

PLACE SWAB IN TUBE & REMOVE SWAB FROM THE TUBE
INSERT CAP

Dispose of the swab and seal the tube securely with the nozzle cap.

INSERT CAP
PLACE CASSETTE &
ADD 4 DROPS

Place the test cassette on a flat surface.

Hold the tube upright above the sample well.

Drop 4 drops onto the sample well.

PLACE CASSETTE & ADD 4 DROPS
START TIMER &
READ TEST RESULT

Set the timer and read the test result at 15 minutes.

Do not read the result after 20 minutes.

START TIMER & READ TEST RESULT
POSITIVE RESULT

If a test line (T) is visible together with a control line (C), this means that the result is positive. Look carefully at the result: The test should be considered positive if two lines are visible – even if they are faint. A positive test result means it is very likely that you have COVID-19. Please contact your doctor/primary care physician or your local health authority immediately and adhere to the local guidelines regarding self-isolation. Your doctor may require you to undergo a molecular PCR test to confirm the result. There is a very small chance that this test can give a positive result that is incorrect (a false positive).

PLACE TUBE IN TUBE HOLDER
NEGATIVE RESULT

If a control line (C) is visible and a test line (T) is not visible, this means that the result is negative. It is unlikely that you have COVID-19. However, even if your test is negative, continue to observe all hygiene and safety measures.

If you suspect that you have an infection, contact your doctor/primary care physician. You may have another infection, or your test result may be false. Negative results do not rule out COVID-19. This means you could possibly still have COVID-19 even though the test is negative. If you do not have COVID-19 symptoms and your result is negative, you should test again with at least 24 hours and no more than 48 hours between tests.

PLACE TUBE IN TUBE HOLDER
INVALID RESULT

If a control line (C) is not visible, the result must be considered invalid. The test is not working correctly and you should perform another test using a different test kit. You may have performed the test incorrectly. Carefully read the Quick Reference Instructions and repeat the test. If your test result is still invalid, please contact your doctor or a COVID-19 test center.

PLACE TUBE IN TUBE HOLDER

In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Product availability may vary by country.

Distributed by Osang LLC.

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