USER INSTRUCTIONS For Emergency Use Authorization (EUA) only. In vitro diagnostic use only.
The QuickVue At-Home OTC COVID-19 Test is for FDA Emergency Use Authorization (EUA) Only For In Vitro Diagnostic (IVD) Use. ■ This product has not been FDA cleared or approved but has been authorized by FDA under an EUA. ■ This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
Frequently Asked Questions Will this test hurt? No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable. If you feel pain, please stop the test and seek advice from a healthcare provider. What are the known and potential risks and benefits of this test? Potential risks include: ■ Possible discomfort during sample collection. ■ Possible incorrect test results (see Results section).
Warnings, Precautions and Safety Information ■ The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms of COVID-19. The test is intended to be used twice over two to three days,with at least 24 hours and no more than 36 hours between tests.
Hazardous Ingredients for Liquid Reagent Chemical Name/CAS Harms (GHS Code) for each ingredient Concentration Sodium Phosphate Monobasic Monohydrate/10049-21-5 Causes skin irritation (H315) Causes serious eye irritation (H319) May cause respiratory irritation (H335) 0.7% Sodium Phosphate Dibasic Anhydrous/7558-79-4 Causes serious eye damage (H318) Causes serious eye irritation (H319) 0.
Intended Use The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests.
Wash Your hands Before you start testing, wash your hands or use hand sanitizer. Make sure your hands are dry before starting.
STEP 1: Check Your Test Kit Locate the kit components: It is recommended gloves (not provided) also be used during testing.
STEP 2: Place Tube in the Tube Holder Remove cap from one TUBE and place it in the TUBE HOLDER. NOTE: Use of gloves is recommended.
STEP 3: Swab the Nostrils A Remove the SWAB from its wrapper, being careful not to touch the SWAB head. B Gently insert the SWAB ½ to ¾ of an inch into the nostril, depending on the size of the person’s nose. Firmly rub the SWAB in a circular motion around the inside wall of EACH NOSTRIL at least 4 times. Be sure to rub BOTH nostrils with the SAME SWAB. NOTE: If you are swabbing others, please wear a face mask. With children, you may not need to insert the swab as far into the nostril.
STEP 4: Place Swab in the Tube B Leave the swab in the A Immediately place the solution for ONE MINUTE. SWAB into the liquid inside the TUBE, and ensure it is touching the bottom. Stir 3-4 times. NOTE: If the swab is in the solution for more than 10-minutes it should not be used.
STEP 5: Remove Swab from the Tube A After ONE MINUTE, B Dispose of swab in remove the swab from the TUBE by rubbing the swab head against the inside wall of the tube to squeeze out as much liquid as possible. the trash.
STEP 6: Open the Test Strip Tear here Open the TEST STRIP pouch carefully at the slit and hold the TEST STRIP as indicated.
STEP 7: Place Test Strip in the Tube Place the TEST STRIP into the TUBE with the arrows pointing down. Leave the strip in the TUBE for a FULL TEN MINUTES – do not handle or remove.
STEP 8: Remove Test Strip from the Tube At TEN MINUTES, remove the TEST STRIP from the TUBE and place on the test strip outline in Steps 10-12. Ensure the TEST STRIP is on a flat surface in good lighting. NOTE: The test is intended to be read at 10 minutes. If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate (false negative, false positive, or invalid) and the test should be repeated.
STEP 9: Check Your Results There are three type of results possible. 1. Check for a Positive Result 2. Check for a Negative Result 3.
STEP 10: Check for a Positive COVID-19 Result Place the TEST STRIP on the test strip outline below and compare with test result examples shown. Positive Result A POSITIVE result must show BOTH a BLUE line and a PINK line near the BLUE line. Results shown at 2x. Look closely! Even a very faint, pink Test Line and a blue Control Line is a POSITIVE result. The intensity of the lines may vary.
Positive COVID-19 Result A positive test result means that proteins from the virus that causes COVID-19 were found in your sample and it is very likely you have COVID-19 and it is important to be under the care of your healthcare provider. It is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give you a positive test result that is wrong (false positive.
STEP 11: Check for a Negative COVID-19 Result Place the TEST STRIP on the test strip outline below and compare with test result examples shown. Negative Result A NEGATIVE result will show a BLUE line but NO PINK line. Results shown at 2x.
Negative COVID-19 Result A negative test result means that proteins from the virus that causes COVID-19 were not found in your sample. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative.
What do I need to know about Results from Serial Testing? If your first or second test is positive, then proteins from the virus that causes COVID-19 has been found in your sample and you likely have COVID-19. If you test positive with the QuickVue At-Home COVID-19 Test, you should self-isolate and seek follow-up care with your healthcare provider to determine the next steps you should take. You may need additional testing, depending on your personal health history and other factors.
STEP 12: Check for an Invalid COVID-19 Result Place the TEST STRIP on the test strip outline below and compare with test result examples shown. Invalid Result Results shown at 2x. If there is NO LINE, or if there is ONLY a PINK line, the test is INVALID and you should repeat the steps starting at the beginning using a new TUBE, SWAB, and TEST STRIP.
Invalid COVID-19 Result If at 10 minutes, the blue Control Line does not appear, even if any shade of pink to-red Test Line appears, the result is invalid. If the Test Result is invalid, a new swab should be collected, and the test should be performed again with a new pre-filled tube and Test Strip. If the second QuickVue At-Home OTC COVID-19 Test is also INVALID, call 833-QUICKVUE (833-784-2588) for assistance.
STEP 13: Dispose Used Test in the Trash All used test components should be disposed of in your household waste.
Wash Your hands After completing all steps, wash hands or use hand sanitizer.
USER INSTRUCTIONS A second test should be obtained with at least 24 hours (and no more than 36 hours) between tests. Please notify your Healthcare provider of the results of your QuickVue At-Home OTC COVID-19 Test. ASSISTANCE If the test does not perform as expected, call 833-QUICKVUE (833-784-2588). Quidel Corporation 10165 McKellar Court, San Diego, CA 92121 USA quidel.
