COVID-19 Antigen Rapid Test Services
STORAGE INSTRUCTIONS Store unused InteliSwab™ COVID-19 Rapid Test kits unopened at 2°- 30°C (35°-86°F). Do not open the Divided Pouch until you are ready to perform the test. If stored refrigerated, ensure that the Divided Pouch is brought to operating temperature (15°- 40°C, 59°- 104°F) before opening. QUALITY CONTROL PROCEDURES Built-in Control Features The InteliSwab™ COVID-19 Rapid Test for anterior nasal specimens has a built-in procedural control that demonstrates the assay components havemigrated adequately through the device. For negative tests, a reddish-purple line in the Control (C) Zone of the Result Window indicates that the fluid migrated appropriately through the Test Device. The line in the Control (C) Zone does not determine if a human sample has been added or if there is an adequate sample. For most positive tests, a reddish-purple line will appear in the Control (C) Zone and the Test (T) Zone; however, in cases where the viral load in the sample is very high, the line in the Control (C) Zone may not be present or may be very faint.
INSTRUCTIONSFOR USE Follow Safety Precautions section in these Instructions for Use.
Gather all the materials you will need. Allow the InteliSwab™ COVID-19 Rapid Test to come to operating temperature (15°- 40°C, 59°- 104°F) before use. SPECIMEN COLLECTION AND TESTING PROCEDURE Set the Test Stand at your workspace. Make sure the Test Stand is on a sturdy surface. Use only the Test Stand provided. Open the two chamber pouch by tearing at the notches on the top of each side of the Pouch Remove the Developer Solution Vial (“Vial”) from the Pouch 3. Hold the Vial firmly in your hand. Carefully remove the cap from the Vial by gently rocking the cap back and forth while pulling it. Slide the Vial into the top of one of the slots in the Test Stand. DO NOT force the Vial into the Stand from the front of the slot as splashing may occur.
Make sure the Vial is pushed all the way to the bottom of the slot in the Test Stand If solution spills out of the vial; you will need to obtain a new test. Blow your nose into a tissue. DO NOT clean out your nose with the tissue discard the tissue and wash or sanitize your hands. 6. Remove the Device from its Pouch DO NOT a touch the Flat Pad Check to make sure that an Absorbent Packet is included with the Device. If no Absorbent Packet is present, discard the Device and obtain a new Pouch for testing. 9. DO NOT cover the two holes on the back of the Device with labels or other materials. Place the Flat Pad of the Device into the nostril, firmly pressing the pad against the nasal wall rotating the pad 15 times. Ensure you swab both nostrils 15 times). If you do not swab both nostrils 15 times each, you may get a false result. Note: Proceed by swabbing the individual, if they are unable to swab themselves. Keep the Test Stand on the flat surface, insert the Device into the Vial and swirl the Device 10 times while making sure the Flat Pad is in the solution. Make sure the flat pad is toward the back of the tube so it contacts the liquid swirling the device less than 10 times may cause invalid results. 12. Leave Device in the Vial making sure that the Flat Pad touches the bottom of the Vial. The Result Window on the Device should be facing you Make sure the tube and device are at an angle. 13. Start timing the test by setting the timer for 30 minutes. DO NOT remove the Device from the Vial while the test is running. 14. Pink fluid will appear and travel up the Result Window. The pink fluid will gradually disappear as the test develops 8 TEST RESULT AND INTERPRETATION OF TEST RESULT Interpret results between 30 and 40 minutes.
Do not read negative results before 30 minutes as it may result in false negative results. Do not read any result after 40 minutes as it may yield inaccurate results. NEGATIVE A test is Negative if: A reddish-purple line appears in the C Zone and NO line appears in the T Zone The line in the C Zone must be present to interpret a negative test result. A Negative test result is interpreted as nucleocapsid protein antigen was not detected in the specimen. The individual is presumed negative for COVID-19. Negative results do not rule out SARS-CoV-2 infection. Individuals without symptoms that test negative should be tested again with at least 24 hours and no more than 36 hours between tests. All negative results are considered presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative 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. POSITIVE A test is Positive if: A reddish-purple line appears in the T Zone and there is a line in the C Zone. Lines may vary in intensity. The test is positive regardless of how faint these lines appear. In some cases the reddish-purple line in the C Zone may not be present or may be very faint if there are high levels of virus in the sample A Positive test result is interpreted as nucleocapsid protein antigen was detected in the specimen.
The individual is positive for COVID-19. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.
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