COVID-19 AT-HOME TEST

Additional Manufacturer Narrative

THE CASE WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. THERE IS A LOW PROBABILITY OF FALSE POSITIVES OCCURRING. POTENTIAL CAUSES OF SAMPLE DEVIATION AND POOR REPRODUCIBILITY CAN BE DUE TO MUCOUS MEMBRANES PRESENT IN THE NOSE, MUCIN AND IGA ACT AS A BRIDGE BETWEEN CAPTURE AND DETECTOR, WHICH MAY CAUSE NON-SPECIFICITY. THE TEST DOES NOT DIFFERENTIATE BETWEEN SARS-COV AND SARS-COV-2. REFER TO THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE. IN GENERAL, THE RAPID AG TEST RESULT SHOULD NOT BE THE SOLE BASIS FOR THE DIAGNOSIS; DEPENDING ON THE SITUATION CONFIRMATORY TESTING IS REQUIRED (PCR). OCCUPATION IS PATIENT/CONSUMER.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED A FALSE POSITIVE RESULT WITH THE COVID-19 AT-HOME TEST COMPARED TO NEGATIVE RESULTS WITH THE BINAX AND POLYMERASE CHAIN REACTION (PCR) TESTS. ON (B)(6) 2023, THE CONSUMER PERFORMED COVID-19 AT-HOME TEST AND THE RESULT WAS POSITIVE. ON (B)(6) 2023, THE CONSUMER PERFORMED TWO BINAX TESTS. THE FIRST AND SECOND RESULTS WERE NEGATIVE. ON (B)(6) 2023, THE CONSUMER UNDERWENT A PCR TEST AND THE RESULT WAS NEGATIVE. THE PATIENT HAD NO SYMPTOMS. NO OTHER INFORMATION WAS PROVIDED.