COVID-19 AT-HOME TEST

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY PROVIDED TO ROCHE BY FDA VIA MEDWATCH MW5116659. ROCHE ATTEMPTED TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION, HOWEVER, NO FURTHER INFORMATION COULD BE OBTAINED. 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).

Description of Event or Problem

THE REPORTER QUESTIONED 2 POSITIVE RESULTS WITH THE COVID-19 AT-HOME TEST COMPARED TO A NEGATIVE RESULT WITH THE COVID-19 PCR TEST AND OTHER MANUFACTURERS' RAPID TESTS. ON (B)(6) 2023, THE CONSUMER PERFORMED A COVID-19 AT-HOME TEST AND THE RESULT WAS FALSE POSITIVE. ON (B)(6) 2023, THE CONSUMER PERFORMED A COVID-19 AT-HOME TEST AND THE RESULT WAS FALSE POSITIVE. ON (B)(6) 2023, THE CONSUMER PERFORMED A COVID-19 TEST (NON-ROCHE) AND THE RESULT WAS NEGATIVE (THE TEST WAS PERFORMED BY A PHARMACIST). ON (B)(6) 2023, THE CONSUMER PERFORMED A COVID-19 PCR LABORATORY TEST AND THE RESULT WAS NEGATIVE. THE TIME DIFFERENCE BETWEEN THE TEST MEASUREMENTS WAS WITHIN 24 HOURS. ON (B)6) 2023, THE CONSUMER PERFORMED A COVID-19 TEST AND THE RESULT WAS POSITIVE. ON (B)(6) 2023, THE CONSUMER PERFORMED 2 COVID-19 RAPID TESTS (NON-ROCHE: BINAX AND VUE) AND THE RESULTS WERE NEGATIVE. NO OTHER INFORMATION CAN BE PROVIDED. NO ADDITIONAL INFORMATION ABOUT TREATMENT AND OUTCOME WAS PROVIDED.