COVID-19 AT-HOME TEST

Description of Event or Problem

THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE COVID-19 AT-HOME TEST COMPARED TO PCR. ON (B)(6) 2023, THE CONSUMER PERFORMED A COVID-19 AT-HOME TEST AND THE RESULT WAS NEGATIVE. THE CONSUMER HAD A PCR TEST PERFORMED THE SAME DAY AT THEIR DOCTOR'S OFFICE AND THE RESULT WAS POSITIVE. THE PATIENT STATED THEY WERE EXPERIENCING DIFFICULTY BREATHING, OXYGEN LEVELS BELOW 90%, COUGHING, AND BODY ACHES. THE PATIENT HAS SINCE FULLY RECOVERED.

Additional Manufacturer Narrative

THE CASE WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. 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. A FALSE NEGATIVE MAY OCCUR WHEN SAMPLING IS NOT PERFORMED AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU). THE LIMIT OF DETECTION VARIES DEPENDING ON THE TYPE OF TEST. A NEGATIVE RESULT MAY OCCUR DUE TO AN INSUFFICIENT AMOUNT OF VIRUS IN THE SAMPLE. 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). THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.