The patient experienced a false negative result with the innova antigen test and received a positive test result from a pcr covid test when tested with nhs.User handling may have contributed to the event.Possible contributing factors of a false negative result are: unpacked test strips have been left too long, resulting in moisture.Sample was spiked too quickly with too much sample; the sample was not diluted at the right multiple or the sample was drunk before the test.The amount of antigen in a sample may decrease as the duration of illness increases.Specimens collected after day 5 of illness are more likely to be negative compared to a rt-pcr assay.A false negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test or if the sample was collected improperly.The production records, product inspection records and material inspection records were checked confirming batch records are qualified.It is recommended that the testing kit must be operated according to the specimen collection and assay methods in the body of the instructions for use and additionally, the kit should be used immediately after opening the lid.The reported event could not be confirmed.
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