THESE TESTS ARE FOR THE QUALITATIVE DETECTION OF ANTIBODIES OR OTHER BIOLOGICAL MARKERS IN HUMAN SERUM, PLASMA OR ANY OTHER BIOLOGICAL SAMPLE THAT MAY CONTAIN ANTIBODIES OR BIOLOGICAL MARKERS, AND DO NOT MEASURE THE QUANTITY OF THE ANTIBODIES OR OTHER BIOLOGICAL MARKERS;
THE RESULTS FROM THESE TESTS DO NOT PROVIDE A DIAGNOSIS FOR THE PRESENCE OR ABSENCE OF A DISEASE STATE. THE FINAL DIAGNOSIS MUST BE MADE UNDER THE DIRECTION OF A MEDICAL PRACTITIONER;
THERE MAY BE “FALSE POSITIVE” TEST RESULTS AND “FALSE NEGATIVE” TEST RESULTS;
A POSITIVE RESULT MAY NOT INDICATE A STATE OF DISEASE OR HEALTH. YOUR MEDICAL PRACTITIONER WILL NEED TO CONSIDER OTHER INFORMATION, INCLUDING YOUR CLINICAL HISTORY AND ANY OTHER RELEVANT FACTORS THAT THEY DEEM NECESSARY IN ASSESSING YOUR HEALTH;
NEGATIVE RESULTS DO NOT RULE OUT DISEASE.
THESE TESTS CANNOT BE USED TO DIAGNOSE. DIAGNOSIS MUST BE MADE UNDER THE CONSULTATION OF A MEDICAL PRACTITIONER. THE RESULTS ARE NOT INTENDED TO BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS;
YOUR SPECIMENS MAY BE NONREACTIVE IF COLLECTED DURING THE AN EARLY OR NON-ACTIVE DISEASE STATE OR DUE TO A DECLINE IN TITER OVER TIME OR DUE TO SPECIMEN DEGREDATION. IN ADDITION, ANTIBODIES OR OTHER BIOLOGICAL MARKERS MAY BE DEPRESSED IN ELDERLY, IMMUNOCOMPROMISED, IMMUNOSUPPRESSED PATIENTS OR OTHER INDIVIDUALS;
THE ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED FOR MATRICES OTHER THAN SERUM OR PLASMA; AND
THESE TESTS SHOULD NOT BE USED FOR DONOR SCREENING.
