LIMITATIONS ON COVID-19 ANTIBODY TESTING

  1. THIS TEST IS FOR THE QUALITATIVE DETECTION OF ANTI-COVID-19 ANTIBODIES IN HUMAN SERUM, PLASMA OR ANY OTHER BIOLOGICAL SAMPLE THAT MAY CONTAIN ANTIBODIES, AND DOES NOT MEASURE THE QUANTITY OF THE ANTIBODIES;
  2. THE RESULTS FROM THIS TEST 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;
  3. THERE MAY BE “FALSE POSITIVE” TEST RESULTS AND “FALSE NEGATIVE” TEST RESULTS;
  4. A POSITIVE RESULT MAY NOT INDICATE SARS-COV-2 IMMUNITY, PREVIOUS VACCINATION, OR PREVIOUS INFECTION. YOUR MEDICAL DOCTOR WILL NEED TO CONSIDER OTHER INFORMATION, INCLUDING YOUR CLINICAL HISTORY AND LOCAL DISEASE PREVALENCE, IN ASSESSING THE NEED FOR A SECOND (BUT DIFFERENT TEST) TO CONFIRM AN IMMUNE RESPONSE;
  5. NEGATIVE RESULTS DO NOT RULE OUT SARS-COV-2 INFECTION, PARTICULARLY IN THOSE WHO HAVE BEEN IN CONTACT WITH THE VIRUS. TESTING USING A DIFFERENT TEST SHOULD BE PERFORMED TO EVALUATE FOR ACTIVE INFECTION IN SYMPTOMATIC INDIVIDUALS;
  6. THIS TEST CANNOT BE USED TO DIAGNOSE OR EXCLUDE ACUTE INFECTION. THE RESULTS ARE NOT INTENDED TO BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS;
  7. YOUR SPECIMENS MAY BE NONREACTIVE IF COLLECTED DURING THE EARLY (“PRE-SEROCONVERSION”) PHASE OF ILLNESS OR DUE TO A DECLINE IN TITER OVER TIME OR DUE TO SPECIMEN DEGREDATION. IN ADDITION, THE IMMUNE RESPONSE MAY BE DEPRESSED IN ELDERLY, IMMUNOCOMPROMISED, OR IMMUNOSUPPRESSED PATIENTS;
  8. THE ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED FOR MATRICES OTHER THAN SERUM OR PLASMA;
  9. THIS TEST SHOULD NOT BE USED FOR DONOR SCREENING; AND
  10. IT IS NOT KNOWN AT THIS TIME IF THE PRESENCE OF ANTIBODIES TO SARS-COV-2 CONFERS IMMUNITY TO REINFECTION.