Description of Event or Problem · 0
DR. (B)(6), PLEASE REMOVE THE SINGULAR FALSE POSITIVE HSV 2 IGM RESULT FROM MY MEDICAL HISTORY FROM THE TEST ON (B)(6) 2020. THE HSV 1, 2 IGG RESULT (ALSO ON (B)(6) 2020) WAS NEGATIVE AND HAS REMAINED NEGATIVE THROUGH SUBSEQUENT YEARS. DUE TO OUR DISCUSSION OF THE FALSE POSITIVE IN 2020, YOU SUGGESTED HSV PCR TESTING FOR CONFIRMATION. I COMPLETED THAT TEST ON (B)(6) 2024, AND THE VALUE FOR HSV 1 & 2 ARE BOTH NOT DETECTED. HERPES SIMPLEX VIRUS TEST RESULTS (B)(6) 2020 HSV 1 IGM NEGATIVE HSV 2 IGM (FALSE POSITIVE) TEST PERFORMED AT: (B)(6), MD HSV 1,2, IGG NEGATIVE (B)(6) 2021 HSV 1,2, IGG NEGATIVE (B)(6) 2023 HSV 1,2, IGG NEGATIVE (B)(6) 2024 HSV 1,2, PCR NOT DETECTED AS WE DISCUSSED PREVIOUSLY, I HAVE NEVER HAD ANY SYMPTOMS OF GENITAL HERPES. I HAVE NOT HAD ANY SEX PARTNERS WITH KNOWN HERPES. THE CDC HAS NOT RECOMMENDED THE USE OF HSV IGM TESTING FOR OVER A DECADE IN ASYMPTOMATIC INDIVIDUALS DUE TO SIGNIFICANT FALSE POSITIVES. THE FDA ALSO CAUTIONS AGAINST UTILIZING THE TEST DUE TO FALSE POSITIVES AND ENCOURAGES COMPLIANCE WITH CDC GUIDELINES AS WELL AS REPORTING OF FALSE POSITIVES THROUGH MEDWATCH, THE FDA SAFETY INFORMATION AND ADVERSE REPORTING PROGRAM. I AM SUBMITTING A REPORT. PLEASE SUBMIT ONE AS WELL. ALLEGEDLY, IN 2022, (B)(6) WHO RAN MY TEST ISSUED THE FOLLOWING STATEMENT: "THANK YOU FOR REACHING OUT REGARDING (B)(6) OFFERING OF HERPES SIMPLEX VIRUS (HSV) 1/2 IGM ANTIBODY TESTING. WE ARE IN THE PROCESS OF DISCONTINUING THIS TEST CODE AS A STANDALONE TEST AS WELL AS HSV 1/2 IGM THAT IS WITHIN SOME TESTING PANELS." THE INFORMATION ABOVE WAS SUBMITTED TO MY PHYSICIAN TO ATTEMPT TO REMOVE THE FALSE POSITIVE FROM MY RECORD. ON (B)(6) 2025 I RECEIVED A CONSULT FOR SURGERY, AND MY SURGEON LISTED IN THE MEDICAL NOTES THAT I HAVE GENITAL HERPES ((B)(6) 2020)- HE OBVIOUSLY TOOK THAT INFORMATION FROM MY CHART WHICH IS STILL BEING LISTED DESPITE REPEATED TESTING TO THE CONTRARY. THE IFA PROCEDURE FOR MEASURING IGM ANTIBODIES TO HSV 1 AND HSV 2 DETECTS BOTH TYPE-COMMON AND TYPE-SPECIFIC HSV ANTIBODIES. THUS, IGM REACTIVITY TO BOTH HSV 1 AND HSV 2 MAY REPRESENT CROSS-REACTIVE HSV ANTIBODIES RATHER THAN EXPOSURE TO BOTH HSV 1 AND HSV 2. THIS ASSAY WAS DEVELOPED AND ITS PERFORMANCE CHARACTERISTICS HAVE BEEN DETERMINED BY (B)(6). PERFORMANCE CHARACTERISTICS REFER TO THE ANALYTICAL PERFORMANCE OF THE TEST.