[592010]
Below is a copy of a letter i sent to my urologist. It summarizes my findings as to the accuracy of focus diagnostics' herpes select tests. It is my opinion, based on extensive research and dialogue with medical professionals, that the herpes select elisa blood test for herpes type 2 is very inaccurate within the range of 1. 1 to 3. 5 and the lack of notification to that affect has likely caused unnecessary expense, worry, depression, & serious impact to the social and familial lives of those who have received this erroneous info, as it has in my case. I had rec'd positive readings on two herpes select elisa tests for herpes type 2, 3. 52 on 06/09/04 & 2. 01 on 06/17/05. I had been told by the health association, and the clinic that it is very rare for the herpes select test to register a false positive. The health association receives financial support from focus diagnostics, the co that makes the herpes select test, and nurse practitioner and owner of clinic serves as moderator for their internet chat groups and intermediary for questions sent to focus, which is how she contacted me. I also have found publications and lab reports where this test has yielded a high rate of false positives in the low positive range. As you can see in the letter below, i was also advised that the herpes select kits had been recalled due to a false positives in this low range. Yet, i was never notified about this and was left to worry about something that i did not have. This affected my relationship with my wife and those around me in that i was obsessively worried about the possibility of inadvertently spreading the disease to others through shared utensils, kissing, and so forth. The herpes select test kits either need a revised upward negative range, or need to display a clear warning that results in the low range may be false and should be confirmed by other methods, such as the univ western blot test. Copy of letter: 11/28/06. Dear dr, i submitted a sample for my third western blot test for herpes simplex on 10/27/06. It too came back "negative for antibody to hsv-1 and hsv-2 by western blot. No evidence of past infection with hsv-1 or hsv-2. " a copy is enclosed for your files. At this time, i felt pretty sure that i do not have herpes. The western blot is considered the reference test, the gold standard, against which all other test methodologies are evaluated. It is used as a confirmatory test as well. In addition to three western blots finding no hsv, i had to consider, based on info i rec'd from clinics at the univ, that a very large percentage of positive hsv-2 results in the low range - 1. 1 to 3. 5- have been found to be false positives by western blot. The false positives for hsv-2 are running at least 30 to 50% in the low range. Another source at univ said the rate of false positive was 50% in a recent research article -10/05 - published by bio med central, the rate of false positive was 65% in the low positive range and 92% in the range above 3. 5. You can access this article at http://www. Biomedcentral. Com/1471-2334/5. You can also refer to the march-april 2002 issue of fda consumer magazine in which you will see a table showing that the herpes select elisa kit accuracy rate for no false positives runs at 89, 100% accurate. A little different from the number i've seen published elsewhere. -statistically speaking, i find it misleading to see a range like this. One could say that with 95% assurance, the mean of samples runs from 89 to 99%, if that is what the statistics support. But this type of range implies 100% accuracy can be achieved, even though the university never claims 100% for its results and that is the far more accurate and selective test. - i had heard for a long time, from a variety of sources, how rare it was to get a false positive in the herpes select test. In my opinion, that is not true. I don't consider 11%, or 8% to be "rare" - no less 30 to 65%. Based on available published data, the following might represent results for an average sample size of 100. I've chosen the worse case scenario of a 65% false positive, but the picture must be retested. Anyway, i understand that focus technologies had recalled their kits about a year ago to fix this false positive problem, and results are as yet not proven. In my opinion, if a pt gets a herpes select score in the low positive range, they should definitely get a western blot test to confirm this. Also, i would think that focus technologies would have provided some notice to the medical community so that pts who have scored low range positive results could be either retested or tested by the western blot test. I hope that was done, but if it was, somehow or other, that info never got to me. I want to make it clear that i think there is a use for an affordable, fairly accurate test in the higher positive ranges and i am not implying that the herpes select test is not good, or not needed.
Patient Sequence No: 1, Text Type: D, B5