adults, would greatly increase the number of false-positive tests, even if specificity were unchanged. 65 Use of HerpeSelect in a population with lower prevalence, similar to that of U.S. Eight studies assessing the accuracy of HerpeSelect enrolled a population with HSV-2 prevalence greater than 40 percent based on Western blot (range, 41% to 70%) one enrolled a population with a prevalence of 28 percent 73 and one enrolled a population with a prevalence of 9 percent. These estimates of the accuracy of serologic tests are generally applicable to populations with a higher prevalence of HSV-2 infection than general primary care populations in the United States. Four of these studies assessed the accuracy of the Biokit HSV-2 serologic test our pooled estimates of sensitivity was 84 percent (95% CI, 73 to 91 1,512 participants) and specificity was 95 percent (95% CI, 92 to 97 1,512 participants). Our pooled estimates of sensitivity was 95 percent (95% CI, 91 to 97 5,516 participants) and specificity was 89 percent (95% CI, 82 to 93 5,516 participants). 65, 70Īt higher cutpoints (2.2 to 3.5), estimates of sensitivity and specificity from eight studies in Africa were still imprecise. 66, 71, 74, 75 Specificity estimates were higher at 93 and 94 percent in two studies with a lower HSV-1 prevalence (1% and 64%). Of the six studies that described HSV-1 prevalence among enrolled participants, four studies had a HSV-1 prevalence of 93 percent or greater and found specificity estimates ranging from 52 to 89 percent. Potential explanations for false-positive serologic test results include cross-reactivity with HSV-1 (or other viruses), recent seroconversion, geographic variability in HSV-2 strain variants, and laboratory error. Estimates for specificity varied and were imprecise, without a clear explanation for the observed heterogeneity. Our pooled estimates of sensitivity and specificity for the commercially available HerpeSelect test found a sensitivity of 99 percent (95% CI, 97 to 100 7,129 participants) and a specificity of 83 percent (95% CI, 68 to 90 6,537 participants) using the manufacturer’s cutpoint (1.1) compared with the Western blot. Positive results for HSV-1 may cause confusion given that the test cannot indicate the site of infection.Īccuracy of Serologic Screening Tests for HSV-2 Infection Some commercially available HSV-2 serologic tests are “paired”-that is, they report both HSV-1 and HSV-2 results. 89 Use of the Biokit HSV-2 has been advocated as a confirmatory test for positive HSV-2 results detected via HerpeSelect. Western blot testing is available through the University of Washington Clinical Virology Laboratory at a cost of about $207. Currently, there is no widely available gold standard to confirm a positive HSV-2 test. Other potential harms of serologic screening include false-positive test results that lead to psychosocial distress and costs of confirmatory testing. We also excluded other studies from our evidence review that were included in prior reviews due to methodological shortcomings (i.e., poor quality), such as high attrition (and no methods to address missing data) and high risk of selection bias. When an assessment of current and prior symptom status was not reported, we contacted authors to confirm whether (and how) prior symptoms were assessed. 86, 87 We also excluded studies that enrolled persons with prior symptoms of HSV-2. For example, we excluded studies enrolling persons who were seeking care for genital symptoms or concerns about recent exposure to someone with genital herpes. 41, 85 This may reflect differences in scope or eligibility criteria (or both). Our conclusions about the potential harms of screening differ slightly from those of other reviews focused on the harms of HSV-2 serologic testing. We found evidence from two uncontrolled observational studies that detection of unexpected HSV-2 by screening is associated with potential psychosocial harms, including anxiety, worry, and distress from a HSV-2 diagnosis. Therefore, we reviewed literature that might establish an indirect chain of evidence from multiple questions that link screening to health outcomes ( KQs 2– 7). We did not identify any eligible studies directly assessing the benefits or harms of serologic screening for HSV-2 compared with no screening. Evidence for Benefit and Harms of Screening for HSV-2 Infection
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