Serologic Screening for Genital Herpes: An Updated Evidence Report and Systematic Review for the US Preventive Services Task Force

摘要

Herpes simplex virus (HSV) can cause genital herpes infection, and there are 2 subtypes of the virus: HSV-1 and HSV-2. The infection is transmitted sexually, and infected patientsmay or may not experience symptoms. Of the 2 subtypes, HSV-2 is more prevalent in genital infections. The infection can also spread vertically from pregnant women to their fetus or neonate and cause fetal/neonatal morbidity and mortality. Many HSVinfections go unnoticed because they are asymptomatic. Several HSV serologic tests that are approved by the US Food and Drug Administration are available, but the US Preventive Services Task Force (USPSTF) does not support screening to identify HSV in asymptomatic patients. A systematic review was conducted to assess the advantages and disadvantages of serological tests for HSV-2 among adolescents, pregnant women, and adults. This was done with the aim of updating the USPSTF recommendation. The study also looked into the accuracy of serological screening and whether the preventive interventions were effective. Sources for the study were trial registries, MEDLINE, EMBASE, and Cochrane library. Reports on randomized clinical trials published in the English language through the end of March 2016 and new evidence received on follow-up studies until October 31, 2016, were included. From 19 published reports on clinical studies, 17 of them (n = 9736 participants; range, 24-3290 participants) were selected. None of them compared cases that were screened and not screened. The majority of the studies were conducted among thosewhere the prevalence of HSV-2 was greater than 40%, based on Western blot. Clinically specified abnormal values of sensitivity and specificity were 99% (95% confidence interval [CI], 97%-100%) and 81% (95% CI, 68%-90%), respectively, from 10 studies (n = 6537). When considering the 7 higher-quality studies (n = 5516), the sensitivity was 95% (95% CI, 91%-97%), and specificity was 89% (95% CI, 82%-93%). On the basis of manufacturers' test thresholds, it was assumed that from a population of 100,000 with 16% occurrence of HSV-2 true-positive results would be found in 15,840 and false-positive results in 15,960 (positive predictive value, 50%). Two clinical trials on HSV-2-seropositive, asymptomatic, and nonpregnant adults and another 2 in HSV-2-serodiscordant couples comparing effects of preventive medication and placebo have been conducted. However, the results of these trials were not consistent and do not support routine antiviral prophylaxis in such settings. It has been described that distress and anxiety are expressed by those who test positive, and unfortunately, there is only 1 research lab with a criterion standard test that is not commonly utilized to verify test results. It was concluded that routine serologic screening for HSV-2 would lead to a high rate of false-positive test results that could adversely affect the psychological well-being of those being screened with unclear benefit.