Advocates Call on FDA to Remove Faulty Tests for Herpes

It is widely recognized among providers of STI screening that serology tests for Herpes Simplex Virus types 1 & 2 are highly inaccurate and often lead to false positives. So much so, that HSV is often not included in standard STI screening, despite it being the largest STI in America with no effective treatment or cure.

Advocates are asking, “If these tests don’t work, why are they on the market?” And are calling for providers and patients to report faulty test results to the FDA immediately. “Testing is the first step on the path to prevention. Americans need to be protected from this virus, and we need tests that work to do that,” says Jason Goldstein, a patient advocate with Herpes Cure Advocacy.

New CDC STI treatment guidelines, released July 2021, recognize the faulty nature of serology tests for HSV and recommend two-step confirmatory testing. Guidelines recommend confirmatory testing using the Western Blot, a test that is only available via mail order from one laboratory at the Univ. of Washington, is not automated, covered by insurance or FDA-approved.

The most commonly used test, HerpeSelect HSV-2 enzyme immunoassay (EIA), often is falsely positive at low index values (1.1–3.0) (457457). One study reported an overall specificity of 57.4%, with a specificity of 39.8% for index values of 1.1–2.9 (458). Because of the poor specificity of commercially available type-specific EIAs, particularly with low index values (<3.0), a confirmatory test (Biokit or Western blot) with a second method should be performed before test interpretation.

2021 CDC STI Treatment Guidelines for Genital Herpes Infections

Many provider advocates have already committed to reporting every test they find with inaccuracies – up to 10 a week in some practices. “It is time we start holding the FDA and manufacturers accountable. We are desperate for better tests and it’s not fair to patients to make them go through multiple, expensive tests to get an accurate answer,” says Terri Warren, RN, ANP, of Westover Research Group.

Advocates are asking providers and patients start reporting faulty tests to the FDA immediately so that manufacturers can be held accountable to either improve the test performance or develop a different test that works according to guidelines.

PROVIDERS: To report a faulty test, see the link for submission here. Each test report takes about 3-4 minutes.

PATIENTS: To report inaccurate test results submit a report here. Each test report takes about 3-4 minutes.

About Herpes Cure Advocacy: Herpes Cure Advocacy is a grassroots, membership-based international advocacy organization of 7,000+ members with a goal of cure and prevention for Herpes Simplex Virus types 1 and 2. Adequate treatment and prevention are needed for the 6 billion globally living with HSV urgently, because Herpes is not benign and because patients are waiting.

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