How to Advocate the FDA for Accurate Herpes Testing

Why do we need advocacy at the FDA? Because any Herpes Simplex Virus prevention strategy in the US is incomplete without an accurate diagnostic test. There is currently NO FDA-approved accurate diagnostic serology test (what we need to diagnose asymptomatic infection) on the market. With a virus that is primarily spread asymptomatically, 85% of new infections are spread by people who are asymptomatic and unaware of their status, the lack of accurate testing is a large and dangerous loophole. People can currently be tested for HSV one of two ways:

Swab Test: Individuals with symptoms can test skin lesions (oral or genital) with either PCR or culture from an active outbreak.

Serology (blood) Test: A test of patient blood sample for the presence of HSV antibodies. The presence of antibodies can be measured to indicate the infection in the body. This type of test is meant to be used for routine STI screenings and/or for asymptomatic patients to diagnose infection.

The FDA approved serology tests (Herpeselect for example) have been proven to have low performance (see studies here, here and here). For this reason, the 2021 CDC STI treatment guidelines recommend confirmatory testing with the Western Blot, which is not FDA approved or covered by insurance.

There are a number of ways Herpes Advocates can ask the FDA to improve the landscape for HSV diagnostics. (Want to join the advocate army? Sign up for emails here.)

How can I advocate the FDA for better Herpes testing?

1. FILE A REPORT. Have a test that was false positive/negative?

Health Care Providers: File a report of tests in your clinical practice that are false positive/negative to the FDA. Providers can do this as often as you are able – each report takes 5 minutes. These reports help the FDA track issues and respond appropriately.

Patients: Patients can also report their inaccurate tests to the FDA – you can order your records from your provider if needed to fill out the form.

2. Contact the FDA directly: Email the following individuals to say that we need accurate FDA approved serology tests for HSV.

3. File a report of misconduct against Focus Diagnostics Herpeselect® 1 and 2 Immunoblot IgG with the FDA.

Name of the company for which you are submitting an allegation: 
Focus Diagnostics

Telephone number: 

11331 Valley View Street
Cypress, California, 90630-4717 USA

Name and model (if applicable) of the Medical Device(s) / Electronic Products in question:
Herpeselect® 1 and 2 Immunoblot IgG

Lot numbers / serial numbers / part numbers:

Under detailed description, please include:

This Herpeselect test has been proven to be inaccurate in a screening population in numerous studies. Additionally, the Product Insert is misleading, as the sensitivity/specificity study is in a pre-screened population that has already tested positive for HSV with a PCR/culture test. The studies enclosed show that when the same test is used to SCREEN people whose status is not known, the results are very different and accuracy is suboptimal.

In summary, the Product Information is misleading as the intended use for general HSV screening and the study design are not consistent which should be more clearly indicated.

See studies proving inaccuracy of this test in population that was not pre-screened here, here and here. Herpeselect, when used in combination with the confirmatory test Western Blot, does not confirm 50% of the time.

Include the detailed description above in your email.

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