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Rapid Screening Test for Syphilis Gets Waiver for Wider Use

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January 30, 2015

A rapid test for syphilis has been granted a waiver by the Food and Drug Administration (FDA) for use in a wider variety of healthcare settings, such as emergency rooms, clinics, and other outpatient settings. Because of the changed status to waived testing, non-laboratorian healthcare personnel are allowed to perform the test.

Originally, the Syphilis Health Check test was approved in 2011 as a moderate to high complexity test. The test could only be performed by laboratories certified by the Clinical Laboratory Improvement Amendments (CLIA) for that level of testing. CLIA regulations were passed by Congress in 1988 to ensure the accuracy of test results. Every clinical laboratory in the U.S. that performs testing on human samples must obtain a certificate that defines the complexity of tests that the particular laboratory can perform.

The FDA's decision to grant the CLIA waiver for the rapid syphilis test was based on data from a study submitted by the test's manufacturer. The data demonstrated that the test is easy to use and that healthcare workers can perform it with consistent and reliable results following basic instructions on how to complete the test. The study was conducted over four months at three separate testing sites that were considered to be non-traditional laboratory facilities, such as doctor's offices. Blood samples were collected from over 400 participants.

The test uses a whole blood sample collected from a fingerstick and provides results in less than 12 minutes. It detects antibodies to Treponema pallidum, the bacteria that cause syphilis. Once a person is infected, these antibodies develop and remain positive for life. Therefore, this test should not be used for people who had syphilis in the past and were treated, as it may be positive even though they don't have an active infection (false positive). Any positive result from the rapid test must be confirmed with a second syphilis blood test performed in a laboratory certified by CLIA to perform more complex testing.

Quick screening results from the fingerstick sample means that patients can wait for results, and if positive, have the second blood sample drawn during the same visit. This helps to reduce the time for confirmatory results and allows patients diagnosed with syphilis to receive treatment sooner, with a lower risk of patients failing to follow up.

"The broader availability and easier access to this test should contribute to a higher rate of detection of syphilis infection," Alberto Gutierrez, PhD, of the FDA's Center for Devices and Radiological Health said in a press announcement. Higher detection rates could allow more people to get appropriate treatment with antibiotics and decrease spread of this sexually-transmitted infection.

Screening for syphilis is important because it can be cured easily if detected and treated in the early stages. Left untreated it can progress through three stages and cause serious complications. Infection with syphilis also increases the likelihood of HIV infection following exposure to HIV.

Though treatable, syphilis continues to be an important public health concern. In 2013, there were over 56,000 new cases of syphilis reported to the Centers for Disease Control and Prevention (CDC). In the last 10 years, men who have sex with men have become disproportionately affected.

Pregnant women, if infected, can pass syphilis to their babies (congenital syphilis). This can result in a stillbirth or the baby may die soon after birth. Newborns who survive may have no signs or symptoms initially, but after a few weeks, they may have delayed development and seizures. Because of the serious consequences, the CDC recommends that all pregnant women be screened for syphilis at the first prenatal visit. Pregnant women at high risk for syphilis should be tested again during the third trimester and at birth.

Others who should be routinely screened include people at risk, such as men who have sex with men, people in correctional facilities, those who have unprotected sex with multiple sex partners or sex partners who have tested positive for syphilis, and people who are sexually active and live in areas with a high rate of syphilis.

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NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used. To access online sources, copy and paste the URL into your browser.

(December 15, 2014) FDA grants CLIA waiver expanding the availability of rapid screening test for syphilis. FDA News Release. Available online at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426843.htm through http://www.fda.gov. Accessed January 2015.

(September 4, 2012) Syphilis - CDC Fact Sheet. Centers for Disease Control and Prevention. Available at http://www.cdc.gov/std/syphilis/stdfact-syphilis-detailed.htm through http://www.cdc.gov. Accessed January 2015.

(December 15, 2014) Michael Smith. Syphilis Test Gets OK for Wider Use. Medpage Today. Available at http://www.medpagetoday.com/InfectiousDisease/STDs/49136 through http://www.medpagetoday.com. Accessed January 2015.