Syphilis Cases On Rise; FDA Approves Rapid Screening Test

As syphilis cases continue to rise across the U.S., the Food and Drug Administration approved a rapid syphilis test to be used more widespread.

The rapid syphilis test is conducted by collecting a sample of a person's blood through a finger stick. The blood is tested with results available in as little as 12 minutes. A clinical exam and a second test are used as a follow up for those who test positive to confirm the presence of the sexually transmitted infection.

The increased number of syphilis patients and proficiency of the test led health officials to submit a review of new data in regards to the test to prove its accuracy, reported Cleveland.

The data review was submitted late 2014 and soon after the FDA to no longer considered the test to fall under the moderate and high complexity designation, reported Cleveland.

Since then the test was approved to be used in non-lab settings - including health fairs, community health clinics, and prisons. No specialized training is needed to administer the test anymore.

"Between 12 and 15 million syphilis tests are done in this country every year, none of which can be done on the spot," Norman Proulx, Diagnostics Direct President and CEO, told Cleveland.

"That's why the CLIA [Clinical Laboratory Improvement Amendments] waiver is such a big deal - the test is given to the person immediately. A simple finger prick of whole blood, in 10 minutes, gives you the answers. It brings the answer much closer to the patient while the patient is within the confines of the medical group. And, you don't need a PhD chemist to [perform] the test."

There were 56,471 syphilis cases in America from 2012-2013, according to the Centers for Disease Control and Prevention, which is a 13.1 percent increase from the year before.

Tags
Syphilis, STD, FDA, Food and Drug Administration
Real Time Analytics