A new over-the-counter syphilis antibody test has received marketing authorization from the Food and Drug Administration (FDA). Branded as First To Know, the at-home screening test requires just a drop of blood and provides results within about 15 minutes, offering an early indication of a possible syphilis infection. However, any positive result must be further confirmed with laboratory testing. In a clinical trial involving 1,270 participants, the test accurately identified 99.5% of negative cases and 93.4% of positive cases when compared to 3 other FDA-approved lab tests. Major retailers are expected to sell the test for less than $20, according to a press release from the manufacturer Now Diagnostics.
Improvement and opportunity: There’s no doubt syphilis cases are on the rise, and many patients don’t notice any symptoms. Inexpensive screening tests can bring both awareness and peace of mind for people who may have been exposed. Even more so, the new screening test can prompt additional visits to urgent care for confirmation testing that can help stop the spread. Read more from the JUCM News archive: Syphilis Cases Rise 80%—10 Times More Newborns Diagnosed
Read More