The trial of the PIFA/Chlamydia rapid assay has been conducted at two sites in Pennsylvania.
The company said the results were successful with sensitivity of 91% and specificity of 98%.
Chlamydia trachomatis is said to be the most common cause of sexually transmitted venereal infection across the globe. As per the Centers for Disease Control and Prevention, around 1.4 million cases of Chlamydia have been reported in the US in 2015.
Akers Bio’s PIFA/Chlamydia rapid assay is an antibody test developed to identify infection of Chlamydia in five minutes or less from only a finger stick blood sample.
The assay has been developed by using the firm’s proprietary platform technology Particle ImmunoFiltration Assay (PIFA). Heparin Platelet Factor 4 rapid assay is also based on the firm’s PIFA technology.
Akers Bio co-founder and chief scientific director Raymond Akers said: "We are delighted with the outcome of these clinical trial results. The test performed extremely well, with a 96% correlation to the gold standard reference laboratory method.
"It is a very exciting outcome to have a five-minute rapid test demonstrate that level of accuracy. This bodes well not only for the PIFA/Chlamydia Rapid Assay but for our other proprietary PIFA technology based tests in development."
The company is seeking 510(k) market clearance from the US Food and Drug Administration for the PIFA/Chlamydia rapid assay.
Akers Biosciences develops, manufactures and offers rapid screening and testing products for healthcare providers and consumers.
Image: Akers Biosciences has completed clinical trial of rapid test for Chlamydia diagnosis. Photo: courtesy of Suwit Ritjaroon / FreeDigitalPhotos.net.
