American Bio Medica Corp, Kinderhook, NY has begun manufacturing diagnostic test strips for syphilis for Hema Diagnostic Systems, Miramar, Fla.
HDS will incorporate the ABMC syphilis test strip into HDS’ Rapid 1-2-3 Hema Express delivery system, a patent-pending device that facilitates testing at the point of care.
The system generates results in about 15 to 20 minutes. It incorporates a pre-marked series of lines on the sample pad, which is used to identify when sufficient blood has been taken up onto the pad. The feature helps to ensure reliable, repeatable test results.
The product will not be sold in the United States until regulatory approval is received. HDS will focus on developing markets outside of the United States where the pandemic is most prevalent.
The World Health Organization estimates some 40 million cases of syphilis are reported worldwide annually; 12 million are new cases. Approximately 36,000 cases are reported annually nationwide, according to health officials.
Syphilis is a curable infection that is sexually transmitted and can be passed on from a mother to her fetus during pregnancy. If left untreated, syphilis can cause serious consequences such as neurological disorders and stroke. In pregnant women it may result in stillbirth, prematurity, and neonatal deaths.
Many countries, especially those in Africa, have established syphilis control programs that include screening of pregnant women and high-risk populations. The WHO recommends syphilis testing be done at the point of care whenever possible to maximize the number of patients who receive results and appropriate treatment.
