Biopool’s New Blood Test Kit Gets FDA Approval

Biopool International announced it has received FDA approval to market a new screening product for use in hospital blood banks and commercial laboratories.

The screening test--called the Fetal D Tection Kit--is able to detect whether blood cells from an infant entered the mother’s system during pregnancy.

The determination is necessary when the mother’s blood type is D negative and her infant’s is D (Rh) positive. If blood cells from the infant have entered the mother’s system, it could cause serious consequences in future pregnancies. Once detected, however, drug treatment can be administered to alleviate future dangers.

The new test offers “some significant advantages over other kits on the market,” said Michael D. Bick, chairman and chief executive officer of Biopool. The test replaces a kit marketed under another company’s name and significantly contributes to the profitability of Biopool’s product line, he said.

Biopool develops test kits to diagnose blood disorders and monitor the presence of drugs of abuse, plus products used to screen for antibodies and type whole blood. The company’s line of more than 1,500 FDA-approved products is sold to hospitals, blood banks and clinical and reference laboratories.