New rapid group B strep test has 94% sensitivity: laboratory staffing an issue for hospitals. (Results in 1 Hour).

A newly approved rapid lab test for group B streptococcus could help address the problem of determining colonization status at the time of delivery in women who have not been tested and are in preterm labor or have not had prenatal care.

The polymerase chain reaction--based test provides results in 1 hour as opposed to the standard culture, which takes 18-48 hours. In clinical trials of 802 women in the United States and Canada, sensitivity of the new test was about 94%.

Still, for the test to be timely, hospitals labs need to be able to analyze results around the clock, which could present staffing problems. The "real world" applicability of the test must therefore be demonstrated, according to experts interviewed for this article.

In a statement announcing the approval, the Food and Drug Administration said that the IDI-Strep B test is the first "nonculture test that meets the performance criteria" recommended for a rapid group B streptococcus test by the Centers for Disease Control and Prevention.

The test "with timely results, could be particularly beneficial" for women who are in preterm labor and those who have not had prenatal care, according to the FDA said.

The test is manufactured by Infectio Diagnostic Inc. (IDI), a Canadian biotech firm based in Quebec City. It is performed using a vaginal-rectal swab sample, which is processed in the "Smart Cycler device," manufactured by a U.S. company, Cepheid. The Smart Cycler, which was also approved for use along with the test, has previously been available in research settings only and must be purchased at a cost of $27,500 or leased, according to Jacques Milette, vice president for sales and marketing at IDI.

In the trial, sensitivity was 94% and the specificity was 97%, but at those centers that did more tests, sensitivity and specificity were closer to 100%, he said.