Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of Brilliance GBS Agar for the testing of Group B streptococci (GBS) during pregnancy. The new agar is designed to reduce the number of test steps for clinical technicians, give more reliable results, and enable faster patient treatment by featuring proprietary Inhibigen™ technology.
The test is CE marked for clinical testing, and has not received FDA clearance in the United States.
GBS is a bacterium that can be passed from mother to baby during labor, and is the most common cause of severe, sometimes fatal, infection in newborns. According to the World Health Organization (WHO), early onset of the disease shows a case fatality rate of up to 29%. Screening women for GBS colonization between weeks 35-37 of pregnancy may allow hospitals time to prescribe eradication therapy prior to labor, eliminating the GBS that is a potential cause of pneumonia, sepsis and meningitis if passed on to the infant prior to, or during birth. The UK GBS Support Group currently believes that timely intervention can reduce GBS infection in newborn babies by 60% and deaths from GBS in babies by 70%.
The new Brilliance GBS Agar differs from traditional GBS screening methods by eliminating the need for a pre-enrichment step that can take up to 18 hours, and thus delivers final results in less than 24 hours. In addition, Inhibigen technology selectively prevents the growth of enterococci that can sometimes lead to false positives and a need for additional confirmation tests.
"The implications of GBS disease include significant threat to patient morbidity and mortality and the additional costs associated with high-dependency baby care", says Sumi Thaker, Global VP Marketing, Microbiology, Thermo Fisher Scientific. "Screening programs are proven to reduce the risks, but offer a challenge to the laboratory as they have to process a huge number of samples, many of which will be negative.
"With the introduction of Brilliance GBS Agar, we offer the laboratory a streamlined workflow and reduced turnaround time from swab to result, making handling the high throughput easier and more cost effective. Identification of GBS is made easier with a medium formulation that colors GBS colonies a bright pink, whilst non-GBS colonies are either inhibited, or grow a dark blue or purple. The inhibition in this product is more powerful than anything we've seen before. In trials, up to 99% of the negatives show no growth, greatly simplifying interpretation. And because the product requires only a single inoculation, it is also ideal for those laboratories who are already automating their test procedures. Screening for GBS can now be as simple as screening for MRSA".
Brilliance GBS Agar is designed for hospital laboratories that are already routinely screening for GBS, but are looking for a more streamlined approach, and for the increasing number that recognize the benefits of screening and need an easy to use test that technicians of all skill levels can confidently adopt.