GBS Answers - Meridian Bioscience, Inc.

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High Tech Testing Can Save Babies’ Lives illumigene ® GBS test module Meet the new technology helping to improve the diagnosis of Group B Streptococcus, the most common cause of life-threatening infections in newborns. Sometimes new technologies are so obvious you can’t miss them: Smart phones and automatic flush toilets are hard not to notice. Other technologies tend to stay in the background, but that doesn’t mean they aren’t having profound effects on our lives. One such technology named illumigene ® GBS is a molecular assay to detect Group B Streptococcus (GBS) colonization in women. GBS can be transmitted from healthy moms to their babies during birth. GBS doesn’t harm the mothers, but it can kill a newborn within a few hours. Currently the majority of laboratories in the U.S are using a traditional culture method. The patient sample that you send to the laboratory is placed in a growth medium, and then streaked on to a culture plate. The plate is then examined to see if any bacteria are present. The problem with this test is that it lacks sensitivity, studies have shown sensitivity to be as low as 42%. 1 Also the procedure is multi-step, cumbersome and time-consuming, and depends on subjective evaluation by lab technicians. A New Approach… Now, however, there is a new and improved way to test for GBS. Advances in molecular technology have made it possible to place the sample in an enrichment broth for as little as 18 hours, then go directly to assay testing to check for presence of GBS, providing a more definitive answer than traditional methods, explains Michael Jozefczyk, MD, president of ClearPath Diagnostics in Syracuse, New York. Molecular testing of this sort has certainly not replaced conventional diagnostics, but it has made more accurate results possible for a variety of tests, particularly GBS. illumigene ® GBS is both faster and more sensitive, giving doctors and hospitals more confidence in the results. Childbirth is a natural part of life, and fortunately it usually goes well without a need for much high-tech intervention. But screening for GBS with illumigene ® , even if done quietly and behind the scenes, can help mothers and doctors make sure that when babies arrive, they are free of the potentially deadly GBS bacterium. –––––––––––––––––––––––––––––––– 1. Fabien Rallue, et al. Sensitivities of Antigen Detection and PCR Assays Greatly Increased Compared to That of the Standard Culture Method for Screening for Group B Streptococcus Carriage in Pregnant Women. Journal of Clinical Microbiology, March 2006, p. 725-728. 6
GBSAnswers When Tests Get It Wrong There are few things more devastating than losing a child — especially when it could have been prevented. The tiny lives lost each year from infection with Group B Streptococcus can be saved by better screening and appropriate treatment. Group B Strep (GBS) is just one of the many bacterial communities that colonize a healthy adult. GBS bacteria live harmlessly in approximately 25 percent of healthy women. However, when the bacteria are transmitted to a baby during birth, the newborn can become seriously ill. Negative Test, False Reassurance Stephanie Worthy was tested for GBS 33 weeks into her pregnancy and the test was negative. Her son, Jaxton, was born on the evening of December 7, 2011. He was completely healthy and sailed through all the newborn tests with high marks. Six hours later he was in neonatal intensive care for observation. Four days later he was dead. “They didn’t diagnose him [with GBS] for eight hours,” Worthy explains, presumably because her GBS test was negative. RaeAnne Latimore also tested negative for GBS, at 35 and a half weeks. Her son, Blake, was born at 5:30 in the afternoon of January 6, 2012, one month after Jaxton Worthy was born. At one o’clock the next morning Blake was making strange grunting sounds and Latimore couldn’t rouse him for feeding. She became concerned, but the nurse reassured her that the noises were normal. Latimore insisted that they look Blake over in the nursery. Half an hour later the doctor came in to tell Latimore that Blake was seriously ill. At 8:37 that morning, “our little fighter gave up his fight,” says Latimore. “They ruled out GBS because of my negative test,” she explains, but a nurse practitioner who had been on the team that tried to save him thought the symptoms looked like GBS and asked the pathologist to check for it in the autopsy.” She was right. GBS infection was the cause of Blake’s death. “Testing negative doesn’t mean you are negative,” warns Worthy. Better Tests “False negatives can be a problem,” explains Amanda Smith, medical technologist in the microbiology department at The Pathology Lab in Lake Charles, Louisiana. “We were researching why even with patients who were getting good prenatal care, mothers who tested negative were sometimes delivering babies that were infected,” says Smith. In January of this year, The Pathology Lab switched from the old culture-based test to the illumigene ® GBS test from Meridian Bioscience, Inc. because the molecular test is more sensitive, according to Smith. As more labs switch to the more sensitive molecular test, perhaps outcomes like Blake’s and Jaxton’s will become even more uncommon. 7
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