Thank you to Vax-Immune Diagnostics for their work to help close the gaps in GBS diagnoses. Dr. Leonard E. Weisman, a world-renowned neonatologist and infectious disease specialist, has studied the effects of inaccurate GBS testing in pregnant women for over 45 years. His research with over 76 peer reviewed articles, abstracts and presentations directly identifies the issues of GBS in neonates, and failures in specimen transport that result in misdiagnosis. Driven by his passion to save babies, he founded Vax-Immune Diagnostics and invented LabReady®, the groundbreaking specimen transport system created to protect and nurture specimen samples before they get to the lab for a more reliable diagnosis when it is needed most.
And now my story, and I wish I could say it was unique, but unfortunately it is not.
I first heard of group B strep in 1998 when I tested positive while pregnant with my fourth child. She was stillborn due to GBS a few weeks later. In hindsight, there were many pivotal points in my care and the information I received (or didn’t receive) that could have made all the difference.
I became involved with group B strep disease awareness after my daughter’s stillbirth, knowing that other women and families must have suffered similar losses. I served as president for GBSI's sister organization, The Jesse Cause, beginning in 1999 and am proud that our organization played a significant role in the collaborative efforts to successfully campaign for universal screening for group B strep in the USA. In 2006 I cofounded Group B Strep International (GBSI) along with John MacDonald, another GBS parent, to expand the scope and audience of our campaign and to further promote awareness and prevention of GBS disease in babies.
Our Panel of Experts
Amber Dobyne, M.D.
Originally from Birmingham, AL, Dr. Amber Dobyne graduated Cum Laude from Florida A&M University where she majored in Biology/Pre-medicine.
She then earned her medical degree from Georgetown University School of Medicine and completed her residency training at Howard University Hospital in Washington, D.C.
Dr. Dobyne has a strong compassion for providing care to underserved areas and is committed to delivering excellent care in women's health. She has special interests in adolescent gynecology, high-risk pregnancy, and contraception management. She is a member of the American Medical Association, the National Medical Association, a Junior Fellow of the American Congress of Obstetricians and Gynecologists and the Houston Medical Forum.
Charleta Guillory, M.D., M.P.H, F.A.A.P
Dr. Guillory is an Associate Professor of Pediatrics in the Section of Neonatology at Baylor College of Medicine and Director of the Texas Children's Hospital Neonatal-Perinatal Public Health Program. She is the immediate past Director of the Texas Children’s Hospital Level II Neonatal Intensive Care Unit having served for over 20 years in that capacity. She earned her MD degree from Louisiana State University Medical School, completed her pediatric residency at Louisiana State Medical Center and the University of Colorado. She received her post-doctoral fellowship training in neonatal-perinatal medicine at Baylor College of Medicine and is board certified in both pediatrics and neonatal-perinatal medicine. She received her Master’s in Public Health from the University of Texas Health Science Center in Houston.
Her primary research focus addresses the issue of decreasing black infant mortality and morbidity. She was recently appointed to the American Association of Pediatrics National Committee on Fetus and Newborn and is the nominee for President-Elect to the Texas Pediatric Society for 2021.
Dr. Tara Randis Dr. Randis is The Pamela and Leslie Muma Endowed Chair of the Division of Neonatology at the University of South Florida. Her experiences as a neonatologist drive her research efforts, focused primarily upon understanding mechanisms by which maternal infections, such as Group B Streptococcus, contribute to adverse pregnancy outcomes and neonatal morbidity and mortality.
By designing novel animal models of GBS vaginal colonization and ascending infection during pregnancy, she has explored the roles of specific microbial factors and the ensuing host immune response to the development of chorioamnionitis, preterm delivery and both early and late-onset neonatal sepsis.
Q&A with Dr. Dobyne and Dr.Gullroy
What is GBS and what are the potential implications of undiagnosed during pregnancy? Group B Streptococcus (group B strep, GBS) is a gram-positive organism often found in the gastrointestinal or genitourinary tract of women. GBS is the leading cause of infections in newborns, with maternal colonization being the primary risk factor. Approximately 10-30% of pregnant woman are colonized with GBS. This colonization may be intermittent or permanent. Approximately 50% of women who are colonized will transmit GBS to their newborn. In the absence of intrapartum antibiotics, 1-2% of newborns will develop GBS early onset disease.
What is the process of testing and diagnosing GBS in pregnant mothers? GBS universal screening is an important component of adequate prenatal care. Pregnant mothers undergo a vaginal-rectal swab that is submitted for culture from 36 0/7 to 37 6/7 weeks gestation. Mothers are also diagnosed with GBS if a urine culture during the pregnancy identifies the organism or an infant from a previous pregnancy acquired a GBS infection.
What are 3 things pregnant mothers need to know about GBS? Three things pregnant mothers need to know about GBS: 1) GBS is easily detected with adequate prenatal care due to the universal screening. 2) If the GBS screen is positive, IV antibiotics are used during labor to decrease the overall GBS vaginal colony count and decrease the frequency of clinical neonatal sepsis. 3) If you are scheduled for a cesarean delivery, in the absence of labor or rupture of membranes, IV antibiotics are not warranted.
What is one thing the medical community needs to know about GBS diagnosis? A GBS culture is only valid for 5 weeks. If collected at 36 weeks gestational age, the result is only valid until 41 weeks gestational age.
If the patient remains pregnant after the gestational age of 41 weeks, the collection swab needs to be repeated and cultured.
How can providers increase awareness about GBS? Providers can increase GBS awareness by promoting adequate and sufficient prenatal care, educating patients about their GBS status during prenatal visits and discussing with them treatment methods expected during labor.
What are some roadblocks in diagnosis and treatment of GBS in pregnant mothers? Some roadblocks in the diagnosis and treatment of GBS in pregnant mothers include insufficient prenatal care due to insurance status, socioeconomic status, or lack of education. Inadequate application of treatment protocols based on GBS status and patient medication allergies can also be barriers to treatment.
What does the future hold for GBS diagnosis and treatment? There are research studies for vaccines to prevent colonization of GBS that are ongoing, but they are not yet applicable to clinical practice.
Q&A with Dr. Randis
What is Group B Strep and what are the potential implications for undetected diagnosis in pregnant mothers? Group B Streptococcus (GBS) is a bacteria that colonizes in the lower reproductive tract and/or the gastrointestinal tract of both men and women. The bacteria infrequently cause problems for adults. However, it can cause invasive infections in the fetus and newborn leading to stillbirth, sepsis, meningitis, or pneumonia. When a pregnant woman is colonized with GBS, she likely will have no signs or symptoms, but her baby is at increased risk for infection. Treatment of colonized mothers with antibiotics at the time of delivery significantly reduces the risk of some types of GBS infection the newborn. For this reason, in the United States, it is recommended that all pregnant women are screened for GBS carriage during pregnancy. Despite decades of research and global efforts to prevent GBS infections, it remains the leading cause of early-onset infection in full term newborns.
What is the process of collecting and diagnosing Group B Strep in pregnant mothers? There are 2 strategies to prevent GBS infection in infants:
1. Universal screening of pregnant women for GBS colonization and treatment of those colonized with antibiotics during labor (this is the current guideline in the US).
2. Administration of antibiotics during labor to women based on the presence of risk factors (such as fever during labor, prolonged rupture of membranes, a previous infant infected with GBS, etc.)
Screening for GBS during pregnancy involves the insertion of a swab into the vagina and then the rectum to collect a specimen. These swabs are then transported to a laboratory where they are tested for GBS (by growing it in special media or through detection of GBS-specific genes). These screening specimens most accurately predict GBS colonization status at birth if the specimens are collected within 5 weeks prior to delivery. For this reason, in the US, screening of pregnant women is recommended at 36 0/7–37 6/7 weeks of gestation.
What are 3 things pregnant mothers need to know about Group B Strep?
1. Anyone can carry GBS (about 1 in 4 pregnant women are colonized) and so it is important to talk to your doctor about screening. If you are tested, KNOW YOUR STATUS. 2. Treatment of GBS-colonized pregnant women with antibiotics at the time of delivery significantly reduces the risk of infection in newborns.
3. Even if you test negative for GBS, is important to stay vigilant for signs of infection in your baby (the screening tests are not perfect, your GBS status may change, babies may acquire GBS from other sources). What is one thing the medical community needs to know about Group B Strep diagnosis? More than 50% of cases of early-onset GBS sepsis occurs in infants whose mothers who screened negative.
How can providers create awareness around Group B Strep?
More discussion of GBS (what, when and why) at prenatal and postpartum visits. Infants of GBS-colonized mothers are at increased risk of late-onset infection (now the most common presentation in the US). Many women are surprised to learn this.
I also believe there needs to be more discussion of alternative “therapies” to treat GBS colonization that are frequently endorsed on the internet. Providers need to anticipate their patients will be seeking this information (and misinformation) and be ready to ask and discuss.
What are common roadblocks for testing and diagnosing Group B Strep in pregnant mothers?
Roadblocks include: inadequate time (mother presents in preterm labor with precipitous delivery), false negatives, and the dynamic nature of colonization (GBS negative at screen and then GBS positive at the time of delivery).
What does the future hold for Group B Strep diagnosis and treatment?
I would hope the future of diagnostics includes more accurate and accessible point of care testing for maternal colonization and for neonates presenting with signs and symptoms of sepsis.
Treatment of maternal colonization with antibiotics, while quite effective, is not without cost (widespread exposure of thousands of women and infants to antibiotics, potential emergence of resistant organisms, etc.). An effective vaccine is the goal!
Do you have questions we have not addressed in this article? Click here to be connected to a LabReady Team member who can discuss your thoughts and questions.
The mission of Group B Strep International (GBSI) is to promote international awareness and prevention of Group B Strep disease in babies before birth through early infancy. Our goal is to be a central resource for GBS information in a variety of languages for both the general public and medical professionals. The scope of our mission includes actively supporting the GBS awareness and prevention efforts of individuals and organizations on a community or national level. Group B Strep International’s focus includes all stages of a baby’s development in which they are susceptible to GBS infection. This ranges from unborn babies in the first trimester to infants up to six months of age. GBSI is also developing GBS awareness and prevention resources for countries that do not have an active program readily available. Group B Strep International is a non-profit public benefit corporation under the State of California.
Vax-Immune Diagnostics is a healthcare technology company that has built the world’s first and only full-integrated specimen enrichment transport system, LabReady, to help the medical community quickly and more accurately detect infectious diseases. Vax-Immune was founded by Leonard E. Weisman, MD, neonatal physician, researcher, and inventor who served as the former Chief of the Newborn Center at Texas Children’s Hospital. Its first product to market will be LabReady GBS. Housed in the world’s largest medical center, Vax-Immune is part of the Texas Medical Center Accelerator (TMCx) and has been a resident company at JLABS in Houston since 2017.
Heather Kramer helps health-tech Founders, Entrepreneurs, and Startups grow through digital marketing, communications, and PR outreach. Through of mix of marketing, PR, and investor relations strategies and tactics, Heather (www.hjkdigital.com) has helped health-tech and technology platforms leverage best in class marketing technologies, tools, and data sources to launch new products, reach new audiences, and create strong business value through social media, public relations, audience targeting, website development, and full funnel lead generation techniques. Heather is a regular staff writer for Vax-Immune Diagnostics, and supports LabReady's marketing strategy and content development.