GBS Answers - Meridian Bioscience, Inc.

GBSAnswers
magazine
IMPORTANT
Information About GBS
(Group B Streptococcus)
3 What Is
Group B Strep?
6 High Tech Testing
Can Save Babies Lives
7 GBS Prevention:
When Tests Get It
Wrong
8 Baby Born With
Life-Threatening
GBS Despite Testing
Negative
9 How To Help
Protect Your Baby,
Before And During
Labor
10 4 Facts About
Group B Strep
11 4 Tips For Moms
Who Test Positive
For GBS
Know Your
Options
Not All Group B Streptococcus
Tests Are Equal…
4

ABOUT MERIDIAN BIOSCIENCE, INC.
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GBSAnswers
What Is
Group B Strep?
Group B Streptococcus, or GBS, is a gram
positive bacteria commonly found in the
gastrointestinal, genital and urinary tract of
healthy adults. Approximately 25% of all
pregnant women are colonized with GBS.
While Group B Streptococcus colonized
mothers typically show no symptoms or
adverse health effects, the bacteria can be
passed to their child during labor and delivery.
Invasive Group B Streptococcal disease emerged in the 1970’s
as the leading cause of infectious disease in infants. Infants with
early onset infection (

When It Comes to GBS
Testing, Ask for the Best
There was a time when losing newborns to Group
B Streptococcus (GBS) was not at all rare. In the
last few decades that has changed. Tragically, it still
happens, but not nearly as often as it used to. The
reason for the improvement? Routine diagnostic
GBS testing of pregnant women.
61.4%
Of term infants with
GBS disease were born
to women who had
tested negative for GBS
before delivery
(99.5% were tested with traditional culture)
Van Dyke, et al., NEJM, June 18, 2009; 360(25):2626-36
Approximately 90 percent of pregnant women who get prenatal care are now
being tested for Group B Strep. When a woman tests positive, she is treated
with IV antibiotics during delivery, preventing the transmission of bacteria
that is harmless in mom, but can be deadly to a newborn. That’s the good
news. The bad news is that laboratory tests aren’t perfect and can sometimes
return a negative result when the mother is actually a carrier of GBS. Studies
indicated that perhaps more than half of term infants born with GBS are born
to mothers who had tested negative for the bacterium.
The traditional method of testing for GBS is to take a vaginal swab from the
mother at 35 to 37 weeks in her pregnancy. This sample is cultured to give
the bacteria an opportunity to grow, and then examined to determine if GBS is
present. In this traditional method, there are many steps along the way where
mistakes can be introduced, explains Donna Mayne B.S (MT) ASCP, (CLS)
NCA, Molecular Lab Manager at Sacred Heart Hospital in Pensacola, Florida.
“Reading the culture is subjective and the bacteria can take two different
forms,” she says. “One is easy to see; the other is subtle.” The result is that
some women who should be testing positive for GBS are getting negative
results back from their tests.
“Accurate testing for GBS is so important,” explains Marti Perhach,
President and Founder of the Group B Strep International. “Otherwise,
moms who test negative are given false assurances that they don’t need
to be concerned about helping protect their baby from Group B Strep.
According to a 2009 Study in The New England Journal of Medicine,
4

GBSAnswers
61 percent of moms who test
negative were actually positive but
the test results were inaccurate.
This translates to babies becoming
infected by GBS when there are
proven prevention strategies in
place to protect them during labor
and delivery had their mother’s test
result been positive.”
Fortunately, modern science has
provided an elegant solution to
this problem. A molecular assay,
which locates the piece of DNA
that indicates the presence of GBS,
is far more sensitive, says Mayne.
Meridian Bioscience markets
illumigene ® Group B Streptococcus,
a molecular assay that can locate
GBS. Molecular assays are faster
and much more sensitive,” says
Mayne. “Culture-only tests are
accurate less than 50 percent of
the time which is close to flipping a
coin. Molecular testing technology
is now available which is both more
accurate and faster, according to the
NEJM study,” notes Perhach.
Speak Up
GBS testing is now a routine part of
prenatal care. The woman goes in for
the test, the clinic sends the swab to
a lab. The results come back, either
positive or negative. An infant’s life
may hang in the balance, but the
mom has no idea what method the
lab is using and all too often, the
doctor doesn’t either.
“As consumers, we never say, ‘I
need a car,’” says Jack Kraeutler,
CEO of Meridian Bioscience, Inc.
“We are specific. We shop for
an SUV with 4-wheel drive or a
subcompact that gets good gas
mileage. But in medicine we don’t
even ask.” Mayne also thinks we
should speak up and request quality.
“I encourage women to get tested,
and when you go in for the test ask
your doctor to use a lab that uses a
molecular assay,” she says.
Don’t be shy about asking. Your
child’s life could depend on it.
––––––––––––––––––––––––––––––––
For more information:
http://www.meridianbioscience.com/diseaseinformation/group-b-streptococcus/patients.aspx
http://www.groupbstrepinternational.org/
http://www.marchofdimes.com/pregnancy/
complications_groupb.html
5

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

Baby Born with Life-
Threatening GBS Despite
Testing Negative
Although Crystal Mikos
tested negative during
pregnancy, her little
boy was born with GBS
and a series of deadly
complications. But this
baby beat the odds.
Crystal Mikos did everything right. Her pregnancy was perfectly normal.
She was screened for Group B Strep (GBS) around 35-37 weeks, as
recommended by the CDC, and tested negative. At 38 weeks, Mikos’
doctor did a procedure called “stripping the membranes” (or sometimes
“sweeping the membranes”) in an attempt to get her to go into labor. This
technique, in which the doctor or midwife runs a finger gently around the
bag of water to separate it from the uterus, is generally considered safe
and is still sometimes used; but many physicians and midwives avoid it
because it is yet another opportunity to introduce infection.
8

GBSAnswers
A Host of
Complications
At 40 weeks, Mikos’ doctor induced
labor. After 30 hours of labor, the baby’s
heart rate plummeted and Mikos had
to have an emergency C-section.
“I only remember that when Anthony
was born, I heard nothing — no
crying, nothing. Then I passed out.”
When she came to in recovery, her
fiancé told her that the baby was in
neonatal intensive care with major
complications.
As Mikos later learned, Anthony had
many problems, including pneumonia,
meconium aspiration syndrome,
severe edema, and respiratory
distress because the umbilical cord
had been wrapped around his neck.
But the most serious of the complications
was GBS. Even though the GBS
screening test had come back negative,
blood tests after he was born
found GBS in little Anthony’s blood.
Because of the many serious problems
Anthony was dealing with,
Mikos was told that if he lived, he
might have brain damage, blindness
or hearing loss.
Anthony spent 17 excruciating days
in NICU, but he survived. Now, almost
two years later, he is a happy, healthy,
perfectly normal toddler — no blindness,
no hearing loss, no neurological
problems. Excellent neonatal care
and a lot of luck saved Anthony. But
the screening test intended to prevent
his ordeal did not.
Be a Partner
There is no way of knowing whether
the membrane sweep introduced
the bacteria after the negative GBS
test or if the test itself was faulty or
perhaps misread. No medical test
How to Help Protect
Your Baby, Before and
During Labor
In addition to adhering to the
CDC’s early-onset prevention
strategy, Moms can take additional
precautions to help protect
their babies from Group B Strep.
The two pillars of the Centers
for Disease Control and Prevention’s
recommendation to protect
against early-onset GBS are to test
all women during week 35 – 37 of
In addition to asking your
doctor about your GBS test,
you should:
• See your provider promptly
for any symptoms of vaginal
infection. Get a copy of all test
results and keep them with you.
• Take caution regarding
invasive procedures.
• Discuss the benefits vs.
risks of possible methods of
induction with your provider
early in pregnancy as not all
providers ask before “stripping”
membranes.
is 100 percent reliable and there are
many ways to contract an infection.
But there is a lot moms can do to
improve the odds that their babies
will be born healthy and stay healthy.
“I know doctors get tired of patients
coming in with information they’ve
read on the Internet,” Mikos says.
their pregnancy, and to administer
antibiotics during labor to those
who test positive.
For the test, a swab will be used
to collect a sample. According
to CDC, about 25 percent of
pregnant women are carriers of
the bacteria and should be treated
during delivery. Ask your doctor
for illumigene ® GBS.
• If you are having a planned
C-section, talk to your provider
about the risks vs. benefits of
starting IV antibiotics well before
your incision. C-sections may
not completely prevent GBS infection,
although the risk during
a planned C-section is extremely
low if performed before your
labor starts/water breaks.
The CDC says pregnant women
who test positive or have had a
previous infant with GBS should
receive antibiotics through the vein
during labor. This method is only
effective during labor because the
bacteria can grow back quickly.
But she still recommends being an
outspoken partner with your health
care providers. Ask questions, get
answers and do your homework. The
more you know and the more input
you provide, the better your chances
of a happy outcome like the one Anthony
and his parents enjoy.
9

4 Facts
About Group B Strep
Group B Strep is the
most common cause
of life-threatening
infections in newborns,
so why haven’t
you heard of it?
Understand these
four important facts
about these naturallyoccurring
bacteria.
1
Not all newborns
exposed to GBS
become infected
One in four pregnant women carry
Group B Streptococcus (Group B Strep
or GBS) in their digestive tract and birth
canal, but not all newborns exposed
to GBS are infected. Many Moms
wonder why. Why are some babies just
fine while others suffer from potentially
deadly complications at the hands of the
infection?
Dr. Carol J. Baker, professor of pediatrics
at Baylor College of Medicine in Houston
explains that there are many potential
answers to this question, but the main
reason seems to be that some women
have developed a natural immunity to
GBS. “Your baby doesn’t get tetanus
if you had the vaccine because your
protection goes through the placenta to
keep the baby well until he or she starts
getting vaccinated,” she explains. “This
analogy explains what happens with
GBS. We don’t know which women are
protected, but some have developed
immunity naturally and they pass that
along to the baby.”
2
Although the
bacteria is usually
harmless to Moms,
it can cause deadly
infections in babies
Although the naturally occurring bacteria
is usually harmless to the mother, it is the
most common cause of life-threatening
infections in newborns, according to
the U.S. Centers for Disease Control
and Prevention (CDC). GBS can cause
sepsis, pneumonia or even meningitis.
It can also cause babies to be stillborn,
miscarried or so sick they die after birth.
3
Women who
test positive for
GBS usually have no
symptoms.
A woman who tests positive for GBS
usually does not have any symptoms,
thus the importance of routine testing.
“The good news is, GBS disease is highly
preventable,” explains Marti Perhach,
executive director, CEO and co-founder
of Group B Strep International. She lost
her baby girl to GBS in 1998.
“If the mom is tested between weeks 35
and 37, as recommended by CDC, and
found to be positive, she should be given
IV antibiotics for GBS during labor and
delivery. However, my daughter, Rose,
was stillborn fullterm because GBS had
already infected her amniotic fluid and
lungs before I could get my IV antibiotics.”
4
Group B Strep is
different than strep
throat and does not
only affect pregnant
women.
GBS is not strep throat, which is caused
by group A strep, and it can affect
people of all ages, especially those with
compromised immune systems.
10

4 Tips
GBSAnswers
For Moms Who Test Positive For GBS
Most Moms who test
positive for Group B
Strep will give birth
to perfectly healthy
babies, but that doesn’t
mean they shouldn’t
takes steps to protect
their newborns from
potentially serious
illness, or even death.
Doctors and real moms
come together to
share their best tips
for handling a GBS
diagnosis.
1
Maintain an open dialogue
with your doctor
“My best tip for a woman who has tested
positive is to discuss that result with her
obstetrician,” says Dr. Carol J. Baker,
professor of pediatrics at Baylor College
of Medicine in Houston and executive
director, Center for Vaccine Awareness &
Research, Texas Children’s Hospital.
Dr. Baker also advises women to have
a clear plan for what will happen once
they go into labor, and to be sure to be
honest with their health care professionals.
“People worry during pregnancy,”
she says. “They wonder, ‘Am I eating
the wrong thing? Am I drinking the right
thing?’ The overwhelming majority of
babies will be healthy whether they carry
Group B Strep or not, so on one hand, I
tell women not to worry; but on the other
hand, if you want to know more—ask!”
Think of the medical professionals you’ve
surrounded yourself with as teammates
in the quest for a happy, healthy birth.
Trust them, of course, but don’t be afraid
to seek second opinions, ask questions
and do your own research.
Support groups, both in-person and
online, can bring comfort in community,
and there are a plethora of reliable online
resources, such as the CDC’s website—just
make sure you’re turning to a
trustworthy source.
2
Go to the hospital as
soon as labor starts
The sooner you get to the hospital, the
sooner you can begin your antibiotic
treatment (which should be administered
intravenously). “Antibiotics to
prevent GBS disease work best if given
4 or more hours before the birth of the
baby. Arriving to the hospital when labor
is starting maximizes the chances that
women can get this effective treatment
in time,” explains Jonathan M. Wortham,
MD, Epidemic Intelligence Service Officer
for the Center for Disease Control, has
taken care of extremely ill infants with
GBS disease
Of the mothers who test positive for GBS
and are treated with antibiotics in labor,
the risk of infection drops from 1 in 200
babies to 1 in 4,000.
3
Remind the hospital
staff that you tested
positive for GBS bacteria.
Remember tip one? Trust your medical
team, but you’re in charge of your own
health. Don’t assume everyone has seen
your files. Speak up and remind everyone
you talk to, nurses included, that you
tested positive for GBS bacteria, even if
you think they already know.
“We have a status card we give to Mom
if she tests positive, just in case the results
aren’t at the hospital in time for the
delivery,” says Marti Perhach, executive
director, CEO and co-founder of Group B
Strep International. “She can show the
card and expedite getting the IV antibiotics.
She should also be sure to alert the
nursing staff as soon as labor starts or
her water breaks.”
If you’re allergic to any medications, such
as Penicillin, note that right away, too.
4
Ask your provider
to not strip your
membranes
“The reason for that recommendation is
that stripping the membranes can allow
the bacteria to get closer to the baby,”
explains Dr. Baker.
11

WHAT’S MISSING?
You may not feel sick or have any symptoms, but approximately
25% of expectant mothers unknowingly carry Group B Streptococcus
(GBS). Without proper treatment during labor, GBS can infect
newborns with sepsis, pneumonia, and even meningitis.
Screening for GBS at 35-37 weeks of pregnancy is a simple
and painless way to protect your baby’s health against
serious GBS-related infections.
Ask your doctor to test you for GBS with illumigene ® —
so you and your baby don’t miss a thing together.
meridianbioscience.com/findwhatsmissing