Charfi et al.

Annals of Clinical Microbiology and Antimicrobials (2024) 23:37 Annals of Clinical Microbiology
https://doi.org/10.1186/s12941-024-00695-2
and Antimicrobials

BRIEF REPORT Open Access

Performances of two rapid LAMP-based

techniques for the intrapartum detection
of Group B Streptococcus vaginal colonization
Rym Charfi1,2†, Cécile Guyonnet1,2,3†, Meiggie Untrau4, Gaëlle Giacometti4, Thierry Paper4, Claire Poyart1,2,3,
Céline Plainvert1,2,3 and Asmaa Tazi1,2,3*

Abstract
Purpose Group B Streptococcus (GBS) is the leading cause of invasive infections in newborns. The prevention of GBS
neonatal disease relies on the administration of an intrapartum antibiotic prophylaxis to GBS-colonized women. In
recent years, rapid intrapartum detection of GBS vaginal colonization using real-time nucleic acid amplification tests
(NAATs) emerged as an alternative to antenatal culture screening methods.
Methods We compared the performances of two loop-mediated isothermal amplification (LAMP) tests, the
Ampliflash® GBS and the PlusLife® GBS tests, to standard culture for GBS detection in vaginal specimens from pregnant
women. The study was conducted from April to July 2023 in a French hospital of the Paris area.
Results A total of 303 samples were analyzed, including 85 culture-positive samples (28.1%). The Ampliflash® GBS test
and the PlusLife® GBS tests gave a result for 100% and 96.3% tests, respectively. The performances of the tests were as
follows: sensitivity 87.1% (95% confidence interval (CI) 78.3–92.6) and 98.7% (95% CI 93.0-99.8), specificity 99.1% (95%
CI 96.7–99.8), and 91.9% (95% CI 87.3–95.0), respectively. False negative results of the Ampliflash® GBS test correlated
with low-density GBS cultures. Time-to-results correlated with GBS culture density only for the PlusLife® GBS test
(p < 0.001).
Conclusion Both techniques provide excellent analytical performances with high sensitivity and specificity together
with a short turnaround time and results available in 10 to 35 min. Their potential to further reduce the burden of GBS
neonatal disease compared with antenatal culture screening needs to be assessed in future clinical studies.
Keywords Group B Streptococcus, Intrapartum screening, NAAT, Neonatal infection, LAMP

†
Rym Charfi and Cécile Guyonnet contributed equally to this work.
*Correspondence:
Asmaa Tazi
[email protected]
1
Université Paris Cité, CNRS, INSERM, Institut Cochin, Paris F-75014, France
2
Service de Bactériologie, Centre National de Référence des
Streptocoques, Assistance Publique – Hôpitaux de Paris Centre Université
Paris Cité, Hôpital Cochin, 27 rue du Faubourg Saint-Jacques, Paris
75014, France
3
Fédération Hospitalo-Universitaire Fighting Prematurity - FHU Préma,
Paris, France
4
Biosynex SA, Illkirch-Graffenstaden 67400, France

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Charfi et al. Annals of Clinical Microbiology and Antimicrobials (2024) 23:37 Page 2 of 8

Introduction More recently, non-PCR nucleic acid amplification tests

Streptococcus agalactiae also known as Group B Strepto- (NAATs) such as loop-mediated isothermal amplification
coccus (GBS) is the worldwide leading cause of invasive (LAMP) assays were developed. These tests which allow
infections including sepsis and meningitis in newborns a faster detection of pathogens and do not require high-
and a major health issue for pregnant and post-partum cost laboratory instruments are increasingly used [22]. In
women [1, 2]. This commensal bacterium colonizes the this study, we aimed to evaluate the performances of two
genitourinary tract of 10–30% women and is responsi- LAMP-based tests approved by the European Commu-
ble for two neonatal syndromes, the early-onset disease nity (CE-IVD, European CE marking for in vitro diagnos-
(EOD, 0–6 days of life) and the late-onset disease (LOD, tic medical devices) for the detection of GBS in vaginal
7–89 days old). Importantly, EOD mainly results from samples, namely the Ampliflash® GBS and PlusLife® GBS
maternofetal transmission during parturition and can tests (Biosynex SA, Illkirch-Graffenstaden, France). We
be prevented by the administration of an intrapartum determined the analytical performances of each test com-
antibiotic prophylaxis (IAP) to GBS-colonized mothers. pared to that of conventional GBS culture and compared
Therefore, most industrialized countries including the key metrics such as the time-to-result (TTR) related to
USA and France have implemented a strategy based on workflow.
the antenatal screening of GBS vaginal or recto-vaginal
colonization to identify women candidates for IAP [3]. Materials and methods
Overall, strategies based on universal screening of preg- Study design
nant women resulted in a significant decline in the inci- This single-center retrospective study was conducted in
dence of EOD in the USA from 1.8 cases/1,000 live births the University Hospital Cochin-Port-Royal between Feb-
in the early 1990s to 0.26 cases/1,000 live births in 2010, ruary and April 2023. The maternity ward of the Cochin
as well as in France [4, 5]. Hospital is a level III maternity with approx. 5,500 deliv-
Current American and European guidelines still rec- eries per year. Non redundant vaginal samples for routine
ommend bacterial culture as the gold standard tech- clinical care including GBS antenatal screening between
nique for antenatal GBS screening. The screening has 35 and 37 weeks of gestational age or intrapartum sam-
to be performed on vaginal or rectal-vaginal samples ples regardless of gestational age were collected from
between 36 and 37 (American guidelines) or 35 and 37 pregnant women and sent to the laboratory in Amies
(European guidelines) weeks of gestational age [6–10]. transport medium (Copan Diagnostics, Brescia, Italy).
However, several reports have pointed limitations of this Samples were immediately processed in the laboratory
strategy. Because GBS colonization of the genitourinary for GBS detection by culture methods and stored at
tract is intermittent, GBS antenatal screening is charac- -80 °C before molecular testing. Based on an expected
terized by a low positive predictive value (PPV) for intra- sensitivity and specificity of 90%, we estimated that a total
partum GBS colonization, leading to inappropriate IAP of 300 samples, including 100 positive samples would be
in 30–40% cases [11–13]. Similarly, up to 10% of women necessary to achieve statistical robustness. Therefore, all
with a negative antenatal screening turn out positive at positive samples were prospectively included. A selection
delivery and do not benefit from IAP [14]. Last, culture of negative samples was made each day to achieve a ratio
techniques require a minimum of 18 h before giving the of two negative samples to one positive sample.
first results and are unhelpful in the case of preterm labor
and in women without prenatal care. Hence, 60 to 80% Sample processing
EOD cases are born to mothers with a negative antenatal Vaginal swabs were cultured on Columbia agar plates
screening or to non-screened mothers [15, 16]. with 5% horse blood incubated under aerobic atmosphere
In this context, rapid intrapartum detection of GBS with 5% CO2 and on Granada plates incubated under
colonization emerged as an alternative to antenatal cul- anaerobic atmosphere (bioMérieux, Marcy L’Étoile,
ture screening methods. Although not considered by France). All plates were examined after 18–24 h incuba-
health authorities as the method of first choice, intra- tion at 37 °C, and incubated for an additional 24 h when
partum GBS testing using rapid and accurate molecular negative for GBS. β-hemolytic orange pigmented colo-
tests has been recommended as the first line screening nies and all suspect colonies including white colonies on
method by a European consensus conference held in Granada plates were identified as GBS by matrix-assisted
2013 [17]. These tests are also recommended in women laser desorption/ionization time-of flight (MALDI-TOF)
without prenatal care in the USA and Canada. Histori- mass spectrometry (Bruker Daltonics, Billerica, Massa-
cally, molecular GBS testing was mainly represented chusetts, USA).
by real-time PCR tests whose analytical and diagnos- To avoid biases due to sample storage at -80 °C, the
tic performances were assessed in several studies, both bacterial culture was repeated in parallel to NAATs test-
as laboratory or point-of-care tests [12, 13, 18–21]. ing. Samples were processed in July 2023 immediately
Charfi et al. Annals of Clinical Microbiology and Antimicrobials (2024) 23:37 Page 3 of 8

after thawing as described above. Besides, 50 µL of sam- Data interpretation and control of discrepancies
ples were inoculated in 9 mL of brain hearth infusion We used conventional culture as the primary reference
broth for a non-selective enrichment and incubated for method. Discrepant results were controlled by culture
24 h at 37 °C. When samples were negative for GBS after and by two additional molecular assays following nucleic
direct plating, a subculture of the enrichment broth was acids extraction using the NucleoMag Dx Pathogen kit
performed on Columbia agar plates with 5% horse blood (MACHEREY-NAGEL, Hoerdt, France). Molecular
and on Granada plates as described above. When samples assays used as controls were the VIASURE Streptococ-
were positive for GBS after direct plating, a semi-quanti- cus B Real Time PCR Detection Kit (CERTEST BIOTEC,
tative evaluation was performed as follows: GBS colonies Zaragoza, Spain), which also targets a conserved region
on a single quadrant (1), on two quadrants (2), on three of the cfb gene, and a homemade Real Time PCR target-
quadrants (3), and on four quadrants (4). Samples show- ing the GBS dltR gene [23].
ing discrepant results regarding the presence or absence Because prior studies have suggested that NAATs can
of GBS before and after storage at -80 °C were excluded be more sensitive than conventional cultures, we also
from subsequent analyses. compared the results of each assay to consensus results
of each of the four molecular assays. In this case, culture-
Assay procedures negative samples were categorized as true positive (TP) if
The Ampliflash® GBS and Pluslife® GBS tests were carried positive by two or more molecular assays [21, 24].
out in parallel to GBS culture confirmation on thawed
samples in July 2023. Testing was performed by a trained Statistical analysis
operator according to the manufacturers’ instructions Analytical performances including sensitivity, speci-
with slight modifications. ficity, PPV and negative predictive value (NPV) were
Briefly, 50 µL of samples in Amies transport medium determined by comparison with the reference method
were aliquoted for the Ampliflash® GBS test and 250µL e.g., culture with enrichment, and with the consensus
for the Pluslife® GBS tests. After centrifugation (14 results where at least 2/4 NAATs agree. Invalid results
000 rpm, 5 min), the supernatant was removed and the and errors were excluded from the statistical analysis.
pellets were resuspended either in 250 µL of the BIO- The 95% confidence intervals (CI) for binomial propor-
SYNEX IntimaSwab transport medium for the Ampli- tions were calculated using the Wilson score method. A
flash® GBS test or in 250 µL of the PlusLife® GBS test lysis McNemar’s chi-square test was performed to compare
buffer. The following steps were performed according to the performances of the tests. For samples giving positive
the manufacturers’ instructions. For the Ampliflash® GBS NAATs results, TTR was correlated to GBS bacterial load
test, lysis was performed at 98 °C (5 min). Next, 35 µL by culture using the Kruskal-Wallis test. A p value < 0.05
of lysed samples were mixed with the rehydration buffer was considered significant.
of the lyophilized Ampliflash® GBS test and transferred
in dedicated wells of the reaction strips. Amplifications Results
were run in Ampliflash® readers, where up to two strips Comparison of the molecular assays to GBS culture
can be placed. For the PlusLife® GBS assay, thermal lysis A total of 317 non-redundant vaginal samples were
was performed in the PlusLife Dry Bath incubator at included between February and April 2023. All samples
65 °C (5 min). Samples were transferred to the reaction were from pregnant women and were performed as part
cards for amplification in the PlusLife instrument where of routine clinical care and included the detection of GBS
up to eight cards can be placed. by culture methods. A total of 14 samples initially found
Both tests target the atr and cfb genes of GBS, which positive (n = 9) and negative (n = 5) for GBS by routine
encode the glutamine transporter protein and the bacterial culture showed discrepant results after storage
CAMP-factor, respectively. The test is interpreted as pos- at -80 °C and were excluded from the study. Eventually, a
itive when either of the two targets is amplified, negative total of 303 samples were analyzed, including 85 culture-
when none of the target is amplified, and invalid when positive samples (28.1%). Among these, all but one were
the internal control for DNA amplification (ubiquitous positive after direct plating, the latter being positive only
human gene encoding the ribonuclease P) is negative. after broth enrichment.
Invalid results may be caused by insufficient DNA con- Due to insufficient volume, 13 samples could only be
centration due to incorrect sampling or excess inhibitors tested by a single molecular technique e.g., the Ampli-
such as mucus or blood in the vaginal sample. In both flash® GBS test. Besides, 4 samples could not be tested
systems, amplification results are available in real-time by the Pluslife® GBS test because of technical problems.
e.g., in 5–30 min and 7–35 min for the Ampliflash® and Overall, 303 and 286 samples were analyzed by the
PlusLife® GBS tests, respectively. Ampliflash® GBS and Pluslife® GBS Nucleic Acid test,
respectively. The Ampliflash® GBS assay gave a result for
Charfi et al. Annals of Clinical Microbiology and Antimicrobials (2024) 23:37 Page 4 of 8

Table 1 Comparison of NAATs to culture results

Assay Assay result Culture result Enrichment culture result Total
Positive Negative Positive Negative
Ampliflash® GBS Positive 74 2 74 2 76
Negative 10 217 11 216 227
PlusLife® GBS Positive 76 16 76 16 92
Negative 1 182 1 182 183
Invalid 2 9 2 9 11
Not tested 6 11 6 11 17
All assays 84 219 85 218 303
GBS: Group B Streptococcus; NAATs: nucleic acid amplification tests

Table 2 Performances of NAATs compared to culture and

control PCR tests. Accordingly, the samples were classi-
consensus results
fied as positive by the consensus method. A total of 14
Assay Sensitiv- Specificity Predictive Predictive
ity (95% (95% CI) positive negative more samples were classified as false positives with the
CI) value (95% value (95% PlusLife® test using culture as the reference method. The
CI) CI) control PCR tests gave a negative result for all of these
Compared to culture results samples, with the exception of one which was therefore
Ampliflash® 87.1% 99.1% 97.4% 95.2% classified as positive by the consensus method.
GBS (78.3–92.6) (96.7–99.8) (90.9–99.3) (91.5–97.3) Overall, the PlusLife® GBS test was significantly more
PlusLife® GBS 98.7% 91.9% 82.6% 99.5% sensitive than the Ampliflash® GBS test compared with
(93.0-99.8) (87.3–95.0) (73.6–89.0) (97.0-99.9)
culture and with consensus results (McNemar’s chi-
Compared to consensus results
square test, p = 0.021). Conversely, the Ampliflash GBS
Ampliflash® 87.4% 100% 100% 95.2%
GBS (78.8–92.8) (98.3–100) (95.2–100) (91.5–97.3)
test was significantly more specific than the PlusLife®
PlusLife® GBS 98.7% 92.9% 84.8% 99.5% GBS test (McNemar’s chi-square test, p < 0.001). Com-
(93.2–99.8) (88.4–95.7) (76.1–90.7) (97.0-99.9) pared to consensus results, the PPV and NPV of the
Culture 97.7% 100% 100% 99.1% Ampliflash® test were of 100% (95% CI 95.2–100) and
(92.0-99.4) (98.3–100) (95.7–100) (96.7–99.8) 95.2% (95% CI 91.5–97.3), respectively, whereas those
CI: confidence interval; GBS: Group B Streptococcus; NAATs: nucleic acid of the PlusLife® test were 84.8% (95% CI 76.1–90.7) and
amplification tests
99.5% (95% CI 97.0-99.9), respectively.

all tested samples, showing a rate of invalid tests < 0.4%. Concordance between NAATs results and GBS culture
This rate was of 3.8% with the PlusLife® GBS test which density
gave a result for 275 of the 286 samples tested. The results To better characterize NAATs performances, we ana-
of both NAATs compared to GBS culture are summa- lyzed false negative results with respect to GBS load as
rized in Table 1. The percent agreement between NAATs assessed by semi-quantitative bacterial culture. Tak-
was 90.3% (260/288 tests). Of note, the sample which ing the consensus results as a reference, among the 12
showed a positive GBS culture only after the enrichment Ampliflash® GBS false negative results, 1 was negative
step gave a negative and an invalid result with the Ampli- by culture, 1 was positive only after enrichment, 8 were
flash® and the PlusLife® test, respectively. associated with a low GBS load (1 quadrant), and 2 with
a moderate GBS load (2 quadrants). Notably, only 5 out
Analytical performances compared with GBS culture and of these 12 samples were detected positive with the com-
with consensus results mercial PCR test used as a control. The threshold cycles
The analytical performances of both NAATs were first (Ct) observed with this latter method were > 35, indica-
compared to GBS culture as the gold standard reference tive of a low DNA load. The PlusLife® GBS test gave only
method (Table 2). The Ampliflash® test showed a sensi- one false negative result which was associated with a
tivity and a specificity of 87.1% (95% CI 78.3–92.6) and high GBS load by culture (4 quadrants). All other NAATs
99.1% (95% CI 96.7–99.8), respectively, compared with detected this sample as positive for GBS. Unfortunately,
98.7% (95% CI 93.0-99.8) and 91.9% (95% CI 87.3–95.0) the PlusLife® GBS test could not be repeated and a tech-
for the PlusLife® test, respectively. nical error cannot be excluded in this particular case.
Next, we sought to investigate the false positive results Next, we analyzed the correlation between TTR and
using two additional PCR tests. The two false positives the GBS load observed in culture. The median TTR was
of the Ampliflash® test were also detected positive by the 12 (range 6–27) and 13 (range 11–25) min for the Ampli-
three other NAATs e.g., the PlusLife® assay and the two flash® and Pluslife® GBS tests, respectively. The TTR was
Charfi et al. Annals of Clinical Microbiology and Antimicrobials (2024) 23:37 Page 5 of 8

not significantly correlated with GBS culture density for Discussion

the Ampliflash® test (Fig. 1). Conversely, for the Pluslife® In the early 2000s, the widespread implementation of
test, the TTR corresponding to GBS-negative cultures preventive strategies based on GBS antenatal screen-
(n = 16, including 13 false negatives and 3 true positives ing and IAP for colonized women resulted in a sub-
according to consensus results) and to GBS low-density stantial decline of GBS EOD in several industrialized
cultures was higher than that of GBS mild- to highly-pos- countries [4]. Whereas universal culture-based screen-
itive cultures. ing in late pregnancy between 35 or 36 and 37 weeks of
gestational age remains the gold standard in the USA,
Canada, and Europe, the European consensus conference

Fig. 1 Time-to-result in minutes for GBS detection according to GBS density in culture
The bottom, middle, and top lines of each box plot correspond to the 25%, 50%, and 75% cumulative frequencies of the observed values, respectively.
The endpoints of the whiskers show the 2.5th and 97.5th percentiles. GBS culture load was categorized as follows: (0) no GBS, (1) colonies on a single
quadrant, (2–3) colonies on two to three quadrants, and (4) colonies on four quadrants. The number of specimens for the Ampliflash® test and the
PlusLife® test by GBS culture category was (0) 2 and 16, (1) 8 and 13, (2–3) 16 and 16, and (4) 52 and 47, respectively. Statistical analysis was performed
using the Kruskall-Wallis test. * p < 0.05, *** p < 0.0001
Charfi et al. Annals of Clinical Microbiology and Antimicrobials (2024) 23:37 Page 6 of 8

recommends intrapartum screening using NAATs for technique, and of experience with this novel technology,
all women, except in case of beta-lactam allergy where it appears difficult to draw any categorical conclusions.
GBS isolation and antibiotic susceptibility testing are In contrast to other studies, taking the consensus
required [6–10, 17]. Although previous studies reported results as the reference method, NAATs did not signifi-
lower sensitivity of NAATs compared with culture for cantly improve GBS detection over culture [19, 31]. For
GBS detection, intrapartum NAATs showed better sen- instance, the consensus method added only three posi-
sitivity and PPV than antenatal culture screening for the tive specimens to the 85 previously identified by culture.
detection of intrapartum GBS colonization [19, 25, 26]. All three specimens showed high Ct values between 33.6
Besides, in more recent studies, several NAATs proved and 37.2 with the commercial PCR test used as a control,
more sensitive than the gold standard enrichment culture indicative of a low bacterial load. Other studies demon-
but only when both NAAT and culture were performed strated that NAATs had significantly higher sensitivity
after an enrichment step [21, 24, 27]. than culture by up to 40%, but only when performed after
In the present study, we compared the performances a step of enrichment in a selective broth [21, 27]. Hence,
of two European Community approved NAATs assays our findings which show lower sensitivity of NAATs com-
with culture for GBS detection in vaginal specimens from pared to culture are in agreement with those reported
pregnant women. Our main finding was that both tests elsewhere [19, 25, 32]. In addition, the sensitivity of
displayed very good to excellent analytical performances the Ampliflash® GBS test in our study is similar to that
and that they both met the criteria specified by the Euro- reported in a recent study conducted in the Democratic
pean consensus conference for such tests e.g., a short Republic of Congo which found a sensitivity of 96.6% and
turnaround time < 45 min, and accuracy with high sensi- 87.5% compared with a reference qPCR performed on
tivity and specificity, not inferior to 90–95% and 95–98% vaginal samples with Ct ≤ 33 and < 40, respectively [33].
respectively [17]. Nevertheless, whereas the Ampliflash® In addition to technical issues that we discussed above,
test had a very high specificity, its sensitivity was at the reduced sensitivity of NAATs compared with culture
threshold limit (87.4%, 95% CI 78.8–92.8), and vice-versa may be due to technical sampling issues in the particular
for the PlusLife® test which also displayed a specificity circumstances of intrapartum testing such as ruptured
at the threshold limit (92.9%, 95% CI 88.4–95.7). These membranes or vaginal bleeding which could decrease
performances are likely linked to the technology used in bacterial density and lead to false negative results.
each of the two tests and to the technical procedure. The Besides, while most studies use blood agar plates for the
Ampliflash® GBS test is a typical LAMP assay and was detection of GBS, we used Granada agar plates, which
expected to be highly sensitive. However, its sensitivity enhances GBS detection in polymicrobial specimens
was lower than that of culture, while remaining similar to such as vaginal specimens [34, 35]. The major limitation
that of the PCR tests used as controls. This finding might when using blood agar plates is that approximately 5–8%
be related to the adaptation of the technical procedure of GBS are not hemolytic and may be unrecognized [36,
that had to be carried out, in which the vaginal specimens 37]. Isolated on Granada medium, beta-hemolytic GBS
were not discharged in the dedicated transport medium appear as pigmented orange to red colonies, whereas non
supplied with the test. Of note, false negative results were beta-hemolytic isolates grow as white colonies. In addi-
mainly associated with low bacterial densities in culture tion to the fact that beta-hemolytic GBS are easily dis-
or PCR, which are less at risk of contaminating neonates tinguished on Granada medium, the latter is selective for
and also, considering bacterial densities in culture, less at streptococci and enterococci. Thus, testing of all white
risk of maternal and neonatal infection [28–30]. colonies enable all GBS isolates to be recognized, likely
The PlusLife® GBS assay is an RNase Hybridization- enhancing culture sensitivity.
Assisted amplification (RHAM) assay, which is a novel According to the European consensus conference, in
technology where LAMP is combined with an RNase addition of being rapid and accurate, intrapartum GBS
HII-mediated fluorescent reporter system presumed to tests should also be easy to perform and to interpret, and
increase both sensitivity and specificity [31]. However, available at all times 24 h a day, seven days a week [17].
taking either culture or the consensus results as the ref- The Ampliflash® GBS test and the PlusLife® GBS test dis-
erence methods, the PlusLife® GBS assay had the lowest play distinct features that can be used in different ways
specificity of all tests. The potential false positives cor- depending on the needs and on the clinical and labora-
related to high TTR values, which as high Ct values are tory settings. The Ampliflash® GBS test requires approx.
often associated with false-positive results [27]. These 10 min of technical handling including pipetting before
results, however, could also represent low-level positives the amplification step is started. This latter step can be
that could not be detected by the other NAATs or by performed either in the Ampliflash® reader or in any
culture. In the absence of an alternative highly sensitive open real-time thermal cycler. Conversely, the PlusLife®
test can be performed without any specific equipment or
Charfi et al. Annals of Clinical Microbiology and Antimicrobials (2024) 23:37 Page 7 of 8

Funding
environment. While the former test is primarily intended This work was partially supported by Assistance Publique – Hôpitaux de Paris,
for laboratory use, the latter could easily be used as Santé publique France, and Biosynex. The funders had no role in the design of
a point-of-care test, in delivery rooms. Although the the study, in data interpretation, and in the decision to write and publish the
manuscript.
PlusLife® GBS test had a higher rate of invalid results, this
rate remained lower than 4% which seems acceptable and Data availability
similar to that previously reported for other NAATs [12, The data generated during the current study are available from the
corresponding author on request.
13, 21].
Our study provides a first evaluation of the analytical
Declarations
performances of two innovative molecular techniques for
intrapartum GBS screening. Nevertheless, certain limi- Competing interests
tations should be highlighted. First of all, this was a ret- MU, GG are employees and TP is a corporate executive officer of Biosynex S.A.
Other authors have no conflicts of interest to disclose.
rospective study and the vaginal specimens were stored
at -80 °C before being tested, which might have induced Ethics approval
bacterial and nucleic acid degradation, and biases in the This is a molecular-based study in which samples were duly anonymized
with no change in the standard of care; therefore, no informed consent was
sensitivities and specificities we report. Secondly, this requested.
was a single-center study where all the tests were car-
ried out by trained and experimented staff, which likely Received: 26 January 2024 / Accepted: 4 April 2024
improved the sensitivity of GBS detection by culture
and NAATs. Last, as all tests were performed on a single
swab, some discrepancies could not be investigated due
to insufficient volume. References
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