scholarly journals Comparative study of GenePOC GBS LB Assay and GeneXpert GBS LB Assay for the detection of Group B Streptococcus in prenatal screening samples

2019 ◽  
Author(s):  
Tsokyi Choera ◽  
Brittney Jung-Hynes ◽  
Derrick J. Chen

Abstract Group B Streptococcal (GBS) infections in the United States are a leading cause of meningitis and sepsis in newborns. The CDC, therefore recommends GBS screening for all pregnant women at 35–37 weeks of gestation and administration of intrapartum prophylaxis (in those that tested positive) as an effective means of controlling disease transmission. Several FDA approved molecular diagnostic tests are available for rapid and accurate detection of GBS in antepartum women. In this study, we report a clinical comparison of the Xpert GBS LB assay and a novel FDA-cleared test, GenePOC GBS LB assay. A total of 250 vaginal-rectal swabs from women undergoing prenatal screening were submitted to the University of Wisconsin’s clinical microbiology laboratory for GBS testing. We found 96.8% of samples were concordant between the two tests, while 3.2% were discordant with higher sensitivity observed for the GenePOC GBS LB assay, and higher specificity for the GeneXpert GBS LB assay.

2019 ◽  
Author(s):  
Tsokyi Choera ◽  
Brittney Jung-Hynes ◽  
Derrick J. Chen

AbstractGroup B Streptococcal (GBS) infections in the United States are a leading cause of meningitis and sepsis in newborns. The CDC, therefore recommends GBS screening for all pregnant women at 35–37 weeks of gestation and administration of intrapartum prophylaxis (in those that tested positive) as an effective means of controlling disease transmission. Several FDA approved molecular diagnostic tests are available for rapid and accurate detection of GBS in antepartum women. In this study, we report a clinical comparison of the Xpert GBS LB assay and a novel FDA-cleared test, GenePOC GBS LB assay. A total of 250 vaginal-rectal swabs from women undergoing prenatal screening were submitted to the University of Wisconsin’s clinical microbiology laboratory for GBS testing. We found 96.8% of samples were concordant between the two tests, while 3.2% were discordant with higher sensitivity observed for the GenePOC GBS LB assay, and higher specificity for the GeneXpert GBS LB assay.


2019 ◽  
Author(s):  
Tsokyi Choera ◽  
Brittney Jung-Hynes ◽  
Derrick J. Chen

Abstract Background: Group B Streptococcal (GBS) infections in the United States are a leading cause of meningitis and sepsis in newborns. The CDC, therefore recommends GBS screening for all pregnant women at 35–37 weeks of gestation and administration of intrapartum prophylaxis (in those that tested positive) as an effective means of controlling disease transmission. Several FDA approved molecular diagnostic tests are available for rapid and accurate detection of GBS in antepartum women. Method: In this study, we report a clinical comparison of the Xpert GBS LB assay and a novel FDA-cleared test, Revogene GBS LB assay. A total of 250 vaginal-rectal swabs from women undergoing prenatal screening were submitted to the University of Wisconsin’s clinical microbiology laboratory for GBS testing. Results: We found 96.8% of samples were concordant between the two tests, while 3.2% were discordant with a positive percent agreement of 98.0% and a negative percent agreement of 96.5% between the Revogene GBS LB assay and the GeneXpert GBS LB assay. Conclusion: Overall, we report that both assays perform well for the detection of GBS colonization in pregnant women.


2019 ◽  
Author(s):  
Tsokyi Choera(Former Corresponding Author) ◽  
Brittney Jung-Hynes ◽  
Derrick J. Chen(New Corresponding Author)

Abstract Background: Group B Streptococcal (GBS) infections in the United States are a leading cause of meningitis and sepsis in newborns. The CDC, therefore recommends GBS screening for all pregnant women at 35–37 weeks of gestation and administration of intrapartum prophylaxis (in those that tested positive) as an effective means of controlling disease transmission. Several FDA approved molecular diagnostic tests are available for rapid and accurate detection of GBS in antepartum women. Method: In this study, we report a clinical comparison of the Xpert GBS LB assay and a novel FDA-cleared test, Revogene GBS LB assay. A total of 250 vaginal-rectal swabs from women undergoing prenatal screening were submitted to the University of Wisconsin’s clinical microbiology laboratory for GBS testing. Results: We found 96.8% of samples were concordant between the two tests, while 3.2% were discordant with a positive percent agreement of 98.0% and a negative percent agreement of 96.5% between the Revogene GBS LB assay and the GeneXpert GBS LB assay. Conclusion: Overall, we report that both assays perform well for the detection of GBS colonization in pregnant women.


2019 ◽  
Author(s):  
Tsokyi Choera ◽  
Brittney Jung-Hynes ◽  
Derrick J. Chen

Abstract Background: Group B Streptococcal (GBS) infections in the United States are a leading cause of meningitis and sepsis in newborns. The CDC, therefore recommends GBS screening for all pregnant women at 35–37 weeks of gestation and administration of intrapartum prophylaxis (in those that tested positive) as an effective means of controlling disease transmission. Several FDA approved molecular diagnostic tests are available for rapid and accurate detection of GBS in antepartum women. Method: In this study, we report a clinical comparison of the Xpert GBS LB assay and a novel FDA-cleared test, Revogene GBS LB assay. A total of 250 vaginal-rectal swabs from women undergoing prenatal screening were submitted to the University of Wisconsin’s clinical microbiology laboratory for GBS testing. Results: We found 96.8% of samples were concordant between the two tests, while 3.2% were discordant with a positive percent agreement of 98.0% and a negative percent agreement of 96.5% between the Revogene GBS LB assay and the GeneXpert GBS LB assay. Conclusion: Overall, we report that both assays perform well for the detection of GBS colonization in pregnant women.


2019 ◽  
Author(s):  
Tsokyi Choera ◽  
Brittney Jung-Hynes ◽  
Derrick J. Chen

Abstract Background: Group B Streptococcal (GBS) infections in the United States are a leading cause of meningitis and sepsis in newborns. The CDC, therefore recommends GBS screening for all pregnant women at 35–37 weeks of gestation and administration of intrapartum prophylaxis (in those that tested positive) as an effective means of controlling disease transmission. Several FDA approved molecular diagnostic tests are available for rapid and accurate detection of GBS in antepartum women. Method: In this study, we report a clinical comparison of the Xpert GBS LB assay and a novel FDA-cleared test, Revogene GBS LB assay. A total of 250 vaginal-rectal swabs from women undergoing prenatal screening were submitted to the University of Wisconsin’s clinical microbiology laboratory for GBS testing. Results: We found 96.8% of samples were concordant between the two tests, while 3.2% were discordant with a positive percent agreement of 98.0% and a negative percent agreement of 96.5% between the Revogene GBS LB assay and the GeneXpert GBS LB assay. Conclusion: Overall, we report that both assays perform well for the detection of GBS colonization in pregnant women.


2016 ◽  
Vol 55 (2) ◽  
pp. 412-422 ◽  
Author(s):  
Sarah Teatero ◽  
Patricia Ferrieri ◽  
Irene Martin ◽  
Walter Demczuk ◽  
Allison McGeer ◽  
...  

ABSTRACTUsing serotyping, multilocus sequence typing, and whole-genome sequencing (WGS) of selected strains, we studied the population structure of 102 group BStreptococcus(GBS) isolates prospectively sampled in 2014 from vaginal/rectal swabs of healthy pregnant women in metropolitan Toronto, Canada. We also determined the susceptibilities of each of the colonizing isolates to penicillin, erythromycin, clindamycin, tetracycline, and other antimicrobial agents. Overall, we observed a high rate of tetracycline resistance (89%) among colonizing GBS isolates. We found resistance to erythromycin in 36% of the strains, and 33% were constitutively or inducibly resistant to clindamycin. The most frequently identified serotypes were III (25%), Ia (23%), and V (19%). Serotype IV accounted for 6% of the colonizing isolates, a rate consistent with that observed among patients with invasive GBS infections in metropolitan Toronto. The majority of serotype IV isolates belonged to sequence type (ST)459, a tetracycline-, erythromycin-, and clindamycin-resistant ST first identified in Minnesota, which is considered to be the main driver of serotype IV GBS expansion in North America. WGS revealed that ST459 isolates from Canada are clonally related to colonizing and invasive ST459 organisms circulating in regions of the United States. We also used WGS to study recombination in selected colonizing strains from metropolitan Toronto, which revealed multiple episodes of capsular switching. Present and future circulating GBS organisms and their genetic diversity may influence GBS vaccine development.


2014 ◽  
Vol 52 (9) ◽  
pp. 3499-3500 ◽  
Author(s):  
Benjamin R. Berg ◽  
Jeana L. Houseman ◽  
Zachary E. terSteeg ◽  
William D. LeBar ◽  
Duane W. Newton

2005 ◽  
Vol 12 (2) ◽  
pp. 60-68 ◽  
Author(s):  
MR Law ◽  
G Palomaki ◽  
Z Alfirevic ◽  
R Gilbert ◽  
P Heath ◽  
...  

Streptococcus agalactiae, or Lancefield group B streptococcus (GBS), is the most frequent cause of serious bacterial sepsis, including neonatal meningitis, in UK neonates. Early-onset neonatal GBS infection, but not late-onset, can be prevented by screening to identify high-risk pregnancies and administering penicillin during delivery. A vaccine has been developed as an alternative means of prevention but it is awaiting a randomized trial before being available for general use. In this review we examine the published literature to assess the morbidity and mortality attributable to neonatal GBS infection, quantify the screening performance of the two alternative modes of screening (microbiological and risk factor based), review the evidence on the efficacy of the vaccine, and estimate the numbers of deaths and cases of serious disability that each strategy in turn might prevent in the UK, in order to assess the most effective means of prevention for the UK.


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