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

2019 ◽  
Author(s):  
Tsokyi Choera ◽  
Brittney Jung-Hynes ◽  
Derrick J. Chen
Keyword(s):  
Disease Transmission ◽  
Prenatal Screening ◽  
Effective Means ◽  
The United States ◽  
Molecular Diagnostic ◽  
Clinical Microbiology Laboratory ◽  
Microbiology Laboratory ◽  
Group B ◽  
The University ◽  
Higher Sensitivity

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.

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
Keyword(s):  
Disease Transmission ◽  
Prenatal Screening ◽  
Effective Means ◽  
Group B Streptococcus ◽  
The United States ◽  
Molecular Diagnostic ◽  
Clinical Microbiology Laboratory ◽  
Group B ◽  
The University ◽  
Higher Sensitivity

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.

scholarly journals Comparative study of Revogene 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
Keyword(s):  
Pregnant Women ◽  
Disease Transmission ◽  
Prenatal Screening ◽  
Effective Means ◽  
Group B Streptococcus ◽  
The United States ◽  
Molecular Diagnostic ◽  
Clinical Microbiology Laboratory ◽  
Percent Agreement ◽  
Group B

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.

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

2019 ◽  
Author(s):  
Tsokyi Choera(Former Corresponding Author) ◽  
Brittney Jung-Hynes ◽  
Derrick J. Chen(New Corresponding Author)
Keyword(s):  
Pregnant Women ◽  
Disease Transmission ◽  
Prenatal Screening ◽  
Effective Means ◽  
Group B Streptococcus ◽  
The United States ◽  
Molecular Diagnostic ◽  
Clinical Microbiology Laboratory ◽  
Percent Agreement ◽  
Group B

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.

scholarly journals Comparative study of Revogene 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
Keyword(s):  
Pregnant Women ◽  
Disease Transmission ◽  
Prenatal Screening ◽  
Effective Means ◽  
Group B Streptococcus ◽  
The United States ◽  
Molecular Diagnostic ◽  
Clinical Microbiology Laboratory ◽  
Percent Agreement ◽  
Group B

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.

scholarly journals Comparative study of Revogene 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
Keyword(s):  
Pregnant Women ◽  
Disease Transmission ◽  
Prenatal Screening ◽  
Effective Means ◽  
Group B Streptococcus ◽  
The United States ◽  
Molecular Diagnostic ◽  
Clinical Microbiology Laboratory ◽  
Percent Agreement ◽  
Group B

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.

scholarly journals Multicenter Clinical Evaluation of the Xpert GBS LB Assay for Detection of Group B Streptococcus in Prenatal Screening Specimens

2014 ◽  
Vol 53 (2) ◽  
pp. 443-448 ◽  
Author(s):  
Blake W. Buchan ◽  
Matthew L. Faron ◽  
DeAnna Fuller ◽  
Thomas E. Davis ◽  
Donna Mayne ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Clinical Evaluation ◽  
Gold Standard ◽  
Early Onset ◽  
Prenatal Screening ◽  
Molecular Diagnostic ◽  
Current Standard ◽  
Culture Methods ◽  
Content Type ◽  
Group B

Neonatal infection withStreptococcus agalactiae(group BStreptococcus[GBS]) is a leading cause of sepsis and meningitis in newborns. Recent guidelines have recommended universal screening of all pregnant women to identify those colonized with GBS and administration of peripartum prophylaxis to those identified as carriers to reduce the risk of early-onset GBS disease in neonates. Enriched culture methods are the current standard for prenatal GBS screening; however, the implementation of more sensitive molecular diagnostic tests may be able to further reduce the risk of early-onset GBS infection. We report a clinical evaluation of the Xpert GBS LB assay, a molecular diagnostic test for the identification of GBS from broth-enriched vaginal/rectal specimens obtained during routine prenatal screening. A total of 826 specimens were collected from women undergoing prenatal screening (35 to 37 weeks' gestation) and tested at one of three clinical centers. Each swab specimen was tested directly prior to enrichment using the Xpert GBS assay. Following 18 to 24 h of broth enrichment, each specimen was tested using the Xpert GBS LB assay and the FDA-cleared Smart GBS assay as a molecular diagnostic comparator. Results obtained using all three molecular tests were compared to those for broth-enriched culture as the gold standard. The sensitivity and specificity of the Xpert GBS LB assay were 99.0% and 92.4%, respectively, compared to those for the gold standard culture. The Smart GBS molecular test demonstrated sensitivity and specificity of 96.8% and 95.5%, respectively. The sensitivities of the two broth-enriched molecular methods were superior to those for direct testing of specimens using the Xpert GBS assay, which demonstrated sensitivity and specificity of 85.7% and 96.2%, respectively.

scholarly journals The Need for Dedicated Microbiology Leadership in the Clinical Microbiology Laboratory

2021 ◽  
Author(s):  
Linoj P. Samuel ◽  
Glen T. Hansen ◽  
Colleen S. Kraft ◽  
Bobbi S. Pritt
Keyword(s):  
Clinical Microbiology ◽  
The United States ◽  
Clinical Microbiology Laboratory ◽  
Microbiology Laboratory ◽  
Sufficient Time ◽  
Emerging Pathogens ◽  
Antibiotic Resistant ◽  
Doctoral Level ◽  
Medical Microbiology ◽  
Healthcare Acquired Infections

Clinical microbiology laboratories play a crucial role in patient care using traditional and innovative diagnostics. Challenges faced by laboratories include emerging pathogens, rapidly evolving technologies, healthcare-acquired infections, antibiotic-resistant organisms and diverse patient populations. Despite these challenges, many clinical microbiology laboratories in the United States are not directed by doctoral level microbiology-trained individuals with sufficient time dedicated to laboratory leadership. This manuscript highlights the need for medical microbiology laboratory directors with appropriate training and qualifications.

Systematic Assessment of Culture Review as a Tool to Assess Errors in the Clinical Microbiology Laboratory

2008 ◽  
Vol 132 (11) ◽  
pp. 1792-1795
Author(s):  
Nancy Goodyear ◽  
Bruce K. Ulness ◽  
Jennifer L. Prentice ◽  
Brad T. Cookson ◽  
Ajit P. Limaye
Keyword(s):  
Clinical Microbiology ◽  
Susceptibility Testing ◽  
Positive Culture ◽  
The United States ◽  
Error Rates ◽  
Clinical Microbiology Laboratory ◽  
Microbiology Laboratory ◽  
Negative Culture ◽  
Clinically Significant ◽  
Potentially Clinically Significant

Abstract Context.—Daily supervisory review is a common practice in microbiology laboratories; however, there are no publications describing errors corrected by this practice. Objective.—To determine (1) the correction rates for routinely reviewed positive cultures, (2) the correction rates for negative cultures, and (3) the types of corrections that are found, including the number with potential clinical significance. Design.—We prospectively assessed errors identified during culture report review for all positive (10-month period) and negative (1-month period) cultures at a single, university-based clinical microbiology laboratory in the United States. Errors were classified using predefined categories, and total and per category error rates were determined. A χ2 test was used to assess significant differences between error rates. Results.—A total of 112 108 culture reports were examined; 914 reports required a total of 1043 corrections. Of 101 703 positive culture reports, 786 (0.8%) required 900 corrections, 302 (0.3%) of which were potentially clinically significant. Of 10 405 negative culture reports, 128 (1.2%) required 143 corrections, 5 (0.05%) of which were potentially clinically significant. The rate of potentially clinically significant errors was significantly higher among positive versus negative culture reports (P < .001). Errors from positive culture reports most commonly involved susceptibility (374 [42%]), reporting (275 [31%]), and identification workup (217 [24%]). Most potentially significant errors from positive culture reports involved susceptibility testing (n = 253) and specimens from wound or lower respiratory tract (P < .001). Conclusions.—Review of culture reports from positive cultures from nonsterile sites with special attention to antimicrobial susceptibility testing and reporting would be most likely to detect potentially significant errors within the clinical microbiology laboratory.

scholarly journals Streptococcus agalactiae Strains with Chromosomal Deletions Evade Detection with Molecular Methods

2019 ◽  
Vol 57 (4) ◽  
Author(s):  
Isabella A. Tickler ◽  
Fred C. Tenover ◽  
Scott Dewell ◽  
Victoria M. Le ◽  
Rachel N. Blackman ◽  
...  
Keyword(s):  
United States ◽  
Streptococcus Agalactiae ◽  
The United States ◽  
Molecular Diagnostic ◽  
Chromosomal Dna ◽  
Convenience Sample ◽  
Geographic Locations ◽  
Content Type ◽  
Chromosomal Deletions ◽  
Group B

ABSTRACT Surveillance of circulating microbial populations is critical for monitoring the performance of a molecular diagnostic test. In this study, we characterized 31 isolates of Streptococcus agalactiae (group B Streptococcus [GBS]) from several geographic locations in the United States and Ireland that contain deletions in or adjacent to the region of the chromosome that encodes the hemolysin gene cfb, the region targeted by the Xpert GBS and GBS LB assays. PCR-negative, culture-positive isolates were recognized during verification studies of the Xpert GBS assay in 12 laboratories between 2012 and 2018. Whole-genome sequencing of 15 GBS isolates from 11 laboratories revealed four unique deletions of chromosomal DNA ranging from 181 bp to 49 kb. Prospective surveillance studies demonstrated that the prevalence of GBS isolates containing deletions in the convenience sample was <1% in three geographic locations but 7% in a fourth location. Among the 15 isolates with chromosomal deletions, multiple pulsed-field gel electrophoresis types were identified, one of which appears to be broadly dispersed across the United States.

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