scholarly journals Multicenter Clinical Evaluation of the Automated AriesBordetellaAssay

2018 ◽  
Vol 57 (2) ◽  
Author(s):  
Ryan F. Relich ◽  
Amy Leber ◽  
Stephen Young ◽  
Ted Schutzbank ◽  
Ronald Dunn ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Clinical Evaluation ◽  
Bordetella Pertussis ◽  
Turnaround Time ◽  
False Positives ◽  
Molecular Methods ◽  
Nasopharyngeal Swab ◽  
Limits Of Detection ◽  
Content Type ◽  
Bordetella Parapertussis

ABSTRACTMolecular methods offer superior sensitivity and specificity and reduce testing turnaround time from days to hours for detection ofBordetella pertussisandBordetella parapertussis. In this study, we evaluated the performance of the automated PCR-based AriesBordetellaAssay, which detects bothB. pertussisandB. parapertussisdirectly from nasopharyngeal swab specimens. The limits of detection (LoDs) were 1,800 CFU·ml−1forB. pertussisand 213 CFU·ml−1forB. parapertussis. The assay detected 16/18 uniqueB. pertussis/B. parapertussisstrains. Of 71 potentially cross-reacting organisms, 5 generated false positives in 1/6 replicates; none of 6 additionalBordetellaspp. were erroneously detected. Specimens were stable at 20 to 25°C for at least 10 h, at 4 to 8°C for 10 days, and at temperatures not exceeding −70°C for 6 months. Of 1,052 nasopharyngeal specimens from patients with suspected pertussis, 3.0% (n= 32) wereB. pertussispositive and 0.2% (n= 2) wereB. parapertussispositive. Combining these data with AriesBordetellaAssay data from 57 nasopharyngeal samples with previously confirmedB. pertussisorB. parapertussisdata and with data from 50 contrivedB. parapertussissamples, the proportions of positive and negative agreement of the respective Aries assays with the reference assays were 97.1% and 99.0% forB. pertussisand 100% and 99.7% forB. parapertussis. The AriesBordetellaAssay provides accurate detection and distinction ofB. pertussisandB. parapertussisinfections within 2 h. (This study has been registered at ClinicalTrials.gov under registration no. NCT02862262.)

scholarly journals Comparative Clinical Evaluation of NeoPlex RB-8 with Seeplex PneumoBacter ACE for Simultaneous Detection of Eight Respiratory Bacterial Pathogens

2019 ◽  
Vol 58 (2) ◽  
Author(s):  
Jeong Woo Kim ◽  
Seong Soo Hong ◽  
In Seop Lee ◽  
Hyun Young Chi ◽  
Soo-Ok Kim ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Legionella Pneumophila ◽  
Simultaneous Detection ◽  
Nasopharyngeal Swab ◽  
Pcr Assay ◽  
Content Type ◽  
Bordetella Parapertussis ◽  
Molecular Assays ◽  
Detection Assay ◽  
Higher Sensitivity

ABSTRACT There are several convenient and accurate molecular assays to detect respiratory bacterial infection. The NeoPlex RB-8 detection kit (NeoPlex RB-8) is a new multiplex real-time PCR assay that simultaneously detects Streptococcus pneumoniae, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Legionella pneumophila, Haemophilus influenzae, Bordetella pertussis, Bordetella parapertussis, and Moraxella catarrhalis in a single test. This study compared the clinical concordance of NeoPlex RB-8 with another method, Seeplex PneumoBacter ACE detection assay (Seeplex PB ACE), which simultaneously detects S. pneumoniae, M. pneumoniae, C. pneumoniae, L. pneumophila, H. influenzae, and B. pertussis. We tested 2,137 nasopharyngeal swab and sputum specimens using both assays. For discordant Bordetella parapertussis and M. catarrhalis specimens, we also performed bidirectional sequencing. For S. pneumoniae, M. pneumoniae, C. pneumoniae, L. pneumophila, H. influenzae, and B. pertussis, which are detected by both NeoPlex RB-8 and Seeplex PB ACE, the positive and negative agreement between the two assays ranged from 91.7 to 100% (κ = 0.918 to 1). S. pneumoniae and H. influenzae were the most discordant targets and measured with higher sensitivity and specificity by NeoPlex RB-8 than Seeplex PB ACE. For Bordetella parapertussis and M. catarrhalis, which are not detected by Seeplex PB ACE, NeoPlex RB-8 sensitivity and specificity were >99%. Overall, NeoPlex RB-8 was highly comparable to Seeplex PB ACE, but NeoPlex RB-8 was more clinically accurate, with higher throughput and more convenience.

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 Melanin Produced by Bordetella parapertussis Confers a Survival Advantage to the Bacterium during Host Infection

mSphere ◽  
2021 ◽  
Author(s):  
Yukihiro Hiramatsu ◽  
Takashi Nishida ◽  
Dendi Krisna Nugraha ◽  
Fuminori Sugihara ◽  
Yasuhiko Horiguchi
Keyword(s):  
Virulence Factors ◽  
Respiratory Infection ◽  
Bordetella Pertussis ◽  
Survival Advantage ◽  
Etiological Agent ◽  
Negative Bacterium ◽  
Gram Negative ◽  
Content Type ◽  
Bordetella Parapertussis ◽  
Host Infection

In addition to the Gram-negative bacterium Bordetella pertussis , the etiological agent of pertussis, Bordetella parapertussis also causes respiratory infection in humans, with a mild pertussis-like disease. These bacteria are genetically closely related and share many virulence factors, including adhesins and toxins.

scholarly journals Multicenter Performance Evaluation of the Simplexa Bordetella Direct Kit in Nasopharyngeal Swab Specimens

2020 ◽  
Vol 59 (1) ◽  
pp. e01041-20
Author(s):  
Siu-Kei Chow ◽  
Sophie Arbefeville ◽  
Bobby L. Boyanton ◽  
Emily M. Dault ◽  
James Dunn ◽  
...  
Keyword(s):  
Bacterial Species ◽  
Turnaround Time ◽  
Cross Reactivity ◽  
Diagnostic Methods ◽  
Nasopharyngeal Swab ◽  
Content Type ◽  
Molecular Assays ◽  
Percent Agreement ◽  
Hands On ◽  
Reactivity Study

ABSTRACTDetection of Bordetella pertussis and Bordetella parapertussis using molecular methods is sensitive and specific with a short turnaround time compared to other diagnostic methods. In this multicenter study, we compared the performance of the Simplexa Bordetella Direct kit to those of other molecular assays in detecting and differentiating B. pertussis and B. parapertussis in nasopharyngeal swab specimens. The limits of detection (LODs) were 150 CFU/ml or 3 fg/μl of DNA for B. pertussis and 1,500 CFU/ml or 10 fg/μl of DNA for B. parapertussis. A total of 1,103 fresh and residual frozen specimens from eight clinical sites were tested. Combining the data from individual clinical sites using different comparative assays, the overall positive percent agreement (PPA) and negative percent agreement (NPA) for B. pertussis were 98.7% and 97.3%, respectively. The overall PPA and NPA for B. parapertussis were 96.7% and 100%, respectively. For prospective fresh specimens, the overall PPA and NPA for both targets were 97.7% and 99.3%, respectively. For retrospective frozen specimens, the overall PPA and NPA for both targets were 92.6% and 93.2%, respectively. The percentage of invalid results was 1.0%. A cross-reactivity study using 74 non-Bordetella bacterial species and five yeast species revealed that the Simplexa Bordetella Direct kit was 100% specific. The hands-on time and assay run time of the Simplexa Bordetella Direct kit are favorable compared to those of other commercial and laboratory-developed tests. In summary, the Simplexa Bordetella Direct kit has a performance comparable to those of other molecular assays for the detection of B. pertussis and B. parapertussis.

scholarly journals Diphtheria-tetanus-pertussis vaccine combined with Bordetella parapertussis vaccine

1962 ◽  
Vol 60 (3) ◽  
pp. 289-293 ◽  
Author(s):  
Neda Köhler-Kubelka
Keyword(s):  
Clinical Examination ◽  
Pertussis Vaccine ◽  
Bordetella Pertussis ◽  
Whooping Cough ◽  
Production Test ◽  
Post Vaccination ◽  
Bordetella Parapertussis ◽  
Cross Reactions ◽  
Combined Vaccine

Investigations carried out to ascertain the ability of various strains of Bordetella pertussis and B. parapertussis to produce agglutinins have shown that the agglutinin response is considerably greater with B. parapertussis.Children inoculated with a combined vaccine in which the parapertussis element contained B. parapertussis in only one-twelfth of the concentration of B. pertussis in the pertussis element showed agglutinins in their sera in titres well above 1:300 for both organisms. There were no cross-reactions and the serological responses were specific throughout. The vaccine used was the standard diphtheria-tetanus-pertussis (DTP) prophylactic to which had been added a vaccine prepared from recently isolated strains of B. parapertussis.Agglutinin titres of both whooping cough components with the combined vaccine were somewhat lower in mice than was the case when monovalent vaccines were used, but they were considered to be satisfactory.It is suggested that the agglutination production test in mice could be used for the assessment of protective power of B. parapertussis vaccines against infection.I wish to thank Dr Ikić, director of the Institute of Immunology, Zagreb, who enabled me to perform all these examinations, further to Dr B. Mravunac and Dr Z. Radanov for having carried out vaccination in children and for the clinical examination of post vaccination reactions.

scholarly journals Evaluation of a New Immunochromatography Technology Test (LDBio Diagnostics) To Detect Toxoplasma IgG and IgM: Comparison with the Routine Architect Technique

2017 ◽  
Vol 55 (12) ◽  
pp. 3395-3404 ◽  
Author(s):  
Caroline Mahinc ◽  
Pierre Flori ◽  
Edouard Delaunay ◽  
Cécile Guillerme ◽  
Sana Charaoui ◽  
...  
Keyword(s):  
Western Blot ◽  
Sensitivity And Specificity ◽  
Blot Analysis ◽  
False Positive ◽  
Automated System ◽  
University Hospitals ◽  
Content Type ◽  
Automated Screening ◽  
Commercial Kits ◽  
Fully Automated System

ABSTRACTA study comparing the ICT (immunochromatography technology)ToxoplasmaIgG and IgM rapid diagnostic test (LDBio Diagnostics, France) with a fully automated system, Architect, was performed on samples from university hospitals of Marseille and Saint-Etienne. A total of 767 prospective sera and 235 selected sera were collected. The panels were selected to test various IgG and IgM parameters. The reference technique,ToxoplasmaIgGII Western blot analysis (LDBio Diagnostics), was used to confirm the IgG results, and commercial kits Platelia Toxo IgM (Bio-Rad) and Toxo-ISAgA (bioMérieux) were used in Saint-Etienne and Marseille, respectively, as the IgM reference techniques. Sensitivity and specificity of the ICT and the Architect IgG assays were compared using a prospective panel. Sensitivity was 100% for the ICT test and 92.1% for Architect (cutoff at 1.6 IU/ml). The low-IgG-titer serum results confirmed that ICT sensitivity was superior to that of Architect. Specificity was 98.7% (ICT) and 99.8% (Architect IgG). The ICT test is also useful for detecting IgM without IgG and is both sensitive (100%) and specific (100%), as it can distinguish nonspecific IgM from specificToxoplasmaIgM. In comparison, IgM sensitivity and specificity on Architect are 96.1% and 99.6%, respectively (cutoff at 0.5 arbitrary units [AU]/ml). To conclude, this new test overcomes the limitations of automated screening techniques, which are not sensitive enough for IgG and lack specificity for IgM (rare IgM false-positive cases).

scholarly journals Evaluation of the New BD Max GC Real-Time PCR Assay, Analytically and Clinically as a Supplementary Test for the BD ProbeTec GC Qx Amplified DNA Assay, for Molecular Detection of Neisseria gonorrhoeae

2015 ◽  
Vol 53 (12) ◽  
pp. 3935-3937 ◽  
Author(s):  
Daniel Golparian ◽  
Stina Boräng ◽  
Martin Sundqvist ◽  
Magnus Unemo
Keyword(s):  
Neisseria Gonorrhoeae ◽  
Real Time ◽  
Sensitivity And Specificity ◽  
Real Time Pcr ◽  
Molecular Detection ◽  
Analytical Sensitivity ◽  
Pcr Assay ◽  
Content Type ◽  
Dna Assay ◽  
Supplementary Test

The new BD Max GC real-time PCR assay showed high clinical and analytical sensitivity and specificity. It can be an effective and accurate supplementary test for the BD ProbeTec GC Qx amplified DNA assay, which had suboptimal specificity, and might also be used for initial detection ofNeisseria gonorrhoeae.

scholarly journals Evaluation of Recombinant Proteins of Burkholderia mallei for Serodiagnosis of Glanders

2012 ◽  
Vol 19 (8) ◽  
pp. 1193-1198 ◽  
Author(s):  
Vijai Pal ◽  
Subodh Kumar ◽  
Praveen Malik ◽  
Ganga Prasad Rai
Keyword(s):  
Sensitivity And Specificity ◽  
Recombinant Proteins ◽  
False Negative ◽  
Enzyme Linked Immunosorbent Assay ◽  
Burkholderia Mallei ◽  
Content Type ◽  
Whole Cells ◽  
Negative Results ◽  
Elisa Format ◽  
Low Sensitivity

ABSTRACTGlanders is a contagious disease caused by the Gram-negative bacillusBurkholderia mallei. The number of equine glanders outbreaks has increased steadily during the last decade. The disease must be reported to the Office International des Epizooties, Paris, France. Glanders serodiagnosis is hampered by the considerable number of false positives and negatives of the internationally prescribed tests. The major problem leading to the low sensitivity and specificity of the complement fixation test (CFT) and enzyme-linked immunosorbent assay (ELISA) has been linked to the test antigens currently used, i.e., crude preparations of whole cells. False-positive results obtained from other diagnostic tests utilizing crude antigens lead to financial losses to animal owners, and false-negative results can turn a risk into a possible threat. In this study, we report on the identification of diagnostic targets using bioinformatics tools for serodiagnosis of glanders. The identified gene sequences were cloned and expressed as recombinant proteins. The purified recombinant proteins ofB. malleiwere used in an indirect ELISA format for serodiagnosis of glanders. Two recombinant proteins, 0375H and 0375TH, exhibited 100% sensitivity and specificity for glanders diagnosis. The proteins also did not cross-react with sera from patients with the closely related disease melioidosis. The results of this investigation highlight the potential of recombinant 0375H and 0375TH proteins in specific and sensitive diagnosis of glanders.

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