Search results - 100 results
Direct comparison of two vaginal self-sampling devices for the detection of human papillomavirus infections.
understand (p <0.001) and to use (p=0.002). DISCUSSION: This study confirms that hr- HPV testing with a clinically validated PCR-based HPV assay is as accurate on self-samples as on clinician-samples ...
Development of a Luminex xTAG® assay for cost-effective multiplex detection of β-lactamases in Gram-negative bacteria.
probe targeting a conserved 16S rRNA region serving as a DNA extraction control. The assay was optimized using a collection of 48 reference strains and further validated using 105 foodborne ESBL-producing ...
Clinical and analytical performance of the PapilloCheck HPV-Screening assay using the VALGENT framework.
context is essential, using well-annotated samples, such as those generated via the Validation of Genotyping Tests- HPV (VALGENT) framework. OBJECTIVE: Our aim was to assess the PapilloCheck HPV assay in ...
Clinical validation of hrHPV testing on vaginal and urine self-samples in primary cervical screening (cross-sectional results from the Papillomavirus Dumfries and Galloway-PaVDaG study).
papillomavirus (hrHPV) PCR-based assay to detect high-grade cervical intraepithelial neoplasia (CIN2 +) in self-collected vaginal and urine samples. SETTING: Women attending routine cervical screening in ...
VALGENT: A protocol for clinical validation of human papillomavirus assays.
comparison and validation of HPV assays in general and HPV genotyping tests in particular according to clinically relevant outcomes and for clinical applications endorsed by scientific evidence. STUDY DESIGN: ...
Generation and Characterization of Six Recombinant Botulinum Neurotoxins as Reference Material to Serve in an International Proficiency Test.
and validated amino acid analysis, respectively. In addition, BoNT/A₁, B₁, E₁ and F₁ were successfully detected by immunological assays, unambiguously identified by mass spectrometric-based methods, and ...
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.
States. This means that once a batch is released by the competent authority of one Member State, Official Control Authority Batch Release is valid for all other Member States, which is also known as ...
A multiplex oligonucleotide ligation-PCR as a complementary tool for subtyping of Salmonella Typhimurium
markers was confirmed in a serial passage experiment. The validation of the MOL- PCR assay for subtyping of S. Typhimurium and S. 1,4,[5],12:i:- on 519 isolates shows that the method is rapid, reproducible, ...
Clinical and Analytical Performance of the Onclarity HPV Assay Using the VALGENT Framework.
generated in the Validation of HPV Genotyping Tests (VALGENT) framework. Through VALGENT, we assessed the performance of the BD Onclarity HPV assay, which detects 14 high-risk (HR) types and resolves six ...
Which high-risk HPV assays fulfil criteria for use in primary cervical cancer screening?
tests, validated assays which assure high-quality screening need to be identified. A systematic review was conducted to answer the question which hrHPV tests fulfil the criteria defined by an international ...