Zoekresultaten - 101 results

Clinical performance of the novel full-genotyping OncoPredict HPV Quantitative Typing assay using the VALGENT framework.

Infections Reproducibility of Results Sensitivity and Specificity Uterine Cervical Dysplasia Uterine Cervical Neoplasms Young adult Abstract: Clinical validation of human papillomavirus (HPV) assays according ...

Applicability of the DPRA on mixture testing: challenges and opportunities.

Keywords: Animal Testing Alternatives Animals Peptides Abstract: The in chemico direct peptide reactivity assay (DPRA) is validated to assess protein reactivity of chemical compounds, relating to the ...

Intra- and interlaboratory reproducibility of the RIATOL qPCR HPV genotyping assay.

detecting high-risk human papillomavirus (hrHPV) deoxyribonucleic acid (DNA) are more effective than cytology-based screening. Validation of new hrHPV DNA assays requires both noninferior clinical accuracy ...

Regulatory expectations on the use of vaccine reference standards for maintaining product quality.

should meet all requirements regarding safety and efficacy before its release to the market. The use of (international) reference standards or reference preparations plays a key role in assay validation ...

Development of a Droplet Digital PCR to Monitor SARS-CoV-2 Omicron Variant BA.2 in Wastewater Samples

applicability of the proposed RT-ddPCR method was evaluated to monitor and quantify the emergence of the BA.2 variant over time. To validate this assay as a proof of concept, the measurement of the proportion of ...

Papilloplex HR-HPV test has non-inferior clinical performance for detection of human papillomavirus infection: assessment using the VALGENT framework.

detection and separate identification of 14 hrHPV types. Here, we present the clinical validation of the test in SurePath samples in comparison to a clinically validated reference test, the GP5 +/6+Enzyme ...

Assessment of the clinical and analytical performance of the Aptima SARS-CoV-2 assay using the VALCOR protocol.

a study protocol designed to set up a framework for test validation of SARS-CoV-2 virus assays. Using clinical samples collated from VALCOR, the performance of Aptima SARS-CoV-2 assay was assessed against ...

Evaluation of the clinical performance of OncoPredict HPV® SCR assay within the VALGENT‐2 framework

papillomavirus (HPV) assays used in cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV ® Screening (SCR) is a partial genotyping multiplex real-time PCR ...

Evaluation of the clinical performance of OncoPredict HPV® SCR assay within the VALGENT-2 framework.

cervical cancer screening should be clinically validated according to international criteria. OncoPredict HPV ® Screening (SCR) is a partial genotyping multiplex real-time PCR assay targeting E6 / E7 genes ...

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