Search results - 19 results
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.
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 ...
Clinical and Analytical Evaluation of the Anyplex II HPV HR Detection Assay within the VALGENT-3 Framework.
Cervical Neoplasms Abstract: In 2012, VAL idation of human papillomavirus (HPV) GEN otyping T ests (VALGENT) was initiated to provide a formalized and uniform study framework for comparison and validation of ...
Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening.
Tests) and aims to determine whether the reproducibility of Xpert HPV is in line with international validation criteria. METHODS Validation of new hrHPV DNA assays requires demonstration of good ...
VALHUDES: A protocol for validation of human papillomavirus assays and collection devices for HPV testing on self-samples and urine samples
evidence that the relative accuracy of HPV-testing on self- vs clinician-samples is robust across clinical settings, the VALHUDES protocol offers a framework for validation of HPV assay/self-sample device ...
Clinical Evaluation of INNO-LiPA HPV Genotyping II Assay Using the VALGENT Framework.
Neoplasms Abstract: In this diagnostic test validation study, we assessed the clinical accuracy and HPV genotyping performance of the INNO-LiPA HPV Genotyping II (INNO-LiPA) within the VALGENT-3 framework. ...
Activity-Based Detection and Bioanalytical Confirmation of a Fatal Carfentanil Intoxication.
department admissions and deaths. Here, we report on the application of a novel opioid activity reporter assay and a sensitive bioanalytical assay in the context of a fatal carfentanil intoxication, revealing ...
Evaluation of the clinical performance of the HPV-Risk assay using the VALGENT-3 panel.
performance of various HPV tests relative to the validated and accepted comparator test in a formalized and uniform manner. The aim of this study was to evaluate the clinical performance of the HPV-Risk assay ...
Performance of a Cartridge-Based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection: Lessons from VALGENT (Validation of HPV Genotyping Tests).
(VALGENT) studies offer an opportunity to clinically validate HPV assays for use in primary screening for cervical cancer and also provide a framework for the comparison of analytical and type-specific ...