Zoekresultaten - 6 results

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

reproducibility of the index was evaluated by overall concordance and Cohen’s kappa, using a sub-population (n = 526). Relative sensitivity and specificity for CIN2 + of the index versus comparator were 1.01 (95% ...

Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening.

intra- and inter-laboratory agreement regarding detection of high-risk HPV DNA exceeding 87% with kappa ≥0.5. RESULTS The Xpert HPV assay showed high intra-laboratory reproducibility with an overall ...

Performance of a Cartridge-Based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection: Lessons from VALGENT (Validation of HPV Genotyping Tests).

HPV were 98% and 97%, respectively. The kappa agreements for HPV16 and HPV18 /45 between the clinically validated reference test (GP5 +/6+ LMNX) and the Xpert HPV were 0.92 and 0.91, respectively. The ...

Direct comparison of two vaginal self-sampling devices for the detection of human papillomavirus infections.

rates between self-collected and clinician-collected specimens (Evalyn: 91.2% [kappa 0.822]; Qvintip: 89.0% [kappa 0.779]). Colposcopy and histological evaluation revealed 55 women without cervical ...

Clinical and Analytical Performance of the Onclarity HPV Assay Using the VALGENT Framework.

a relative specificity of 0.99 (95% CI, 0.97 to 1.00; P = 0.186 for noninferiority). The kappa for agreement between the Onclarity assay and the GP5+/6+ LMNX assay for HR-HPV was 0.92 (95% CI, 0.89 to 0.94), ...

Clinical evaluation of a GP5+/6+-based luminex assay having full high-risk human papillomavirus genotyping capability and an internal control.

and EIA were in high agreement (Cohen’s kappa = 0.969) for the detection of 14 hrHPVs in aggregate, and no significant difference was observed (McNemar’s P = 0.629). The LMNX internal control detected ...

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