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

100.0% [95% CI 95.9-100.0] and specificity of 96.7% [95% CI 90.8-99.3]. The overall percent agreement was 98.3% with an excellent Cohen’s coefficient of κ = 0.967 [95% CI 0.929-1.000]. For the limit of ...

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% ...

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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