Clinical and analytical performance of the CLART HPV 4S assay with SurePath screening samples from the Danish cervical cancer screening program using the VALGENT framework.

Abstract excerpt

The CLART HPV4S (CLART4S) is a novel full genotyping assay, based on PCR/microarray technology. We assessed the clinical accuracy of the CLART4S assays under the fourth installment of the VALGENT framework. The VALGENT cohort comprised 998 consecutive cervical samples from women participating in the Danish screening programme enriched with 297 samples with abnormal cytology (100 ASCUS, 100 LSIL, 97 HSIL). The...

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