On 27 March WHO prequalified one additional in vitro diagnostic, the Alinity m HR HPV manufactured by Abbott Molecular Inc. The product is a qualitative in vitro test for use with the automated Alinity m System for the detection of DNA from 14 high-risk human papillomavirus (HPV) genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in clinical specimens. The assay specifically identifies HPV genotypes 16, 18, and 45 while reporting the concurrent detection of the other high-risk genotypes (31/ 33/ 52/ 58) and (35/ 39/ 51/ 56/ 59/ 66/ 68) at clinically relevant infection levels.
The results from the Alinity m HR HPV, together with the physician’s assessment of cytology, history, other risk factors, and professional guidelines, may be used to guide patient management.