Testing with an index and a comparator HPV test of clinician-collected cervical specimens and assessment of disease outcome (
Gary agena update#
To update the list of high-risk HPV assays that fulfil the 2009 international validation criteria (Meijer-2009). Only clinically validated HPV assays can be accepted in cervical cancer screening. The assay in its current form seems more suited to play a role in settings where specificity is of lesser importance, but where high sensitivity is paramount. The MA-HPV assay is a clinical sensitive assay with a lower clinical specificity compared to the GP-EIA. The genotype concordance between MA-HPV and GP-LMNX was good for the majority of the oncogenic types. The sensitivity of MA-HPV was non-inferior to GP-EIA (p=0.0001), whereas the specificity MA-HPV was inferior (0.89, CI 0.85-0.91, P=1.00). The relative sensitivity of the MA-HPV assay for ≥CIN2 and ≥CIN3 was 1.02 (CI: 0.98-1.05) and 1.01 (CI:0.99-1.04), respectively. The type specific concordance of the MA-HPV assay with the GP5+/6+ PCR with Luminex genotyping (GP-LMNX) was assessed as well. The clinical accuracy of the MA-HPV assay for sensitivity and specificity was assessed relative to that of the GP5+/6+ PCR Enzyme ImmunoAssay (GP-EIA) by a non-inferiority test. The MA-HPV was validated using the VALGENT4 panel, which constitutes 997 consecutive samples from a screening population in addition to 297 disease enriched samples with abnormal cytology. The MA-HPV assay is a mass-array based assay, which individually detects 14 oncogenic HPV genotypes and five non-oncogenic types. The clinical performance evaluation of the novel MassARRAY HPV assay (MA-HPV) was performed using Danish SurePath cervical cancer screening samples under the fourth VALGENT framework.
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