Effect of glacial acetic acid pre‐treatment of cervical liquid‐based cytology specimens on the molecular detection of human papillomavirus

Abstract

GAA pre-treatment of cervical ThinPrep Preservcyt LBC specimens had little effect on the two commercial HPV tests used in this study. The impact of GAA treatment on HPV testing should, however, be validated for all HPV tests and all LBC collection media used in each particular diagnostic setting.

Clinical sensitivity of HPV assays for the detection of high grade cervical disease in cervical samples treated with glacial acetic acid

“…Another limitation of this study was that it was not a 'split specimen' study, as knowledge of pathology status was only available after cytology and associated biopsy. However, an earlier split-specimen study undertaken in our laboratory which assessed analytical, rather than clinical, performance again showed that GAA did not affect qualitative HPV detection by rtHPV and HC2 and the present study was designed to be complimentary to those earlier data [7]. Finally only two assays were assessed in this study while an increasing number of clinically validated tests are now available [12].…”

“…Of the small number of studies where the impact of GAA has been assessed, the evidence would indicate that the COBAS 4800HPV Assay (Roche Molecular Systems, Pleasanton, CA, USA) and APTIMA HPV Test (Gen-Probe Inc., San Diego, CA) are unaffected by GAA treatment − as opposed to the Cervista Test (Hologic, Inc., Bedford, MA) where it has a deleterious influence [3][4][5][6]. Furthermore, in an earlier splitspecimen study of untreated vs treated specimens undertaken in our laboratory, while the impact of GAA on HPV detection was insignificant at the qualitative level, GAA treatment was associated with lower read-outs according to the semi-quantitative measures of the assays chosen: HC2 and rtHPV [7].…”

“…Both cytology laboratories, Greater Glasgow and Clyde (GGC) and Lothian use the Hologic protocol for the processing of ThinPrep Papanicolaou specimens (Hologic, Malborough, MA, USA) with slight variations described previously [7] …”

“…types, whereas the HC2 test is a signal amplification assay which detects 13 high-risk types in aggregate. These assays were those used in the split-sample study described earlier [7].…”

“…For example, in Munson et al no pathology (cytology or histology) status was provided, whereas in the studies of McMenamin et al [3,6] and Moore et al [7] while cytology was reported, only 17/121 (14.0%) and 4/150 (2.6%) cases respectively were associated with high grade cytology-and no histological data was presented. The present article builds on existing data by focussing on the assessment of a key clinical-performance measure of HPV assays (sensitivity for the detection of CIN2+) in GAA treated samples, rather than focussing solely on analytical performance.…”