Several HPV tests have been shown to have good performance as screening or triage tests. Most studies of HPV testing have been conducted in either ThinPrep Preservcyt medium or STM collection medium. Increasingly SurePath is now being used for liquid based cytology and there is a need to evaluate the performance of HPV testing assays in this collection medium as well.
The data on different HPV tests in different media will be reviewed. We focus attention on the range of Predictors studies where up to 6 different tests have been compared both in a screening and triage context and especially on Predictors 4 which studied samples taken in both Preservcyt and Surepath in the 630 women attending for colposcopy due to an abnormal cytology. Two samples were taken from each woman and stored in 20ml of ThinPrep and 10 ml SurePath. The order in which the collection media were used was randomised (319 SurePath first and 311 ThinPrep first). HC2 results were only available for the second part of the study (n=344).
All (N=630) |
CIN3+ (N96) |
CIN2+ (N176) |
CIN2+ (N454) |
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Test | Assay | % Positive | Sensitivity | Sensitivity | Specificity |
HC2 (Qiagen) (N=344) | ThinPrep/SurePath | 84%/78% | 0.98/0.98 | 0.97/0.96 | 0.21/0.28 |
Onclarity (BD) | ThinPrep/SurePath | 77%/78% | 1.00/1.00 | 0.97/0.97 | 0.31/0.29 |
RealTime (Abbott) | ThinPrep/SurePath | 76%/71% | 0.99/0.97 | 0.95/0.92 | 0.32/0.37 |
Sirocco (Genera) (N=585) | ThinPrep/SurePath | 79%/80% | 0.96/0.96 | 0.93/0.94 | 0.26/0.25 |
APTIMA (Gen-Probe) (N=613) | ThinPrep/SurePath | 77%/72% | 0.99/0.98 | 0.97/0.92 | 0.31/0.36 |
OncoHealth | ThinPrep/SurePath | 57%/48% | 0.58/0.55 | 0.60/0.52 | 0.45/0.54 |
These results will be compared to other recent comparisons between HPV tests and transport media.
The histologic abnormalities were 96 CIN3+ (15%), 80 CIN2 (13%), 122 CIN1/HPV (19%), 332 (53%) normal or no biopsy. HPV positivity was lower in SurePath except for the BD and Genera tests (Table). There were always more SurePath negative discordant pairs (ie T pos/Sneg / vs T-neg /S-pos/) and quantitative readings were lower.