Comparing the performance of six human papillomavirus tests in a screening population.
BACKGROUND
Several new assays have been developed for high-risk HPV testing of cervical samples; we compare six HPV tests in a screening population.


METHODS
Residual material from liquid-based PreservCyt samples was assayed. Four tests (Hybrid Capture 2, Cobas, Abbott and Becton-Dickinson (BD)) measured HPV DNA while two used RNA (APTIMA and NorChip).


RESULTS
Positivity rates ranged from 13.4 to 16.3% for the DNA-based tests with a significantly lower positivity rate for the Abbott assay. The Gen-Probe APTIMA assay was positive in 10.3% of women, which was significantly lower than all the DNA tests; the NorChip PreTect HPV-Proofer test was much lower at 5.2%. 40 CIN2+ cases were identified, of which 19 were CIN3+. All CIN3+ cases were HPV positive by all tests except for one, which was negative by the Abbott assay and five which were negative by the NorChip test.


CONCLUSIONS
All HPV tests except NorChip showed high sensitivity for high-grade lesions positive by cytology, suggesting co-testing is unnecessary when using HPV tests. Positivity rates in cytology-negative specimens were similar for the DNA-based tests, but lower for the APTIMA test suggesting this maintains the high sensitivity of DNA tests, but with better specificity.
Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, Charterhouse Square, London EC1M 6BQ, UK.
J
J
Cuzick
L
L
Cadman
D
D
Mesher
J
J
Austin
L
L
Ashdown-Barr
L
L
Ho
G
G
Terry
S
S
Liddle
C
C
Wright
D
D
Lyons
A
A
Szarewski
D015415:Biomarkers / Q000032:analysis; D002584:Cervix Uteri / Q000821:virology*; D003581:Cytodiagnosis; D004279:DNA, Viral; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis
D015415:Biomarkers; D004279:DNA, Viral