Objective To determine if semi-quantitative human papillomavirus (HPV) type
s 16 and 18 detection by polymerase chain reaction can increase: the sensit
ivity and specificity of repeat cytology alone for underlying high grade ce
rvical intraepithelial neoplasia (CIN).
Design Prospective randomised study of immediate treatment and surveillance
.
Setting A dedicated colposcopy clinic serving a regional population.
Sample Three hundred and four women with smears reported as mild dyskaryosi
s.
Methods Repeat cytology, HPV 16 and 18 tests, and colposcopy were performed
at study entry. Women were randomised to either immediate treatment or sur
veillance with repeated tests at 6 and 12 months. Unless all study smears w
ere negative, women were treated at study exit by large loop excision of th
e transformation zone.
Main outcome measures Sensitivity and specificity of HPV testing for types
16 and 18 in conjunction with cytology for high grade CIN.
Results Combining repeat cytology with HPV 16 and 18 testing had a sensitiv
ity of 94% and a specificity of 26%, a positive predictive value of 71%, an
d a negative predictive value of 71%, for underlying high grade CIN. If use
d to secondary screen in conjunction with repeat cytology for mild dyskaryo
sis, 88% of women would have been referred for colposcopy on the basis of e
ither test being positive.
Conclusion Combining repeat cytology and HPV 16 and 18 detection would resu
lt in the majority of women being referred for immediate colposcopy. Taken
with an overall default rate of 17%, immediate referral of all women with m
ild dyskaryosis for colposcopic assessment still appears to be a more effec
tive clinical strategy.