Patients, in whom conventional cytology, HC-II test and colposcopy-directed biopsy were done, formed the basis of this study.
Interpretation & conclusion: The main utility of HC-II is in the triage of patients with cytology smear diagnosis of ASC-US, ASC-H or L-SIL, for referral to colposcopic examination.
The study population was restricted to high risk individuals for more focused application and more meaningful evaluation of HC-II.
Patients were called again for biopsy when either cytology report or HC-II was positive, if biopsy had not already been performed.
Specimen for HC-II was obtained in the same sitting, immediately after making the conventional cytology smear, using a conical brush and a vial containing the specimen transport medium (STM), both obtained from the manufacturer of HC-II (Digene Corporation, Maryland, USA).
HPV testing was done using HC-II assay (Digene Corporation, Maryland, USA) following the manufacturer's instructions.
HC-II testing: High-risk HPV infection was seen in 25 patients (18.
This selective screening method was adopted to increase the yield of positive cases; so that the utility of HC-II could be evaluated without unnecessarily increasing the sample size.
HC-II has been studied as a modality for screening of carcinoma cervix and has been shown to have high sensitivity but low specificity, reported as 100 and 85.
The main role of HC-II is in triage of patients having abnormal cytology smears since high cost prevents utility as a general screening technique.