Background: APTIMA is a new test to detect mRNA of E6/E7 oncoprotein of 14 most high-risk types of Human Papillomavirus (HPV).Detection of HPV-E6/E7 mRNA is likely to be more specific as it signifies transforming infection. Hybrid Capture 2 (HC2) test for HPV DNA detection is widely evaluated and is considered as the ‘gold standard’ for HPV detection technologies.
Aim:The objectives of the study were to compare the sensitivity of APTIMA test with that of HC2 test for detection of cervical cancer and also to find out the concordance between the two tests.
Methods:: Study is ongoing and has institutional ethics committee approval. Cervical swabs were collected in PreservCytTM solution from biopsy-confirmed cervical cancer patients. Cervical specimens were also obtained from women with colposcopy and/or biopsy proved normal cervix or CIN1.Samples were tested by APTIMA and HC2 tests. The discrepant samples were genotyped using Linear-Array assay.
Results:: Total 248 cervical cancer patients have been recruited till date, of which 74 cases have been tested for both APTIMA and HC2. All the women were positive on APTIMA, though HC2 was negative for 2 cases. One of the discrepant samples was negative on Linear-Array and the other had HPV 16 and 18. HC2 report alone was available for 248 cases of invasive cancers, of which 12 were test negative. The APTIMA test reports of these samples are awaited. Concordance between APTIMA and HC2 could be estimated for 192 samples analyzed for both tests. The agreement was 91.0% with kappa 0.78 (97% C.I. 0.68-0.87).
Conclusions:Sensitivity of APTIMA test assay was higher than HC2 for detection of cervical cancer. Strength of agreement between the two tests was good. Updated results of 300 cases of cervical cancer and 400 cases with normal cervix/ CIN 1 will be presented.