CIN2+ detection by HPV DNA array genotyping assay

Background:

Cervical cancer, caused by persistent HPV infection, is a highly preventable disease. HPV DNA Array is an E1-targeting PCR genotyping test, with capability of distinguishing 18 high-risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) and 11 low-risk HPV types (6, 11, 40, 42, 44, 54, 67, 69, 70, 85, 97). Aim of the study was to evaluate the clinical performance of the assay against internationally accepted Cobas 4800 (Roche).

Methods:

Multiplex PCR is used to amplify E1-gene sequences. The PCR product is detected by reverse hybridization to immobilized DNA probes spotted as triplets together in single 96 well-plate wells and read by an AID ELISPOT reader. Study population comprised of 500 cervical scrapings stored in PreserveCyte. Qiagen DNA extraction Kit was used. HPV results were compared to Cobas 4800 HPV test.

Results:

HPV DNA Array demonstrated a very high sensitivity of 100% for CIN2+ and 100% for CIN3+ detection, same as Cobas 4800. HPV DNA Array showed greater sensitivity for CIN2+ detection than cytology (100% vs. 18.2%). The agreement to Cobas 4800 for HPV detection, irrespective of type, was 81.4% with κ 0.613. The agreement for HPV 16 was 92.8% (κ= 0.929), and for HPV 18 54.2% (κ= 0.681).

Conclusion:

HPV DNA Array demonstrated good clinical performance for detection of high-grade lesions. Due to simplicity and high throughput potential this method may be suitable for genotyping in HPV primary screening.