Abstract
The present study describes analytical and clinical performance of the HPV 16 & 18 assay for the detection of HPV specific DNA with near point-of-care utility. A room temperature compatible real time PCR test was developed for detection and discrimination of HPV 16/18 in a single tube. The test was integrated and validated on Compact series automated platform for analytical performance (sensitivity, specificity, accuracy). The clinical evaluation was performed on cervico-vaginal specimens. The analytical sensitivity data showed dynamic range from 50 IU/mL to 1´106 IU/mL using NIBSC international standard (19/224 for HPV16 and HPV18). The test was found to be highly specific for both the HPV targets with no cross reactivity against other HPV genotypes (high and low risk) and similar pathogens. The clinical performance on cervical sampling indicated up to 100% agreement with a comparator test method. The HPV 16 and 18 detection assay employing an integrated automated system offers low to high-throughput analysis with a cost-effective, pipette-free approach, eliminating the need for molecular infrastructure and technical expertise. This test named “HPV 16 and 18 detection kit” has been approved by Central Drugs Standard Control Organisation (India) for commercial utility, and would have significant implications for mass screening of cervical cancer.
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