B-208 Correlation Studies of Human Papillomavirus DNA on Roche Cobas vs Human Papillomavirus mRNA on Hologic Panther

Abstract

Abstract Background Molecular testing, specifically HPV DNA has revolutionised the screening and management of cervical cancer. WHO in 2021 has recommended HPV DNA as the primary screening test and also the newer technology HPV mRNA as alternative assay. This evaluation aims to study the result concordance between HPV DNA and mRNA assay. Methods The evaluation was conducted on Roche Cobas 4800 (HPV DNA) and Hologic Panther (HPV mRNA) at NHGD IMH lab in 2021. Both instruments underwent precision studies and carryover test to ascertain its performance prior to the concordance study. 64 samples were used in the correlation against the reference method- HPV DNA testing on Roche Cobas 6800. Results Both Cobas 4800 and Hologic Panther demonstrated acceptable performance in precision, carryover and LoD (for Hologic only). However closer result agreement is observed in Roche 4800 results to the testing laboratory, Quest which is using Roche 6800. Conclusion The disconcordance between cobas 6800 vs cobas 4800 came from the negative samples in cobas 4800 in which their Ct value were found to be near to the detection limit. Similar to Cobas 4800, the discordance observed in Hologic came from the negative samples. However, HPV mRNA screening has been recognized for its higher specificity at baseline in the recent studies which improve clinical outcomes and reduce colposcopy referrals by 14%. Unfortunately, this could not be verified in our evaluation as colposcopy results for those HPV DNA positive sample were not available.