Table 1. Human Papillomavirus assays compared in the Horizon study.
Human papillomavirus assay | Targeted human papillomavirusgenotypes | Detection technology | DNA/RNA, and the targeted HPV gene | Controls | Certificates |
APTIMA | 13 HR + 1 LR | MMLV reverse transcriptaseand T7 RNA polymerasemediated amplification | RNA, E6/E7 | Spiked control for sample processvalidity | FDA, IVD, CE |
CLART | 13 HR + 22 LR | Polymerase chain reaction/microarray | DNA, L1 | Sample by sample hCFTR gene forsample sufficiency | IVD, CE |
Cobas | 13 HR + 1 LR | Real-time polymerase chain reaction | DNA, L1 | Sample by sampleβ-globin for samplesufficiency | FDA, IVD, CE |
Hybrid Capture 2 | 13 HR | Sandwich capture molecular | DNA, whole genome | Batch control for process | FDA, IVD, CE |
Abbreviations: CE = Conformité Européenne mark; FDA = US Food and Drug Administration; HR = high risk genotypes using the International Agency for Research on Cancer’s classification, including the “probably carcinogenic” genotype 68 [26]; IVD = in vitro diagnostic medical device; LR = low risk genotypes using the International Agency for Research on Cancer’s classification, including the “possibly carcinogenic” genotype 66 [26].