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. 2014 Jan 20;9(1):e86835. doi: 10.1371/journal.pone.0086835

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].