Table 1.: Characteristics and Analytical Sensitivity of the Main HR-HPV Screening Assays with Reflex or Concurrent HPV-16 and HPV-18 Genotyping and HPV Genotyping Assays

HPV Assay Technology Automation Analytical Sensitivity
HR-HPV screening assays with HPV-16/18 genotyping
Cobas 4800 HPV Test
(Roche Molecular Systems) */** 		Real time PCR Fully automated high-throughput
(COBAS 4800) 		80-2,400 copies/ml
Cervista HPV 16/18 Test
(Hologic) */** 		Invader® chemistry Automation available
(Cervista Medium throughput automation - MTA) 		625-1,250 copies/reaction
RealTime High Risk HPV test (Abbott
Molecular)* 		Real time PCR Fully automated high-throughput
(m2000sp + m2000rt) 		500-5,000 copies/assay
HR-HPV 16/18/45 Probe Set Test
(Qiagen)* 		Hybrid Capture Automation available
(Rapid Capture System-RCS) 		5,000 copies/assay
HPV genotyping assays
INNO-LiPA HPV Genotyping Extra
(Innogenetics) * 		Reverse hybridisation Partially automated
  • DNA extraction
  • Hybridization/Detection
  • Interpretation
 20-70 copies/assay
Linear Array HPV Genotyping Test
(Roche) * 		Reverse hybridisation Partially automated
  • DNA extraction
  • Hybridization/Detection
 50-8,000 copies/ml
PapilloCheck HPV-Screening Test
(Greiner Bio-One) * 		PCR-microarray Partially automated
  • DNA extraction
  • Interpretation
 30-750 copies/reaction
Clart HPV 2 (Genomica) * PCR-microarray Partially automated
  • DNA extraction:
  • Detection/Interpretation
 10-100 copies/reaction
Infiniti HPV Genotyping assay
(AutoGenomics) * 		PCR-microarray Fully automated: Infiniti analyzer
Partially automated
 • Detection/Interpretation		 300-3,000/assay

* Conformité Européenne (CE marked);
** U.S Food and Drug Administration approval.