Comparison of the Roche Cobas® 4800 HPV assay to Roche Amplicor for detection of high-risk human papillomavirus

S Phillips; A M Cornall; D A Machalek; S M Garland; D Bateson; M Garefalakis; S N Tabrizi

doi:10.1007/s10096-016-2665-1

Comparison of the Roche Cobas® 4800 HPV assay to Roche Amplicor for detection of high-risk human papillomavirus

Eur J Clin Microbiol Infect Dis. 2016 Aug;35(8):1305-7. doi: 10.1007/s10096-016-2665-1. Epub 2016 May 13.

Authors

S Phillips^{1

2

3}, A M Cornall^{4

5}, D A Machalek^{4

5}, S M Garland^{4

5

6}, D Bateson⁷, M Garefalakis⁸, S N Tabrizi^{4

5

6}

Affiliations

¹ Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia. sam.phillips@mcri.edu.au.
² Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Bio 21 Institute, Parkville, 3052, Australia. sam.phillips@mcri.edu.au.
³ Murdoch Childrens Research Institute, Parkville, Victoria, 3052, Australia. sam.phillips@mcri.edu.au.
⁴ Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia.
⁵ Murdoch Childrens Research Institute, Parkville, Victoria, 3052, Australia.
⁶ Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia.
⁷ Family Planning New South Wales, Ashfield, NSW, Australia.
⁸ Family Planning Western Australia, Northbridge, WA, Australia.

PMID: 27177752
DOI: 10.1007/s10096-016-2665-1

Abstract

Roche Amplicor HPV (AMP) had previously been used for detection of high-risk human papillomavirus (HR-HPV) in epidemiological and clinical studies. As this assay is no longer available, we compared its performance using PreservCyt samples from women aged of 18-24 years attending for routine cervical cytology screening to Roche Cobas® 4800 (Cobas) to determine if subsequent studies could continue using the Cobas assay. Overall 507 samples were tested on Cobas and compared to previous AMP results, with discrepant samples tested on Roche Linear Array.

Results: Overall, agreement between the Cobas and AMP for the presence of HR HPV types was very high (κ = 0.81) (95 % CI: 0.76 - 0.87) with percentage agreement of 91.57 %. Cobas is comparable to AMP for the detection of HR-HPV types in a community recruited cohort of healthy women.

Publication types

Comparative Study

MeSH terms

Adolescent
Adult
Female
Humans
Nucleic Acid Amplification Techniques / methods*
Nucleic Acid Amplification Techniques / standards*
Papillomaviridae / genetics*
Papillomavirus Infections / diagnosis*
Papillomavirus Infections / virology
Reagent Kits, Diagnostic / standards*
Reagent Kits, Diagnostic / virology*
Reproducibility of Results
Young Adult

Substances

Reagent Kits, Diagnostic