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Eur J Clin Microbiol Infect Dis. 2017 Mar;36(3):545-551. doi: 10.1007/s10096-016-2831-5. Epub 2016 Nov 8.

Anyplex II HPV28 detection and Anyplex II HPV HR detection assays are highly concordant with other commercial assays for detection of high-risk HPV genotypes in women with high grade cervical abnormalities.

Author information

1
Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, 3052, Victoria, Australia. Alyssa.Cornall@mcri.edu.au.
2
Murdoch Childrens Research Institute, Parkville, 3052, Victoria, Australia. Alyssa.Cornall@mcri.edu.au.
3
Department of Obstetrics and Gynecology, University of Melbourne, Parkville, 3052, Victoria, Australia. Alyssa.Cornall@mcri.edu.au.
4
Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, 3052, Victoria, Australia.
5
Murdoch Childrens Research Institute, Parkville, 3052, Victoria, Australia.
6
Department of Obstetrics and Gynecology, University of Melbourne, Parkville, 3052, Victoria, Australia.
7
Oncology and Dysplasia Unit, Royal Women's Hospital, Parkville, 3052, Victoria, Australia.

Abstract

PURPOSE:

to evaluate the performance of Anyplex II HPV28 and HPV HR Detection assays against the EuroArray HPV, Cobas 4800 HPV (Cobas), HPV Amplicor (Amp), Linear Array HPV (LA) and Hybrid Capture 2 (HC2) in detection of high-risk HPV (HR-HPV) from liquid-based cervical cytology samples.

METHODS:

cervical specimens from 404 women undergoing management of high-grade cytological abnormality were evaluated by Anyplex II HPV28 and HPV HR Detection assays for detection of HR-HPV genotypes and prediction of histologically-confirmed cervical intraepithelial neoplasia grade 2 or higher (≥CIN2). The results were compared to EuroArray, HC2, Cobas, Amp, and LA.

RESULTS:

specimens were evaluated from 404 women with an average age of 30 years, including 336 with a histological diagnosis of ≥ CIN2 and 68 with ≤ CIN1. Concordance of HR-HPV detection between Anyplex II HPV28 and other genotyping assays was 94.79 % (κ = 0.84; EuroArray) and 97.27 % (κ = 0.91; LA); and between Anyplex II HPV HR and other HR-HPV detection assays was 86.35 % (κ = 0.62; HC2), 96.03 % (κ = 0.87; Cobas) and 96.77 % (κ = 0.89; Amp). Using HR-HPV detection for prediction of ≥ CIN2 by Anyplex II HPV28 and HPV HR, sensitivity (90.18, 95 % CI 86.48-93.14; 90.77, 95 % CI 87.16-93.65) and specificity (both 67.16, 95 % CI 54.60-78.15) were not significantly different to the other HPV assays tested, with one exception. Both Anyplex assays had significantly higher sensitivity than HC2 (p < 0.0001), with a specificity of 96 % (p > 0.05) of HC2 in this high-risk population.

CONCLUSIONS:

both Anyplex II HPV detection assays were concordant with other commercial assays for HR-HPV detection, with comparable sensitivity and specificity for ≥ CIN2 detection.

PMID:
27822653
DOI:
10.1007/s10096-016-2831-5
[Indexed for MEDLINE]

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