Agreement between the AMPLICOR Human Papillomavirus Test and the Hybrid Capture 2 assay in detection of high-risk human papillomavirus and diagnosis of biopsy-confirmed high-grade cervical disease

J Clin Microbiol. 2007 Feb;45(2):364-9. doi: 10.1128/JCM.00706-06. Epub 2006 Nov 22.

Abstract

The AMPLICOR HPV test (AMP) and the Hybrid Capture 2 assay (HC2) detect 13 high-risk human papillomavirus (HR-HPV) types. Evaluation of comparative performance with clinical samples is needed to allow informed implementation of AMP into clinical practice. AMP was used (i) to assess the prevalence of HR-HPV in 1,032 samples of known cytology, HC2 status, and/or confirmed histology; (ii) to determine agreement between AMP and HC2; (iii) to evaluate the clinical sensitivity and specificity for detecting HR-HPV; and (iv) to detect the presence of biopsy-confirmed high-grade cervical intraepithelial neoplasia. The prevalence of HR-HPV was 39.3% and 45.6% by AMP and HC2, respectively. Overall agreement was 89.2% (kappa value, 0.78). Of 509 HR-HPV-negative specimens by HC2, 488 (95.9%) were AMP negative. Of 427 HR-HPV-positive specimens by HC2, 347 (81.2%) were AMP positive. In comparing the ability to detect high-grade squamous intraepithelial lesions (HSIL), the two tests were positive for all HSIL samples. Both tests performed similarly on CIN2+ samples (clinical sensitivities were 96.7% and 97.8%, respectively, for AMP and HC2). The clinical specificities of AMP and HC2 were comparable (54.9% versus 51.6%; P=0.18). Genotyping of 20 HC2-negative/AMP-positive cases using alternative technologies revealed target HR genotypes in 63.1% of cases and low-risk types in 15.7% of cases, while 21% of cases were negative. In conclusion, AMP provides a viable alternative to HC2, with good agreement for samples with high-grade cytology and similar sensitivity in detecting CIN2+ lesions.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adenocarcinoma / diagnosis*
  • Adenocarcinoma / virology
  • Adult
  • Carcinoma, Squamous Cell / diagnosis*
  • Carcinoma, Squamous Cell / virology
  • Cervix Uteri / virology
  • DNA, Viral / analysis
  • Female
  • Genotype
  • Humans
  • Middle Aged
  • Papillomaviridae / classification*
  • Papillomaviridae / genetics
  • Papillomaviridae / isolation & purification*
  • Papillomavirus Infections / diagnosis
  • Papillomavirus Infections / virology
  • Polymerase Chain Reaction
  • Reagent Kits, Diagnostic*
  • Sensitivity and Specificity
  • Uterine Cervical Dysplasia / diagnosis*
  • Uterine Cervical Dysplasia / virology
  • Uterine Cervical Neoplasms / diagnosis*
  • Uterine Cervical Neoplasms / virology
  • Vaginal Smears

Substances

  • DNA, Viral
  • Reagent Kits, Diagnostic