Detection of human papillomavirus genotypes among high-risk women: a comparison of hybrid capture and linear array tests.
OBJECTIVE
To assess the concordance and performance of 2 different assays in detection of human papillomavirus (HPV) genotypes among women with abnormal Pap smear.


METHODS
A series of 575 women referred for colposcopy due to an abnormal Pap smear were analyzed with the Linear Array HPV Genotyping test detecting 37 HPV types and compared with Hybrid Capture II (HCII) assay for detection of carcinogenic HPV. Histologic outcomes of cervical intraepithelial neoplasia grade 2 (CIN2) or worse (CIN2+) and CIN3+ were the primary endpoints. Clinical performance, including receiver operating characteristics, was determined for both tests.


RESULTS
HCII and linear array (LA) were concordant in 88.1% (433/491; 95% CI 85.3%-91.0%), having a substantial agreement with regular kappa (kappa = 0.70, 95% CI 0.62-0.77) and almost perfect agreement with weighted kappa (ICC = 0.82, 95% CI 0.7-0.85). In detecting CIN2+ and CIN3+, LA is 5% and 6% more sensitive but 9.5% and 8.7% less specific than HCII (area under ROC curve; P = 0.317 and P = 0.875, respectively).


CONCLUSIONS
Performance of HCII and LA does not significantly differ in detecting CIN2+ or CIN3+.
Monsonego
Joseph
J
Institut Alfred Fournier Paris, France. jm@eurogin.com
Pollini
Giuseppe
G
Evrard
Marie José
MJ
Sednaoui
Patrice
P
Monfort
Laura
L
Zerat
Laurent
L
Syrjänen
Kari
K
D000293:Adolescent; D000328:Adult; D000368:Aged; D003127:Colposcopy; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D008875:Middle Aged; D009693:Nucleic Acid Hybridization / Q000379:methods; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics*; D030361:Papillomavirus Infections / Q000473:pathology / Q000821:virology*; D011237:Predictive Value of Tests; D015995:Prevalence; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology / Q000473:pathology / Q000821:virology*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000453:epidemiology / Q000473:pathology / Q000821:virology*
D004279:DNA, Viral