Comparison of analytical and clinical performances of the digene HC2 HPV DNA assay and the INNO-LiPA HPV genotyping assay for detecting high-risk HPV infection and cervical neoplasia among HIV-positive African women.
OBJECTIVE
To compare the Hybrid Capture 2 human papillomaviruses (HPV) DNA assay (HC2) and the INNO-LiPA HPV Genotyping Extra assay (INNO-LiPA) for cervical cancer screening in HIV-1-infected African women.


METHODS
The tests were compared for agreement in detecting high-risk HPV (hr-HPV) and performance to detect squamous intraepithelial lesions (SIL), by cytology, and cervical intraepithelial neoplasia, by histology, in cervical samples from 1224 women in Burkina Faso (N = 604) and South Africa (N = 620).


RESULTS
When considering the 13 hr-HPV types detected by HC2, 634 (51.8%) and 849 (69.4%) samples were positive by HC2 and INNO-LiPA, respectively. Agreement between assays was 73.9% [adjusted kappa coefficient value, 0.44 (95% confidence interval: 0.43 to 0.53)]. Agreement improved with analysis restricted to women with high-grade cervical lesions [adjusted kappa coefficient value, 0.83 (95% confidence interval: 0.74 to 0.91)]. The prevalence of hr-HPV, as determined by HC2 and INNO-LiPA, was 34.5% and 54.5%, respectively, in samples with normal cytology, 48.0% and 68.0%, respectively, in samples with atypical squamous cells of undetermined significance, 51.8% and 75.2%, respectively, in samples with low-grade SIL, and 86.3% and 89.8%, respectively, in samples with high-grade SIL/atypical squamous cells that cannot exclude HSIL. Sensitivity, specificity, positive, and negative predictive values for the diagnosis of histological high-grade lesions (CIN2+) were 88.8%, 55.2%, 24.7% and 96.7%, and 92.5%, 35.1%, 19.1% and 96.6% for HC2 and INNO-LiPA, respectively.


CONCLUSIONS
HC2 has lower analytical sensitivity but higher specificity than INNO-LiPA for diagnosing high-grade lesions; the 2 tests presented a comparable clinical sensitivity. HC2 might be suitable for cervical cancer screening in HIV-1-infected African women, but its use in resource-limited settings merits to be further evaluated in comparison with other prevention strategies.
*INSERM U1058 and Department of Biology and Pathology, Montpellier University Hospital (CHU), Montpellier, France; †Departments of Clinical Research and Non Communicable Diseases Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom; ‡Department of Anatomical Pathology, University of the Witwatersrand, Johannesburg, South Africa; §University Hospital and Centre of International Research for Health, University of Ouagadougou, Ouagadougou, Burkina Faso; and ‖Wits Reproductive Health and HIV Institute, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.
Jean
J
Ngou
Clare
C
Gilham
Tanvier
T
Omar
Olga
O
Goumbri-Lompo
Sylviane
S
Doutre
Pamela
P
Michelow
Helen
H
Kelly
Marie-Noelle
MN
Didelot
Admire
A
Chikandiwa
Bernard
B
Sawadogo
Sinead
S
Delany-Moretlwe
Nicolas
N
Meda
Valérie
V
Costes
Philippe
P
Mayaud
Michel
M
Segondy
D000328:Adult; D002050:Burkina Faso; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D005838:Genotype; D060005:Genotyping Techniques / Q000379:methods*; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D012680:Sensitivity and Specificity; D013019:South Africa; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology