Agreement between careHPV and hybrid capture 2 in detecting high-risk HPV in women in Tanzania.


Journal

Acta obstetricia et gynecologica Scandinavica
ISSN: 1600-0412
Titre abrégé: Acta Obstet Gynecol Scand
Pays: United States
ID NLM: 0370343

Informations de publication

Date de publication:
04 2021
Historique:
revised: 28 12 2020
received: 26 08 2020
accepted: 22 01 2021
pubmed: 27 1 2021
medline: 29 4 2021
entrez: 26 1 2021
Statut: ppublish

Résumé

Visual inspection of the cervix with acetic acid is used to control the burden of cervical cancer in low- and middle-income countries. This method has some limitations and HPV DNA testing may be an alternative, but it is expensive and requires a laboratory setup. Cheaper and faster HPV tests have been developed. This study describe the agreement between a fast HPV test (careHPV) and hybrid capture 2 (HC2) in detection of high-risk HPV among Tanzanian women. The study involved women attending routine cervical cancer screening at the Ocean Road Cancer Institute and Kilimanjaro Christian Medical Centre in Tanzania. The women were offered HIV testing. Two cervical samples were subsequently obtained; the first sample was processed at the clinics using careHPV and the second sample was transported to Denmark and Germany for cytology and HC2 analysis. Kappa statistic was calculated to assess the agreement between careHPV and HC2. The sensitivity, specificity and predictive values of careHPV were calculated using HC2 as reference. The analyses were done for the overall study population and stratified by testing site and HIV status. A total of 4080 women were enrolled, with 437 being excluded due to invalid information, lack of careHPV or HC2 results. Overall agreement between the tests was substantial with a kappa value of 0.69 (95% confidence interval [CI] 0.66-0.72). The sensitivity and specificity of careHPV was 90.7% (95% CI 89.6-91.8) and 84.2% (95% CI 81.2-86.8), respectively. The agreement was similar in the stratified analyses where the kappa values were 0.75 (95% CI 0.70-0.79) in women aged 25-34, 0.66 (95% CI 0.62-0.70) in women aged 35-60, 0.73 (95% CI 0.70-0.77) at the Ocean Road Cancer Institute, 0.64 (95% CI 0.60-0.69) at the Kilimanjaro Christian Medical Center, 0.73 (95% CI 0.68-0.79) in HIV-positive and 0.66 (95% CI 0.63-0.70) in HIV-negative women. The kappa value of 0.64 (95% CI 0.39-0.88) for cervical high-grade lesions indicates a substantial agreement between careHPV and HC2 in detecting HPV among women with cervical high-grade lesions. A substantial agreement was found between careHPV and HC2 in detecting HPV overall as well as detecting HPV among women with cervical high-grade lesions. However, given the limited resources available in low and middle-income countries, the HPV testing assay should be weighed against the cost-effectiveness of the test.

Identifiants

pubmed: 33497480
doi: 10.1111/aogs.14101
doi:

Substances chimiques

Biomarkers, Tumor 0
DNA, Viral 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

786-793

Informations de copyright

© 2021 Nordic Federation of Societies of Obstetrics and Gynecology.

Références

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Auteurs

Johnson Katanga (J)

Department of Cancer Prevention Services, Ocean Road Cancer Institute, Dar es Salaam, Tanzania.
Department of Clinical Oncology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

Susanne K Kjaer (SK)

Danish Cancer Society Research Center, Unit of Virus, Lifestyle and Genes, Copenhagen, Denmark.
Department of Gynecology, Rigshospitalet University Hosptial, University of Copenhagen, Copenhagen, Denmark.

Rachel Manongi (R)

Institute of Public Health, Kilimanjaro Christian Medical University College, Kilimanjaro, Tanzania.

Andrea B Pembe (AB)

Department of Obstetrics and Gynaecology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

Thomas Iftner (T)

Institute of Medical Virology, University Hospital Tuebingen, Tuebingen, Germany.

Marianne Waldstrom (M)

Department of Pathology, Vejle Hospital, Vejle, Denmark.

Julius Mwaiselage (J)

Department of Cancer Prevention Services, Ocean Road Cancer Institute, Dar es Salaam, Tanzania.

Vibeke Rasch (V)

Department of Gynecology and Obstetrics, Odense University Hospital, Odense, Denmark.
University of Southern Denmark, Odense, Denmark.

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