Options in human papillomavirus (HPV) detection for cervical cancer screening: comparison between full genotyping and a rapid qualitative HPV-DNA assay in Ghana

Abstract

BackgroundModern cervical cancer screening increasingly relies on the use of molecular techniques detecting high-risk oncogenic human papillomavirus (hr-HPV). A major challenge for developing countries like Ghana has been the unavailability and costs of HPV DNA-based testing. This study compares the performance of careHPV, a semi-rapid and affordable qualitative detection assay for 14 hr-HPV genotypes, with HPV genotyping, for the detection of cytological cervical squamous intraepithelial lesions (SIL).MethodsA study comparing between frequency matched HIV-1 seropositive and HIV-seronegative women was conducted in the Cape Coast Teaching Hospital, Ghana. A systematic sampling method was used to select women attending clinics in the hospital. Cervical samples were tested for HPV by careHPV and Anyplex-II HPV28 genotyping assay, and by conventional cytology.ResultsA total of 175 paired results (94 from HIV-1 seropositive and 81 from HIV-seronegative women) were analyzed based on the ability of both tests to detect the 14 hr-HPV types included in the careHPV assay. The inter-assay concordance was 94.3% (95%CI: 89.7–97.2%, kappa = 0.88), similar by HIV serostatus. The careHPV assay was equally sensitive among HIV-1 seropositive and seronegative women (97.3% vs. 95.7%, p = 0.50) and slightly more specific among HIV-seronegative women (85.0% vs. 93.1%, p = 0.10). careHPV had good sensitivity (87.5%) but low specificity (52.1%) for the detection of low SIL or greater lesions, but its performance was superior to genotyping (87.5 and 38.8%, respectively). Reproducibility of careHPV, tested on 97 samples by the same individual was 82.5% (95%CI: 73.4–89.4%).ConclusionsThe performance characteristics of careHPV compared to genotyping suggest that this simpler and cheaper HPV detection assay could offer a suitable alternative for HPV screening in Ghana.

Low sensitivity of the careHPV™ Assay for detection of Oncogenic Human Papillomavirus in cervical samples from HIV-infected and HIV-uninfected Kenyan women

“…Data from 155 samples tested by the two assays were used for evaluation of the virologic performance of the careHPV assay. The 14 HR-HPV types (16,18,31,33,35,39,45,51,52,56,58,59, 66, and 68) that are detected by two assays were considered for the analysis. The LA assay was used as the comparative test to calculate the virologic sensitivity and speci icity of the careHPV assay…”

“…Brie ly, 450 base pair fragments from the HPV L1 region were ampli ied from puri ied DNA samples by polymerase chain reaction (PCR), followed by hybridization using a reverse line blot system as previously described [12]. Genotypes identi ied in the LA assay include HPV types 6,11,16,18,26,31,33,35,39,40 The careHPV™ (careHPV) (Qiagen, Gaithersburg, MD, USA) is an assay that does not differentiate speci ic HPV genotypes, but detects the presence and absence of one or more of the 14 HR-HPV types (16,18,31,33,35,39,45,51,52,56,58,59, 66, and 68) as a group. The careHPV assay utilizes an antibodybound paramagnetic bead technique to qualitatively detect one or more of these 14 high-risk HPV types.…”

“…In sub-Saharan Africa, CC screening programs are limited and diagnosis is often made at late stages when treatment is ineffective. Thus, efforts have been made towards inding tools that are acceptable options for HPV detection and CC screening [15][16][17][18]. The careHPV assay demonstrated good virologic speci icity compared to LA but was less sensitive than LA for the detection of 14 HR-HPVs in overall cervical swab samples.…”

“…Human papillomavirus (HPV) is the causative agent of CC [2,3]. Of the many HPV types, HPV types 16,18,31,33,35,39,45,51,52,56,58,59, 68, are classi ied as oncogenic, or "high risk" (HR) types due to epidemiological studies that demonstrated a high degree of oncogenicity [4]. HPV 26, 53, and 66 are classi ied as probable HR types.…”

Erratum to: Options in human papillomavirus (HPV) detection for cervical cancer screening: comparison between full genotyping and a rapid qualitative HPV-DNA assay in Ghana

“…Upon publication of the original article [1], it was noticed that the author’s name “Jacques Simpore” was incorrectly given as “Simpore Jacques”. This has now also been corrected in the original article.…”