Linear array genotyping and hybrid capture II assay in detecting human papillomavirus genotypes in women referred for colposcopy due to abnormal Papanicolaou smear

Nucleic acids of human papillomavirus (HPV) isolated by manual extraction method (AmpliLute) and automated MagNA pure system were compared and evaluated with cytohistological findings in 253 women. The concordance level between AmpliLute and MagNA was very good 93.3% (κ = 0.864, P < .0001). Overall HPVpositivity detected by AmpliLute was 57.3% (30.4% as single and 27% as multiple infections) in contrast to MagNA 54.5% (32% and 23%, resp.). Discrepant results observed in 25 cases: 11 MagNA(−)/AmpliLute(+), 10 of which had positive histology; 5 MagNA(+)/AmpliLute(−) with negative histology; 8 MagNA(+)/AmpliLute(+): in 7 of which AmpliLute detected extra HPV genotypes and 1 MagNA(invalid)/AmpliLute(+) with positive histology. Both methods performed well when compared against cytological (area under curve (AUC) of AmpliLute 0.712 versus 0.672 of MagNA) and histological diagnoses (AUC of AmpliLute 0.935 versus 0.877 of MagNA), with AmpliLute showing a slightly predominance over MagNA. However, higher sensitivities, specificities, and positive/negative predictive values were obtained by AmpliLute.

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“…The advantages and disadvantages of these two basically different methodologies have been extensively discussed [7–19]. …”

Section: Introductionmentioning

confidence: 99%

Performance Evaluation of Manual and Automated (MagNA Pure) Nucleic Acid Isolation in HPV Detection and Genotyping Using Roche Linear Array HPV Test

Chranioti

Aga

Margari

et al. 2011

Infectious Diseases in Obstetrics and Gynecology

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“…The pooled absolute specificity for excluding CIN2 + and CIN3 + was 45% (95% CI, 41%‐50%) and 42% (95% CI, 34%‐51%), respectively (Table and Fig. ) . The corresponding SROC plots for the outcomes of CIN2 + and CIN3+, shown in Figure , display the variation of the test accuracy in the individual studies as well as the overall pooled accuracy.…”

Section: Resultsmentioning

confidence: 95%

“…Nineteen studies reported accuracy data for the HC2 assay (Digene Corp, Gaithersburg, Md) . Four studies reported accuracy data for other hrHPV DNA testing; they included 2 using Linear Array HPV genotyping (Roche Molecular Diagnostics, Almeda, Calif), 1 using the Cervista HPV HR test (Hologic, Marlborough, Mass), and 1 using multiplex polymerase chain reaction with genotype‐specific primers (Eurofins MWG Operon, Huntsville, Ala) . For 2 studies, accuracy data were obtained for HPV‐16/18 genotyping .…”

Section: Resultsmentioning

confidence: 99%

Triage of ASC‐H: A meta‐analysis of the accuracy of high‐risk HPV testing and other markers to detect cervical precancer

Verdoodt

Wentzensen

et al. 2015

Cancer Cytopathology

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Background Women with a cytological diagnosis of atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion (ASC-H) are usually immediately referred to colposcopy. However, triage may reduce the burden of diagnostic work-up and avoid over-treatment. Methods A meta-analysis was conducted to assess the accuracy of hrHPV testing, and testing for other molecular markers to detect CIN of grade II or III or worse (CIN2+ or CIN3+) in women with ASC-H. An additional question assessed was whether triage is useful given the relatively high pre-triage probability of underlying precancer. Results The pooled absolute sensitivity and specificity for CIN2+ of HC2 (derived from 19 studies) was 93% (95% CI: 89–95%) and 45% (95% CI: 41–50%), respectively. The p16INK4a staining (only 3 studies) has similar sensitivity (93%, 95% CI:75–100%) but superior specificity (specificity ratio: 1.69) to HC2 for CIN2+. Testing for PAX1 gene methylation (only 1 study) showed a superior specificity of 95% (specificity ratio: 2.08). The average pre-test risk was 34% for CIN2+ and 20% for CIN3+. A negative HC2 result decreased this to 8% and 5%, whereas a positive result upgraded the risk to 47% and 28%. Conclusions Due to the high probability of precancer in ASC-H, the utility of triage is limited. The usual recommendation to refer women with ASC-H to colposcopy is not altered by a positive triage test, whatever the test used. A negative hrHPV DNA or p16INK4a test may allow for repeat testing but this recommendation will depend on local decision thresholds for referral.

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“…This test detects the presence of HR-HPV and does distinguish the genotype present. The Linear Array genotyping test is a reverse line blot assay for detection and genotyping of 37 types of HPV [Lenselink et al, 2008;Monsonego et al, 2008;Iftner et al, 2009]. The LA test is the standard for assessment of new HPV genotyping tests [Meijer et al, 2006;Liu et al, 2009;Mariani et al, 2010;Koshiol et al, 2013;Lan et al, 2013].…”

Section: Introductionmentioning

confidence: 99%

HPV prevalence and type distribution in women with normal or abnormal Pap smear in Bulgaria

Grozdanov

Zlatkov

Ganchev³

et al. 2014

Journal of Medical Virology

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Human papillomavirus (HPV) is a well-known pathogen for lower genital tract neoplasias, yet little is known regarding HPV prevalence in Bulgaria. The aim of this study was to investigate the prevalence of HPV DNA and to determine HPV types distribution among women with normal and abnormal cytology. Cervical smears with different cytological diagnoses were collected from 355 Bulgarian patients. The cohort of patients selected is the biggest ever studied in this country. Using the Roche Linear Array HPV Genotyping Test, papillomavirus DNA was found in 217 out of the 355 samples, 164 of which had only one and 53 had more than one HPV type. The distribution of the viruses tested in 355 samples was as follows: (i) the most common type was HPV 16, which was found in 61 samples; (ii) the next most frequent HPV type was HPV 33, found in 14 of the samples. A high prevalence of HPV infection was observed in this study. As HPV infection has a high correlation with cervical cancer, this study emphasizes the need for both primary prevention of cervical cancer with HPV vaccines as well as secondary prevention with screening. Currently, two HPV vaccines are included in the National immunization schedule in Bulgaria. Thus, new clinical studies will benefit from patient stratification by the presence or absence of HPV, and by designing separate clinical trials specifically for HPV associated cancers.

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Linear array genotyping and hybrid capture II assay in detecting human papillomavirus genotypes in women referred for colposcopy due to abnormal Papanicolaou smear

Cited by 14 publications

References 47 publications

Performance Evaluation of Manual and Automated (MagNA Pure) Nucleic Acid Isolation in HPV Detection and Genotyping Using Roche Linear Array HPV Test

Performance Evaluation of Manual and Automated (MagNA Pure) Nucleic Acid Isolation in HPV Detection and Genotyping Using Roche Linear Array HPV Test

Triage of ASC‐H: A meta‐analysis of the accuracy of high‐risk HPV testing and other markers to detect cervical precancer

HPV prevalence and type distribution in women with normal or abnormal Pap smear in Bulgaria

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