scholarly journals Comparison of Hybribio GenoArray and Roche Human Papillomavirus (HPV) Linear Array for HPV Genotyping in Anal Swab Samples

2014 ◽  
Vol 53 (2) ◽  
pp. 550-556 ◽  
Author(s):  
Huey Chi Low ◽  
Michelle I. Silver ◽  
Brandon J. Brown ◽  
Chan Yoon Leng ◽  
Magaly M. Blas ◽  
...  

Human papillomavirus (HPV) is causally associated with anal cancer, as HPV DNA is detected in up to 90% of anal intraepithelial neoplasias and anal cancers. With the gradual increase of anal cancer rates, there is a growing need to establish reliable and clinically relevant methods to detect anal cancer precursors. In resource-limited settings, HPV DNA detection is a potentially relevant tool for anal cancer screening. Here, we evaluated the performance of the Hybribio GenoArray (GA) for genotyping HPV in anal samples, against the reference standard Roche Linear Array (LA). Anal swab samples were obtained from sexually active men who have sex with men. Following DNA extraction, each sample was genotyped using GA and LA. The overall interassay agreement, type-specific, and single and multiple genotype agreements were evaluated by kappa statistics and McNemar's χ2tests. Using GA and LA, 68% and 76% of samples were HPV DNA positive, respectively. There was substantial interassay agreements for the detection of all HPV genotypes (κ = 0.70, 86% agreement). Although LA was able to detect more genotypes per sample, the interassay agreement was acceptable (κ = 0.53, 63% agreement). GA had poorer specific detection of HPV genotypes 35, 42, and 51 (κ < 0.60). In conclusion, GA and LA showed good interassay agreement for the detection of most HPV genotypes in anal samples. However, the detection of HPV DNA in up to 76% of anal samples warrants further evaluation of its clinical significance.

Pathogens ◽  
2021 ◽  
Vol 10 (7) ◽  
pp. 888
Author(s):  
Francesca Rollo ◽  
Alessandra Latini ◽  
Massimo Giuliani ◽  
Amalia Giglio ◽  
Maria Gabriella Donà ◽  
...  

Men who have sex with men (MSM) harbor the highest risk for anal carcinoma, mainly caused by Human Papillomavirus (HPV). The use of HPV-related biomarkers in the screening for this neoplasia is still debated. We assessed the association between high-risk (hr)HPV DNA, HPV16/18 DNA, hrHPV E6/E7 mRNA, and p16/Ki-67 with cytological abnormalities (any grade) and high-grade intraepithelial lesions (HSIL) in HIV-uninfected and HIV-infected MSM. Overall, 150 cytological samples in PreservCyt (Hologic), with a negative to HSIL report, were analyzed for hrHPV DNA, hrHPV E6/E7 mRNA, and p16/Ki-67 using the Linear Array (Roche), Aptima (Hologic), and CINtec® PLUS (Roche) assays. In HIV-infected MSM, positivity for all the biomarkers significantly increased with the cytological grade. In both populations, the association of hrHPV E6/E7 mRNA and p16/Ki-67 positivity with HPV16 did not differ significantly compared to hrHPVs other than HPV16. In HIV-uninfected MSM, the odds of having an HSIL increased approximately six times for the p16/Ki-67 positive cases. In HIV-infected individuals, all the biomarkers showed a significant association with HSIL, except for hrHPV DNA, with the strongest association observed for p16/Ki-67. The odds of HSIL increased almost 21 times in those positive for this biomarker. Our results encourage further investigation on the use of p16/Ki-67 dual staining in anal cancer screening for HIV-uninfected and HIV-infected MSM.


Author(s):  
Michael M Gaisa ◽  
Keith M Sigel ◽  
Ashish A DESHMUKH ◽  
Volha LENSKAYA ◽  
Courtney A CHAN ◽  
...  

Abstract Background Screening strategies for high-risk human papillomavirus (hrHPV)-associated anal cancer are evolving. This study compares the screening performance of anal cytology to hrHPV DNA testing and two novel cytology/hrHPV cotesting algorithms among three high-risk populations. Methods Anal cytology, hrHPV DNA testing, and high-resolution anoscopy (HRA)-guided biopsy results were analyzed from 1,837 participants comprising 1,504 HIV-infected men who have sex with men (MSM), 155 HIV-uninfected MSM, and 178 HIV-infected women. Screening performance to detect histological high-grade squamous intraepithelial lesions (HSIL)/cancer was compared between four strategies with distinct HRA referral thresholds: cytology (ASCUS); hrHPV testing (any hrHPV+); algorithm A (benign cytology/HPV16/18+ or ASCUS/hrHPV+); and algorithm B (benign or ASCUS cytology/hrHPV+). Results Histological HSIL/cancer was detected in 756 (41%) participants. Cytology alone had the lowest sensitivity (0.76-0.89) but the highest specificity (0.33-0.36) overall and for each subgroup. Algorithm B was the most sensitive strategy overall (0.97) and for MSM (HIV-infected 0.97; HIV-uninfected 1.00). For HIV-infected women, hrHPV testing and both algorithms yielded higher sensitivity than cytology (0.96, 0.98, and 0.96). Specificity was low for all strategies and subgroups (range 0.16-0.36). Conclusions Screening algorithms that incoporate cytology and hrHPV testing significantly increased sensitivity and further decreased specificity to detect anal precancer/cancer among high-risk populations.


2018 ◽  
Vol 163 (4) ◽  
pp. 925-935 ◽  
Author(s):  
Luz A. González-Hernández ◽  
María G. Flores-Miramontes ◽  
Adriana Aguilar-Lemarroy ◽  
Krissya S. Quintanilla-Peña ◽  
Fabiola L. Martin-Amaya-Barajas ◽  
...  

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Yiying Wang ◽  
Yan Wang ◽  
Michael M. Gaisa ◽  
Keith Sigel ◽  
Wenxin Zheng ◽  
...  

Objectives. People living with HIV/AIDS (PLWHA) have an increased incidence of anal squamous cell carcinoma. Since high-risk human papillomavirus (hrHPV) is the primary cause, hrHPV DNA testing may play an important role in anal cancer screening. This study aims to determine the negative predictive value (NPV) of hrHPV testing in PLWHA as well as factors that may lead to false-negative results. Methods. Anal swabs were collected for cytology and Cobas® 4800 HPV test for 14 hrHPV types. Patients underwent concomitant high-resolution anoscopy (HRA) examination and biopsy. High-grade squamous intraepithelial lesions (HSIL, synonymous with anal intraepithelial neoplasia AIN2 and 3) detected in Cobas-negative patients were genotyped for 22 HPV types using BioPerfectus Multiplex Real-time PCR. Results. 156 PLWHA tested negative for hrHPV on anal swab samples (i.e., Cobas-negative). HRA-guided biopsy detected HSIL/AIN3 in 13 patients (8%, NPV 92%), HSIL/AIN2 in 5 patients (3%), low-grade squamous intraepithelial lesions in 82 (LSIL, 53%), or benign findings in 56 (36%). No cancer was found. The HSIL group was similar to the LSIL/benign group regarding age, gender, race/ethnicity, clinical HIV parameters, cytological diagnoses, history of receptive anal sex, and smoking (p≥0.02). Genotyping HSIL tissue derived from Cobas-negative patients revealed hrHPV (n=7), possibly carcinogenic HPV53, 67, 73, 82 (n=12), or absence of hrHPV (n=4). Conclusions. In this series, anal hrHPV DNA testing offered 92% NPV for PLWHA; in other words, a 8% risk of occult precancer remains for those who test hrHPV negative on anal swab samples.


Diagnostics ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. 173
Author(s):  
Pino ◽  
Martí ◽  
Gaber ◽  
Svanholm-Barrie ◽  
Rodríguez-Carunchio ◽  
...  

There is growing interest in anal cancer screening strategies. However, cytological/molecular evaluation of anal samples is challenging. We aimed to determine the feasibility of detecting, in anal liquid-based cytologies, the expression of biomarkers involved in the cell cycle disturbance elicited by human papillomavirus (HPV). The accuracy of this approach in the identification of high-grade squamous intraepithelial lesions/anal intraepithelial neoplasia grade2–3 (HSIL/AIN2–3) was also evaluated. 215 anal cytologies from men having sex with men living with human immunodeficiency virus were evaluated. Patients showing concordant cytological and anoscopy-directed biopsy diagnosis were selected: 70 with negative cytology and HPV test, 70 with low-grade SIL (LSIL/AIN1) cytology and biopsy, and 75 with cytology and biopsy of HSIL/AIN2–3. CDKN2A/p16, MKI67 and TOP2A mRNA expression was analyzed. HPV detection was performed with Xpert HPV Assay (Cepheid, Sunnyvale, CA, USA). HSIL/AIN2–3 showed higher expression for the biomarkers than LSIL/AIN1 or negative samples. The specificity for HSIL/AIN2–3 detection for a sensitivity established at 70% was 44.7% (95%confidence interval [CI] 36.5–53.2) for TOP2A and MKI67 and 54.5% (95%CI 46.0–62.8%) for CDKN2A/p16. mRNA detection of cell biomarkers in anal liquid-based cytology is feasible. Further studies are warranted to confirm if strategies based on mRNA detection have any role in anal cancer screening.


Sexual Health ◽  
2016 ◽  
Vol 13 (6) ◽  
pp. 597 ◽  
Author(s):  
Francesco Drago ◽  
Astrid Herzum ◽  
Giulia Ciccarese ◽  
Roberto Bandelloni

A high-risk population, formed by 79 consecutive male attendees of our sexually transmissible infections clinic, and who did not have any overt signs of human papillomavirus (HPV) infection, were examined. Oral HPV prevalence (37%) was much higher than previously reported. Periurethral HPV-DNA was found in 49% of the patients and anal HPV-DNA was found in 43% of the patients. Considering the high prevalence of oral HPV obtained in the current study, it is important to further investigate the burden of oral HPV, not only in men who have sex with men, but also in heterosexual men and in women.


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