Detection of HPV DNA Using MY09/MY11 and G5/G6 Primer Sets in HIV Positive Patients with Positive Linear Array Genotype Assay Results

IntroductionSquamous cell carcinoma of the anus is a common cancer among sexual minority men, especially HIV-positive sexual minority men; however, there is no evidenced-based national screening protocol for detection of anal precancers. Our objective is to determine compliance with annual anal canal self-sampling or clinician-sampling for human papillomavirus (HPV) DNA.Methods and analysisThis is a prospective, randomised, two-arm clinical study to evaluate compliance with annual home-based versus clinic-based HPV DNA screening of anal canal exfoliated cells. The setting is primary care community-based clinics. Recruitment is ongoing for 400 HIV-positive and HIV-negative sexual minority men and transgender persons, aged >25 years, English or Spanish speaking, no current use of anticoagulants other than nonsteroidal anti-inflammatory drugs and no prior diagnosis of anal cancer. Participants are randomised to either receive a swab in the mail for home-based collection of an anal canal specimen at 0 and 12 months (arm 1) or attend a clinic for clinician collection of an anal canal specimen at 0 and 12 months (arm 2). Persons will receive clinic-based Digital Anal Rectal Examinations and high-resolution anoscopy-directed biopsy to assess precancerous lesions, stratified by study arm. Anal exfoliated cells collected in the study are assessed for high-risk HPV persistence and host/viral methylation. The primary analysis will use the intention-to-treat principle to compare the proportion of those who comply with 0-month and 12-month sampling in the home-based and clinic-based arms. The a priori hypothesis is that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm versus clinic-based arm.Ethics and disseminationThe study has been approved by the Medical College of Wisconsin Human Protections Committee. Results will be disseminated to communities where recruitment occurred and through peer-reviewed literature and conferences.Trial registration numberNCT03489707.

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The Need for Cervical Cancer Control in HIV-Positive and HIV-Negative Women from Romania by Primary Prevention and by Early Detection Using Clinically Validated HPV/DNA Tests

PLoS ONE ◽

10.1371/journal.pone.0132271 ◽

2015 ◽

Vol 10 (7) ◽

pp. e0132271 ◽

Cited By ~ 4

Author(s):

Ramona Gabriela Ursu ◽

Mircea Onofriescu ◽

Alexandru Luca ◽

Liviu Jany Prisecariu ◽

Silvia Olivia Sălceanu ◽

...

Keyword(s):

Cervical Cancer ◽

Primary Prevention ◽

Early Detection ◽

Cancer Control ◽

Hiv Positive ◽

Hpv Dna ◽

Hpv Dna Tests ◽

Hiv Negative

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Comparison of Human Papillomavirus Detection and Typing by Hybrid Capture 2, Linear Array, DNA Chip, and Cycle Sequencing in Cervical Swab Samples

International Journal of Gynecological Cancer ◽

10.1111/igc.0b013e31819bcd0a ◽

2009 ◽

Vol 19 (2) ◽

pp. 266-272 ◽

Cited By ~ 16

Author(s):

Jae Kwan Lee ◽

Mi Kyung Kim ◽

Seung Hun Song ◽

Jin Hwa Hong ◽

Kyung Jin Min ◽

...

Keyword(s):

High Risk ◽

Linear Array ◽

Intraepithelial Neoplasia ◽

Dna Chip ◽

Substantial Agreement ◽

Cervical Lesions ◽

Cycle Sequencing ◽

Hpv Dna ◽

Hpv Dna Tests ◽

High Risk Hpv

Although the Hybrid Capture II (HC II) assay can detect 13 high-risk human papillomavirus (HPVs), it does not yield any genotype-specific information. We evaluated the performance of 4 HPV DNA tests, namely, HC II, Linear Array (LA), DNA chip, and cycle sequencing for their capacity to detect the presence of high-risk HPV DNA and HPV-associated cervical lesions. Seventy-six women who were referred to the colposcopy clinic for abnormal cytology were enrolled. The women were examined using liquid-based cytology, colposcopy-directed biopsy, and HPV DNA tests. After DNA extraction from a single sample, HPV DNA tests were performed by all 4 methods on the same specimen. The LA test has higher HPV-positive rates than HC II for cervical intraepithelial neoplasia I (83.3% vs 61.1%;P< 0.01) and for cervical intraepithelial neoplasia II and more severe lesions (100.0% vs 80.0%;P< 0.01). The concordance between the DNA chip and LA tests was 89.5%, confirming substantial agreement (κcoefficient = 0.73), and the concordance between HC II and the DNA chip was 80.3%, also showing substantial agreement (κcoefficient = 0.738). The concordance for 15 high-risk HPV genotypes between LA and sequencing was 82.5% with aκvalue of 0.536. Furthermore, the LA test was more sensitive in the detection of high-grade cervical lesions than HC II (100% vs 92.3%,P< 0.01). The LA test showed superior sensitivity in the detection of clinically relevant HPV infections and has proven to be an accurate tool for identifying individual HPV types, especially in cases of multiple HPV infections.

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Prevalence of abnormal cervical cytology and HPV DNA positivity among HIV positive women

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20193791 ◽

2019 ◽

Vol 8 (9) ◽

pp. 3649

Author(s):

Sunita Malik ◽

Supriti Kumari ◽

Harsha S. Gaikwad ◽

Archana Mishra ◽

Mausumi Bharadwaj

Keyword(s):

Hpv Infection ◽

Cervical Cytology ◽

Hiv Positive ◽

Abnormal Cytology ◽

Cross Sectional ◽

Hpv Dna ◽

Hpv Dna Testing ◽

Abnormal Cervical Cytology ◽

Hiv Positive Women ◽

Relationship Of

Background: The relationship among HIV, HPV, and development of CIN is complex and incompletely understood. Present study is undertaken to find out the prevalence and relationship of abnormal cervical cytology and HPV infection in HIV positive women.Methods: This was a cross-sectional, case control study conducted on 95 HIV seropositive and 95 seronegative women. Specimen was collected from the cervix for HPV DNA testing, subtyping and cytology.Results: HPV DNA positivity was higher in seropositive group (18.6% vs. 7.4%). Premalignant conditions were found only in seropositive group. At CD4 count <249 HPV DNA positivity was 53%, at 250-499 the percentage of HPV DNA positivity was 31% and at >500 HPV DNA positivity was 19%.Conclusions: Prevalence of abnormal cytology and HPV DNA positivity is higher amongst HIV positive women and there is an association between HPV DNA positivity with lower CD4 counts.

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HPV genotypes detected by linear array and next-generation sequencing in anal samples from HIV positive men who have sex with men in Mexico

Archives of Virology ◽

10.1007/s00705-017-3697-2 ◽

2018 ◽

Vol 163 (4) ◽

pp. 925-935 ◽

Cited By ~ 3

Author(s):

Luz A. González-Hernández ◽

María G. Flores-Miramontes ◽

Adriana Aguilar-Lemarroy ◽

Krissya S. Quintanilla-Peña ◽

Fabiola L. Martin-Amaya-Barajas ◽

...

Keyword(s):

Next Generation Sequencing ◽

Linear Array ◽

Hiv Positive ◽

Next Generation ◽

Hpv Genotypes ◽

Sex With Men ◽

Generation Sequencing ◽

Hiv Positive Men

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4. High prevalence of anal HPV infection among HIV-positive male subjects in the absence of anal intercourse

Sexual Health ◽

10.1071/shv10n6ab4 ◽

2013 ◽

Vol 10 (6) ◽

pp. 571

Author(s):

Eugenio Nelson Cavallari ◽

Gabriella d'Ettorre ◽

Giancarlo Ceccarelli ◽

Sara Serafini ◽

Alessandra Pierangeli ◽

...

Keyword(s):

Anal Cancer ◽

Injection Drug Users ◽

Anal Intercourse ◽

Hpv Infection ◽

Hiv Positive ◽

Receptive Anal Intercourse ◽

Cross Sectional ◽

Hpv Dna ◽

Significant Difference ◽

History Of

Background The risk of progression to cancer from HPV infection is increased in HIV-positive subjects. Anal HPV infection is a concern among men who have sex with men (MSM), especially in the setting of HIV infection. Methods: Cross-sectional study including 62 HIV-positive injection drug users (IDUs) without history of receptive anal intercourse and 110 HIV-positive MSM. All patients were receiving HAART with HIV-RNA <37 copies/mL. Patients answered a self-administered questionnaire investigating their sexual habits. Participants underwent anal brushing collecting samples for cytology examination (Bethesda 2001 criteria for cervical cytology) and high resolution anoscopy collecting samples for histological classification. HPV-DNA polymerase chain reaction (PCR) identification was performed. Results: Of the IDUs, 62.5% showed CD4 nadir <200 cell/mmc compared with 12% of MSM (P < 0.05), the actual CD4+ T-cells count did not show a statistical difference. HPV-DNA PCR tested positive in 52% of IDUs and 69% of MSM (P < 0.05). Presence of high-risk genotypes did not show significant difference between the groups (38% of IDUs and 31% of MSM). LSIL prevalence was higher among MSM than IDUs (38% v. 23%), HSIL was higher among IDUs than MSM (26% v. 21%). The prevalence of anal cancer was similar in the two populations (3% in each group). All patients, except for men presenting with anal cancer, were completely asymptomatic. Conclusions: Anal HPV infection and anal SIL may be acquired in the absence of anal intercourse in HIV-infected men. The prevalence of HSIL is high among HIV-positive IDUs. All HIV-infected men, regardless of history of anal intercourse, should be considered for anal cytology screening.

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Enhanced Detection and Typing of Human Papillomavirus (HPV) DNA in Anogenital Samples with PGMY Primers and the Linear Array HPV Genotyping Test

Journal of Clinical Microbiology ◽

10.1128/jcm.00104-06 ◽

2006 ◽

Vol 44 (6) ◽

pp. 1998-2006 ◽

Cited By ~ 96

Author(s):

F. Coutlee ◽

D. Rouleau ◽

P. Petignat ◽

G. Ghattas ◽

J. R. Kornegay ◽

...

Keyword(s):

Human Papillomavirus ◽

Linear Array ◽

Hpv Dna ◽

Hpv Genotyping

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PDL1 expression predicts therapeutic outcome in non metastatic anal squamous cell carcinoma (NMASCC).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.4054 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 4054-4054

Author(s):

Ilma Soledad Iseas ◽

Mariano Golubicki ◽

Juan Robbio ◽

Gonzalo Ruiz ◽

Ruben Salanova ◽

...

Keyword(s):

Treatment Failure ◽

Mitomycin C ◽

Statistical Power ◽

Strong Association ◽

Treatment Completion ◽

Complete Response ◽

Stage Iii ◽

Hiv Positive ◽

Anal Squamous Cell Carcinoma ◽

Hpv Dna

4054 Background: NMASCC is a rising incidence disease with up to 30% of treatment failure to achieve complete response (CR) after standard chemoradiotherapy (CRT) leading to severe morbidity and death. Stage III-TNM, p53 mutations, HPV negativity, HIV infection are linked to treatment failure. We investigated the predictive/prognostic role of TNM, CR, HPV, PDL1 positivity and CD3/CD8 densities in NM-ASCC from a single institution. Methods: All 79 eligible consecutive NMASCC pts (available FFPE pre-treatment samples) seen from October-2009 to April-2019 having completed definitive CRT (50.4 Gy Pelvic Radiotherapy with Mitomycin-C 12mg/m2/IV/d1-5 / FU 1000mg/m2/d1-4 d29-32 (28%), Mitomycin-C/Capecitabine 825 mg/m2/bid (38%), Cisplatin 60 mg/m2/IV d1-29 and 5FU (34%) were analyzed. Mean age: 59 (range 26-87), 72% female, Stage III: 59%, HPV positive: 86% (HPV-16: 80%);14% HIV positive. IHC assessed by two pathologist for PD-L1 expression (ClonSP263) and CD3-CD8+ TILS densities (Clone 2GV6, Clone SP57). HPV-DNA assessed by PCR (BSGP5+/6+ multiplexed with beta-globin). Kaplan-Meier survival, CR, DFS, OS and Univariate analyses were performed using Cox proportional hazard model. Results: CR achieved within 6 months of treatment completion was 68%( 53pts). Median follow-up after treatment completion: 35 months (range 6 –149). As of February 2020, 82% (65 pts) are alive, no evidence of disease:(57%) 46 pts, recurrence rate: 26%(22 pts), cancer death: 18% (14 pts). PDL1+ tumors ( > 1% positivity-CPS score): 56%, expression levels: 1-5% (57%,26p), > 10%-100% (43%,19p). PDL1+ had a strong association with CR (p = 0.021); higher PDL1+ levels had 8-fold of CR-likelihood than PDL1 negative.(OR 8.50 vs. 1.12). Significative Spearman correlation between PDL1 tumors with CR and CD3-CD8 TILS density was observed (R = 0.43,p = 0.0017 and R = 0.36,p = 0.00094 respectively), albeit CD3-CD8 failed to reach significance as prognostic factors for either CR, DFS or OS. Only CR and PDL1 positive were strongly significantly associated to DFS (HR 0.10 [IC 95% 0.04-0.28] p < 0.001 and HR 0.28 [IC 95% 0.11-0.73] p = 0.006) and OS (HR 0.12 [IC 95% 0.03-0.45] p < 0.001 and HR 0.15 [IC 95% 0.03-0.68] p < 0.004). Low prevalence of HPV negative, early tumors, HIV positive cases in our series probably impacted in statistical power for prognosis correlation. Conclusions: PDL1 positivity was the strongest predictive/prognostic factor in NM-ASCC. Alternative therapeutics options to standard CRT should be explored on poor-risk patients as HPV-negative, P53-mutated and PDL1 negative patients.

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Nested PCR with the PGMY09/11 and GP5+/6+ primer sets improves detection of HPV DNA in cervical samples

Journal of Virological Methods ◽

10.1016/j.jviromet.2004.08.007 ◽

2004 ◽

Vol 122 (1) ◽

pp. 87-93 ◽

Cited By ~ 105

Author(s):

Andrea L. Fuessel Haws ◽

Qin He ◽

Peter L. Rady ◽

Lifang Zhang ◽

James Grady ◽

...

Keyword(s):

Nested Pcr ◽

Hpv Dna ◽

Primer Sets

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Detection of human papillomavirus in cervical cell specimens by hybrid capture and PCR with different primers.

Acta Biochimica Polonica ◽

10.18388/abp.2006_3334 ◽

2006 ◽

Vol 53 (3) ◽

pp. 603-607 ◽

Cited By ~ 11

Author(s):

Slawa Szostek ◽

Malgorzata Klimek ◽

Barbara Zawilinska ◽

Janusz Rys ◽

Jolanta Kope ◽

...

Keyword(s):

Human Papillomavirus ◽

High Risk ◽

Consensus Primer ◽

Hybrid Capture ◽

Hpv Dna ◽

Cervical Smears ◽

Capture Assay ◽

Cervical Cell ◽

Target Dna ◽

Primer Sets

The purpose of this study was to compare hybrid capture assay with PCRs using different primers for the L1, E6-E7 regions for the detection of human papillomavirus (HPV) genome. One hundred twenty-five cervical smears with normal (n=42) and abnormal (n=83) cytology were investigated. Those at high-risk for HPV were studied by hybridization antibody capture assay and PCR with the pU-1M/pU-2R primers. Target DNA from the HPV L1 region was amplified by SPF10 primer set and home-PCR with MY09/MY11 primers. The presence of HPV DNA in cervical smears was detected by SPF10 (in 72% of cases), MY09/MY11 (58%), hybrid capture (55%) and pU-1M/pU-2R (39%). Results obtained with the SPF10 and MY09/MY11 consensus primer sets as well as hybrid capture and pU-1M/pU-2R specific for high-risk types differed significantly (chi2, P

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