scholarly journals Evaluation of a Chip-Based, Point-of-Care, Portable, Real-Time Micro PCR Analyzer for the Detection of High-Risk Human Papillomavirus in Uterine Cervix in India

2020 ◽  
pp. 1147-1154
Author(s):  
Roopa Hariprasad ◽  
Sonam Tulsyan ◽  
Roshani Babu ◽  
Kavitha Dhanasekaran ◽  
Nisha Thakur ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Low Income ◽  
Point Of Care ◽  
Cost Effective ◽  
Cross Sectional ◽  
Dna Test ◽  
Hpv Dna ◽  
Hpv Genotypes ◽  
Continuous Power

PURPOSE Currently available human papillomavirus (HPV) detection devices are expensive, requiring a continuous power supply, high-priced reagents, skilled laboratory personnel, and infrastructure. These make it difficult to implement primary HPV screening in high-risk (HR) populations, particularly in low-income settings such as in India. The objective of our study was to evaluate the diagnostic performance of a point-of-care, portable, battery-operated device called Truenat, which detects 4 HR HPV genotypes (16, 18, 31, and 45), as a potentially cost-effective alternative to conventional HPV diagnostic tests. PATIENTS AND METHODS This was a single-site, blinded, cross-sectional study that evaluated the performance of the Trunat HPV-HR using cervical samples collected from nonpregnant women > 30 years old via consecutive sampling. The comparison was conducted against the Hybrid Capture 2 (HC2) method. All the positive samples were validated by 14 Real-TM Quant Kit. RESULTS Of 615 cervical samples, the HR-HPV DNA test was positive in 78 women (12.7%) by HC2 and in 49 (8%) by Truenat. With the consideration of limited genotype inclusivity, the sensitivity and specificity of Truenat HPV-HR were 97.7% and 98.9%, respectively. CONCLUSION The performance of Truenat HPV-HR test was comparable to that of HC2 in the 4 HPV genotypes and would be appropriate to consider for use in primary HR cervical cancer screening and particularly in low-income settings.

Detection of human papillomavirus DNA in self-administered vaginal swabs as compared to cervical swabs

2003 ◽  
Vol 14 (8) ◽  
pp. 560-567 ◽  
Author(s):  
Melanie E Palmisano ◽  
Ann M Gaffga ◽  
Jennifer Daigle ◽  
Joeli Brinkman ◽  
Kristina Mire ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Phase I ◽  
Phase Ii ◽  
Pap Smear ◽  
Blot Hybridization ◽  
Epidemiological Data ◽  
Hpv Dna ◽  
Vaginal Swabs ◽  
Hpv Genotypes

The primary risk factor for cervical cancer is infection with high-risk genotypes of human papillomavirus (HPV). This study compared HPV DNA detection between cervical swabs (CX) and self-administered vaginal swabs (SV). Phase I participants were 199 women chosen from a study comparing the detection of Chlamydia trachomatis from various anogenital sites. Phase II participants were 135 women from either the Colposcopy or HIV Outpatient Clinic. HPV DNA testing was performed using polymerase chain reaction and Roche reverse line blot hybridization. In Phase I samples, more CX samples amplified and more HPV genotypes ( P < 0.05) were detected in CX. Genotype 52 were seen more in the cervix, whereas genotype 82 (MM4) was detected solely in the vagina. The presence of high-risk HPV genotypes in the cervix was a predictor of an abnormal Papanicolaou (Pap) smear. In Phase II samples, CX samples amplified more, but similar rates of HPV genotypes were seen in SV and CX samples. Higher concordance rates of high-risk genotypes were seen in Phase II compared to Phase I samples. Phase II demonstrated the feasibility of utilizing SV sampling to reflect cervical status. If validated, a self-vaginal swab method to detect cervical HPV DNA status could be utilized to triage women with indeterminate Pap smears and be a useful method to collect epidemiological data from large populations.

Human papillomavirus genotyping using HPV DNA chip analysis in Korean women

2007 ◽  
Vol 17 (2) ◽  
pp. 497-501 ◽  
Author(s):  
H. S. Lee ◽  
K. M. Kim ◽  
S. M. Kim ◽  
Y. D. Choi ◽  
J. H. Nam ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Cervical Neoplasia ◽  
Dna Chip ◽  
Korean Women ◽  
Hpv 16 ◽  
Hpv Dna ◽  
Hpv Genotypes ◽  
High Risk Hpv ◽  
Chip Analysis

This study was designed to investigate the genotypes of human papillomavirus (HPV) in Korean women who had abnormal cervical cytology and to evaluate the clinical accuracy of HPV DNA chip analysis for the diagnosis of cervical neoplasia. Liquid-based cytology preparations, HPV DNA chip analysis, and cervical biopsy were performed in 2358 women. High-risk HPV was identified in 23.5% of 1650 histologically confirmed normal samples (including cervicitis and squamous metaplasia) and in 81.8% of 708 samples with cervical intraepithelial neoplasia (CIN) and carcinoma (P< 0.01). The major prevalent high-risk HPV genotypes in 381 samples of CIN II/III were HPV-16, -58, -33, and -31, in order of prevalence rate (average overall, 78.0%), and HPV-16, -18, -58, and -33 (average overall, 81.2%) in 133 samples of squamous cell carcinoma (SCC). The infection rate of HPV-16 was significantly higher than that of other high-risk HPV genotypes in all normal, CIN, and SCC cases (P< 0.01) and increased with more advanced squamous cervical lesions (P< 0.01). The detection accuracy of high-risk HPV using HPV DNA chip analysis for CIN II or worse was as follows: sensitivity 84% (81–87%), specificity 72% (70–74%), positive predictive value 47% (44–50%), and negative predictive value 94% (92–95%). These results suggest that HPV DNA chip analysis may be a reliable diagnostic tool for the detection of cervical neoplasia and that there are geographic differences in the distribution of high-risk HPV genotypes.

Dry self-sampling versus provider-sampling of cervicovaginal specimens for human papillomavirus detection in the Inuit population of Nunavik, Quebec

2012 ◽  
Vol 19 (1) ◽  
pp. 42-48 ◽  
Author(s):  
Helen Cerigo ◽  
François Coutlée ◽  
Eduardo L Franco ◽  
Paul Brassard
Keyword(s):  
Human Papillomavirus ◽  
Study Participant ◽  
The Self ◽  
Kappa Statistics ◽  
Cross Sectional ◽  
Dna Test ◽  
Hpv Dna ◽  
Hpv Types ◽  
Sectional Measurement ◽  
Inuit Population

Objective To assess the comparability of self-collected cervicovaginal samples and provider-collected cervical samples for the detection of human papillomavirus (HPV) DNA among Inuit women in Nunavik, Quebec, avoiding the use of liquid-based storage and transport of the self-collected samples. Methods Ninety-three women aged 18–69 years were recruited from a previously formed cohort on the natural history of HPV to this cross-sectional measurement study. This study utilized HPV DNA test results from 89 paired specimens collected by study participant and health provider with Dacron swabs. Samples were tested for 36 HPV types with the PGMY-primer PCR protocol and genotyping with the linear array method. Unweighted kappa statistics and McNemar tests were used to measure the agreement between sampling techniques. Results In the self-collected samples, 30 different HPV types were found, compared with 29 types found in the provider-collected samples. The prevalence of high-risk (HR) HPV was 38.2% in the self-collected samples and 28.1% in the provider-collected samples. The agreement between collection methods for the detection of HR-HPV DNA (85.4%) was good. HR-HPV and type-specific HPV 16/18 were as likely to be detected in the self-collected samples compared with the provider-obtained samples. Conclusions Women in this population were easily able to collect adequate cervicovaginal specimens for HPV testing. As self-sampling has a high recovery of HR-HPV and is comparable with provider-sampling, we conclude that self-sampling with dry storage and transport could be a good cervical cancer screening alternative for Inuit women in Nunavik who have traditionally avoided speculum examination.

scholarly journals Molecular Detection of Oncogenic Human Papillomavirus (HPV) Genotypes in Vulva Cancers, Penile Cancers and Anal Cancers in Myanmar

2016 ◽  
Vol 2 (3_suppl) ◽  
pp. 1s-1s
Author(s):  
Mu Mu Shwe ◽  
Hlaing Myat Thu ◽  
Khin Shwe Mar
Keyword(s):  
Human Papillomavirus ◽  
Conflicts Of Interest ◽  
Consensus Sequence ◽  
Restriction Enzymes ◽  
Cross Sectional ◽  
Hpv 16 ◽  
Hpv Dna ◽  
Hpv Genotypes ◽  
Hpv 18 ◽  
Oncogenic Hpv

Abstract 12 A causal role for human papillomavirus (HPV) associated cancers of vulva, penile, and anus is supported by evidence from molecular and epidemiologic investigations. This study detected the oncogenic HPV genotypes in vulva cancers, penile cancers and anal cancers by a cross-sectional descriptive study in 2013. A total of 100 paraffin embedded biopsy tissues of histologically confirmed vulva cancers, penile cancers and anal cancers within past five years during 2008 and 2012 were studied. Those cases were 61 vulva cancers from Central Women Hospital, Yangon and 30 penile cancers and 9 anal cancers from Yangon General Hospital. HPV-DNA testing and genotyping were performed by polymerase chain reaction and restriction fragment length polymorphism (PCR-RFLP). Consensus sequence primer pairs within the E6 andE7 open reading were used to amplify oncogenic HPV genotypes (HPV-16,-18,-31,-33,-35,-52b,-58). Restriction enzymes were used for determination of specific HPV genotypes. HPV was identified in 36.1% of vulva cancers (22/61), 26.7% of penile cancers (8/30) and 44.4% of anal cancers (4/9). In vulva cancers, HPV-33 was the most common genotype (40.9%) followed by HPV-16 (31.8%), HPV-31 (22.7%), and HPV-18 (4.6%). In penile cancers, HPV-16 (62.5%) was the most common genotype followed by HPV-33 (25%) and HPV-18 (12.5%). Among anal cancers, the most frequent genotypes were HPV-16 (75%) and HPV-18 (25%). This study is the first report of evidence based oncogenic HPV genotypes in vulva cancers, penile cancers and anal cancers in Myanmar. This research provides the valuable information in understanding the burden of HPV associated cancers of the vulva, penile, and anus in Myanmar and the consideration of the effectiveness of prophylactic HPV vaccination in not only cervical cancer but also non-cervical cancers. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: No COIs from the authors.

Evaluation of a New Multiplex Real-Time Polymerase Chain Reaction Assay for the Detection of Human Papillomavirus Infections in a Referral Population

2012 ◽  
Vol 22 (6) ◽  
pp. 1050-1056 ◽  
Author(s):  
Matthias Jentschke ◽  
Philipp Soergel ◽  
Victoria Lange ◽  
Boštjan Kocjan ◽  
Thilo Doerk ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Human Papillomavirus ◽  
High Risk ◽  
Polymerase Chain Reaction Assay ◽  
Clinical Performance ◽  
Chain Reaction ◽  
Hpv Dna ◽  
Hpv Genotypes ◽  
Polymerase Chain ◽  
High Risk Hpv

ObjectivesHuman papillomavirus (HPV) testing is an important part of cervical cancer screening and management of women with atypical screening results. This study was conducted to evaluate the analytical and clinical performance of the Abbott RealTime High-Risk HPV assay (RealTime) in a referral population, in comparison to the Qiagen Hybrid Capture 2 High-Risk HPV DNA Test (hc2).MethodsRealTime is a new polymerase chain reaction assay that detects 14 high-risk HPV genotypes with simultaneous differentiation between HPV 16 and HPV 18. Five hundred forty-five routine cervical smear samples (ThinPrep) from women who were referred to 2 German colposcopy clinics were included in the study. All samples were tested with both assays for the detection of high-risk HPV DNA. Specimens with repeatedly discordant results were genotyped by Linear Array (Roche) and in-house polymerase chain reaction assays.ResultsBoth assays showed excellent overall agreement (92.8%; κ = 0.86) on 545 samples. Analytical sensitivity of RealTime was comparable to that of hc2 (97.6% vs 95.1%,P= 0.189), whereas RealTime demonstrated significantly higher analytical specificity compared with hc2 (100% vs 93.1%,P< 0.0001). RealTime showed no cross-reactivity with untargeted HPV genotypes in this study. The clinical performance of the assays was evaluated based on histology results available from 319 women (90 nonpathological, 73 cervical intraepithelial neoplasia [CIN] 1, 75 CIN 2, 74 CIN 3, and 7 invasive cancers). High-risk HPV detection rates observed in women with CIN 1, CIN 2+, and CIN 3+ diagnosis, respectively, were comparable for both assays: 47.9%, 92.3%, and 97.5% (RealTime) and 47.9%, 92.3%, and 93.8% (hc2). Detection of HPV 16/18 with RealTime was highly correlated with severity of dysplasia: less than CIN 2, 30.5%; CIN 2+, 59.0%; CIN 3+, 71.6%.ConclusionsThese results support the use of RealTime for routine detection of HPV infections in a referral population.

Human papillomavirus genotype prevalence in cervical biopsies from women diagnosed with cervical intraepithelial neoplasia or cervical cancer in Fiji

Sexual Health ◽  
2011 ◽  
Vol 8 (3) ◽  
pp. 338 ◽  
Author(s):  
Sepehr N. Tabrizi ◽  
Irwin Law ◽  
Eka Buadromo ◽  
Matthew P. Stevens ◽  
James Fong ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Intraepithelial Neoplasia ◽  
Genotype Distribution ◽  
Limited Information ◽  
Cross Sectional ◽  
Detection Rates ◽  
Hpv Dna ◽  
Hpv Genotypes ◽  
Sectional Analysis

Background There is currently limited information about human papillomavirus (HPV) genotype distribution in women in the South Pacific region. This study’s objective was to determine HPV genotypes present in cervical cancer (CC) and precancers (cervical intraepithelial lesion (CIN) 3) in Fiji. Methods: Cross-sectional analysis evaluated archival CC and CIN3 biopsy samples from 296 women of Melanesian Fijian ethnicity (n = 182, 61.5%) and Indo-Fijian ethnicity (n = 114, 38.5%). HPV genotypes were evaluated using the INNO-LiPA assay in archival samples from CC (n = 174) and CIN3 (n = 122) among women in Fiji over a 5-year period from 2003 to 2007. Results: Overall, 99% of the specimens tested were HPV DNA-positive for high-risk genotypes, with detection rates of 100%, 97.4% and 100% in CIN3, squamous cell carcinoma (SCC) and adenosquamous carcinoma biopsies, respectively. Genotypes 16 and 18 were the most common (77%), followed by HPV 31 (4.3%). Genotype HPV 16 was the most common identified (59%) in CIN3 specimens, followed by HPV 31 (9%) and HPV 52 (6.6%). Multiple genotypes were detected in 12.5–33.3% of specimens, depending on the pathology. Conclusion: These results indicated that the two most prevalent CC-associated HPV genotypes in Fiji parallel those described in other regions worldwide, with genotype variations thereafter. These data suggest that the currently available bivalent and quadrivalent HPV vaccines could potentially reduce cervical cancers in Fiji by over 80% and reduce precancers by at least 60%.

scholarly journals Wide Spectrum Analysis of Human Papillomavirus Genotypes in External Anogenital Warts

Vaccines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 604
Author(s):  
Orsolya Rideg ◽  
Angéla Oszter ◽  
Evelin Makk ◽  
Endre Kálmán ◽  
Kornélia Farkas ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Vaccine Development ◽  
Wide Spectrum ◽  
Low Risk ◽  
Anogenital Warts ◽  
Vaccination Programs ◽  
Hpv Dna ◽  
Hpv Genotypes ◽  
Formalin Fixed Paraffin Embedded

External anogenital warts (EGW) are primarily associated with the low-risk human papillomavirus (HPV) genotypes 6 and 11, though coinfection with other low-risk and oncogenic high-risk HPV genotypes also occurs. Although there have been many studies on HPV-associated disease, the prevalence of HPV genotypes associated with EGW is not well characterized. The objective of our retrospective study was to determine the prevalence of HPV genotypes among patients diagnosed with EGW in the south-west of Hungary. Archived formalin-fixed paraffin-embedded tissues from 94 patients were processed in our study. HPV genotypes were determined, applying HPV Direct Flow CHIP test. The overall prevalence of HPV DNA in the EGW samples was 100%, yielding 131 infections among the 94 samples. Of these cases, 72.3% were mono while 27.6% were multi-infections. Out of the 131 infections, the cumulative prevalence of HPV 6 and 11 was 71%. A total of 98.9% of the samples were carrying at least one of these genotypes, while 19.1% of the cases occurred with at least one high-risk genotype. Data from our study could provide invaluable information concerning the prevalence of HPV types among patients with EGW, enabling improved assessment of the actual and future efficacy of vaccination programs, vaccine development, and forecast changes in infection patterns.

scholarly journals Retrospective Analysis of Prevalence of High-risk and Low-risk Human Papillomavirus (HPV) Genotypes in Iranian Women During 2013-2016

2017 ◽  
Vol 2 (4) ◽  
pp. 85-90 ◽  
Author(s):  
Siavash Chalabiani ◽  
Mina Khodadad Nazari ◽  
Mahdi Shabani ◽  
Neda Razavi Davoodi ◽  
Abdolfattah Sarafnejad ◽  
...  
Keyword(s):  
High Risk ◽  
Age Groups ◽  
Hpv Infection ◽  
Low Risk ◽  
Age Group ◽  
Cancer Etiology ◽  
Cross Sectional ◽  
Hpv Dna ◽  
Hpv Prevalence ◽  
Hpv Genotypes

Background and objective: Considering the importance of HPV in cancer etiology, awareness of HPV prevalence and frequency of high-risk genotypes could help improve health care system management. We analyzed HPV prevalence in women forms different provinces of Iran that is the largest sample till now. Material and Methods: In this retrospective cross-sectional study, 2969 outpatient and suspicious women aged 17- 78 referred to Noor pathobiology laboratory from 24 provinces of Iran were studies. DNA extraction and PCR were performed on samples and then HPV genotypes were also determined using hybridization kit. Results: HPV DNA was detected in 29.3% of valid liquid-based samples. Among HPV positive cases, 67.2% and 52.0% accounted for high-risk and low-risk HPV subtypes, respectively. In patients with high-risk HPV types, HPV16 was confirmed as predominate type (30.5%) followed by HPV53 (17.3%) and HPV39 (13.3 %). HPV6 was found as the most common low-risk HPV type with 60.6% frequency rate followed by HPV11 (17.9%) and HPV81 (8.6%) in this age group. It was apparent that age group >25 years accounted the highest frequency of HPV positivity. The prevalence of HPV was significantly different among different age groups (p<0.0001). Conclusion: It can be concluded that HPV infection is currently at a considerable high level in Iran. Looking at the high risk and oncogenic HPV subtypes frequency especially in younger age groups, a concern could be noticed about HPV relevant cancers which can be prevented by commercial and approved HPV vaccines.

scholarly journals Cervical Dysplasia, Infection, and Phylogeny of Human Papillomavirus in HIV-Infected and HIV-Uninfected Women at a Reproductive Health Clinic in Nairobi, Kenya

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Agnes Omire ◽  
Nancy L. M. Budambula ◽  
Leah Kirumbi ◽  
Hillary Langat ◽  
Danvas Kerosi ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
High Risk ◽  
Reproductive Health ◽  
Health Clinic ◽  
Cancer Etiology ◽  
Hpv 16 ◽  
Hpv Dna ◽  
Hpv Genotypes ◽  
High Risk Hpv

High risk human Papillomavirus (HPV) infections ultimately cause cervical cancer. Human Immunodeficiency Virus (HIV) infected women often present with multiple high-risk HPV infections and are thus at a higher risk of developing cervical cancer. However, information on the circulating high-risk HPV genotypes in Kenya in both HIV-infected and HIV-uninfected women is still scanty. This study is aimed at determining the phylogeny and the HPV genotypes in women with respect to their HIV status and at correlating this with cytology results. This study was carried out among women attending the Reproductive Health Clinic at Kenyatta National Hospital, a referral hospital in Nairobi, Kenya. A cross-sectional study recruited a total of 217 women aged 18 to 50 years. Paired blood and cervical samples were obtained from consenting participants. Blood was used for serological HIV screening while cervical smears were used for cytology followed by HPV DNA extraction, HPV DNA PCR amplification, and phylogenetic analysis. Out of 217 participants, 29 (13.4%) were HIV seropositive, while 68 (31.3%) were positive for HPV DNA. Eight (3.7%) of the participants had abnormal cervical cytology. High-risk HPV 16 was the most prevalent followed by HPV 81, 73, 35, and 52. One participant had cervical cancer, was HIV infected, and had multiple high-risk infections with HPV 26, 35, and 58. HPV 16, 6, and 81 had two variants each. HPV 16 in this study clustered with HPV from Iran and Africa. This study shows the circulation of other HPV 35, 52, 73, 81, 31, 51, 45, 58, and 26 in the Kenyan population that play important roles in cancer etiology but are not included in the HPV vaccine. Data from this study could inform vaccination strategies. Additionally, this data will be useful in future epidemiological studies of HPV in Nairobi as the introduction or development of new variants can be detected.

Human Papillomavirus Genome based Detection and Typing: A Holistic Molecular Approach

2019 ◽  
Vol 19 (4) ◽  
pp. 237-246 ◽  
Author(s):  
Abhilasha Gautam ◽  
Mallikarjuna R. Gedda ◽  
Madhukar Rai ◽  
Shyam Sundar ◽  
Jaya Chakravarty
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Genome Structure ◽  
Cost Effective ◽  
Detection Sensitivity ◽  
Screening Methods ◽  
Consensus Primer ◽  
Hpv Dna ◽  
Primer Sets ◽  
Consensus Primers

Human Papillomavirus (HPV) is a species specific double-stranded DNA virus infecting human cutaneous or mucosal tissues. The genome structure of HPV is extremely polymorphic hence making it difficult to discriminate between them. HPV exhibits numerous dissimilar types that can be subdivided into high-risk (HR), probably high-risk and low-risk (LR), causing numerous types of cancers and warts around the genital organs in humans. Several screening methods are performed in order to detect cytological abnormalities and presence or absence of HPV genome. Currently available commercial kits and methods are designed to detect only a few HR/LR-HPV types, which are expensive adding to the economic burden of the affected individual and are not freely available. These gaps could be minimized through Polymerase Chain reaction (PCR) method, which is a gold standard and a cost-effective technique for the detection of most HPV (both known and unknown) types by using specific consensus primers in minimal lab setup. In this context, numerous studies have validated the effectiveness of different sets of consensus primers in the screening of HPVs. Numerous consensus primers, such as E6, E6/E7, GP-E6/E7, MY09/11, GP5+/GP6+, SPF10, and PGMY09/11 have been developed to detect the presence of HPV DNA. In addition, HPV detection sensitivity could be achieved through consensus primer sets targeting specific ORF regions like L1 and E6, which may finally assist in better diagnosis of several unknown HR-HPVs. The present review, provides a summary of the available methods, kits and consensus primer sets for HPV genome based detection, their advantages and limitations along with future goals to be set for HPV detection.

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