Human Papillomavirus GenoArray Test Kit Research Articles

A retrospective analysis of human papillomavirus (HPV) prevalence and genotype distribution among 25,238 women in Shanghai, China revealed the limitations of current HPV-based screening and HPV vaccine

BackgroundTo determine the human papillomavirus (HPV) type-specific prevalence and distribution among women with various age and cervical lesions in Shanghai, China. And to evaluate the carcinogenicity of different high-risk HPV (HR-HPV) and the efficacy of HR-HPV testing and HPV vaccine. MethodsThe clinical data from 25,238 participants who received HR-HPV testing (HPV GenoArray test kit, HybriBio Ltd) at the Affiliated Hospital of Tongji University from 2016 to 2019 were reviewed and analyzed using SPSS (version 20.0, Tongji University, China). ResultsThe overall prevalence of HPV was 45.57% in the study population, of which 93.51% were found HR-HPV infection. The three most prevalent HR-HPV genotypes were HPV 52 (22.47%), 16 (16.4%) and 58 (15.93%) among HPV-positive women, and HPV 16 (43.30%), 18 (9.28%) and 58 (7.22%) in women with histologically confirmed cervical cancer (CC). 8.25% of CC were found to be HPV negative. Only 83.51% of CC cases were related to the HPV genotypes covered by nine-valent HPV vaccine. HPV prevalence and genotype distribution varied with age and cervical histology. The odds ratios (OR) of HR-HPV for CC were also different, among which the top three types were HPV 45 [OR= 40.13, 95% confidence intervals (CI) 10.37–155.38], 16 (OR=33.98, 95%CI 15.90–72.60) and 18 (OR=21.11, 95%CI 8.09–55.09). The increase in the types of HPV infection did not increase the risk of CC correspondingly. As the primary cervical screening method, HR-HPV testing showed the high sensitivity (93.97%, 95%CI 92.00–95.49) but low specificity (42.82%, 95%CI 41.81–43.84). ConclusionsOur study provide the comprehensive epidemiological data on HPV prevalence and genotype distribution among Shanghai women with various cervical histology, which can not only serve as a significant reference for clinical practice, but also implicated the need of more effective CC screening methods and HPV vaccine covering more subtypes.

Prevalence and genotype distribution of human papillomavirus infection among female outpatients in Northeast China: a population-based survey of 110,927 women.

Human papillomavirus (HPV) infection, especially high-risk HPV, is a major etiological factor for cervical cancer. This study aimed to investigate the distribution of human papillomavirus infection among female outpatients in Northeast China. A total of 110,927 women aged between 18 and 80years from Shengjing Hospital of China Medical University, tested with the HPV Geno-Array Test Kit (HybriBio), were enrolled in this study. The overall prevalence of HPV infection in the study population was 16.95% (18,802/110,927). A total of 21 HPV genotypes were identified and the six most prevalent ones were HPV16 (5.78%), HPV58 (2.62%), HPV52 (1.91%), HPV33 (1.55%), HPV53 (1.45%), and HPV18 (1.16%). The prevalence of single HPV was 83.58% (15,714/18802) and that of multiple HPV was 16.42% (3088/18802). HPV16, HPV58, and HPV52 were the most common types of HR-HPV infections, while CP8304, HPV11, and HPV6 were the most common types of LR-HPV infections. Among the multiple infection groups, HPV16 was the most common type of co-infection. Furthermore, the prevalence of HPV infections varied among different age groups. Age-specific prevalence of HPV exhibited two peaks in the youngest age group and in the group aged 50-60years. HPV16, 58, 52, 33, 53, and 18 were the most common types in the general female population. The prevalence of HPV infection varied among different age groups. This study provides guidance for future HPV-based cervical cancer screening tests and prophylactic HPV vaccinations in China.

Prevalence and Genotypes of Human Papillomavirus among Men in Yunnan Province, China.

Human papillomavirus (HPV) infection is one of the most commonly reported sexually transmitted infections. Persistent infection is associated with the development of cervical cancer. Men may serve as a medium for HPV transmission among women, and much remains unknown about the prevalence and genotypes of HPV infection among men in Yunnan Province. This study was designed to investigate these parameters among men in this region. Clinical information was collected from January 2015 to May 2020, and 369 men who wished to undergo tests for HPV were included in this study. HPV screening was performed using the HPV GenoArray Test Kit, and the anatomical site of sample collection was the urethra. The mean age was 36.15 ± 9.08 years. Our results revealed that the prevalence of HPV infection among men was 23.85% in Yunnan Province, and there was no association between age and HPV prevalence in men. There were 72 (81.81%) individuals positive for a single HPV type, and 16 (18.19%) positive for multiple HPV types. The most prevalent oncogenic HPV types were found to be 52, 51, and 16. The most prevalent types of HPV infection were similar between men and women in this region, though the prevalence of HPV in men was relatively high.

Prevalence and distribution of human papillomavirus genotypes among women with high-grade squamous intraepithelial lesion and invasive cervical cancer in Ganzhou, China.

Human papillomavirus (HPV) infection can lead to the development of cervical cancer. This study assessed the genotype distribution of HPV of high-grade squamous intraepithelial lesion (HSIL) and invasive cervical cancer (ICC) in Ganzhou population. A total of 935 females who got HPV testing from January 2016 to July 2018 in the maternal and child health hospital of Ganzhou were enrolled in the study, including 806 HSIL and 129 ICC. HPV detection and genotyping were tested by HPV Geno-Array test kit. The overall HPV-positive rate was 74.0% in Ganzhou. Among the HSIL and ICC patients, the positive rates of HPV detection were 75.6% and 64.3%. Among the HSIL individuals, the most prevalent hr-HPV genotype was HPV 16. And the 4 common subtypes in decreasing order were HPV 52, 58, 33, and 18. Of the ICC patients, the most frequently hr-HPV subtype was HPV 16 followed by 18, 52, 58, and 59. Among the squamous cell carcinoma (SCC) patients, for hr-HPV genotypes, HPV 16, 18, 52, 58, and 59 were five most common subtypes. In patients with adenocarcinoma (ADC), the most common hr-HPV genotype was HPV 18, followed by HPV 16, 52, 56, 68, 73. And, we found U-shaped and S-shaped curves in the HPV distribution of different age groups. The prevalence and distribution of HPV genotypes in Ganzhou differed from other regions of China and Western countries. These results can serve as valuable reference for HPV vaccination programs for Ganzhou women.

The Genotype of Human Papillomavirus and Associated Factors Among High Risk Males in Shanghai, China: A Molecular Epidemiology Study.

BackgroundThe aim of this study was to describe the infection rate of human papillomavirus (HPV), its genotype distribution, and associated factors among high-risk males in Shanghai, China.Material/MethodsA total of 1,205 participants were enrolled in this study from October 2015 to March 2017. Each individual signed an informed consent before agreeing to take part in this study; participants completed a questionnaire about associated factors related to HPV infection. The HPV GenoArray test kit was used to perform HPV genotyping and was also used in DNA amplification and HybriBio’s proprietary flow-through hybridization technique.ResultsThe overall infection rate of HPV was 58.4%. HPV 11 (177, 14%) was the most common low-risk (LR) genotype and HPV 16 (78, 6.47%) was the top prevalent high-risk (HR) genotype among all the male patients. Additionally, multiple infections (387, 32.1%) was the most common type among all the infected cases, while single infection was only 317 cases (26.3%). Sexual preference, number of sex partners, sexual activity, and frequency of condom use were significantly associated with HR and LR infection.ConclusionsThe infection rate of HPV infection among high-risk males in Shanghai was very high.

Prevalence and genotype distribution of human papillomavirus among females in the suburb of Shanghai, China.

To describe the prevalence of human papillomavirus (HPV) and its genotype distribution among females in the suburb of Shanghai. A total of 33 562 participants were enrolled in this study from January to December 2016. HPV GenoArray test kit was used to perform HPV genotyping and was also used in DNA amplification and HybriBio's proprietary flow-through hybridization technique. The overall prevalence of HPV was 18.98% and the top ten genotypes of HPV infection were HPV 16 (3.36%), HPV 58 (2.65%), HPV 52 (2.48%), HPV 51 (1.58%), HPV 54 (1.40%), HPV 68 (1.32%), HPV 18 (1.23%), HPV 6 (1.15%), HPV 56 (1.10%), and HPV 33 (1.07%). Single infection (4749, 14.15%) was the most common types among all the infected cases. Significant differences were found among age groups and month groups in terms of simple and multiple infection (P < 0.05), pure HR, LR and mixed HPV infection (P < 0.05). The prevalence of HR and LR HPV infection among females in the suburb of Shanghai is high, prevalence of single and multiple infection, pure HR, LR and mixed infection is correlated with the age and month.

HPV genotyping: need of the hour for cervical cancer screening

Objectives: Cervical cancer is the most common cancer and leading cause of cancer deaths in women in developing countries. India shares about one-fourth of the global burden of cervical cancer and almost all cases harbour high risk Humanpapilloma virus (HPV) infection. This is a unique cancer in the sense that it is totally attributable to the effects of an infectious virus. Therefore, the present study was undertaken to evaluate the distribution of HPV genotypes in a rural area of Punjab, with the aim of identifying the most frequent HPV genotypes associated with different cervical lesions in this population. Materials and Methods: The study was conducted over a period of two years i.e. from January2013 to January 2015, on women attending obstetrics and gynaecology department of a tertiary care hospital. One hundred sixty consecutive scrape samples or cervical brushings were collected from women presenting with any type of cervical lesions. DNA was extracted from the clinical sample using Hybribio DNA extraction kit. Hybribio HPV genoarray test kit was used to genotype the HPV risk groups. Results: Out of 160 cervical brushings collected over a period of two years, 17 (10.6%) were positive for HPV genotypes. Among the latter, HPV18 genotype was observed in 7(41.17%), HPV16 genotype in 3 (17.65%) and HPV53 genotype in 2(11.76%). One of the genotypes 68, 52, 39, 33 and 15 were present in rest of the samples. Conclusion: HPV genotypes 18 followed by 16 were the most common genotypes found in the present study. HPV vaccination along with HPV based screening may go a long way in controlling cervical cancer in India. J Microbiol Infect Dis 2016;6(4): 168-171

Distribution of various types of low-risk human papillomavirus according to cervical cytology and histology in northern Chinese women

ObjectiveTo describe the distribution of specific types of low-risk (LR) human papillomavirus (HPV) among a general population of northern Chinese women. MethodsBetween 2007 and 2012, 118 096 women were tested with the HPV Geno-Array Test Kit (HybriBio) at China Medical University’s Shengjing Affiliated Hospital, Shenyang, China. Among these women, 80 418 underwent cervical cytology and colposcopic examination, and 30 961 of these had a cervical biopsy. The prevalence of HPV infection among the women was analyzed according to age, and cytologic and histologic findings. ResultsCP8304 was the most common type of LR-HPV overall, and was most prevalent in the youngest age group. The overall prevalence of LR-HPV (averaged across all types) was 1.7% in women with normal cytology, 8.8% in those with atypical squamous cells of undetermined significance (ASCUS), 8.0% in those with low-grade squamous intraepithelial lesions (LSIL), and 5.8% in those with high-grade squamous intraepithelial lesions (HSIL). LR-HPV alone, without any high-risk (HR)-HPV, was most common among women with ASCUS and cervical intraepithelial neoplasia (CIN) not otherwise specified (CINNOS) together. Co-infections of LR-HPV and HR-HPV were most common among women with LSIL and CIN1. ConclusionThese data will facilitate modeling of the cost-effectiveness of a prophylactic LR-HPV vaccination in China.

Prevalence of human papillomavirus infection in esophageal and cervical cancers in the high incidence area for the two diseases from 2007 to 2009 in Linzhou of Henan Province, Northern China

The etiological role of human papillomavirus (HPV) in cervical cancer has been well established. However, it is inconclusive whether HPV plays the same role in esophageal carcinogenesis. In this study, we detected HPV infection in 145 frozen esophageal tissues, including 30 normal epithelium (ENOR), 37 dysplasia (DYS) and 78 invasive squamous cell carcinoma (ESCC), and in 143 frozen cervical tissues composed of 30 normal epithelium (CNOR), 38 intraepithelial neoplasia (CIN) and 75 invasive squamous cell carcinoma (CSCC). The patients and symptom-free subjects enrolled in this study were from a high-incidence area for both ESCC and CSCC, Linzhou City, Northern China, from 2007 to 2009. The HPV infection analysis was conducted by using an HPV GenoArray Test Kit. We found that the high-risk HPV types accounted for more than 90 % of the HPV-positive lesions of esophagus and cervix tissues. The prevalence of high-risk HPV types increased significantly during the progression of both esophageal and cervical carcinogenesis (positive rate in esophageal tissues: 33 % ENOR, 70 % in DYS and 69 % in ESCC; positive rate in cervical tissues: 27 % in CNOR, 82 % in CIN and 88 % in CSCC; P < 0.001, respectively). Infection with the high-risk HPV types increased the risk for both DYS and ESCC by 4-fold (DYS vs. ENOR: OR = 4.73, 95 %CI = 1.68-13.32; ESCC vs. ENOR: OR = 4.50, 95 %CI = 1.83-11.05) and increased the risk for both CIN and CSCC by 12-fold and 20-fold (CIN vs. CNOR: OR = 12.18, 95 %CI = 3.85-38.55; CSCC vs. CNOR: OR = 20.17, 95 %CI = 6.93-58.65), respectively. The prevalence of high-risk types in ESCC patients was lower than that in CSCC patients (P = 0.005) and was significantly associated with the degree of ESCC tumor infiltration (P = 0.001). HPV 16 was the most prevalent subtype in both esophageal and cervical tissues. Single HPV infection increased significantly along with the progression of ESCC and maintained a high level in cervical tissues, regardless of whether they were CNOR or CSCC tissues. Our results showed that infection with HPV, especially the high-risk types, was positively associated with both esophageal and cervical cancers, suggesting that HPV also plays a role in the etiology of ESCC in the high-incidence area.

Pattern of human papillomavirus infection in uterine cervical adenocarcinoma in a university hospital setting in Malaysia

Adenocarcinoma of the uterine cervix is fast gaining prominence with the worldwide decreasing trend of squamous and adenosqua-mous carcinoma. Most human papillomavirus (HPV) type-specific prevalence studies however do not specifically address this increasingly important histological type. Hence a study was conducted at the Department of Pathology, University of Malaya Medical Centre, to interrogate the HPV type-specific prevalence in 51 consecutive cases of histologically-confirmed, formalin-fixed, paraffin-embedded cervical adenocarcinoma. Prior to HPV testing all cases were subjected to amplification of a 268-bp human beta-globin fragment to ensure extracted DNA integrity. Specific HPV types were determined using the commercially available Hybribio 21 HPV GenoArray test kit which incorporates amplification and flow-through hybridisation with HPV type-specific probes. Furthermore, all HPV-negative cases were amplified using consensus L1 ORF (MY09/11) primers. Patients' ages ranged between 14-75 years (mean 48 years). Ethnically 21 cases were Malay, 20 Chinese, 6 Indian and 4 of other racial origins. Twenty-seven (52.9%) were HPV positive. Twenty-four (88.9%) had single infections (17 HPV18, 4 HPV16, 1 HPV45, 1 HPV68 and 1 positive for LIORF) and 3 double infections (2 HPV16+18 and 1 HPV18+59). As in most studies, HPV18 (74.1%) was the most frequently encountered followed by HPV16 (22.2%) and HPV45 and HPV 68 at 3.7% each.

Are the Human Papillomavirus Genotypes Different in Cervical Cancer and Intraepithelial Neoplasia in Jewish Israeli Women, a Low-Risk Population?

Israel is traditionally considered to have the lowest prevalence of cervical cancer compared with that in other countries of the Western world. The aim of the present study was to establish the human papillomavirus (HPV) genotypes distribution among Israeli Jewish women with premalignant and cervical cancer. Fifty-two specimens with invasive cervical cancer and 50 specimens with high-grade cervical intraepithelial neoplasia (CIN2/3) were identified. Human papillomavirus genotyping in paraffin-embedded specimens was performed by deparaffinization of the tissue sections and DNA extraction, followed by HPV genotype detection using a validated polymerase chain reaction (PCR)-based HPV GenoArray test kit, to simultaneously identify 21 HPV genotypes. Forty-eight (48/52; 92.3%) cervical cancer samples demonstrated PCR-amplifiable DNA (non-HPV DNA). Forty (83.3%) of 48 samples were high-risk (HR) HPV positive. Six (12.5%) of 48 patients showed multiple HR HPV infections. Human papillomavirus types 16 and 18 dominated covering 28 (58.3%) and 14 (29.16%) of 48 samples. Human papillomavirus types 16 and 18 coinfected all 6 cases of multiple HR HPV infections. In CIN2/3 samples, 37 (78.7%) of 47 samples demonstrated PCR-amplifiable DNA (non-HPV DNA), and 20 (54.0%) of these 37 samples were infected by HPV. Human papillomavirus type 16 was found in 19 (95.0%) of 20 cases. Human papillomavirus type 18 was found in 3 (15.0%) of 20 cases; hence, HPV16 and HPV18 contributed to 100% of the cases. Human papillomavirus types 16 and 18 were responsible for the vast majority of invasive cervical cancer and CIN2/3 specimens (81.2% and 100%, respectively). Therefore, it is essential to include the HPV vaccine in the vaccine schedule of the Israeli population.

English

A new method using HybriBio HPV GenoArray test kit was developed for detection of human papillomavirus (HPV) in anogenital non-tumor diseases, which was compared with the real-time PCR, and sequencing for specificity and sensitivity. All initial validation studies with the control DNA proved to be type-specific. Tissue specimens were obtained from 66 patients with external genital condylomata acuminate (n = 28) and bowenoid papulosis (n = 28) and 10 negative controls. HPV 6 DNA and HPV 11 DNA were detected in 14 and 9 of 28 condylomata acuminate patients, respectively and simultaneous infection of HPV 6 and HPV 11 DNA, HPV 11 and HPV 18 DNA were detected in 3 and 1 of 28 condylomata acuminate patients. HPV 16 DNA and HPV 6 DNA were detected in 17 and 1 of 28 bowenoid papulosis patients, and the other ten bowenoid papulosis patients were detected negative. The sensitivity of HybriBio HPV GenoArray test and real-time polymerase chain reaction (PCR) were 97.8% (45/46) and 95.7% (44/46), and the specificity was 100% (20/20) and 95% (19/20). The overall agreement between HybriBio HPV GenoArray test and sequencing was 98.5% (Cohen’s kappa value = 0.96), while real-time PCR and sequencing was 95.5% (Cohen’s kappa value = 0.89). HPV genotyping was performed by using the newly commercially introduced HPV GenoArray test kit which makes use of both DNA amplification and HybriBio’s proprietary flowthrough hybridization technique to simultaneously identify 21 HPV genotypes, with 3 common subtypes of HPV 53, HPV 66 and cp8304 in Chinese, which can potentially be a valuable tool for the detection of HPV DNA. Key words: Human papillomavirus, condylomata acuminate, bowenoid papulosis.

Study of the prevalence of human Papillomavirus infection in Chinese women with cervical cancer

Human papillomavirus (HPV) have been recognized as oncogenic factor in cervical carcinoma. There was an increased incidence of cervical cancer in Chinese women. However, little is known about the prevalence of HPV genotypes in Chinese women with cervical cancer and risk factors of cervical cancer. Cervical exfoliated cells were prospectively collected from 792 women with cervical cancer referred for colposcopic examination. The individual HPV genotypes in these specimens were identified (HPV GenoArray test kit; Hybribio Ltd., Hong Kong). Meanwhile, the clinical data and laboratory result of these patients were gathered. HPV-positive was found in 588/792 (74.2%). The prevalence of the HR-HPV were 516/792 (65.2%). and 51.0% of these patients were infected with mixtures of HR genotypes. HPV positive rate in various clinical stages and differentiation degree of uterine cervical cancer had no statistical differences (P>0.05). HPV positive rate in squamous cancer and adeno-carcinoma had statistical differences respectively with other pathological types (P<0.05).The logistic regression analysis showed that HPV16 infection or HPV58 infection or age over 40 might increase the risk of carcinogennesis of the cervix. The infection rate and superinfection rate of HPV from Chinese women with disease of uterine cervix were high. The patients with HPV16 or HPV58 infection or age over 40 years were associated with increased risk of cervical cancer. Key words: Human papillomavirus, Chinese women, cervical cancer.

Expression of Toll-like receptors in the lesions of condyloma acuminatum

Objective To investigate the expression of Toll-like receptors(TLRs) in condyloma acuminatum(CA) lesions and their possible roles in the pathogenesis of CA. Methods The expressions of TLR1-10 mRNA level in the lesions of CA and in the cervix scrape cells from the patients with human papillomavirus(HPV) negative chronic cervicitis were detected by real-time quantitative fluorescent PCR. HPV typing was detected by HPV GenoArray test kit. Results Low-risk HPV type 6 and type 11 were the most prevalent types in the forty CA cases with positive rate of 77.5% and 55% respectively. 55% CA patients were found infected with more than two types of HPV. 35% CA patients were concurrently infected with high-risk HPV. The expressions of TLR3, 7, 8 mRNA were higher than other TLRs and the expression of TLR9 mRNA was lower than others in the lesions of CA. No significant differences of the TLR1-10 mRNA levels were found between HPV6 and HPV11 positive CA lesions, so did it between low-risk and high-risk HPV concurrent infected CA lesions. The expressions of TLR1-3, TLR5-8, TLR10 mRNA, especially TLR2, TLR7 and TLR8 in the lesions of CA were significantly higher than that in cervix scrape cells of HPV negative chronic cervicitis. There were no significant differences of TLR4 and TLR9 mRNA levels between the two groups. Conclusion There were higher expressions of some TLRs (3, 7, 8) and lower expression of TLR9 in the lesions of CA. Compared with HPV negative chronic cervicitis, the expressions of TLR1-3, TLR5-8, TLR10 mRNA in the lesions of CA were up-regulated. The expression profile of TLRs in different type of HPV infected CA lesions had no significant differences. Our results suggested that the expression profile of TLRs in CA may be associated with the HPV infection. Whether it was associated with the immune escape mechanism and persistent infection of HPV need further demonstration. Key words: Quantitative fluorescent PCR; Condyloma acuminatum; HPV; TLR

Pilot Study of Prevalence of High-Risk Human Papillomavirus Genotypes in Israeli Jewish Women Referred for Colposcopic Examination

The objective of the present study was to determine the prevalence of high-risk (HR) human papillomavirus (HPV) genotypes in a group of Israeli Jewish women referred for colposcopic examination. Scrape specimens were prospectively collected from 84 women referred for colposcopic examination. All the women underwent Papanicolaou (Pap) smears and colposcopies, and some also underwent cervical or loop electrosurgical excision procedure biopsy. HR HPV was detected in scrape specimens (Amplicor HPV test; Roche Molecular Systems), and the individual genotypes in these specimens were identified (HPV GenoArray test kit; Hybribio Ltd., Hong Kong). Forty-one (49%) specimens were positive by the Amplicor HPV test. Sixty-four samples (41 positive and 23 negative by the Amplicor HPV test) were also assayed by use of the HPV GenoArray kit. The overall level of agreement between the two assays was 93.8% (Cohen's kappa = 0.98). HR genotypes were found in 37/41 (90%) HPV-positive samples. The prevalences of the HR HPV genotypes in the 37 HPV-positive samples were 41% of patients for HPV type 16 (HPV-16), 22% for HPV-39, 19% for HPV-52, and 14% for HPV-18. Forty-one percent of these patients were infected with a single HR genotype, whereas 59% were infected with mixtures of HR genotypes. The presence of a relatively high percentage of HPV types 39 and 52 and the relatively high incidence of infections with mixtures of genotypes may be one of the reasons for the low rate of conversion from high-grade squamous intraepithelial lesions to invasive carcinoma in Israeli women. Larger and more comprehensive studies are warranted to investigate this issue in greater detail.