Clinical application value of human papillomavirus typing combined with cervical thin-prep cytology test in cervical cancer screening / 上海预防医学

Objective To explore the clinical value of the third-generation hybrid capture nucleic acid detection technology （DH3） typing detection of human papillomavirus （HPV） combined with thin-prep cytology test （TCT） in screening cervical cancer. Methods A total of1 582 female patients who received HPV and TCT cervical screening in Liuzhou Workers Hospital， Fourth Affiliated Hospital of Guangxi Medical University， from October 2020 to March 2021， were selected for this retrospective analysis. The cervical histopathological diagnosis was used as the gold standard to evaluate the diagnosis accuracies of HPV and TCT test results. Results Among the 1 582 patients， 334 were positive for HPV and 1 248 were negative； 234 were positive for TCT and 1 348 were negative； 180 were positive for histopathological diagnostic and 1 402 were negative. The sensitivity of HPV detection was 100%， the positive predictive value was 53.9%， the specificity was 89.0%， and the negative predictive value was 100.0%. In the HPV typing test， the positive rate for high-risk types 16/18 was 94.8%， and the positive rate for other 12 high-risk types was 73.8%. There was a little difference between TCT test and pathological test， and the detection consistency rate of high-grade squamous intraepithelial lesions and squamous carcinoma was same. Conclusion HPV testing combined with TCT to screen cervical cancer can reduce the misdiagnosis rate by a single test. The classification test is helpful for the hierarchical management of patients， and has a high clinical value for examination triage and grade screening.

Clinical significance of HPV-HC2 in diagnosis and prognosis of cervical lesions: a retrospective study

Background: To evaluate the human papillomavirus HC2 different range detection values and their clinical significance in prediction of CIN lesions grades as well as their role in the follow-up outcome after treatment.Methods: Using the hybrid capture 2 to detect and measure the HPV and the viral load quantity, we enrolled a total of 527 HPV positive women. All patients underwent thin prep liquid-based cytology test (TCT) and only 325 underwent colposcopy guided biopsy due to abnormal cytology results. All cytology and biopsy results were collected and analyzed according to the HPV viral load. Among these patients 108 patients were followed during 2years post-operatives and their prognosis results were collected and analyzed.Results: The proportion and severity of cytological abnormalities was positively correlated with the HPV-HC2 viral load (P<0.05). There was a positive correlation between cervical biopsy results and the HPV viral load P <0.05). The more the HPV-HC2 viral load was, the higher CIN2-3 grade percentage was getting. However no statically significant correlation was found between the HPV-HC2 viral load and the follow up outcomes after treatment (P>0.05).Conclusions: High HPV-HC2 viral load is significantly associated with the severity of cervical lesions (CIN), however it does not predict any further prognosis on follow-up after treatment.

Comparison of Analytical and Clinical Performance of HPV 9G DNA Chip, PANArray HPV Genotyping Chip, and Hybrid-Capture II Assay in Cervicovaginal Swabs

BACKGROUND: Human papillomavirus (HPV) infection can be detected by using several molecular methods, including Hybrid-Capture II (HC2) assay and variable HPV DNA chip tests, although each method has different sensitivities and specificities. METHODS: We performed HPV 9G DNA Chip (9G) and PANArray HPV Genotyping Chip (PANArray) tests on 118 cervicovaginal swabs and compared the results with HC2, cytology, histology, and direct sequencing results. RESULTS: The overall and high-risk HPV (HR-HPV) positivity rates were 62.7% and 44.9% using 9G, and 61.0% and 30.5% using PANArray, respectively. The positivity rates for HR-HPV with these two chips were significantly lower than 55.1% when HC2 was used. The sensitivity of overall HPV positivity in detecting histologically confirmed low-grade cervical squamous intraepithelial lesions or higher was 88.7% for all three tests. The specificity was 58.5% for 9G and 61.5% for PANArray, which was significantly lower than the 72.3% for HC2. With the HR-HPV+ genotype threshold, the sensitivity decreased to 75.5% for 9G and 52.8% for PANArray, which was significantly lower than the 88.7% for HC2. Comparison of the two chips showed concordant results in 55.1% of the samples, compatible results in 16.9%, and discordant results in 28.0%, exhibiting poor agreement in detecting  certain HPV genotypes. Compared with direct sequencing, 9G yielded no discordant results, whereas PANArray yielded 31 discordant results (26.7%). CONCLUSIONS: Compared with HC2, the HPV genotyping tests showed lower sensitivity in histologic correlation. When the two chips were compared, the 9G was more sensitive and accurate for detecting HR-HPV than the PANArray.

Clinical Significance of an HPV DNA Chip Test with Emphasis on HPV-16 and/or HPV-18 Detection in Korean Gynecological Patients

BACKGROUND: Human papillomavirus (HPV) is a major risk factor for cervical cancer. METHODS: We evaluated the clinical significance of the HPV DNA chip genotyping assay (MyHPV chip, Mygene Co.) compared with the Hybrid Capture 2 (HC2) chemiluminescent nucleic acid hybridization kit (Digene Corp.) in 867 patients. RESULTS: The concordance rate between the MyHPV chip and HC2 was 79.4% (kappa coefficient, κ = 0.55). The sensitivity and specificity of both HPV tests were very similar (approximately 85% and 50%, respectively). The addition of HPV result (either MyHPV chip or HC2) to cytology improved the sensitivity (95%, each) but reduced the specificity (approximately 30%, each) compared with the HPV test or cytology alone. Based on the MyHPV chip results, the odds ratio (OR) for ≥ high-grade squamous intraepithelial lesions (HSILs) was 9.9 in the HPV-16/18 (+) group and 3.7 in the non-16/18 high-risk (HR)-HPV (+) group. Based on the HC2 results, the OR for ≥ HSILs was 5.9 in the HR-HPV (+) group. When considering only patients with cytological diagnoses of “negative for intraepithelial lesion or malignancy” and “atypical squamous cell or atypical glandular cell,” based on the MyHPV chip results, the ORs for ≥ HSILs were 6.8 and 11.7, respectively, in the HPV-16/18 (+) group. CONCLUSIONS: The sensitivity and specificity of the MyHPV chip test are similar to the HC2. Detecting HPV-16/18 with an HPV DNA chip test, which is commonly used in many Asian countries, is useful in assessing the risk of high-grade cervical lesions.

Prevalence of HR-HPV and risk factors associated with the development of lesion cervical precousor of cervical cancer, a sample of the Curitiba metropolitan region, case-control study / Prevalência do HPV-AR e fatores de risco associados ao desenvolvimento de lesões cervicais precursoras do câncer cervical, numa amostra da região metropolitana de Curitiba, estudo caso-controle

Objective: Characterize the risk factors associated with the development of cervical intraepithelial neoplasia (CIN) and determine the prevalence of Highrisk Human Papillomavirus (HR-HPV) infection in women without cytological abnormalities and women diagnose with CIN 2 and 3, living in metropolitan region Curitiba, Parana state, Brazil. Material and Methods: Case-control study consisting of 382 women without cytological abnormalities, 233 women with high-grade intraepithelial lesions, which were subdivided in 131 women with CIN 2 and 102 women with CIN 3 diagnose by histological analysis of the cervical segment conical excision material. The age range of the women in the study was 15-45 years old, collected in the period of 2009 to 2012. The detection of HR-HPV DNA was performed by Hybrid Capture 2 test (CH2)...

Objetivo: Caracterizar os fatores de risco associados ao desenvolvimento de neoplasias intraepiteliais cervicais (NIC) e verificar a prevalência da infecçãopelo HPV de alto risco (HPV-AR) em mulheres sem anormalidade citológicas e com NIC 2 e 3, residentes na Região Metropolitana de Curitiba, Paraná,Brasil. Materiais e Métodos: Estudo caso-controle, composto por 382 mulheres sem anormalidades citológicas, 233 mulheres com lesão intraepitelial de alto grau, sendo estas subdivididas em 131 mulheres com NIC 2 e 102 com NIC 3 após a análise histológica do material da excisão cônica do segmento do colo do útero. A faixa etária das mulheres do estudo foi de 15 a 45 anos, coletadas no período de 2009 a 2012. A detecção do DNA do HPV-AR foi realizada pelo teste Captura Híbrida (CH2)...

Prevalência de infecção por HPV de alto risco em mulheres utilizando captura híbrida na prevenção do câncer do colo do útero no sul do Brasil / Prevalence of infection with high-risk HPV in women using hybrid capture conducting prevention of cervical cancer in south ern Brazil

Sabe-se que infecções por HPV de alto risco (HPV AR) estão ligadas ao desenvolvimento de câncer cervical. objetivo: Esse estudo teve como objetivo quantificar a prevalência de infecções por HPV em mulheres da metade sul do Estado do Rio Grande do Sul, Brasil, correlacionando fatores associados ao desenvolvimento de lesões precursoras e câncer cervical. Métodos: Para tanto, 643 mulheres foram incluídas no estudo, preenchendo um questionário padronizado e submetidas aos exames de citologia, colposcopia e HPV AR (Captura Híbrida 2). resultados: A maioria das pacientes tinha idade entre 20 e 39 anos (70,6%), houve decréscimo na porcentagem de fumantes de 23% para 11% e a média de idade ao início da vida sexual era de 18 anos. A prevalência de HPV AR é correlacionada com idades mais jovens, com menos pacientes infectadas por HPV AR quando estas eram mais velhas no momento do início da atividade sexual. Prevalência próxima a 70% foi observada em mulheres que tiveram 4 ou mais parceiros sexuais. Resultados citológicos e colposcológicos alterados tiveram taxas significativamente mais altas de infecção por HPV AR. 334 mulheres foram encaminhadas à biópsia. Destas, 321 tiveram resultados de colposcopia alterados e citopatologia ASC-US/AGC-US, LSILs e HSILs, com 231 biópsias realizadas neste estudo. Nenhum dos resultados indicou câncer. O teste de CH2 mostrou mais especificade do que a citologia, com altos valores preditivos positivos e negativos (49,8% e 78,6%, respectivamente). conclusão: A inclusão de testes para HPV AR nos programas de triagem no Brasil, de acordo com as políticas internacionais, levará à redução de biópsias em mulheres não infectadas e aumentará o intervalo entre exames.

High-risk Human Papillomavirus (HR HPV) infection is known to be linked to cervical cancer, with molecular biology tests being an important tool in diagnosis. objective: This study is aimed to quantify the prevalence of HPV infection in women from the Southern part of the State of Rio Grande do Sul, Brazil, correlating factors associated with the development of precursor lesions and of cervical cancer. Methods: 643 women were enrolled in the study, by filling out a standardized questionnaire and undergoing cytology, colposcopy, and HR HPV Hybrid Capture 2 (HC2) tests. results: Most patients were aged between 20 to 39 years (70.6%), this decreased the percentage of smokers from 23% to 11%. The average age of sexual debut through the period studied was of 18 years old. HR HPV prevalence was correlated with younger ages, with fewer patients infected by HR HPV when they were older at first sexual activity. Almost 70% prevalence of infection was observed in women who had 4 or more sexual partners. Altered cytology and colposcopy results had significantly higher rates of HR HPV infection. 334 women were referred for biopsy. Of those, 321 had altered colposcopy results and cytopathology of ASC-US/AGC-US, LSILs and HSILs, with 231 biopsies performed by the study. None of the results indicated cervical cancer. HC2 showed higher specificity than cytology, with high positive and negative prediction values (49.8% and 78.6%, respectively).conclusion: The inclusion of HR HPV testing in screening programs in Brazil, according to international policies, will lead to fewer biopsies in women without infection and increased interval between screenings.

Detección del virus del papiloma humano de alto riesgo por captura híbrida II® según hallazgos citológicos en mujeres tratadas por lesiones escamosas intraepiteliales de cuello uterino, período 2006/2010 / Detection of high risk human papillomavirus by hybrid capture II(r) according cytological findings in women treated for squamous intraepithelial lesions of the cervix, period 2006/2010

OBJETIVO: Determinar la frecuencia del virus de papiloma humano de alto riesgo oncogénico (HR-HPV) por captura híbrida II (r) (CH II(r)) según hallazgos citológicos en mujeres tratadas por lesiones escamosas intraepiteliales (SIL) de cuello uterino. MATERIAL Y MÉTODO: Estudio descriptivo de corte transverso de una serie de casos, en donde se incluyeron 122 mujeres tratadas, 79 (65%) por SIL de bajo grado (LSIL) y 43 (35%) por SIL de alto grado (HSIL) que concurrieron al Laboratorio de HPV del Instituto de Investigaciones en Ciencias de la Salud, Universidad Nacional de Asunción, para realizarse un control post-tratamiento, periodo 2006/2010. RESULTADOS: Se observó un total del 28% (34/122) de mujeres tratadas por SIL positivas para HR-HPV, detectándose infección viral en un 20% de las mujeres con ausencia de SIL (NSIL) (22/108), 83% de las mujeres con LSIL (10/12) y 100% de las mujeres con HSIL (2/2). De las 34 mujeres positivas para HR-HPV, 10 mujeres (29%) presentaron valores altos (100 pg/mL o más) de carga viral relativa, detectándose un aumento de casos positivos con la severidad de la lesión (28% NSIL, 30% LSIL, 50% HSIL). CONCLUSION: La detección de HR-HPV por CH II(r), así como los valores de carga viral relativa altos, en especial en mujeres con NSIL podrían ayudar a identificar mujeres tratadas con riesgo a desarrollar recidivas, contribuyendo así a fortalecer el programa de prevención de cáncer de cuello uterino. .

OBJECTIVE: To determinate the frequency of high risk human papillomavirus (HR-HPV) by hybrid capture II (r) (CH II(r)), according cytology results in women treated for squamous intraepithelial lesions of the cervix (SIL). MATERIAL AND METHODS: A descriptive cross-sectional study of a series of cases that included 122 women treated, 79 (75%) for low grade SIL (LSIL) and 43 (35%) for high grade SIL (HSIL) attending at the HPV Laboratory at the Health Sciences Research Institute (IICS), National University of Asunción (UNA), for post-treatment control during period 2006/2010. RESULTS: A total of 28% (34/122) of women treated for SIL were positive for HR-HPV, detecting viral infection in 20% of women with no SIL (NSIL) (22/108), in 83% of women with LSIL (10/12) and in 100% of women with HSIL (2/2). Of 34 women positive for HR-HPV, 10 women (29%) had high values (100 pg / mL or more) of relative viral load, detecting an increase of positive cases with severity of the lesion (28% NSIL, 30% LSIL, 50% HSIL). CONCLUSION: HR-HPV detection by CH II(r) and high relative viral load values especially in women with NSIL could help to identify treated women at risk of developing recurrence, thereby contributing to strengthening the cervical cancer prevention program. .

Evaluation of clinical application of approaches in cervical cancer screening / 肿瘤研究与临床

Objective To evaluate the function of Hybrid capture 2 (HC2) human papillomavirus (HPV) test,liquid-based cytology test (LCT),HPV serial test,LCT serial test and HPV-LCT parallel test for cervical high-grade lesions screening and to guide in selecting the scheme of cervical cancer screening.Methods HPV test,LCT,and colpescopic biopsy were performed in 545 women treated in Centrale Hospital of Klamayi from Sep.2009 and Dec.2011.The pathology results were the final diagnosis to evaluate the value of each approach for screening cervical cancer.Results Of 545 patients, 10 had cervical cancer.41 had cervical intraepithelial neoplasia CIN3,69 had CIN2,and 120 had CIN 1.Positive rate of high risk HPV was 64.22 ％.The sensitivity,specificity,accuracy,positive pre-value,and negative pre-value of HPV test for detecting high-grade cervical lesions were 95.83 ％,84.71％,88.48 ％,30.68 ％,99.12 ％,respectively.The values of LCT were 84.20 ％,89.53 ％,85.53 ％,36.69 ％,91.76 ％,respectively.The values of LCT serial test were 81.03 ％,95.96 ％,78.33 ％,40.69 ％,92.92 ％,respectively.The values of HPV serial test were 81.03 ％,95.26 ％,78.33 ％,42.15 ％,99.52 ％,respectively.The values of HPV-LCT parallel test were 99.20 ％,81.53 ％,90.03 ％,32.09 ％,99.33 ％,respectively.Conclusion HPV-LCT parallel test can significantly improve the detection rate of cervical cancer screening.

Assays for detection of human papillomavirus infection in diagnosis of high grade cervical lesions / 中华临床感染病杂志

Objective To evaluate the application of different assays for detection of human papillomavirus(HPV)in diagnosis of high grade cervical lesions.Methods Two hundred subjects with abnormal thinprep liquid-based cytology test(TCT)Resultswere selected for HPV DNA detection by hybrid capture 2(HC-Ⅱ) and Methodsbased on PCR including flow-through hybridization and gene chip (HybriMax),real-time fluorescent quantitative PCR(FQ-PCR)and flow fluorescent hybridization assay.Cytopathological Resultswere used as gold standards to evaluate the test performance of the above assays for diagnosing cervical intraepithelial neoplasia(CIN)≥Ⅱ. SPSS 13.0 software was used for statistical analysis.Results HPV DNA positive rates of 200 samples by HybriMax,FQ-PCR,flow fluorescent hybridization assay and HC-Ⅱ were 72.5%(145/200),71.5%(143/200),70.0%(140/200)and 69.0%(138/200),respectively,and the differences were not statistically si(g)nificant(x2 =0.252,0134,0.012 and 0.027,P ＞ 0.05).The sensitivity,Youden index and negative predictive value of the above assays were statistically different(x2 =7.923,7.819 and 8.108,P ＜0.05).Conclusion HC-Ⅱ is superior to PCR Methodsin diagnosis of CIN Ⅱ and above.

Frecuencia y carga viral relativa del virus del papiloma humano de alto riesgo según el diagnóstico citológico en mujeres paraguayas por captura híbrida II / Frequency and relative viral load of high risk human papilloma virus according to the cytological diagnosis in paraguayan women by hybrid capture II

El cáncer de cuello uterino es el tumor maligno más frecuente en mujeres de Latinoamérica y su agente causal es el virus del papiloma humano (HPV). Recientemente en Paraguay incorporamos el método de captura híbrida II (CH II), el cual detecta 13tipos de HPV de alto riesgo oncogénico (HR-HPV) y proporciona valores relativos de carga viral. El objetivo del estudio fue determinar la carga viral relativa de HR-HPV por CH IIsegún el diagnóstico citológico. Fueron incluidas 566 mujeres (33 + 10 años) atendidas en el Instituto de Investigaciones en Ciencias de la Salud 2006/2009. Fue detectado HRHPVen 43% de las mujeres (241/566), observándose una alta frecuencia del 23% en mujeres con ausencia de lesión intraepitelial (NSIL). Según el diagnóstico citológico, se evidenció una diferencia altamente significativa entre los valores de carga viral relativa(p<0,0001; Kruskal Wallis), observándose un aumento de carga viral relativa de mujeres con NSIL a mujeres con SIL (68 pg/ml en ausencia de SIL; 710 pg/ml para SIL de bajo grado-LSIL y 474 pg/ml para SIL de alto grado-HSIL). No se observó cambio significativo en la carga viral relativa entre LSIL y HSIL (p=0,60; prueba t de Student). Los resultados sugieren que los valores de carga viral relativa proporcionados por CH II pueden ser considerados como un indicador importante en el manejo de mujeres con sospecha de SIL.

Cervical cancer is the most frequent malignant tumor in women of Latin America being human papillomavirus (HPV) the main causative agent. Recently in Paraguay, we incorporated the method of hybrid capture II (CH II) which detects 13 types of HPV ofhigh oncogenic risk (HR-HPV) and provides relative values of viral load. The aim of this study was to determine the frequency and relative viral load of HR-HPV by CH II according to the cytological diagnosis. There were 566 women (33 + 10 years) included in the study that attended the Research Institute in Health Sciences during the period 2006/2009. HR-HPV was detected in 43% of the women (241/566), being observed a high frequency of 23% in women negative to squamous intraepithelial lesions (NSIL). According to the cytological diagnosis, there was a highly significant difference between the values of relative viral load (p <0.0001; Kruskal Wallis), with an increase of relative viral load of women with NSIL to women with SIL (mean values: 68 pg/ml in NSIL; 710 pg/ml in low grade SIL-LSIL and 474 pg/ml in high grade SIL-HSIL). Significant change was not observed in the relative viral load between LSIL and HSIL (p=0.60; Student’s t test).The results suggest that the values of relative viral load provided by CH II could be considered an important indicator for managing women with suspicion of SIL.

Comparação das técnicas de captura de híbridos e PCR para a detecção de HPV em amostras clínicas / Comparison of hybrid capture and PCR for HPV detection in clinical samples

INTRODUÇÃO E OBJETIVOS: São conhecidos mais de 100 tipos de papilomavírus humano (HPV), dos quais 30 têm sido reportados em infecções anogenitais. A infecção tem importância clínica, pois alguns tipos virais estão associados a lesões que podem progredir para o câncer cervical. Sabe-se que os métodos moleculares são muito importantes para o diagnóstico dessa infecção. O objetivo do estudo é comparar a detecção de HPV de alto risco pelo método de captura híbrida 2 (CH2) com a detecção do vírus pela reação em cadeia da polimerase convencional (PCRc) e em tempo real (PCR-TR). METODOLOGIA: Foram analisadas 56 amostras ectocervicais por CH2 e, após, por PCRc e PCR-TR. RESULTADOS: Ambas, PCRc e PCR-TR, apresentaram alta concordância entre si (95,1 por cento), enquanto a comparação entre as PCRs e a CH2 mostrou concordância razoável entre os resultados (PCRc = 90,2 por cento e PCR-TR = 87,8 por cento). DISCUSSÃO E CONCLUSÃO: A CH é aceita para a detecção do HPV, entretanto pode ser menos sensível em comparação com as técnicas de PCR. A PCR-TR tem a vantagem sobre a PCRc em termos de velocidade, sendo também um pouco mais sensível. Devido à alta sensibilidade e à rapidez, os métodos de PCR poderiam ser usados para a triagem de HPV em amostras ectocervicais.

INTRODUCTION AND OBJECTIVE: More than 100 types of human papillomaviruses (HPV) are known, of which 30 have been reported in anogenital infections. The infection has clinical importance, inasmuch as some viral types are associated with lesions that can progress to cervical cancer. Molecular methods are considered an important tool for the diagnosis of this infection. The objective of this study was to compare the detection of high risk HPV using hybrid capture 2 with HPV detection by conventional and real time PCR. METHODOLOGY: 56 ectocervical samples were analyzed by hybrid capture and after that by conventional and real time PCR. RESULTS: Both PCR and RT-PCR showed a high degree of correlation (95.1 percent), whereas the comparison between PCR and HC2 showed a fair correlation (90.2 percent and 87.8 percent for PCR and RT-PCR, respectively). DISCUSSION AND CONCLUSIONS: HC is widely accepted for the detection of HPV, however, it may lack sensitivity in comparison with PCR techniques. RT-PCR has further advantages over the conventional PCR in terms of speed as well as it is slightly more sensitive. Due to their high sensitivity and fast response, PCR methods could be used as a screening method for HPV detection in ectocervical samples.

Human papillomavirus false positive cytological diagnosis in low grade squamous intraepithelial lesion

The purpose of this study was to investigate the number of Human Papillomavirus false positive cytological diagnosis in low grade squamous intraepithelial lesions (LSIL). Three hundred and two women who assisted to an Out-Patient Gynecologic Clinic in Maracaibo, Venezuela, were recruited for this study. Each patient had the Pap smear and a cervical swab for Hybrid Capture 2 (HC2). Three cytotechnologists reviewed the Pap smears and two pathologists rescreened all of them. The cytotechnologists reported 161 (53.3 percent) Pap smears negatives for intraepithelial lesion (IL) or malignancy, and 141 cases (46.7 percent) with epithelial abnormalities. They reported 46 percent of 302 patients with HPV infection in Pap smear slides. The pathologists found that 241 (79.8 percent) Pap smears were negatives for IL or malignancy and 61 (20.2 percent), with abnormal Pap smears. They found 14.6 percent HPV infection in all Pap smears (p<0.0001; 46 percent vs 14.6 percent). The HC2 study showed that 47 samples (15.6 percent) were positive for HPV. The study found that 114 Pap smears (False Positive: 85 percent) of 134 reported by the cytotechnologists and 24 (False Positive: 43 percent) of 56 cytologies reported by the pathologists as LSIL, were negative for HPV infection determined by HC2 (p<0.00003). The present study suggests that the cytotechnologists overdiagnosed cellular changes associated with HPV infection in the Pap smear, increasing the FP cytological diagnosis of LSIL.

El presente trabajo tuvo por objeto el investigar el número de falsos positivos reportados en la citología cervicovaginal (CCV) de la presencia del Virus del Papiloma Humano (VPH) con diagnóstico de Lesión Intraepitelial Escamosa de bajo grado (LIE-BG). Se estudiaron 302 mujeres que asistieron a la Consulta de Patología de Cuello Uterino del Hospital Manuel Noriega Trigo, en Maracaibo, Venezuela. A cada paciente se le practicaron una CCV y muestra para la captura de híbridos 2 (CH2). Tres citotecnólogos y 2 patólogos estudiaron las CCV. Los citotecnólogos reportaron 161(53,3 por ciento) de CCV negativas para lesión intraepitelial o malignidad y 141 casos (46,7 por ciento) con anomalías epiteliales. Éstos encontraron 46 por ciento de presencia de VPH en las 302 CCV. Los patólogos reportaron 241 CCV (79,8 por ciento) negativas y 61 CCV (20,2 por ciento) anormales. Estos encontraron en 14,6 por ciento de las CCV, la presencia de VPH (p < 0, 0001; 46 por ciento vs 14,6 por ciento). La CH2 mostró que 47 muestras (15, 6 por ciento) fueron positivas a VPH. Esta investigación mostró que 112 CCV de 134 (Falso Positivo: 85 por ciento) reportados por los citotecnólogos y 24 de 56 CCV (Falso Positivo: 43 por ciento) reportados por los patólogos como LIE-BG, fueron negativos a la infección del VPH determinados por la CH2 (p < 0,00003). La investigación sugiere un sobrediagnóstico de la presencia de cambios celulares debidos al VPH en la CCV, por parte de los citotecnólogos, incrementando los falsos positivos de la presencia del VPH en CCV con diagnóstico de LIE-BG.

Prevalence and risk factors of human papillomavirus infection in asymptomatic women in a Venezuelan urban area

The purpose of this study was to investigate the prevalence and risk factors of genital human papillomavirus (HPV) infection in asymptomatic women, using the HPV DNA Hybrid Capture 2 (HC2) test. Three hundred and two women who attended the Out-Patient Gynecological Clinic of a tertiary level hospital, in a Venezuelan urban area, were selected for the study. A pap smear, a cervical swab for HC2 and gynecological exam were performed to each patient. The HC2 testing showed that 47 samples (15.6%) were positive to HPV. Forty patients (13.2%) were positive to high risk-HPV (HR-HPV) and 11 (3.6%) were positive to low-risk-HPV (LR-HPV). The prevalence of HPV infections was higher for women under 35 years (51.1%; p < 0.02), and decreased to 6.4% for women 65 years old. Women who had not finished high school had a higher prevalence of HPV infection (p < 0.035). Twenty six (42.6%) of 61 pathological Pap smears were positives to HPV infection. A statistically significant difference was found when HPV infection was compared in normal and abnormal Pap smear (HSIL+LSIL; p<0.0001). Twenty four of 56 (43%) women with diagnosis of LSIL, and 2(40%) of 5 with diagnosis of HSIL were positive for HPV infection. A statistically significant difference was found when we compared HPV infection in negative Pap smears and those with LSIL (p<0.001). The present study found that the prevalence of HPV infection in asymptomatic Venezuelan women who attended a tertiary level hospital was 15.6%. HPV infection was more frequent in young adult, and in women with low educational level.

El propósito de este estudio fue investigar la prevalencia y factores de riesgo que influencia la presencia de la infección por el virus del papiloma humano (VPH) en pacientes asintomáticas que asistieron a un hospital nivel 3 en un área urbana venezolana. Se estudiaron las pacientes que acudieron a la Consulta de Patología del Cuello Uterino del Hospital Manuel Noriega Trigo. A cada paciente se le realizó una historia clínica, toma de citología cervico-vaginal y una muestra del cérvix para captura de híbridos 2(CH2). Se incluyeron 302 pacientes. La CH2 mostró 47 muestras (15,6%) positivas al VPH. Cuarenta mujeres (13,2%) fueron positivas a VPH de alto riesgo (VPH-AR) y 11 (3,6%) a VPH de bajo riesgo (VPH-BR). La prevalencia de la infección por VPH fue más alta en mujeres 35 años (51,1%; p < 0,02) y disminuyó a un 6,4% en mujeres 65 años. Las pacientes que no habían terminado los estudios de bachillerato presentaron un prevalencia más elevada del VPH (p < 0,035). Veinte y seis (42,6%) de 61 CCV patológicas fueron positivas a la infección del VPH. Una diferencia estadísticamente significativa fue encontrada cuando se comparó la presencia del VPH en las CCV normales con las CCV anormales (Lesión Intraepitelial Escamosa de Alto y Bajo Grado-LIE-AG y LIE-BG; p < 0,0001). Veinte y cuatro de 56 (43%) mujeres con diagnostico de LIE-BG, y 2(40%) de 5 con diagnóstico de LIE-AG fueron positivos a la presencia del VPH. Se encontró una diferencia estadísticamente significativa cuando se comparó la presencia de infección por el VPH en CCV normales y CCV con LIE-BG (p < 0,001). El presente estudio encontró una prevalencia de la infección por el VPH en mujeres asintomáticas que asisten a un hospital nivel 3 de 15,6% en área urbana venezolana. Fue más frecuente en mujeres jóvenes y de bajo nivel educacional.

Detection of high risk human papillomavirus cervical infections by the hybrid capture in Asunción, Paraguay

Cervical cancer is the most frequent malignant tumour of women in Latin America being human papillomavirus (HPV) the main cause. The aim of this study was to increase the knowledge about the cervical infections with oncogenic HPV types (HR-HPV) in Asuncion, Paraguay. Two hundred and seventy-two cervical samples were analyzed using hybrid capture II assay (HCA II) for HR-HPV. The frequency of HR-HPV in the study group was 44 percent. HR-HPV was detected in 25 percent of the women negative for squamous intraepithelial lesions (NSIL), 72 percent with atypical squamous cells of undetermined significance (ASCUS), 68 percent with low SIL and 78 percent with high SIL. A moderate concordance was observed between HCA II assay and cytology (kappa: 0.43 IC95 percent 0.3 - 0.5). It was detected a high frequency of HR-HPV in women from 11 to 30 years old and in those over 60 years old. The data obtained in this study showed a high frequency of HR-HPV in woman with NSIL and ASCUS, which corroborate that the use of cytology together with HCA II assay for HR-HPV could improve remarkably the efficiency of screening programs of cervical cancer in Paraguay. Furthermore, these findings point out the need for the periodical follow-up of HR-HPV infections in older women.

Predictive Value of Detection of hTERC Gene Copy Number in Cervical Epithelial Cells by means of Fluorescence in situ Hybridization and Human Papilloma Virus Testing for Cervical Intraepithelial Neoplasia / 中华医院感染学杂志

OBJECTIVE To explore the predictive value of human telomerase RNA gene component(hTERC) gene amplification and high-risk human papilomavirus(HR-HPV) testing in cervical intraepithelial neoplasia(CIN) as a marker for early diagnosis of cervix carcinoma.METHODS Fluorescence in situ hybridization(FISH) was used to detect the amplification of hTERC of cervical epithelial cells in 72 cases.By using hybrid capture 2(HC-2),two types of the HR-HPV DNA(HPV16/18) of each case were detected.Then,the results were compared with the pathologic diagnosis.The dual-color probe we used was GLP TERC/CSP 3.HeLa cells and lymphocytes from normal marrow were the positive control,while the cervical specimens from healthy outpatients were the negative control.RESULTS hTERC Gene amplification of specimens was tested in 72 cases,the positive amplification rate of hTERC gene in the cervicitis/CINⅠgroup and normal,compared to the cervical carcinomas(100%) and CIN Ⅱ/Ⅲ(68.75%),which showed a significant difference.The rates in CINⅡ and CINⅢ were 60.00% and 83.33%,respectively,which showed a significant difference compared with normal and CINⅠ/inflammation groups.hTERC gene amplification was positive in both HeLa cells and lymphocytes from normal marrow and HC-2 testing was positive in 32 cases of patients containing 11 cases of CINⅡ/Ⅲ,3 cases of cervical cancer,18 cases of cervicitis/CIN1 diagnosed.The positive predictive value(PPV) and specificity(Sp) of hTERC for the high-grade CIN was significantly higher than the PPV and Sp of HC-2 HR-HPV testing.CONCLUSIONS hTERC Gene involves in the progression and occurrence of cervical intraepithelial neoplasia and cervical squamous carcinoma.As a marker for early diagnosis of cervical intraepithelial neoplasia and cervical squamous carcinoma,the FISH method for hTERC gene is more reliable to differentiate the malignant diseases from the benign ones in cervixes than HC-2 HR-HPV DNA testing.The combined detection of HR-HPV and hTERC gene will provide more effective and suitable management to enhance the early diagnosis rate of cervical intraepithelial neoplasia and cervical squamous carcinoma.

Low prevalence of high risk human papillomavirus in normal oral mucosa by hybrid capture 2

High risk human papillomavirus (HR-HPV) are recognized as a necessary factor to development cervical cancer. During the last decade many studies have found HR-HPV in oral squamous cell carcinoma (OSCC) and normal oral mucosa, however the association between HR-HPV and OSCC is still uncertain. The aim of the study was to determine DNA HR-HPV in normal oral cavity of healthy adults. A cross-sectional study was performed; samples from 77 patients with normal oral cavity were collected at the Dentistry school, Autonomous University of Yucatan, Merida, Yucatan, México. HR-HPV was detected by hybrid capture 2. One sample out of 77(1.2 percent) was positive for HR-PVH. It was from a man of 50 years old. HR-HPV is present in low rate among healthy oral mucosa. Hybrid capture 2 could be a good methodology for large epidemiology studies.

Papilomavírus humano de alto risco (HR-HPV) é um fator reconhecido como necessário para o desenvolvimento de câncer cervical. Na última década vários estudos encontraram HR-HPV em OSCC (oral squamous cell carcinoma) e em mucosa oral normal, mas a associação entre HR-HPV e OSCC não é bem conhecida. O objetivo desse estudo foi determinar DNA de HR-HPV na cavidade oral normal de adultos saudáveis. Realizou-se um estudo cross-sectional com amostras da cavidade oral normal de 77 pacientes da Escola de Odontologia da Autonomous University of Yucatan, Merida, Yucatan, México. HR-HPV foi detectado através de Captura Híbrida 2. Uma amostra em 77 (1,2 por cento) foi positiva para HR-PVH e era proveniente de um homem de 50 anos de idade. Concluiu-se que HR-HPV tem baixa prevalência na mucosa oral normal e a Captura Híbrida 2 pode ser um método adequado para estudos epidemiológicos.

The clinical value of using xMAP technology for detection of high-risk human papillomavirus / 肿瘤

Objective: To explore the clinical values of using flexible multi-analyte profiling (xMAP) technology for detection of high-risk human papillomavirus (HR-HPV). Methods: Six hundred and thirty eight cervical exfoliated cell samples were collected from women who lived in the region with high-incidence of cervical cancer in Shanxi province. The samples were tested with xMAP technology and Hybrid Capture 2 ® Assay (hc2). Pathological diagnosis was used as a hallmark to evaluate the detection results. HR-HPV infection rate and its genotyping distribution were analyzed and the coincidence of two methods above was assessed. Results: The sensitivity, specificity and accuracy of xMAP technology were 77.78%, 93.59% and 92.42%, respectively. The negative and positive predictive values were 98.13% and 49.30%, respectively. The prevalence rate of HR-HPV was 11.7%. HPV16 and 52 were the dominant types in non-neoplastic disease and cervical intraepithelial neoplasia (CIN) grade 1; HPV16 and 58 were the most common types in CIN2 samples; HPV16 was the most frequent type in CIN3 and cervical cancer. The lesion progress was positively related to the infection rate of HPV16, 52 or 58 (P<0.01). The Kappa value for agreement between xMAP technology and hc2 was 0.60. Conclusions: Compared with the hc2 test, the xMAP technology was highly specific, and the sensitivity is 77.78%. The agreement of these two methods is satisfactory. More improvements should be made to elevate the sensitivity of xMAP method and to increase the numbers of genotypes that can be detected.

Comparison of the AMPLICOR human papillomavirus (HPV) Test and the Hybrid Capture 2 Assay for detection of high-risk HPV / 대한산부인과학회지

OBJECTIVE: The purpose of this study was to determine the efficacy of the AMPLICOR HPV test in comparison with the Hybrid Capture 2 (HC2) test in detecting HR HPV. METHODS: One hundred and fifty-three consecutive women attending the Colposcopy Clinic were included and cervical scrape specimens were tested for the presence of 13 HR HPV genotypes by both AMPLICOR HPV test and HC2 assay. RESULTS: The prevalence of HR HPV was 53/153 (34.6%) and 52/153 (34.0%) by AMPLICOR HPV test and HC2 assay, respectively. When discordant results were observed between AMPLICOR HPV test and HC2 assay, we used the HPV genotyping DNA chip and DNA sequence analysis, as reference standards. Concordant results were obtained for 128 (83.7%) of the 153 samples (Cohen's kappa=0.63, p<0.001). The genotyping showed that no HR HPV was detected in the 10 AMPLICOR negative HC2 positive samples, while HR HPV genotype was found in 3/13 (23.1%) AMPLICOR positive HC2 negative samples. The detection rates of HR HPV with AMPLICOR HPV test and HC2 assay were 38.7% and 48.4%, respectively, in CIN1; 95.0% and 100%, respectively, in CIN3/cancer. HPV positivity of AMPLICOR HPV test and HC2 assay increased linearly with the increasing grade of cytology or histology (p<0.001). In detecting high grade (CIN2+) lesions, sensitivities were 90.9% (CI, 75.9~97.0%), 95.5% (CI, 81.9~99.0%), respectively, for AMPLICOR HPV test and HC2 assay (p=1.00). The specificities of AMPLICOR HPV test and HC2 assay were 72.7% (CI, 64.3~79.8%) and 69.3% (CI, 60.7~76.7%), respectively (p=0.75). CONCLUSIONS: AMPLICOR HPV test is comparable to HC2 assay for detection of HR HPV, with similar sensitivity and specificity in detecting CIN2+ lesions. AMPLICOR HPV test can be considered clinically useful for detection of HR HPV. However, more data are clearly needed on the performance of AMPLICOR HPV test as a screening tool.

A Comparision of Surepath(TM) Liquid-Based Smear with a Conventional Smear for Cervicovaginal Cytology-with Reference to a Histological Diagnosis / 대한세포병리학회지

This study was performed to compare Surepath(TM) liquid-based smear and a conventional cervicovaginal smear with reference to a histological diagnosis. A hybrid capture test (HCII) was also performed and analyzed. We collected matched cases for cervicovaginal cytology- histology: 207 cases for conventional cytology (CC) and 199 cases for liquid-based cytology (LBC). HCII was performed in 254 patients. When a cytological diagnosis of ASCUS or above (ASCUS+) is classified as positive and a histological diagnosis of LSIL+ is classified as positive, the sensitivity and specificity for LBC was 91.7% and 75.9%, respectively and the sensitivity and specificity for CC was 62.6% and 96.1%, respectively. When a cytological and histological diagnosis of LSIL+ is classified as positive, the sensitivity and specificity for LBC was 77.5 and 96.6%, respectively and the sensitivity and specificity for CC was 49.7% and 100%, respectively. When a histological diagnosis of LSIL+ is classified as positive, the sensitivity and specificity for HCII was 78.9% and 78.1%, respectively. The concordance ratio between the cytological and histological diagnosis was 80.4% (kappa=76.0) for LBC and 56.5% (kappa=55.1) for CC. LBC is more sensitive and less specific then CC, as a cytological cutoff level of ASCUS, but more sensitive and equally specific, as a cytological cutoff level LSIL or HSIL. LBC is more reliable with a high concordance ratio between the cytological and histological diagnosis.

The comparative evaluation of clinical screening in combined tests cytology (ThinPrep(R)), HPV DNA test (Hybrid capture(R) II),cervicography for uterine cervical cancer / 부인종양

OBJECTIVE: Since the accuracy of Pap smear for cervical neoplasm has been questioned, a number of adjunctive tests have been developed. The purpose of this study was to evaluate which protocol is the most effective screening test among cervical cytology (ThinPrep(R)), HPV DNA test (Hybrid capture(R) II) and cervicography. METHODS: We chose 252 patients who were underwent the biopsy among 829 patients who visited our hospital for cervical cancer screening test. These 252 patients were engaged in this study simultaneously. They underwent triple combined test [cervical cytology (ThinPrep(R)), HPV DNA test (Hybrid capture(R) II), cervicography] and colposcopic-directed biopsy or biopsy on operation for diagnostic evaluation. RESULTS: The triple combined test showed a sensitivity of 96.0%, while double combined test [cervical cytology (ThinPrep(R))+cervicography] showed a sensitivity of 89.0%, the other double combined test [cervical cytology (ThinPrep(R))+HPV DNA test (Hybrid capture(R) II)] showed a sensitivity of 86.7%. Cervicography showed a specificity of 75.4% (highest among the single test), positive predictability of 89.8% (also highest). CONCLUSION: The sensitivity of cervical cytology was markedly improved by combination with HPV DNA test and cervicography. So the triple combined tests which improved the high false negative rate of cervical cytology may be a new effective method as a cervical cancer screening test, if the effectiveness could be confirmed by mass screening study.