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1.
Cytopathology ; 35(1): 2-6, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37877689

RESUMO

This report highlights information and outcomes from the November 2022 ASC/IAC joint Cytology Education Symposium, an annual conference organized by the Cytology Programs Review Committee. The manuscript provides information on shared educational opportunities and practices for cytology students and other learners in anatomic pathology, discusses recruitment strategies for schools of cytology, conveys teaching resources, introduces perspectives on virtual microscopy and online learning, and transmits information about wellness of students in schools of cytology.


Assuntos
Currículo , Simbiose , Humanos , Técnicas Citológicas , Instituições Acadêmicas , América do Norte
3.
Gynecol Oncol ; 136(2): 178-82, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25579107

RESUMO

In 2011, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated screening guidelines for the early detection of cervical cancer and its precursors. Recommended screening strategies were cytology and cotesting (cytology in combination with hrHPV testing). These guidelines also addressed the use of hrHPV testing alone as a primary screening approach, which was not recommended for use at that time. There is now a growing body of evidence for screening with primary hrHPV testing, including a prospective US-based registration study. Thirteen experts including representatives from the Society of Gynecologic Oncology, American Society for Colposcopy and Cervical Pathology, American College of Obstetricians and Gynecologists, American Cancer Society, American Society of Cytopathology, College of American Pathologists, and the American Society for Clinical Pathology, convened to provide interim guidance for primary hrHPV screening. This guidance panel was specifically triggered by an application to the FDA for a currently marketed HPV test to be labeled for the additional indication of primary cervical cancer screening. Guidance was based on literature review and review of data from the FDA registration study, supplemented by expert opinion. This document aims to provide information for healthcare providers who are interested in primary hrHPV testing and an overview of the potential advantages and disadvantages of this strategy for screening as well as to highlight areas in need of further investigation.


Assuntos
Infecções por Papillomavirus/diagnóstico , Neoplasias do Colo do Útero/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Detecção Precoce de Câncer , Feminino , Humanos , Masculino , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Infecções por Papillomavirus/virologia , Neoplasias do Colo do Útero/virologia
4.
J Low Genit Tract Dis ; 19(2): 91-6, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25574659

RESUMO

In 2011, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated screening guidelines for the early detection of cervical cancer and its precursors. Recommended screening strategies were cytology or cotesting (cytology in combination with high-risk HPV (hrHPV) testing). These guidelines also addressed the use of hrHPV testing alone as a primary screening approach, which was not recommended for use at that time. There is now a growing body of evidence for screening with primary hrHPV testing, including a prospective US-based registration study. Thirteen experts including representatives from the Society of Gynecologic Oncology, American Society for Colposcopy and Cervical Pathology, American College of Obstetricians and Gynecologists, American Cancer Society, American Society of Cytopathology, College of American Pathologists, and the American Society for Clinical Pathology, convened to provide interim guidance for primary hrHPV screening. This guidance panel was specifically triggered by an application to the FDA for a currently marketed HPV test to be labeled for the additional indication of primary cervical cancer screening. Guidance was based on literature review and review of data from the FDA registration study, supplemented by expert opinion. This document aims to provide information for health care providers who are interested in primary hrHPV testing and an overview of the potential advantages and disadvantages of this strategy for screening as well as to highlight areas in need of further investigation.


Assuntos
Detecção Precoce de Câncer/métodos , Técnicas de Diagnóstico Molecular/métodos , Papillomaviridae/classificação , Papillomaviridae/isolamento & purificação , Neoplasias do Colo do Útero/diagnóstico , Adulto , Diagnóstico Precoce , Feminino , Humanos , Papillomaviridae/genética , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Adulto Jovem
5.
Adv Physiol Educ ; 38(4): 315-20, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25434014

RESUMO

In the present study, we describe the innovative use of the National Board of Medical Examiners (NBME) Comprehensive Basic Science Examination (CBSE) as a progress test during the preclerkship medical curriculum. The main aim of this study was to provide external validation of internally developed multiple-choice assessments in a new medical school. The CBSE is a practice exam for the United States Medical Licensing Examination (USMLE) Step 1 and is purchased directly from the NBME. We administered the CBSE five times during the first 2 yr of medical school. Student scores were compared with scores on newly created internal summative exams and to the USMLE Step 1. Significant correlations were observed between almost all our internal exams and CBSE scores over time as well as with USMLE Step 1 scores. The strength of correlations of internal exams to the CBSE and USMLE Step 1 broadly increased over time during the curriculum. Student scores on courses that have strong emphasis on physiology and pathophysiology correlated particularly well with USMLE Step 1 scores. Student progress, as measured by the CBSE, was found to be linear across time, and test performance fell behind the anticipated level by the end of the formal curriculum. These findings are discussed with respect to student learning behaviors. In conclusion, the CBSE was found to have good utility as a progress test and provided external validation of our new internally developed multiple-choice assessments. The data also provide performance benchmarks both for our future students to formatively assess their own progress and for other medical schools to compare learning progression patterns in different curricular models.


Assuntos
Estágio Clínico/normas , Currículo/normas , Educação de Graduação em Medicina/normas , Avaliação Educacional/normas , Faculdades de Medicina/normas , Estágio Clínico/métodos , Estágio Clínico/tendências , Currículo/tendências , Educação de Graduação em Medicina/métodos , Educação de Graduação em Medicina/tendências , Avaliação Educacional/métodos , Humanos , Reprodutibilidade dos Testes , Faculdades de Medicina/tendências , Estados Unidos
6.
J Am Soc Cytopathol ; 13(1): 4-9, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38184364

RESUMO

This report highlights information and outcomes from the November 2022 ASC/IAC joint Cytology Education Symposium, an annual conference organized by the Cytology Programs Review Committee. The manuscript provides information on shared educational opportunities and practices for cytology students and other learners in anatomic pathology, discusses recruitment strategies for schools of cytology, conveys teaching resources, introduces perspectives on virtual microscopy and online learning, and transmits information about wellness of students in schools of cytology.


Assuntos
Técnicas Citológicas , Instituições Acadêmicas , Simbiose , Humanos , Escolaridade , América do Norte
7.
Arch Pathol Lab Med ; 147(1): 52-61, 2023 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-35271691

RESUMO

CONTEXT.­: The College of American Pathologists (CAP) updated the Laboratory Accreditation Program Cytopathology Checklist to assist laboratories in meeting and exceeding the Clinical Laboratory Improvement Amendments standards for gynecologic cytologic-histologic correlation (CHC). OBJECTIVE.­: To survey the current CHC practices. DESIGN.­: Data were analyzed from a survey developed by the committee and distributed to participants in the CAP Gynecologic Cytopathology PAP Education Program mailing. RESULTS.­: Worldwide, CHC practice is nearly universally adopted, with an overall rate of 87.0% (568 of 653). CHC material was highly accessible. CHC was commonly performed real time/concurrently at the time the corresponding surgical pathology was reviewed. Investigation of CHC discordances varied with North American laboratories usually having a single pathologist review all discrepant histology and cytology slides to determine the reason for discordance, while international laboratories have a second pathologist review histology slides to determine the reason for discordance. The cause of CHC discordance was primarily sampling issues. The more common statistical metrics for CHC monitoring were the total percentage of cases that correlated with subsequent biopsies, screening error rate by cytotechnologist, and interpretative error rate by cytotechnologist. CONCLUSIONS.­: Many laboratories have adopted and implemented the CHC guidelines with identifiable differences in practices between North American and international laboratories. We identify the commonalities and differences between North American and international institutional practices including where CHC is performed, how CHC cases are identified and their accessibility, when CHC is performed, who investigates discordances, what discordances are identified, and how the findings affect quality improvement.


Assuntos
Laboratórios , Patologistas , Sociedades Médicas , Feminino , Humanos , Citodiagnóstico , Garantia da Qualidade dos Cuidados de Saúde , Estados Unidos
8.
Arch Pathol Lab Med ; 146(1): 78-83, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-33929528

RESUMO

CONTEXT.­: The yield of the prospective rescreening process for "negative for intraepithelial lesion or malignancy" (NILM) Papanicolaou (Pap) tests is higher with the inclusion of a greater proportion of high-risk cases. One of the suggested criteria for classifying a Pap test finding as high risk is recent or concurrent high-risk human papillomavirus (HPV) positivity. OBJECTIVE.­: To evaluate how the results of HPV testing have been incorporated in the prospective rescreening of NILM Pap tests across a wide range of laboratories. DESIGN.­: A questionnaire survey was sent to laboratories participating in the 2019 College of American Pathologists (CAP) Gynecologic Cytology (PAP Education) Program. RESULTS.­: Of the 1507 participating laboratories, 667 (44%) responded to the survey. Most laboratories (59.4%; 396 of 667) had not incorporated HPV test/genotyping results to select NILM Pap tests for rescreening. Amongst the remaining laboratories, for NILM HPV-positive Pap test results, 112 (16.8%) had a policy to rescreen by a cytotechnologist only, 51 (7.6%) by a pathologist only, and 86 (12.9%) by both. Of 264 laboratories, 181 (68.6%) reported the cytology upon availability of the HPV test result and completion of the secondary review. Of 661 laboratories, 145 (21.9%) included consensus-type recommendations in the cytology report for such Pap tests. CONCLUSIONS.­: This CAP survey provides significant information regarding the current trends in the use of HPV test results in prospective rescreening of NILM Pap tests. Future studies on quality improvement can further assist in the standardization of this process across different laboratories.


Assuntos
Alphapapillomavirus , Infecções por Papillomavirus , Displasia do Colo do Útero , Neoplasias do Colo do Útero , Feminino , Humanos , Teste de Papanicolaou , Papillomaviridae/genética , Infecções por Papillomavirus/diagnóstico , Estudos Prospectivos , Neoplasias do Colo do Útero/diagnóstico , Esfregaço Vaginal
9.
J Am Soc Cytopathol ; 9(4): 291-303, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32565297

RESUMO

The 2019 ASCCP Risk Based Management Consensus Guidelines for prevention of cervical cancer promote clinical management recommendations aligned with our increased understanding of HPV biology and cervical carcinogenesis. They employ HPV-based testing as the basis for risk estimation, allow for personalized risk-based management by incorporating knowledge of current results with prior results, and streamline incorporation of new test methods as they are validated. They continue to support the principles of "equal management for equal risk" and "balancing harms and benefits" adopted in the 2012 version of the guidelines. These updated guidelines will be able to adjust for decreasing CIN3+ risks as more patients who received HPV vaccination reach screening age. Pathology organizations were closely involved in the development of these guidelines. Herein the pathologists who served as representatives to the 2019 ASCCP guidelines steering committee and workgroups, summarize the changes that are relevant to laboratories, pathologists, and cytotechnologists. Prior relevant screening and reporting recommendations that have not been widely and/or inconsistently adopted by laboratories are also discussed and considerations for modification of laboratory practices offered.


Assuntos
Consenso , Detecção Precoce de Câncer/métodos , Programas de Rastreamento/métodos , Papillomaviridae/genética , Infecções por Papillomavirus/diagnóstico , Lesões Intraepiteliais Escamosas/diagnóstico , Displasia do Colo do Útero/prevenção & controle , Neoplasias do Colo do Útero/prevenção & controle , Adulto , Idoso , Algoritmos , Colposcopia/métodos , Feminino , Genótipo , Humanos , Laboratórios Hospitalares , Pessoa de Meia-Idade , Infecções por Papillomavirus/patologia , Infecções por Papillomavirus/virologia , Patologistas , Risco , Lesões Intraepiteliais Escamosas/patologia , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/patologia , Adulto Jovem , Displasia do Colo do Útero/diagnóstico , Displasia do Colo do Útero/patologia
10.
J Am Soc Cytopathol ; 7(1): 50-55, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-31043251

RESUMO

In September 2017, the United States Preventive Services Task Force put forth updated draft guidelines for cervical cancer screening in the United States, which were then open to public comment. The recommendations allowed for every-3-year cervical cytology screening in women aged 21 to 65 years with an option for every-5-year high-risk human papillomavirus testing in women aged 30 to 65 years. There was no option for cotesting. Other recommendations were similar to those published by other professional organizations. The Cytopathology Education and Technology Consortium provided an official response during the open comment period, which is summarized here along with additional commentary by the authors.

11.
Arch Pathol Lab Med ; 142(7): 833-837, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29624076

RESUMO

CONTEXT: - Cerebrospinal fluid cytology is a critical diagnostic tool for the diagnosis of many conditions affecting the central nervous system. OBJECTIVE: - To assess the performance characteristics of cerebrospinal fluid cytology samples by evaluating participant interpretations within the College of American Pathologists Nongynecologic Cytopathology Education program. DESIGN: - Participant interpretations (N = 46 264) evaluated in the College of American Pathologists Nongynecologic Cytopathology Education Program were examined for concordance with the general category and with the reference diagnosis. Two nonlinear mixed models were used to analyze the concordance rates. RESULTS: - The overall concordance rates for the general category and reference diagnosis were 92.1% and 81.0%, respectively. In the malignant category, the concordance rates with the reference diagnosis were lowest for diagnoses of nonhematopoietic small blue round cell tumors (54.8%) and metastatic malignancy (77.5%); the concordance rate with the reference diagnosis was highest for leukemia/lymphoma (94.0%). In the benign category, the concordance rate was lowest for normal cerebrospinal fluid reference diagnoses (58.6%), followed by acute and chronic inflammation (64.6%), fungal infection (80.8%), and macrophages (85.3%). Significant differences in concordance were uncovered when performance was evaluated by participant type and stain technique. Leukemia/lymphoma was the most common diagnosis for misclassified nonhematopoietic small blue round cell tumor cases and negative or inflammatory cerebrospinal fluid cases. CONCLUSIONS: - This study illustrates the difficulties in achieving accurate diagnoses from cerebrospinal fluid specimens, particularly for nonhematopoietic small blue round cell tumors and normal and inflammatory cerebrospinal fluid specimens.


Assuntos
Neoplasias/líquido cefalorraquidiano , Patologia Clínica/educação , Citodiagnóstico , Diagnóstico Diferencial , Humanos , Neoplasias/diagnóstico , Neoplasias/patologia , Estudos Retrospectivos , Coloração e Rotulagem/métodos , Estados Unidos
12.
Arch Pathol Lab Med ; 141(5): 666-670, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28301226

RESUMO

CONTEXT: - Adenocarcinoma in situ (AIS) is difficult to correctly interpret on Papanicolaou (Pap) cytology slides and false-negative interpretations of AIS can cause significant problems in daily practice. OBJECTIVE: - To investigate the false-negative interpretation rate of AIS and the factors related to false-negative interpretation through responses in an educational environment. DESIGN: - We retrospectively evaluated 11 337 responses in the PAP Education Program (PAP-Edu) from 173 AIS slides from 2011 to 2015. The false-negative interpretation rate, most common false-negative interpretations, and related other factors were evaluated. RESULTS: - The overall false-negative rate was 6.9% (784 of 11 337). Respondents correctly interpreted AIS 50.0% (5667 of 11 337) of the time; high-grade intraepithelial lesion (HSIL) and malignancies (adenocarcinoma, squamous cell carcinoma, and other carcinomas) accounted for 42.7% (4842 of 11 337) and low-grade intraepithelial lesion accounted for 0.4% (44 of 11 337) of responses. Overall, 92.7% (10 509 of 11 337) of responses were HSIL and above. Among 784 false-negative responses, negative for intraepithelial lesion or malignancy was the most common (61.5% [482 of 784]), followed by reparative changes (24.1% [189 of 784]) and atrophic vaginitis (7.7% [60 of 784]). Overall, pathologists' responses showed a significantly higher false-negative rate than cytotechnologists' responses (8.3%, 403 of 4835 versus 5.7%, 275 of 4816; P < .001). The false-negative response rates were not statistically different among preparation types. CONCLUSIONS: - The low correct interpretation rate and higher false-negative rate for AIS demonstrate the difficulty in interpreting AIS on Pap cytology, which may cause clinical consequences. The higher false-negative rate with pathologists than with cytotechnologists suggests cytotechnologists' higher screening sensitivity for AIS or cautious interpretation to avoid false-positive results by pathologists.


Assuntos
Adenocarcinoma in Situ/patologia , Vaginite Atrófica/patologia , Carcinoma de Células Escamosas/patologia , Patologia Clínica/educação , Patologia Molecular/educação , Adenocarcinoma in Situ/diagnóstico , American Medical Association , Vaginite Atrófica/diagnóstico , Carcinoma de Células Escamosas/diagnóstico , Erros de Diagnóstico , Reações Falso-Negativas , Feminino , Humanos , Teste de Papanicolaou , Estudos Retrospectivos , Estados Unidos
13.
Int J Oncol ; 29(6): 1437-43, 2006 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-17088982

RESUMO

Progressive accumulation of DNA lesions leads to genetic mutations that are central to the process of tumorigenesis. Human cervix provides an ideal system to determine progressive accumulation of DNA adducts in the target tissue because of its accessibility during routine diagnostic checkups. Uterine cervix samples from various pathologies, i.e. normal (n=13), inflammation (n=9), dysplasia (n=5) and different stages of invasive cancer (n=47), were analyzed for DNA adduct burden by modified 32P-postlabeling/TLC systems. Six subgroups of adducts were detected in the following descending order of polarities: P-1, P-2, PL-1, PL-2, L-1 and L-2 (P, polar; L, lipophilic; PL, between polar and lipophilic). No qualitative differences were observed in adduct profiles in the various cervix pathologies analyzed. However, significant quantitative differences were found. Previously known lipophilic adducts increased significantly from normal to cancer (144+/-61 to 503+/-51 adducts/10(9) nucleotides). Interestingly, the newly discovered polar adducts were present at 61- to 527-fold higher levels than lipophilic adducts. Of all the polar adducts, the known mutagenic lesion, 8-oxodeoxyguanosine, predominated in all cervix conditions. Notably, this lesion was elevated 27-fold in inflammation compared with normal cervix (51,058+/-9,863 versus 1,886+/-507 adducts/10(9) nucleotides). The P-1, PL-1, PL-2 and L-1 adducts were elevated 3- to 13-fold in inflammation compared with normal cervix, and were also higher in dysplasia and cancer. Our data suggest that inflammation may be involved in directing the course of disease progression by accumulating higher levels of DNA lesions. The data further suggest the biomarker potential of the newly detected array of DNA adducts.


Assuntos
Adutos de DNA/metabolismo , Displasia do Colo do Útero/metabolismo , Neoplasias do Colo do Útero/metabolismo , Cromatografia em Camada Fina/métodos , Adutos de DNA/análise , Adutos de DNA/genética , DNA de Neoplasias/metabolismo , Progressão da Doença , Feminino , Humanos , Espécies Reativas de Oxigênio/metabolismo , Neoplasias do Colo do Útero/genética , Neoplasias do Colo do Útero/patologia , Displasia do Colo do Útero/genética , Displasia do Colo do Útero/patologia
14.
Obstet Gynecol ; 107(1): 71-6, 2006 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-16394042

RESUMO

OBJECTIVE: Cytologic screening is commonly used in follow-up of women with uterine cancer to detect vaginal recurrence. The study objective was to assess the efficacy and costs associated with Pap tests in routine surveillance of women with uterine cancer. METHODS: Medical records and pathology databases identified patients with uterine cancer at one institution from 1990 to 2002. Patients with their cytologic follow-up at our institution were selected for a subset analysis of Pap tests to estimate the number of Paps and associated charges and costs during follow-up. RESULTS: Seven hundred seventeen women were diagnosed with uterine cancer; the mean age was 60.9 years and the median follow-up was 46 months. A total of 36 women had a recurrence in the vagina; 31 (86%) were apparent clinically, and only 5 (14%) were asymptomatic and identified by Pap test. Women with grade 1 tumors had decreased risk of vaginal recurrence, with an odds ratio of 0.186 (95% confidence interval 0.49-0.712) on multivariate analysis (stage and histology were not significant factors for vaginal recurrence). A subset of 435 patients received cytologic follow-up at our institution, with a median 3 Pap tests/patient (mean 4.25, range 1-24). Estimates based on our data demonstrate that 430 Pap tests are required to detect one asymptomatic vaginal recurrence, and the addition of the Pap test increases the cost of surveillance by $15,142 per asymptomatic recurrence detected (but a charge to insurance of $23,487). Pap tests identified an asymptomatic vaginal recurrence in only 0.7% of this uterine cancer population. CONCLUSION: Pap tests after diagnosis and treatment of uterine cancer infrequently detect asymptomatic vaginal recurrences and may not be cost-effective. LEVEL OF EVIDENCE: III.


Assuntos
Citodiagnóstico/métodos , Recidiva Local de Neoplasia/patologia , Neoplasias Uterinas/patologia , Neoplasias Vaginais/epidemiologia , Neoplasias Vaginais/secundário , Esfregaço Vaginal , Adulto , Distribuição por Idade , Idoso , Biópsia por Agulha , Feminino , Seguimentos , Humanos , Histerectomia/métodos , Imuno-Histoquímica , Incidência , Modelos Logísticos , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Monitorização Fisiológica/métodos , Análise Multivariada , Recidiva Local de Neoplasia/epidemiologia , Estadiamento de Neoplasias , Probabilidade , Estudos Retrospectivos , Medição de Risco , Sensibilidade e Especificidade , Taxa de Sobrevida , Neoplasias Uterinas/cirurgia , Neoplasias Vaginais/patologia
15.
Cytojournal ; 3: 11, 2006 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-16620384

RESUMO

The member organizations of the Cytology Education and Technology Consortium believe there are significant flaws in current cytology proficiency testing regulations. The most immediate needed modifications include lengthening the required testing interval, utilizing stringently validated and continuously monitored slides, changing the grading scheme, and changing the focus of the test from the individual to laboratory level testing. Integration of new computer-assisted and located-guided screening technologies into the testing protocols is necessary for the testing protocol to be compliant with the law.

16.
Arch Pathol Lab Med ; 140(12): 1371-1374, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27557412

RESUMO

CONTEXT: - Since 2008, the College of American Pathologists has provided the human papillomavirus for cytology laboratories (CHPV) proficiency testing program to help laboratories meet the requirements of the Clinical Laboratory Improvement Amendments of 1988. OBJECTIVES: - To provide an update on trends in proficiency testing performance in the College of American Pathologists CHPV program during the 4-year period from 2011 through 2014 and to compare those trends with the preceding first 3 years of the program. DESIGN: - Responses of laboratories participating in the CHPV program from 2011 through 2014 were analyzed using a nonlinear mixed model to compare different combinations of testing medium and platform. RESULTS: - In total, 818 laboratories participated in the CHPV program at least once during the 4 years, with participation increasing during the study period. Concordance of participant responses with the target result was more than 98% (38 280 of 38 892). Overall performance with all 3 testing media-ThinPrep (Hologic, Bedford, Massachusetts), SurePath (Becton, Dickinson and Company, Franklin Lakes, New Jersey), or Digene (Qiagen, Valencia, California)-was equivalent (P = .51), and all 4 US Food and Drug Administration (FDA)-approved platforms-Hybrid Capture 2 (Qiagen), Cervista (Hologic), Aptima (Hologic), and cobas (Roche Molecular Systems, Pleasanton, California)-outperformed laboratory-developed tests, unspecified commercial kits, and other (noncommercial) methods in ThinPrep medium (P < .001). However, certain off-label combinations of platform and medium, most notably Cervista with SurePath, demonstrated suboptimal performance (P < .001). CONCLUSIONS: - Laboratories demonstrated proficiency in using various combinations of testing media and platforms offered in the CHPV program, with statistically significant performance differences in certain combinations. These observations may be relevant in the current discussions about FDA oversight of laboratory-developed tests.


Assuntos
Testes de DNA para Papilomavírus Humano , Papillomaviridae/isolamento & purificação , Infecções por Papillomavirus/diagnóstico , Displasia do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/diagnóstico , Adulto , DNA Viral/isolamento & purificação , DNA Viral/metabolismo , Atenção à Saúde , Feminino , Pesquisas sobre Atenção à Saúde , Testes de DNA para Papilomavírus Humano/normas , Humanos , Ensaio de Proficiência Laboratorial , Pessoa de Meia-Idade , Teste de Papanicolaou , Papillomaviridae/classificação , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/virologia , Patologia Clínica/métodos , Patologia Clínica/tendências , Melhoria de Qualidade , RNA Mensageiro/metabolismo , RNA Viral/metabolismo , Kit de Reagentes para Diagnóstico , Risco , Estados Unidos/epidemiologia , Neoplasias do Colo do Útero/epidemiologia , Neoplasias do Colo do Útero/metabolismo , Neoplasias do Colo do Útero/virologia , Esfregaço Vaginal , Recursos Humanos , Displasia do Colo do Útero/epidemiologia , Displasia do Colo do Útero/metabolismo , Displasia do Colo do Útero/virologia
17.
Arch Pathol Lab Med ; 140(12): 1364-1370, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27479334

RESUMO

CONTEXT: - College of American Pathologists (CAP) surveys are used to establish national benchmarks for laboratories. OBJECTIVE: - To investigate human papillomavirus (HPV) genotyping testing practice patterns in laboratories in 2014. DESIGN: - Data were analyzed from the CAP HPV Genotyping Practices Supplemental Questionnaire distributed to 749 laboratories participating in the CAP Human Papillomavirus (High Risk) for Cytology Program. RESULTS: - Six hundred four of 749 laboratories (80.6%) responded to the survey. More laboratories offered HPV genotyping testing and performed in-house HPV genotyping testing as compared to previous surveys. The Roche cobas HPV test was the most commonly used genotyping method (37.0%; 160 of 433), followed by Hologic Aptima HPV16 18/45 (26.1%; 113 of 433) and Hologic Cervista HPV16/18 (14.3%; 62 of 433). Most laboratories (287 of 399; 71.9%) offered HPV genotyping for high-risk HPV cases regardless of Papanicolaou (Pap) test results and patient age; this pattern was more common in laboratories using cobas. The remaining laboratories specifically offered testing to women with a negative Pap test result at age 30 years and older (65.2%, 73 of 112) or all ages (37.5%, 42 of 112). The median reporting rates of HPV16 and/or HPV18 positivity were 20.6%, 25.7%, 21.1%, and 57.4% for women with positive high-risk HPV adjunctive negative Pap results, atypical squamous cells of undermined significance, low-grade squamous intraepithelial lesion, and high-grade squamous lesion, respectively. CONCLUSIONS: - Human papillomavirus genotyping testing has increased. Roche cobas and Hologic Aptima genotype methods were the most common, and laboratories using cobas usually offered genotyping regardless of Pap test result and age. The data provide a baseline and trend of HPV genotyping test practices in 2014.


Assuntos
Testes de DNA para Papilomavírus Humano , Papillomaviridae/isolamento & purificação , Infecções por Papillomavirus/diagnóstico , Displasia do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/diagnóstico , Adulto , Atenção à Saúde , Feminino , Pesquisas sobre Atenção à Saúde , Testes de DNA para Papilomavírus Humano/normas , Testes de DNA para Papilomavírus Humano/tendências , Papillomavirus Humano 16/classificação , Papillomavirus Humano 16/isolamento & purificação , Papillomavirus Humano 16/metabolismo , Papillomavirus Humano 18/classificação , Papillomavirus Humano 18/isolamento & purificação , Papillomavirus Humano 18/metabolismo , Humanos , Pessoa de Meia-Idade , Teste de Papanicolaou , Papillomaviridae/classificação , Papillomaviridae/metabolismo , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/metabolismo , Infecções por Papillomavirus/virologia , Patologia Clínica/métodos , Patologia Clínica/tendências , Prevalência , RNA Mensageiro/metabolismo , RNA Viral/metabolismo , Risco , Sociedades Científicas , Estados Unidos/epidemiologia , Neoplasias do Colo do Útero/epidemiologia , Neoplasias do Colo do Útero/metabolismo , Neoplasias do Colo do Útero/virologia , Esfregaço Vaginal , Recursos Humanos , Displasia do Colo do Útero/epidemiologia , Displasia do Colo do Útero/metabolismo , Displasia do Colo do Útero/virologia
18.
Arch Pathol Lab Med ; 140(11): 1221-1224, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27552094

RESUMO

Context .- Misinterpretation of high-grade squamous intraepithelial lesion (HSIL) is an important problem in daily practice and in the College of American Pathologists (CAP) PAP Proficiency Test (PAP-PT). Objective .- To investigate factors related to misinterpretation of HSIL through responses in a proficiency test versus an educational environment. Design .- We retrospectively evaluated 28 000 responses in the PAP Education Program (PAP-Edu) and 59 140 responses in PAP-PT from 1147 field-validated HSIL slides from 2007 to 2014. The related factors, such as program types, preparation types, participant types, and program years, were evaluated. Results .- Overall, 4.0% (2379 of 59 140) of responses for HSIL slides from PAP-PT were misinterpreted as either low-grade squamous intraepithelial lesion (LSIL) or negative, significantly more than those from PAP-Edu (3.2%; 898 of 28 000). However, the false-negative rate (misinterpreted as negative) was 0.9% (519 of 59 140) for PAP-PT, lower than that for PAP-Edu (1.0%; 266 of 28 000). The misinterpretation rates in PAP-PT trended down with time. Misinterpretation rates did not vary significantly by preparation methods. The misinterpretation rate for HSIL in the pathologists' responses was lower than that in cytotechnologists' in PAP-PT. More HSIL was misinterpreted as LSIL than as benign in both programs. Cytotechnologists interpreted HSIL as LSIL twice as much as pathologists. The most common false-negative misinterpretations were negative for intraepithelial lesion or malignancy and reparative change. Conclusions .- The higher LSIL misinterpretation rate by cytotechnologists may be related to the differences in reporting responsibilities and proficiency test grading criteria. The trend of gradually decreasing misinterpretation rates of a reference diagnosis of HSIL in the PAP-PT program may be related to higher test-taking confidence and better preparation through educational programs. The fact that pathologists performed better than cytotechnologists in PAP-PT, but not in PAP-Edu, may reflect a heightened approach and attentiveness in the test-taking environment for pathologists.

19.
Obstet Gynecol ; 125(2): 330-337, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25569009

RESUMO

In 2011, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated screening guidelines for the early detection of cervical cancer and its precursors. Recommended screening strategies were cytology or cotesting (cytology in combination with high-risk human papillomavirus [hrHPV] testing). These guidelines also addressed the use of hrHPV testing alone as a primary screening approach, which was not recommended for use at that time. There is now a growing body of evidence for screening with primary hrHPV testing, including a prospective U.S.-based registration study. Thirteen experts, including representatives from the Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology, convened to provide interim guidance for primary hrHPV screening. This guidance panel was specifically triggered by an application to the U.S. Food and Drug Administration (FDA) for a currently marketed HPV test to be labeled for the additional indication of primary cervical cancer screening. Guidance was based on literature review and review of data from the FDA registration study, supplemented by expert opinion. This document aims to provide information for health care providers who are interested in primary hrHPV testing and an overview of the potential advantages and disadvantages of this strategy for screening as well as to highlight areas in need of further investigation.


Assuntos
Programas de Rastreamento/normas , Infecções por Papillomavirus/diagnóstico , Displasia do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/diagnóstico , Feminino , Papillomavirus Humano 16/isolamento & purificação , Papillomavirus Humano 18/isolamento & purificação , Humanos
20.
Am J Clin Pathol ; 118(5): 714-8, 2002 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-12428791

RESUMO

Our objective was to provide management guidelines according to Papanicolaou (Pap) test specimen adequacy based on literature review and expert opinion. A task force named by the American Society for Colposcopy and Cervical Pathology (ASCCP) conducted a literature review and discussed appropriate management. The Steering Committee of the ASCCP and other experts reviewed the guidelines. The guidelines recommend a repeated Pap test in 12 months for most women undergoing routine annual/biennial screening if the current Pap test is negative but either lacks an endocervical/ transformation zone component or is partially obscured. Indications for considering an earlier repeat are also provided. The preferred managementfor unsatisfactory Pap tests is a repeated Pap test within a short interval of 2 to 4 months. The management guidelines will help promote optimal and uniform follow-up of women according to Pap test specimen adequacy.


Assuntos
Programas de Rastreamento/normas , Teste de Papanicolaou , Indicadores de Qualidade em Assistência à Saúde/normas , Manejo de Espécimes/normas , Neoplasias do Colo do Útero/prevenção & controle , Esfregaço Vaginal/normas , Feminino , Humanos , Programas de Rastreamento/métodos
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