Pap smear risk management by process control

Gill, Gary W.

doi:10.1002/(sici)1097-0142(19970825)81:4<198::aid-cncr2>3.0.co;2-m

Cited by 12 publications

(7 citation statements)

References 9 publications

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“…A taxa de falsos negativos pode ser atribuída a três tipos de erro: de amostragem, no rastreamento e na interpretação do esfregaço (12). Mais da metade de todos os resultados falsos negativos é atribuída à amostragem inadequada (5). Um erro de amostragem ocorre quando as células de uma lesão não estão presentes no esfregaço cervicovaginal.…”

Section: Sensibilidade Do Exame Colpocitológico Para Os Diferentes Grunclassified

Validade da citologia cervicovaginal na detecção de lesões pré-neoplásicas e neoplásicas de colo de útero

Pinho

Mattos

2002

J. Bras. Patol. Med. Lab.

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Section: Sensibilidade Do Exame Colpocitológico Para Os Diferentes Grunclassified

Validade da citologia cervicovaginal na detecção de lesões pré-neoplásicas e neoplásicas de colo de útero

Pinho

Mattos

2002

J. Bras. Patol. Med. Lab.

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“…Q uality-management programs in cytopathology practice long have been preoccupied with false-negative (FN) Papanicolaou (Pap) tests because of their potential health risk to patients and their litigation risk to the laboratory. [1][2][3] Practice guidelines and federal regulations mandate procedures to identify FN results and to estimate their rates and their probable causes. Utilization of reflex human papillomavirus (HPV)-DNA testing introduces new types of errors, including FN/ false-positive (FP) results for which, to date, there are no clear guidelines on reporting and no understanding of their significance or possible causes.…”

mentioning

confidence: 99%

Significance and possible causes of false-negative results of reflex human papillomavirus infection testing

Eltoum

Chhieng

Crowe

et al. 2007

Cancer

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BACKGROUND. The objective of this study was to assess the rate and possible reasons for false‐negative (FN) reflex human papillomavirus (HPV)‐DNA tests. METHODS. The authors reviewed all ThinPrep cervical specimens that were submitted for reflex HPV‐DNA testing using the Digene Hybrid Capture II (HC2) method from January 2002 to January 2004. Follow‐up biopsies were reviewed. The results were considered HPV‐FN if the HPV‐DNA test was negative and the biopsy was positive for grade ≥2 cervical intraepithelial neoplasia (CIN2+), and the results were considered true positive (HPV‐TP) if the HPV‐DNA test was positive and the biopsy showed CIN2+. HPV‐FN cases were compared with HPV‐TP cases regarding the grade and extent of CIN, the number of abnormal cells on the original ThinPrep slide, and the presence of amplifiable, viral DNA on biopsy. RESULTS. In total, 1520 (66%) of 2309 patients who had diagnoses of atypical squamous cells of undetermined significance (ASCUS) were negative for HPV DNA and 789 patients of 2309 patients (34%) were positive for HPV DNA. Three hundred sixteen women (40%) who had a positive HPV‐DNA test underwent a biopsy. Of those, 36 biopsies (11%) showed CIN2+ (HPV‐TP), and 154 biopsies (66%) showed CIN1. Cervical tissue was available for review from 82 women who had negative HPV‐DNA tests; of these, 6 tissue samples (7%) showed CIN2+ (HPV‐FN), and 13 tissue samples (16%) showed CIN1. Therefore, in the total ASCUS population that was triaged with reflex HPV testing, there were at least 42 women who were diagnosed with CIN2+, for an estimated CIN2+ FN fraction of 14% (6 of 42 women). HPV‐FN lesions were smaller (but the difference was not statistically significant) and shed significantly fewer abnormal cells than HPV‐TP cases. Polymerase chain reaction testing for viral DNA in the biopsy was detected in 3 of 6 women who had HPV‐FN results; none of those positive results demonstrated a viral type that was not included in the Digene probes. CONCLUSIONS. Although the rate of FN high‐grade lesions was significantly higher than that reported in the ASCUS/Low‐grade Squamous Intraepithelial Lesion Triage trial, most missed lesions were small and shed few abnormal cells. It was assumed that those lesions were either in early stages or in regressing stages, which made their clinical significance uncertain. Cancer (Cancer Cytopathol) 2007. © 2007 American Cancer Society.

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“…Areas of interest must be examined at higher magnification. Whatever system or screening technique is used, individual screeners must overlap fields by at least 30% . Potentially abnormal cells identified should be marked for checking according to agreed laboratory protocol.…”

Section: Screening and Reporting Of Cervical Cytologymentioning

confidence: 99%

BAC recommended code of practice for cytology laboratories participating in the UK cervical screening programmes 2015: a secondary publication

et al. 2016

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BAC recommended code of practice for cytology laboratories participating in the UK cervical screening programmes 2015: a secondary publication 1 Produced by the British Association for Cytopathology October 2015.Keywords: British Association for Cytopathology, code of practice, cervical cytology, cervical screening ForewordThe NHS cervical screening programmes (CSPs) (Appendix 1A) have been successful in reducing both the incidence of and mortality from cervical cancer in women in the UK. While the laboratory is only one element of the screening programme, it has a pivotal role, and the previous BSCC code of practice for cytology laboratories (CoP) 1 has been instrumental in providing certain common principles and standards for laboratories to work within, irrespective of their geographical location. Over time, the screening programmes in the constituent parts of the UK have developed different approaches to screening women and these differences are illustrated elsewhere in this document. The previous BSCC CoP was last updated 5 years ago and, while much of the guidance remains relevant, there have been such significant changes both to the technology and the terminology used within the UK that the British Association for Cytopathology (BAC) felt that a further update was required if the code was to remain relevant. It is intended that the code will be more concise and easier to update in the light of expected changes to the various NHS cervical screening programmes (NHS CSPs) in the future. It is anticipated that an annual review, with appropriate revisions, will take place rather than completely rewriting the document on a periodic basis.As before, the recommendations in the guidance will be evidence based if possible. Where current hard scientific evidence is lacking, the recommendations remain based on professional consensus.

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Pap smear risk management by process control

Cited by 12 publications

References 9 publications

Validade da citologia cervicovaginal na detecção de lesões pré-neoplásicas e neoplásicas de colo de útero

Validade da citologia cervicovaginal na detecção de lesões pré-neoplásicas e neoplásicas de colo de útero

Significance and possible causes of false-negative results of reflex human papillomavirus infection testing

BAC recommended code of practice for cytology laboratories participating in the UK cervical screening programmes 2015: a secondary publication

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