False-Negative Rate of Papanicolaou Testing: A National Survey from the Thai Society of Cytology

2017 ◽  
Vol 61 (6) ◽  
pp. 434-440 ◽  
Author(s):  
Supinda Koonmee ◽  
Andrey Bychkov ◽  
Somruetai Shuangshoti ◽  
Kanyaprin Bhummichitra ◽  
Wanwisa Himakhun ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
National Level ◽  
False Negative ◽  
False Negative Rate ◽  
Internal Quality ◽  
Negative Rate ◽  
Quality Control Study ◽  
Internal Quality Assurance

Objective: To evaluate the performance of Papanicolaou smear screening in Thailand at the national level, and to propose recommendations for continuing quality control. Study Design: This study was conducted by The Thai Society of Cytology and involved 124 laboratories in 76 provinces during 2010-2014. Random sampling suggested recalling of 10% of slides defined as negative at routine screenings (10% random rescreening [R10] model) directly from the reading unit. Results: Out of 330,075 smears covered by the rescreening project throughout its 5-year duration, the rates of abnormal, unsatisfactory, and normal results were 0.63, 1.82, and 97.55%, respectively. Abnormal findings were largely represented by ASC-US (54%) and L-SIL (21%). The average false-negative rate (FNR) measured at the level of L-SIL and higher was 13.8%. Conclusion: The national project was developed to address the accuracy of cervical cancer screening and to promote internal quality assurance based on the R10, on-site surveys, and education. The major output parameters of this study (FNR and number and distribution of abnormal cases on rescreening) improved significantly in the main phase of the project (2012-2014), after revising substantial logistics issues encountered during the first 2 years of this study. This project provided objective measurable evidence related to the quality of cytology-based cervical cancer screening in Thailand.

scholarly journals Cervical acid phosphatase: A new biomarker of cervical dysplasia

2003 ◽  
Vol 11 (4) ◽  
pp. 243-247 ◽  
Author(s):  
Olivera Markovic ◽  
Nenad Markovic
Keyword(s):  
Cervical Cancer ◽  
Acid Phosphatase ◽  
Cancer Screening ◽  
Adverse Events ◽  
Cervical Cancer Screening ◽  
False Negative ◽  
False Negative Rate ◽  
Pap Test ◽  
Negative Rate ◽  
Primary Endpoints

BACKGROUND: Cervical acid phosphatase (CAP) has recently been described as a biomarker labeling abnormal squamous cells on Pap smears (USPTO #6,143,512). The enzyme activity is presented as a red, granular deposit on a modified Papanicolaou background. This unique property was utilized for development of a test and tools intended for cervical cancer screening. METHODS: We conducted a multicenter, random assignment, assessor blinded, 2-group (test and control), and split-sample design clinical trial on 1,500 subject/specimens to assess safety and efficacy of the new test in comparison with the control for cervical cancer screening in standard Pap test environment. Safety was measured with frequency, severity and relation of adverse events. Efficacy was measured with primary endpoints (portion of positive/abnormal specimens detected, and the false negative rate), and with accuracy (sensitivity/specificity) and predictive values as secondary efficacy endpoints. RESULTS: In March 2003, the recruitment was completed and the first thousand cases were evaluated. There were no serious or related adverse events in both groups. Minor, unrelated adverse events were rare and insignificantly distributed in both groups. Primary endpoints: A Portion of positive/abnormal specimens detected: Pe (new test) = 0.17, Ps (pap test): 0.082; Ps' (American standard): 0.07. Pe >=Ps + beta, for beta = 0.5Ps. B. False negative rate: Pe = 0.05, Ps' = 0.10. Test sensitivity 0.81, specificity: 0.97, PPV: 0.83, NPV: 0.96. Chi-square between test and controls 40.69101 was greater than the critical value of 3.841 (p<0.05). CONCLUSION: We concluded that CAP had added to visibility of Pap test and has enabled cytoscreeners to significantly improve detection of positive/abnormal specimens and reduce false negative rate.

Cervical intra-epithelial neoplasia and koilocytotic lesions of the lower genitalia in an Icelandic population

1991 ◽  
Vol 1 (2) ◽  
pp. 49-57 ◽  
Author(s):  
K. Sigurdsson ◽  
K. Benediktsdottir ◽  
M. Snorradottir ◽  
H. Saemundsson ◽  
J. H. Olafssonh ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
False Negative ◽  
False Negative Rate ◽  
Clinical Expression ◽  
Normal Cytology ◽  
Histologic Diagnosis ◽  
Negative Rate ◽  
Icelandic Population

This study is based on women who participated in cervical cancer screening and on 390 women referred from the screened group for colposcopy. The study analyzed the frequency of atypia, CIN and koilocytosis and evaluated the efficiency of cytologic vs. histologic diagnosis. The clinical expression of the koilocytotic lesions and the rate of infected partners were evaluated. In the screened population the prevalence of smears with atypia and CIN was 3.2% and that of koilocytosis 0.5%. In the colposcopic group the frequency of koilocytosis in the histologic sections was 98% compared to 18% of the smears. The koilocytotic lesions were mostly multicentric, subclinical and asymptomatic and often associated with normal cytology. The rate of infected partners of women with normal smears and non-symptomatic vulvar lesions was low (15%), increased if smears were abnormal (30%), and was highest when the partner had gross condylomata (89%). As to atypia and CIN, the rate of undegraded smears was 18%, false-negative smears 8%, undergraded colposcopic biopsies 33%, false-negative colposcopic biopsies 3%, and the false-negative rate of combined cytology and colposcopy was less that 1%. Colposcopy is recommended for unclassified CIN and CIN 2–3 repeat smear for atypia and CIN 1 and combined cytology and colposcopy for condylomata.

scholarly journals Cervical Acid Phosphatase: A Biomarker of Cervical Dysplasia and a Potential Surrogate Endpoint for Colposcopy

2004 ◽  
Vol 19 (6) ◽  
pp. 279-286 ◽  
Author(s):  
Olivera Markovic ◽  
Nenad Markovic
Keyword(s):  
Cervical Cancer ◽  
Acid Phosphatase ◽  
Cancer Screening ◽  
False Negative ◽  
False Negative Rate ◽  
Pap Test ◽  
Surrogate Endpoint ◽  
Unique Property ◽  
Negative Rate ◽  
Primary Endpoints

Background:In 2000, cervical acid phosphatase (CAP) has been recently described as a biomarker labeling abnormal squamous cells on Pap smears (USPTO #6,143,512). The enzyme activity is presented as a red, granular deposit on a modified Papanicolaou background. This unique property was utilized for development of MarkPap® technology intended for cervical cancer screening.Material/patients & methods:We conduct a multicenter, random assignment, assessor blinded, 2-group (test and control), split-sample designed clinical trial on 1,500 subject/specimens to assess safety and efficacy of the new test, in comparison with the control, for cervical cancer screening in standard Pap test environment. Safety is measured with frequency, severity and relation of adverse events. Efficacy is measured with primary endpoints (portion of positive/abnormal specimens detected, and the false negative rate). At the end of the follow-up period (two years) when the study will be completed, other efficacy endpoints such as accuracy (sensitivity/specificity) and predictive values will be added to the method evaluation. Here we present in interim analysis.Results:In April 2003, the recruitment was completed and the first twelve hundred cases have been evaluated. There was no serious or related adverse event in both groups. Minor, unrelated adverse events were rare and insignificantly distributed in both groups.Primary endpoints:A: Portion of positive/abnormal specimens detected: Pe (new test) = 0.166, Ps (Pap control): 0.082; Ps’ (ACS reported value for US in year 2000): 0.07. Pe ≥ Ps +δ, forδ; = 0.5Ps. B. False negative rate: Pe = 0.05, Ps’ = 0.10. Confidence intervals: 95% CI: Test [0.148–0.193], Pap control [0.068–0.098]. OR = 2.26.χ2= 40.69101 is greater than the critical value of 3.841 (P< 0.01).Conclusion:We concluded that CAP had added to visibility of Pap test and has enabled cytoscreeners to significantly improve the detection of positive/abnormal specimens and reduce false negative rate. We discuss this unique property of CAP with emphasis on using it as a surrogate endpoint for colposcopy and eventual removal of a cervical lesion that, if untreated, could progress into cancer.

scholarly journals Role of Protein Biomarkers in the Detection of High-Grade Disease in Cervical Cancer Screening Programs

2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Charlotte A. Brown ◽  
Johnannes Bogers ◽  
Shaira Sahebali ◽  
Christophe E. Depuydt ◽  
Frans De Prins ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Cervical Screening ◽  
False Negative ◽  
Pap Test ◽  
Developed Countries ◽  
Protein Biomarkers ◽  
Ki 67 ◽  
Screening Programs

Since the Pap test was introduced in the 1940s, there has been an approximately 70% reduction in the incidence of squamous cell cervical cancers in many developed countries by the application of organized and opportunistic screening programs. The efficacy of the Pap test, however, is hampered by high interobserver variability and high false-negative and false-positive rates. The use of biomarkers has demonstrated the ability to overcome these issues, leading to improved positive predictive value of cervical screening results. In addition, the introduction of HPV primary screening programs will necessitate the use of a follow-up test with high specificity to triage the high number of HPV-positive tests. This paper will focus on protein biomarkers currently available for use in cervical cancer screening, which appear to improve the detection of women at greatest risk for developing cervical cancer, including Ki-67,p16INK4a, BD ProEx C, and Cytoactiv HPV L1.

Bilateral ultrastaging of sentinel lymph node in cervical cancer: Lowering the false-negative rate and improving the detection of micrometastasis

2012 ◽  
Vol 127 (3) ◽  
pp. 462-466 ◽  
Author(s):  
David Cibula ◽  
Nadeem R. Abu-Rustum ◽  
Ladislav Dusek ◽  
Jiri Slama ◽  
Michal Zikán ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
False Negative ◽  
False Negative Rate ◽  
Negative Rate

scholarly journals Conventional pap’s test and liquid-based cytology for the screening of cervical cancer with back up colposcopy directed biopsy

2019 ◽  
Vol 12 (2) ◽  
pp. 105-108
Author(s):  
Sabera Khatun ◽  
Sayada Fatema Khatun
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cancer Patients ◽  
Cervical Cancer Screening ◽  
False Negative ◽  
Precancerous Lesion ◽  
True Negative ◽  
Liquid Based Cytology

The aim of this study was to screen the suspected cervical cancer patients (n=100) by liquid-based cytology and conventional pap’s smear followed by colposcopic biopsy from July 2016 to June 2017. In conventional pap’s test, 73 cases were true negative whereas 25 cases were false negative. However, in liquid-based cytology, 68 cases were true negative and 23 cases were false negative. Finally when colposcopic examinations were done, 61 cases were true negative and 15 cases were false negative. The sensitivity of liquid-based cytology was 11.5% for cervical cancer screening which was more than the conventional pap’s smear (3.8%). In conclusion, liquid-based cytology should be more preferable method than the than conventional pap’s smear for the diagnosis of precancerous lesion of the cervix.

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