[Value of the induced vaginal keratinization test (Papanicolaou test) in differential diagnosis of dysfunctional amenorrheas].
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Amenorrhea↗
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[Value of the induced vaginal keratinization test (Papanicolaou test) in differential diagnosis of functional amenorrhea].
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Amenorrhea↗
Comparison of human papillomavirus DNA testing and repeat Papanicolaou test in women with low-grade cervical cytologic abnormalities: a randomized trial. HPV Effectiveness in Lowgrade Paps (HELP) Study No. 1 Group.
BACKGROUND: Results of cervical cytology screening showing atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) indicate risk for high-grade cervical intraepithelial neoplasia (CIN 2 or 3). In a community-based randomized trial we compared the test performance of human papillomavirus (HPV) DNA testing with that of 6-month repeat Papanicolaou (Pap) test in detecting histologically confirmed CIN 2 or 3. METHODS: We randomly assigned 212 women aged 16-50 years with ASCUS or LSIL on cervical cytology screening to undergo either immediate HPV DNA testing or a repeat Pap test in 6 months. Cervical swabs for the HPV DNA testing and the Pap smears were obtained by their family physicians. We tested the swabs for oncogenic HPV using the Hybrid Capture II assay (Digene Corp., Beltsville, Md.). Community-based pathologists examined the Pap smears. All women were referred for colposcopy by their family physicians. Two gynecological pathologists assessed the histology findings. We calculated test performance in women who completed the trial using CIN 2 or 3 as the reference standard. RESULTS: A total of 159 women completed the study. Compared with HPV DNA testing, which detected 87.5% (7/8) of the cases of CIN 2 or 3, repeat Pap smear showing high-grade intraepithelial neoplasia (HSIL) detected 11.1% (1/9) of cases (p = 0.004), and repeat Pap smear showing ASCUS, LSIL or HSIL detected 55.6% (5/9) (p = 0.16). Corresponding specificities were 50.6%, 95.2% (p = 0.002) and 55.6% (p = 0.61). Loss to follow-up was 17.1% in the HPV test group and 32.7% in the repeat Pap group (p = 0.009). Given the 7 cases of CIN 2 or 3 detected by HPV testing and the 5 cases detected by the repeat Pap smear, the incremental cost of HPV testing was calculated to be $3003 per additional case of CIN identified. INTERPRETATION: HPV DNA testing was more costly but was associated with significantly less loss to follow-up. It may detect more cases of CIN 2 or 3 in women with low-grade cytologic abnormalities.
Adolescent↗
A large-scale investigator-sponsored field study of the test performance of the ThinPrep papanicolaou test in a low-risk routine outpatient setting.
The performance of the ThinPrep Papanicolaou test (TP)(CYTYC Corp., Boxborough, MA) was evaluated in a low- risk outpatient population in order to assess its efficacy in routine clinical use. A total of 18,246 cervical cytology samples were prepared using TP during a 6-month evaluation period from January through June 1997. Results of TP interpretation, assessed for specimen quality and diagnostic information as reported according to the Bethesda system terminology, were reviewed and compared with corresponding results from 2 historical control series of 35,347 and 35,409 conventional cervical smears (Papanicolaou smears). Archived conventional smears obtained during the first 6 months of 1995 and 1996 from the same general patient population by the same group of gynecologists and general practitioners were selected for analysis. Positive cytologic diagnoses in the TP series were reviewed and cytologic-histologic correlations were analyzed when biopsy material was available. The results demonstrated that the proportion of cytologic examinations classified as "satisfactory" was significantly greater in the TP series as compared to conventional controls (88.8% vs 71.1%, P <.0001). There was a significant increase in the number of TP examinations with an adequate endocervical component as compared to conventional controls (90.2% vs 86.9%, P <.005) and a significant decrease in the number of TP examinations that were classified as "satisfactory but limited by" either poor fixation or obscuring factors, such as blood, neutrophils, and contaminants (1.1% TP vs 14.1% nonTP, P <.0001). The overall sensitivity of detection for abnormal cells as indicated by the number of positive diagnoses was increased in the TP series (5.7% vs 2.4%, P <.01). The cytologic diagnoses of ASCUS, LSIL, and HSIL were respectively 1.6, 3.6, and 3 times more frequent in the TP series than in controls. Cytologic-histologic correlations were available for 110 (27%) of the 403 cytologic diagnoses of LSIL and for 90 (83%) of the 121 cytologic diagnoses of HSIL. The presence of a histologic lesion (LSIL or HSIL) was confirmed in 71 (65%) biopsies for LSIL and in 81 (90%) biopsies for HSIL. In conclusion, both sample quality and diagnostic sensitivity were significantly improved using the ThinPrep Papanicolaou test under routine conditions in a low-risk population.
Journal Article↗
Virtual microscopy as a tool for proficiency testing in cytopathology: a model using multiple digital images of Papanicolaou tests.
BACKGROUND: Modern digital cameras can acquire images from cytologic slides at sufficient resolution to allow for digital enlargement and scrolling on a video monitor, allowing for the simulation of microscopy using a computer. OBJECTIVE: The purpose of this study was to develop a tool for proficiency testing in cytopathology using multiple digital images of Papanicolaou tests. METHODS: Nine images were photographed from each of 10 Papanicolaou tests at x100 optical magnification, 3400 x 2300-pixel resolution, using a light microscope and a digital camera. All images from each case were tiled in a single canvas with Photoshop 4.0 software. Two cytopathologists and 3 cytotechnologists interpreted these "virtual slides" using a computer and graded diagnostic codes (PAP program, College of American Pathologists). Subjects were retested a year later using the glass slides from the same cases and routine microscopy. Both test results, by diagnostic code, were compared with the McNemar test of symmetry. RESULTS: The 5 test subjects provided 42 and 50 correct diagnostic codes by "virtual microscopy" and light microscopy, respectively. No significant asymmetry in results obtained by virtual microscopy and light microscopy was encountered with the McNemar test of symmetry. All test answers were correctly classified by selection series, using both virtual microscopy and light microscopy, and the responses would have been graded as 100% by current PAP program scoring guidelines. This suggests that virtual microscopy could be used for proficiency testing purposes. CONCLUSIONS: A simple virtual microscopy method designed to challenge participants to locate and diagnose cells of interest was effective for the administration of standardized proficiency tests. Virtual microscopy methods that rely on single-plane images to locate and diagnose cells of interest could provide effective proficiency testing tools prior to the development of more computationally intensive systems that represent an entire Papanicolaou test at multiple focal planes.
Computer Simulation↗
Is the human papillomavirus test in combination with the Papanicolaou test useful for management of patients with diagnoses of atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesions?
OBJECTIVE: To determine whether human papillomavirus (HPV) testing is useful in the evaluation of patients diagnosed with atypical squamous cells of undetermined significance (ASCUS)/low-grade squamous intraepithelial lesion (LSIL) and whether the HPV test is appropriate as an alternative screening method. DESIGN: The results of Papanicolaou (Pap) tests and subsequent hybrid capture tube (HCT) II tests for high-risk-type HPV were analyzed for 457 patients. Among these tests, 208 histologic diagnoses were made and correlated with the results of Pap and HPV tests. The sensitivity and specificity of the Pap test, HPV test, and the combined method of Pap and HPV tests to detect cervical intraepithelial neoplasia (CIN) 2/3 and all CIN were also measured. RESULTS: Sixty (63.8%) of 94 women with LSIL and 31 (26.3%) of 118 women with ASCUS tested positive for high-risk HPV. The sensitivity values for Pap tests in detecting all cases of CIN and CIN 2/3 were 91.4% and 92.9%, respectively. The sensitivity values of HCT II tests using the high-risk probe for detecting all cases of CIN and CIN 2/3 were 62.6% and 88.1%, respectively. Biopsies confirmed that 10 (22.7%) of 44 LSIL patients with high-risk HPV had CIN 2/3, but only 1 (4.5%) of 22 LSIL patients without high-risk HPV had CIN 2/3. CONCLUSION: Testing for high-risk HPV with the HCT II test is useful in the detection of CIN 2/3 in LSIL groups and in the selection of patients for colposcopy in ASCUS groups, but it is not suitable for cervical cancer screening tests.
Biopsy↗
Using reminder systems to improve Papanicolaou test follow-up. An example of continuous quality improvement.
OBJECTIVE: Using continuous quality improvement principles, we developed a Papanicolaou test recall system with the goal of increasing first and second follow-up Papanicolaou tests after cryotherapy by 20%. DESIGN: An initial study showed rates of 67% for the first follow-up Papanicolaou test and 31% for the second follow-up test. We formed a dysplasia project team. Using continuous quality improvement principles, we instituted a Papanicolaou test recall system. We remeasured first and second follow-up rates for Papanicolaou tests after cryotherapy. The staff and providers were surveyed regarding their acceptance of the system. No attempt was made to control for confounding factors. SETTING: The study was performed at the Family Medicine Clinic in Eau Claire, Wis. This is a community-based, university-administered family practice residency training clinic. PARTICIPANTS: The first 53 consecutive women who had cryotherapy beginning August 1, 1991, were included in the study. All staff and providers were invited to answer a survey questionnaire. INTERVENTION: Patients received a reminder postcard when they were due for a Papanicolaou test. They received a follow-up letter the next month if no Papanicolaou test was done. MAIN OUTCOME MEASURES: First and second follow-up Papanicolaou test rates after cryotherapy. Staff and provider satisfaction as measured by a survey. RESULTS: Eighty-four percent of the women returned for their first follow-up Papanicolaou test, and 53% returned for their second after cryotherapy. Staff and providers supported the recall system. CONCLUSION: Continuous quality improvement principles led to a Papanicolaou test reminder system. Follow-up Papanicolaou test rates appeared to increase by 17% for the first Papanicolaou test and by 22% for the second.
Cryotherapy↗
Cervicography combined with repeat Papanicolaou test as triage for low-grade cytologic abnormalities.
OBJECTIVE: To determine the efficacy of combined repeat Papanicolaou test and cervicography for identification of high-grade squamous lesions among patients who previously have had atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL) diagnosed by the Bethesda System. METHODS: All patients who presented to a charity hospital gynecology clinic between July 1, 1994, and December 31, 1995, with a Papanicolaou test result of ASCUS or LSIL underwent repeat Papanicolaou test, cervicography, colposcopy with colposcopic-directed biopsy when appropriate, and an endocervical curettage. Pregnant patients and those who had undergone hysterectomy were excluded. The mean and median time from abnormal Papanicolaou test to clinical investigation was 61 and 58 days, respectively (range 6-162 days). RESULTS: One hundred eighty-seven of the patients had an initial ASCUS Papanicolaou test. Of these 187, 24 (13%) were found to have cervical intraepithelial neoplasia (CIN) grades II-III. The second Papanicolaou test would have resulted in the detection of 11 of 24 lesions (sensitivity 46%), whereas the cervigram would have detected 22 of 24 (sensitivity 92%). The combined Papanicolaou test and cervigram sensitivity for ASCUS was 91%. One hundred forty-one of the patients had an initial LSIL Papanicolaou test. Of these 141, 37 (26%) patients were found to have CIN II-III. The repeat Papanicolaou test would have detected 29 of 37 lesions (sensitivity 78%), whereas the cervigram would have detected 33 of 37 (sensitivity 89%). The combined Papanicolaou test and cervigram sensitivity for LSIL was 97%. CONCLUSION: Cervicography is a helpful adjunctive technique for detection of CIN II-III lesions in patients with previous ASCUS or LSIL Papanicolaou tests.
Adolescent↗
Evaluating the role of HPV testing for women with equivocal Papanicolaou test findings.
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DNA, Viral↗
Does the system of Papanicolaou test nomenclature affect the rate of referral for colposcopy? A survey of family physicians.
OBJECTIVE: To determine whether a new system of Papanicolaou test nomenclature (the Bethesda system) or other physician variables influence recommendations for colposcopy and biopsy for women with borderline to moderately abnormal Papanicolaou test results. We hypothesized that physician demographic and practice variables, in addition to Papanicolaou test nomenclature, would influence recommendations for colposcopy. DESIGN: A survey was mailed to a random sample of 510 active members of the American Academy of Family Physicians. PARTICIPANTS: Three hundred thirty-five (66%) of the eligible physicians responded, representing all 50 states. Of those in active practice, 78% were in private practice, with a mean age of 44 years and a mean time in practice of 10 years. Ninety-three percent of respondents in active practice performed Papanicolaou tests. MAIN OUTCOME MEASURE: Rates of recommendation for colposcopy and biopsy in response to abnormal Papanicolaou test reports framed by a single clinical scenario. RESULTS: Physicians recommended colposcopy more often when the Bethesda nomenclature system was used to describe the results of the Papanicolaou test. These differences were significant for four specific Papanicolaou smear pairs. Inclusion of recommendations for further evaluation strongly influenced physicians to recommend colposcopy. In multivariable analyses, demographic and practice variables were not associated with recommendations for colposcopy. CONCLUSIONS: The Bethesda system of nomenclature, when compared with a traditional descriptive nomenclature system, influenced family physicians to recommend colposcopy and biopsy more often for abnormal Papanicolaou test results presented in a clinical scenario. Greater utilization of technology and higher medical care costs may result from use of the Bethesda system. Guidelines for evaluation of abnormal Papanicolaou test results are needed for use in conjunction with the Bethesda system guidelines for Papanicolaou test reports.
Adult↗
The effect of hysterectomy on the risk of an abnormal screening Papanicolaou test result.
OBJECTIVE: Our aim was to determine the risk of cytologic abnormality on a screening Papanicolaou test for women >/=50 years old with and without a uterine cervix. STUDY DESIGN: The effect of hysterectomy on abnormal screening Papanicolaou test rates was determined in a cross-sectional analysis of 21,152 women aged >/=50 years who had screening Papanicolaou tests between January and August 1995. We then conducted a nested 1:1 case-control study of 172 case patients and 172 age-matched randomly selected control patients from the cohort. To control for potential confounders, conditional logistic regression was used to assess the effect of hysterectomy status on the risk of an abnormal Papanicolaou test. RESULTS: Compared with age-matched women with a uterine cervix, those who had a hysterectomy had a 10-fold lower risk of a screening Papanicolaou test abnormality (odds ratio 0.09, 95% confidence interval 0.02-0.24). The risk was further reduced among women taking estrogens (odds ratio 0.02, 95% confidence interval 0.004-0.14) compared with women not using estrogens (odds ratio 0.14, 95% confidence interval 0.04-0.56). CONCLUSIONS: The reduced risk of Papanicolaou test abnormalities among women aged >/=50 years who have had a hysterectomy should be considered when individual patients are being counseled, screening guidelines are being formulated, and health care resources are being allocated.
Aged↗
Improving Papanicolaou test quality and reducing medical errors by using Toyota production system methods.
OBJECTIVE: The objective of the study was to determine whether the Toyota production system process improves Papanicolaou test quality and patient safety. STUDY DESIGN: An 8-month nonconcurrent cohort study that included 464 case and 639 control women who had a Papanicolaou test was performed. Office workflow was redesigned using Toyota production system methods by introducing a 1-by-1 continuous flow process. We measured the frequency of Papanicolaou tests without a transformation zone component, follow-up and Bethesda System diagnostic frequency of atypical squamous cells of undetermined significance, and diagnostic error frequency. RESULTS: After the intervention, the percentage of Papanicolaou tests lacking a transformation zone component decreased from 9.9% to 4.7% (P = .001). The percentage of Papanicolaou tests with a diagnosis of atypical squamous cells of undetermined significance decreased from 7.8% to 3.9% (P = .007). The frequency of error per correlating cytologic-histologic specimen pair decreased from 9.52% to 7.84%. CONCLUSIONS: The introduction of the Toyota production system process resulted in improved Papanicolaou test quality.
Case-Control Studies↗
Efforts to improve the follow-up of patients with abnormal Papanicolaou test results.
BACKGROUND: We describe and evaluate efforts to improve the follow-up care of patients with abnormal Papanicolaou test results at an academic family practice center at Shadyside Hospital in Pittsburgh. METHODS: From 1994 to 1996, 1796 patients received Papanicolaou testing; 147 (8 percent) of the smears had abnormal findings--16 percent had atypia, 83 percent had dysplasia, and 1 percent had carcinoma in situ. Patients received follow-up care based on a formalized protocol using educational input, logistic aids, and automated prompting. RESULTS: Overall follow-up success rates and colposcopy completion rates increased dramatically. Whereas 36 percent of patients with abnormal findings on Papanicolaou smears had been overdue for follow-up in 1990, only 13 percent were overdue in 1996 after our interventions. Patients assigned to Papanicolaou testing for follow-up of abnormal findings failed to receive a test in 9 of 45 (20 percent) cases, but those assigned to colposcopy follow-up failed to receive a test in only 10 of 102 (10 percent) of cases. Appointment failure rates at colposcopy clinic dropped from 56 percent in 1993 to 12 percent in 1996. Colposcopic biopsy was far superior to Papanicolaou test for detecting precursors of cervical cancer at follow-up. CONCLUSIONS: Educational programs, formalized approaches to care, transportation assistance, and reminder systems are not only practical but also can dramatically improve the outcome of cervical cancer screening programs.
Adolescent↗
The effect of access and satisfaction on regular mammogram and Papanicolaou test screening in a multiethnic population.
BACKGROUND: Access and satisfaction are determinants of preventive service use, but few studies have evaluated their role in breast and cervical cancer screening in multiethnic populations. OBJECTIVES: We sought to investigate the relationship between race/ethnicity, access, satisfaction, and regular mammogram and Papanicolaou test receipt in 5 racial/ethnic groups. RESEARCH DESIGN: We conducted a telephone survey in 4 languages. SUBJECTS: Our subjects were black, Chinese, Filipino, Latino, or white women aged 40 to 74 residing in Alameda County, California. MEASURES OUTCOME: regular mammograms (last test within 15 months and another within 2 years prior) and Papanicolaou tests (36 months and 3 years, respectively). Independent: race/ethnicity, sociodemographic variables, access (health insurance, usual site of care, regular doctor, check-up within 12 months, knowing where to go, copayment for tests), and satisfaction (overall satisfaction scale, waiting times, test-related pain and embarrassment, test satisfaction). RESULTS: Among women who had ever had a mammogram or Papanicolaou test, 54% and 77%, respectively, received regular screening. In multivariate analyses, regular mammography was positively associated with increased age (odds ratio [OR] 1.05 per year), private insurance (OR 1.7), check-up in the past year (OR 2.3), knowing where to go for mammography (OR 3.0), and greater satisfaction with processes of care (OR 1.04 per unit), and negatively with not knowing copayment amount (OR 0.4), too many forms to fill out (OR 0.5), embarrassment at the last mammogram (OR 0.6), and Filipino race/ethnicity. Similar results were found for regular Papanicolaou tests. CONCLUSIONS: Access and satisfaction are important predictors of screening but do little to explain racial/ethnic variation. Tailored interventions to improve regular mammography and Papanicolaou test screening in multiethnic populations are needed.
Adult↗
Patient knowledge about human papillomavirus and relationship to history of abnormal Papanicolaou test results.
OBJECTIVE: To assess patient knowledge about human papillomavirus (HPV) and determine if self-report of a previous abnormal Papanicolaou test result improves knowledge. MATERIALS AND METHODS: A survey was designed and administered to patients at three obstetrics and gynecology clinics in Milwaukee, WI. The anonymous surveys assessed demographics, history of sexually transmitted infections or abnormal Papanicolaou test results, and knowledge about HPV and cervical cancer. The chi and Wilcoxon tests were used for statistical comparisons. RESULTS: Three hundred sixty-three surveys were collected, representing a diverse patient population. Forty-two percent of patients had heard of HPV. Women who reported a history of abnormal Papanicolaou test results were not more likely to have heard of HPV or to know that it causes cervical cancer than those who did not report abnormal Papanicolaou test results. CONCLUSIONS: There is no significant difference in knowledge about HPV between patients who reported a history of abnormal Papanicolaou tests and those who did not.
Adolescent↗
Factors associated with an increased risk of prevalent and incident grade III cervical intraepithelial neoplasia and invasive cervical cancer among women with Papanicolaou tests classified as grades I or II cervical intraepithelial neoplasia.
OBJECTIVE: Women with Papanicolaou tests classified as cervical intraepithelial neoplasia grade I or II are treated conservatively in many countries. However, these women are at an increased risk of having underlying prevalent and incident grade III cervical intraepithelial neoplasia and invasive cancer. This study was undertaken to identify factors that could predict these clinically important disease states. STUDY DESIGN: Five hundred women with Papanicolaou tests classified as persistent grade I or II cervical intraepithelial neoplasia underwent a repeat test, human papillomavirus testing with Hybrid Capture assay (Digene, Silver Spring, Md) and polymerase chain reaction, and colposcopy with histologic assessment. One hundred fifty-seven women with histologically proven grade I or II cervical intraepithelial neoplasia were monitored conservatively for a minimum of 9 months to assess predictors of incident grade III cervical intraepithelial neoplasia. RESULTS: One hundred fifty-one women with prevalent grade III cervical intraepithelial neoplasia and 5 women with prevalent invasive cancer were identified at the first colposcopy. A repeated Papanicolaou test classified as higher than grade II cervical intraepithelial neoplasia and detection of oncogenic human papillomavirus types were significant predictors of underlying grade III cervical intraepithelial neoplasia and cancer in the multivariate analysis. Seventeen of 157 women (10.8%) with grade I or II cervical intraepithelial neoplasia progressed to grade III cervical intraepithelial neoplasia. Age >30 years and detection of oncogenic human papillomavirus were significantly correlated with progression in the multivariate analysis. No progression was observed in women who were negative for human papillomavirus. CONCLUSION: The high rate of underlying prevalent grade III cervical intraepithelial neoplasia and cancer found in our study (31.2%) indicates that conservative management of women with persistent grade I or II cervical intraepithelial neoplasia should be discouraged. Colposcopy with histologic assessment should be recommended as the standard of care. However, for women with histologically proven grade I or II cervical intraepithelial neoplasia, subsequent conservative management was safe in our study for those who were negative for human papillomavirus by type-specific polymerase chain reaction.
Adolescent↗
Evaluation of the ThinPrep Papanicolaou test in clinical practice: 6-month study of 16,541 cases with histological correlation in 220 cases.
OBJECTIVE: To evaluate the liquid-based ThinPrep Papanicolaou test. DESIGN: Prospective comparison of the ThinPrep test with the conventional Papanicolaou test. SETTING: Cervical smear specimens sent to a private practice, Hong Kong. PATIENTS: A total of 16,541 ThinPrep test specimens and 7258 conventional Papanicolaou smears from Hong Kong women who had been screened for cervical cancer between mid-July 1998 and mid-January 1999. MAIN OUTCOME MEASURES: Specimen adequacy, endocervical cell content, epithelial cell abnormalities, and micro-organisms present in both types of cervical smears; histological diagnosis of cervical biopsy specimens of women who had the ThinPrep test. RESULTS: Compared with the conventional Papanicolaou smear test, the ThinPrep test showed a reduction in the frequency of 'unsatisfactory' (0.56% versus 1.36%; P<0.01), 'satisfactory but limited' (1.67% versus 15.87%; P<0.01), and 'atypical squamous cells of undetermined significance' reports (1.72% versus 3.64%; P<0.01). The ThinPrep test was also more effective at detecting squamous intraepithelial lesions, showing a 58% increase for low-grade lesions (2.66% versus 1.68%; P<0.01) and 28% increase for high-grade lesions (1.71% versus 1.34%; P<0.01). The sensitivity and positive predictive value of the ThinPrep system were 97.5% and 94.2%, respectively. The liquid-based method yielded a higher percentage of samples that contained endocervical cells compared with conventional smear specimens (70.57% versus 51.23%; P<0.001). CONCLUSIONS: The ThinPrep test has a high sensitivity and positive predictive value. The ThinPrep test gives higher-quality specimens and has a higher detection rate of squamous intraepithelial lesions than the conventional Papanicolaou smear test. The drawbacks of the liquid-based system, however, pertain to cost and the additional procedures and training needed.
Journal Article↗
A comparative evaluation of the Papanicolaou test for the diagnosis of trichomoniasis.
BACKGROUND: Trichomoniasis is the most prevalent nonviral sexually transmitted disease in humans worldwide. In addition to its pathologic implications, trichomoniasis is a risk factor for the transmission of the HIV and is associated with reproductive complications in females. Diagnosis of the disease is problematic due to inadequate accuracy of current diagnostic methods. Recently developed DNA-based techniques for detection of Trichomonas vaginalis seem to be promising alternatives. GOAL: The goal of this study was to evaluate the accuracy of the Papanicolaou test for the diagnosis of trichomoniasis by comparing polymerase chain reaction (PCR) with other current diagnostic methods. STUDY DESIGN: A total of 1008 cervicovaginal swab specimens from a randomized population attending a gynecological service were analyzed in this study. In addition to current diagnostic methods, two sets of specific primers were used for PCR detection of T vaginalis in the cervicovaginal DNA samples, with a PCR quality control. Different examiners conducted PCR and Papanicolaou analyses in a double-blind trial. RESULTS: The prevalence of trichomoniasis in this population was 6%. A considerable number of diagnostic results of the Papanicolaou test were false negative or false positive. Compared with PCR, specificity of the Papanicolaou test was 97.6%, whereas sensitivity was only 60.7%. The positive predictive value of the Papanicolaou smear was 61.7%. These results suggest that irregularly shaped parasites without clearly defined nuclei and flagella and bacteria-induced focal cytolysis limit the ability of the Papanicolaou test to detect T vaginalis. CONCLUSION: The Papanicolaou test, the most readily available cytologic method for screening sexually transmitted pathogens and cellular abnormalities in most developing countries, is inadequate for the diagnosis of trichomoniasis due to its inherent limitations. However, PCR is a highly sensitive and specific test for the diagnosis of trichomoniasis.
Adult↗