Inadequate Smears Research Articles

The PapCone® as a valid cervical sampling device: a comparative ultrastructural and semiquantitative study

The efficiency of cervical cancer screening depends on the proper interpretation of results and on the quality of the sample. For a smear to be considered adequate, cell samples from the endocervix, transformation zone and ectocervix must be present. Our aim was to analyse cervicovaginal smears’ with scanning electron microscopy (SEM), comparing the traditional Ayre’s wooden spatula (Sp) and endocervical cytobrush (Cb) with a new cone-shaped polyurethane (foam) device, the PapCone®(Otto Bock, Duderstadt, Germany). Pap tests were performed with the related informed consent in 22 adult fertile (aged 20-46) women using Sp and/or Cb; sampling with the PapCone® followed 3 months after. The apical extremity of each device was fractured and fixed in toto in 2.5% glutaraldehyde containing vials. Samples were stored at 4°C, postfixed in 1% osmium tetroxide, dehydrated, critical-point dried, mounted on aluminum stubs, coated with platinum, and observed with a Hitachi S-4000 FE-SEM. Statistical analysis was performed evaluating ecto-/endocervical cells, erythrocytes, and/or mucus contained in ten 250x-microscopic fields. There were no significant differences in the number of ectocervical cells and in the quantity of mucus sampled when comparing the 3 devices. The PapCone® sampled significantly more endocervical cells with respect to Sp and Cb, and more erythrocytes with respect to the Sp. These latter data may be due to the characteristic porous and trabecular surface of the PapCone®, which samples a larger volume of material that tends to be also present in less overlapping layers. In conclusion, PapCone® is a better device with respect to Sp and Cb for sampling endocervical cells. Improved cervical sampling will certainly lead to better quality smears and hopefully decrease both false negative and inadequate smear rates.

Review of negative and low‐grade cervical smears in women with invasive cervical cancer after the first 3 years of the national cervical screening programme in Slovenia

The purpose of the study was to perform a national review of negative, low-grade and inadequate smears reported during the latest screening period before cervical cancer diagnosis in 2006, after the first 3 years of the screening programme. Among 162 new cervical cancer cases there were 47 (29%) without previous cytology, 47 (29%) with one high-grade smear prior to diagnosis and 68 (42.0%) with at least one previous negative, low-grade, atypical or inadequate smear 1-40 months before diagnosis. Of the latter 68 cases, 37 patients with 59 smears (together with 118 control slides) were included in the review as 31 had smears reported at laboratories no longer operating. Findings were related to the last cytology report before diagnosis as well as to histological type and stage of the cancer. In our study group, 19 (51%) of 37 patients had squamous cell carcinoma, 15 (41%) adenocarcinoma and 3 (8%) adenosquamous carcinoma, compared with 121 (75%), 26 (16%), 12 (7%), respectively, and 3 (2%) other types, for all carcinomas. Twenty-one of 37 women also had high-grade cytology prior to diagnosis of cancer. Women with previous cytology (with or without recent high-grade smears) were more likely to have stage I cancers than those without cytology (P < 0.0001). The expert group upgraded 17/33 smears in the patients with squamous carcinomas, which was more than in those with adeno- and adenosquamous carcinomas (5/24, P < 0.05). As expected, a higher proportion of smears preceding adenocarcinomas were true negative. Under-diagnosed smears were not related to cancer stage or last cytology report before diagnosis.

Clinicopathological study of Papanicolaou (Pap) smears for diagnosing of cervical infections

Cervical infections are not uncommon in our population especially in young and sexually active women. One thousand samples of married women, aged between 20 and 70 years, were studied by conventional Papanicolaou smears. These samples were examined in the Department of Pathology, King Edward Medical University, Lahore from January 2007 to June 2009. Only cases without (pre)neoplastic cytology were included. Six types of infections were diagnosed cytologically. The overall frequency of normal, inadequate, neoplastic, and infective smears was 50%, 1.8%, 10.2%, and 38.3%, respectively. Most of the patients (67%) were in the reproductive age group with mean age 34.7 ± 2.6 years. The commonest clinical sign seen in 354/383 (92%) cases and symptom in (349/383; 91%) cases were vaginal discharge and pruritis vulvae. Among the infective smears, 290 cases (75.7%), the cytologic diagnosis was nonspecific inflammation. Most of these 290 smears contained clue cells (indicating Gardnerella infection) and a lack of lactobacilli. Such smears are predominant in patients suffering from bacterial vaginosis (BV). Twenty-eight smears (7.3%) were positive for Trichomonas vaginalis, 27 cases (7%) were smears with koilocytic change pathognomonic of human papilloma virus infection. Twenty-five smears (6.5%) were positive for fungal infection. Seven cases (1.8%) were diagnosed as herpes simplex virus infection. Finally, there were six cases (1.5%) with atrophic vaginitis. We conclude that the cervical smear is well suited for diagnosing cervical infections. It is clear that Gardnerella, known to be associated with bacterial vaginosis, is a major problem in our Pakistani population.

Tuberculosis of the cervix: a rare cause of postcoital bleeding and inadequate cervical smear

Tuberculosis of the cervix: a rare cause of postcoital bleeding and inadequate cervical smear

Value of Centrifugated Liquid-Based Cytology by Papanicolaou and May-Grünwald in Oral Epithelial Cells

For many years, liquid-based cytology (LBC) has been developed for cervical cancer screening and not oral cancer, as it requires automated devices. The aim of this study was to compare the utility of centrifugated CLBC preparation with that of direct preparation in oral lesions, by Papanicolaou (Pap) and May Grünwald-Giemsa's (MGG) methods. A total of 100 consecutive cases of oral lesions were investigated. We compared the results obtained by the CLBC performed by cytocentrifugation with those obtained by direct smear applying Pap and MGG methods. The comparison between CLBC and direct smears was based on the thickening or adequacy of the smear, distribution of cells and staining quality. All smears in CLBC and direct preparation were found adequate. For thickness of the smear, 40% and 42% were excellent, 33% and 30% were good, and 27% and 28% were acceptable by LBC and direct preparation, respectively. For the distribution of cells and scantiness of background elements, 92 (92%) smears of the CLBC have revealed clear, well distributed smears, compared to 70 (70%) of those in direct preparation. For the staining quality with the Pap method, 39% and 69% were excellent staining quality, 25% and 20% were good, and 36% and 11% were acceptable for CLBC and direct preparation, respectively. In MGG method, 9% and 22% were excellent staining quality, 23% and 36% were good and 68% and 43% were acceptable for CLBC and direct preparation respectively. CLBC performed by cytocentrifugation is inexpensive, and reduces inadequate smears and background staining.

Risk of cervical abnormality after age 50 in women with previously negative smears

There is discussion over the benefit of continuing cervical screening in women over the age of 50 with a history of negative cytology. We aimed to determine the risk of abnormal cytology in such women. Screening history data from 1985 to 2003 were obtained for a cohort of 2 million women from the NHS cervical screening programme from four Health Authorities in England. The 57 651 women in the cohort who reached age 40 between 1 January 1985 and 31 December 1990 and had at least one routine or opportunistic smear between ages 50 and 54 were included in the analysis. Exposure groups (negative cytology history, negative but including inadequate smears, and positive history) were defined on the basis of screening histories from ages 40 to 49. Sixty-four percent (134/206) (95% CI: 57–71%) of the moderate dyskaryosis or worse lesions at ages over 50 were detected from women in the negative smear history group. After allowance for time since last negative smear, the relative risk for the first primary smear over the age of 50 having moderate dyskaryosis or worse decreased from 0.60 (95% CI: 0.41–0.84) for two negative smear episodes to 0.25 (95% CI: 0.10–0.56) for four negative smear episodes, compared with the positive history group. If screening were discontinued for all women over 50 with a negative history, the majority of cytological abnormalities now being detected at these ages that lead directly to referral to colposcopy would be missed.

Comparison of the efficacy of the cervex brush and the extended-tip wooden spatula with conventional cytology: A longitudinal study

Background:Within the United Kingdom, the change from conventional to liquid based cytology (LBC) has brought with it the universal introduction of broom style samplers, as represented by the Cervex sampler. The aim of this study was to assess whether or not there were benefits associated with a change from wooden spatulae to broom style samplers for those countries where conversion to LBC might not be readily available or is not fully supported.Methods:A longitudinal study was designed to compare the performance of Cervex brushes and extended-tip wooden spatulae as sampling devices for conventionally prepared cervical smears. General Practices serving the population of Hull and East Yorkshire (UK) were provided with Cervex brushes for a period of nine months to routinely collect cervical smears. The results of 66,931 cervical smear tests were compared between those practices that were using extended-tip wooden spatulae before the trial and then returned to their use afterwards, and those who were previously using Cervex samplers and continued to use them throughout. Analyses comparing both specimen inadequacy, as recorded on the standard cervical screening request form (HMR101), and also the presence of identified transformation zone (TZ) elements in smears, both indicated significant advantages associated with the Cervex brush.Results:Inadequate smears decreased from 5.96% with extended-tip spatulae to 4.77% with Cervex brushes (p<0.001) and increased back to 7.34% when practices reverted to extended-tip spatulae after nine months. Under the same conditions, the proportion of smears containing identified TZ elements increased from 50.52% to 54.75% (p<0.001), before reverting to 45.47% (p<0.001). In contrast, for a control group of practices using the Cervex brush throughout, inadequate smears decreased in all phases of the study, with no significant variation in TZ sampling rates.Conclusions:Using the Cervex brush with conventional cytology significantly decreases inadequate smears and increases TZ sampling when compared to the extended-tip spatula and can offer improved cervical screening in countries unable or unwilling to convert to LBC.

Different measures of risk perceptions and distress yield different patterns of results: The importance of specificity in measurement and theory

There is little consensus on how to conceptualise and measure both cognitive perceptions of risks and affective responses to risks. We report data on two measures of risk perceptions and affective responses, as well as attendance behaviour, for 226 women who received a normal test result and 180 women who received a first or non-consecutive inadequate cervical smear test result. Different measures of risk perceptions (cognition) and distress about test result (affect) were not always strongly associated, often yielding markedly different patterns of results. This highlights the need for more precise reporting of measures and greater specificity of theoretical predictions. Suggestions for further studies investigating cognitive and affective reactions to health risk information are outlined.

Fine Needle Aspiration Cytology of the Breast

To evaluate the impact of experience on the accuracy of breast fine needle aspiration cytology (FNAC) using standardized microscopic criteria and review the possible complementarities between FNAC and core biopsy (CB).We studied 292 breast FNAC samples and their subsequent biopsies. The cytologic samples were blindly reevaluated 4-7 years later, when we had gained more experience and refined our diagnostic criteria. The accuracy of the first reading was compared to that obtained at the second reading. Inadequate smears were included in the accuracy calculations.In the second reading, the identification of carcinomas and of benign lesions became more accurate. The improvement was statistically significant. Absolute sensitivity passed from 59.9% to 67.7%. Specificity increased from 52.0% to 56.0%. The inadequacy rate varied from 12.7% to 14.0% and complete sensitivity from 92.2% to 91.7%. The majority of inadequate smears were associated with benign lesions.Significant improvements are associated with increased experience. A more detailed evaluation of nuclear atypia and the use of Papanicolaou-stained material were also important. Accurate selection of patients may improve specificity. FNAC could be used in a complementary way with CB.

The impact of the introduction of liquid based cytology on the variation in the proportion of inadequate samples between GP practices.

BackgroundHistorically there has been a wide variation in the proportion of inadequate smears between general practices. Cervical screening in the UK is undergoing a fundamental change by moving from conventional to liquid based cytology (LBC). The main driver for this change has been a predicted reduction in the proportions of inadequate samples. This study investigates the effect of LBC on the variation in the proportion of inadequate samples between general practices using Shewhart's theory of variation and control charts.MethodsRoutinely collected cervical cytology data was obtained for all general practices in two localities in South Staffordshire for periods before and after the introduction of liquid based cytology. Control charts of the proportion of inadequate smears were plotted for the practices stratified by laboratory. A standardised measure of variation for all of the practices in each laboratory and each time period was also calculated.ResultsFollowing the introduction of liquid based cytology the overall proportion of inadequate samples in the two localities fell from 11.8 to 1.3% (p < 0.05). This fall was associated with a reduction in the average variation between the GP practices in the two localities from 1.6 to 1.0 standard deviations. There has also been a reduction in the number of practices showing special cause variation from eight to one following the introduction of liquid based cytology.ConclusionA reduction in the proportion of inadequate samples has been realised in these localities. The reduction in the overall proportion of inadequate samples has also been accompanied by a reduction in variation between GP practices.

Should fine needle aspiration biopsy be the first pathological investigation in the diagnosis of a bone lesion? An algorithmic approach with review of literature

BackgroundFine needle aspiration biopsy (FNAB) is gaining increasing popularity in the diagnosis of musculoskeletal lesions; and in many patients, a definitive diagnosis can be rendered from aspiration smears alone. Its applicability in bone pathology, however, has been controversial due to a high percentage of inadequate smears, difficulty in evaluation of tissue architecture and nonspecific results in the diagnosis of primary bone lesions. In this study, the value of aspiration as the first pathological investigation in the diagnosis of a bone lesion was evaluated.Methods91 cases of clinically suspected cases of bone lesions were aspirated over a period of two years. Direct or cytospin smears were fixed in 95% alcohol and stained by Hematoxylin and Eosin or air-dried and later fixed in methanol for May Grŭnwald Giemsa staining.ResultsOf the 91 patients who were subjected to FNAB, 81 were considered satisfactory and 10.9 % (10) were inadequate\\inconclusive for diagnosis. Cyto-histological concordance was obtained in 78.5 % (51/65) patients. Positive and negative predictive values were 87.5% and 97.2 % respectively. Sensitivity as a preliminary diagnostic technique was 93.3%, whereas specificity was 94.5 %. Overall, diagnostic accuracy was 94.2 %. Metastatic lesions were detected with 100% accuracy. Two cases were reported as false positive and one case as false negative.ConclusionCytology provides valuable information to the clinician to make an informed decision regarding appropriate therapy. We conclude that time-consuming and costly investigations may be reduced by choosing FNAB as the initial pathological diagnostic method for skeletal lesions of unknown origin. The choice of radiological examinations, laboratory tests and surgical biopsies can be determined after the FNAB diagnosis.

A new method for the classification of invasive cervical cancer screening histories

To examine the ability of existing classification systems to provide screening histories for invasive cervical cancers which can be used in the evaluation of the NHS Cervical Screening Programme (NHSCSP), and to provide the diagnostic route data item required for the National Cancer Data Set (NCDS). The ability of existing classification systems to derive unique, consistent screening histories for a cohort of invasive cervical cancers diagnosed in the West Midlands region in the period 2000-03 was tested using two separate timelines for women on normal routine recall (usually 3 or 5 years) and those on early recall having had an inadequate, low-grade abnormal or negative smear. Neither of the existing classification systems was capable of adequately categorizing all invasive cervical cancers. An original classification system incorporating features from the existing systems was therefore developed. This system includes both a 'screening status' component that essentially describes the status of a woman's interaction with the NHSCSP at the time her cancer was diagnosed, and a 'screening history' component that describes the results of previous screening tests. National adoption of this new screening histories classification system would provide a detailed, consistent, nationally comparable screening history for all invasive cervical cancers which can be used in the national and regional evaluation of the NHSCSP and in local audit by clinical teams supplemented by histology and colposcopy data. The classification categories could be collapsed down to provide the diagnostic route data item required for the NCDS.

The cervical smear test: does timing have an effect on sample adequacy?

The aim of this study was to determine the effect of timing of the cervical smear test on sample adequacy. Inadequate and negative smears from pre-menopausal women, with a regular menstrual cycle and who were not undertaking any hormone therapy, were selected and re-screened. The inadequate smears were then categorized according to the reasons for the inadequate result. The time of the cycle that the smear was taken was recorded for both inadequate and negative smears. The expected frequency of smears per phase was compared with the observed frequency per phase using the chi-squared statistical test. There was no significant difference between the overall observed and expected rate of the inadequate smears of nine general practitioner (GP) practices (P = 0.886), of GP practice 4 (lowest inadequate rate) (P = 0.610), or GP practice 6 (highest inadequate rate) (P = 0.621) at any phase of the cycle. Results show that there is no optimum phase for adequate sample collection, therefore it is suggested that there is no effect of timing of the cervical smear test on sample adequacy, that timing is not a relevant factor in reducing the inadequate smear rate, and restricting smear taking to mid-cycle is unnecessary. (The information regarding last menstrual period/length of cycle from which these conclusions were reached relied upon the accuracy of patient information given to the smear taker.).

Follow-up of Abnormal or Inadequate Cervical Smears Using Two Guidance Systems: RCT on Effectiveness

Follow-up of Abnormal or Inadequate Cervical Smears Using Two Guidance Systems: RCT on Effectiveness

Effect of Specimen Order on Chlamydia trachomatis and Neisseria gonorrhoeae Test Performance and Adequacy of Papanicolaou Smear

Abstract Study Objective To evaluate the effect of specimen collection order on the performance of diagnostic tests for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC), and the specimen adequacy of ThinPrep Papanicolaou (Pap) smears. Design Prospective cohort study. Setting Public adolescent clinic. Population 313 women. Interventions The order of five cervical testing specimens was randomized for (1) ligase chain reaction (LCR) and (2) polymerase chain reaction (PCR) for both CT and GC; (3) transcription-mediated amplification (TMA) for CT; (4) culture for CT; and (5) cytology and LCR for GC and CT performed on ThinPrep Pap specimens. For CT and GC, a reference standard was based on three different tests performed on separate specimens. Generalized estimating equations were used to account for repeated measures. Main Outcome Measure Sensitivity and specificity of diagnostic tests. Results The proportion of inadequate Pap smears was independent of specimen order. As a group, nucleic acid amplification test (NAAT) sensitivity and specificity for GC and CT were similar in the first two (early) and last three (late) swabs. Although point estimates for sensitivity were higher in the early swabs compared to the late swabs for GC LCR (13% difference), GC PCR (13%), and CT TMA (10%), these differences were not statistically significant. Their clinical significance warrants further investigation. Conclusions In clinical settings where both Pap smears and STI testing are performed in adolescents, clinical considerations can influence the order of specimen collection, since neither Pap specimen adequacy nor test performance of NAAT for CT and GC were significantly associated with swab order.

A comparative study of two devices used for cervical cell sampling raises some doubts about liquid-based cytology

The objective of this study was to compare the quality of smears obtained by a newly designed cervical cell sampler (the implement) to those obtained with the cervex brush, using liquid-based cytology (LBC). A prospective randomized controlled trial with the approval of the local ethics committees after informing the Medical Devices Agency in the UK was used in this study. The study was carried out in colposcopy clinics in two district general NHS Trust Hospitals in London. A total of 200 women were recruited (100 from each hospital). The women were randomized into two groups, each of them having two smears at the same time. One hundred (50%) of the women had their first smear with the new implement, and the other 100 (50%) had their first smear with the cervex brush. The main outcome of this study is good-quality smears, assessed by evidence of effective sampling of the transformation zone, including immature metaplastic cells and also endocervical cells. Eighty-five percent of the smears taken by the new implement showed good-quality smears compared to 91% of those taken by the cervex brush, a statistically marginally nonsignificant result, with P value = 0.052 (McNemar exact test). A larger number of good-quality smears, judged by evidence of sampling of transformation zone, were obtained with the cervex brush, though the difference was statistically marginally nonsignificant, using the British society for clinical cytology criteria. Surprisingly, despite the use of LBC, there was a higher rate of inadequate smears obtained with both the devices (8% with each) compared to our previous study using the conventional slide test (1.3% with the new implement and 1.8% with the Jordan's spatula).

The agreement between self-reported cervical smear abnormalities and screening programme records

The Million Women Study is a cohort study of women aged 50-64 years in England and Scotland. As a component of the follow-up questionnaire, participants were asked to indicate if they had an abnormal cervical smear in the previous five years. This study compared self-reported cervical abnormalities with screening records obtained from the National Health Service Cervical Screening Programme. For 1944 randomly selected Million Women Study participants in Oxfordshire, screening records were assessed over a six-year period prior to the date of self-reporting. The six-year period was chosen to allow for errors in the recall of timing of abnormal smears. A total of 68 women (3.5%) had a record of at least one equivocal or abnormal smear within the last six years, whereas 49 women (2.5%) self-reported an abnormality. There was a strong trend for an increased probability of self-reporting a history of an abnormal smear as the severity of the recorded abnormality increased (P <0.001). For women with an NHS record of borderline dyskaryosis, mild dyskaryosis, or moderate dyskaryosis/severe dyskaryosis/invasive cancer, the proportions reporting an abnormality were 40%, 58% and 77%, respectively. For women with negative and inadequate smears, the proportion self-reporting an abnormality were 0.6% and 0.7%, respectively. These results indicate that among women whose screening programme records show an abnormal smear, the proportion self-reporting an abnormality increases with the severity of the recorded lesion. Almost all women with a record of negative or inadequate smear(s) correctly interpret the result and do not self-report an abnormality.

Rapid rescreening of cervical smears as a quality control method in a high‐risk population

Cancer of the cervix is one of the commonest cancers in South Africa. Accurate cytological diagnosis is one of the prerequisites for an effective cervical screening programme and requires the implementation of appropriate quality assurance modalities. This study was undertaken to determine if rapid review of reportedly negative cervical smears is a useful internal quality assurance modality in an unscreened population with very high rates of cervical carcinoma. Approximately 26% of all cervical smears received at the study institution between 1 January 1998 and 31 December 2003, and initially reported as negative or inadequate, underwent rapid review. A total of 62,866 (26%) cervical smears out of 241,796 reportedly negative or inadequate cervical smears underwent rapid review. An amended report was sent out in 373 (0.59%) of these 62,866 cervical smears. This included 101 cases of high-grade squamous intraepithelial lesion (HSIL) and high-grade atypical squamous cells (ASC-H), 143 low-grade squamous intraepithelial lesions, 54 atypical squamous cells of undetermined significance (ASC-US) and 33 atypical glandular cells that were not reported initially. The false-negative proportion for HSIL and ASC-H (combined) in this study was 5.76%. No squamous cell carcinomas were diagnosed on rapid review but one patient with HSIL/ASC-H on review had squamous cell carcinoma on biopsy. Three cytotechnologists had a lower sensitivity of primary screening and required retraining. Rapid review is beneficial as an internal quality assurance modality in an unscreened high-risk population and increases the detection of women with significant cervical lesions requiring treatment. The relatively low cost of rapid review compared with other rescreening modalities makes this an attractive option in low resource settings.

Review of cervical smears from 76 women with invasive cervical cancer: cytological findings and medicolegal implications

To review cervical smears from 76 women which were taken prior to the diagnosis of invasive cervical cancer and to determine the appropriateness of the cytology reports issued on the smears. Cervical smears, clinical records, cervical smear history and cytology reports from 76 women with invasive cervical cancer were reviewed. After microscopic review of the cervical smears, the cases were divided into two groups: Group 1 comprised 50 women who were found to have had at least one false-negative (F/N) smear report prior to the diagnosis of invasive cervical cancer. Group 2 comprised 26 women for whom no evidence of F/N reporting was found. A total of 209 cervical smears from the 50 women in group 1 were available for review (range 2-12 smears per woman); 100 of the 209 smears were considered to have been reported appropriately. Ninety-seven smears which had been reported originally as negative or inadequate were found, on review, to contain numerous severely dyskaryotic cells and were reclassified as F/N smears. All of the 50 women had at least one F/N smear and 29 had two or more. Twelve smears from eight women contained only a few (<200 severely dyskaryotic cells). Forty women developed invasive squamous carcinoma and 10 developed invasive adenocarcinoma. The stage at diagnosis ranged from 1A to stage 4. Seventy-one smears from the 24 women in group 2 were available for review (range 1-15 smears per woman). In two cases included in group 2, no smears were provided for review as the smears had been lost or mislaid. Review of the 71 smears confirmed the accuracy of the original cytological classification of the smear. Nineteen women were diagnosed with squamous cancer, two microinvasive cancer, one glassy cell, two adenocarcinomas, and one with adenosquamous carcinoma. One women was found to have an embryonal rhabdomyosarcoma of the corpus uteri involving the cervix. The medicolegal implications are discussed in the light of the above findings. Evidence of breach of duty of care was presented in all 50 cases in group I although causation was not established in every case. There was no evidence of failure of duty of care in terms of the standard of the cervical cytology reports issued or standard of clinical management in 17 of the 26 cases in group 2. However, in seven of the 26 cases in group 2, clinical management of the case was substandard due to failure to investigate symptoms of irregular bleeding regardless of a negative cytology report (two cases), failure to act upon a suspicious smear report or consecutive inadequate smear reports (two cases), failure of follow-up after treatment of CIN3 (two cases) and histological misdiagnosis (one case).

Effect of Specimen Order on Chlamydia trachomatis and Neisseria gonorrhoeae Test Performance and Adequacy of Papanicolaou Smear

Study Objective To evaluate the effect of specimen collection order on the performance of diagnostic tests for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC), and the specimen adequacy of ThinPrep Papanicolaou (Pap) smears. Design Prospective cohort study. Setting Public adolescent clinic. Population 313 women. Interventions The order of five cervical testing specimens was randomized for (1) ligase chain reaction (LCR) and (2) polymerase chain reaction (PCR) for both CT and GC; (3) transcription-mediated amplification (TMA) for CT; (4) culture for CT; and (5) cytology and LCR for GC and CT performed on ThinPrep Pap specimens. For CT and GC, a reference standard was based on three different tests performed on separate specimens. Generalized estimating equations were used to account for repeated measures. Main Outcome Measure Sensitivity and specificity of diagnostic tests. Results The proportion of inadequate Pap smears was independent of specimen order. As a group, nucleic acid amplification test (NAAT) sensitivity and specificity for GC and CT were similar in the first two (early) and last three (late) swabs. Although point estimates for sensitivity were higher in the early swabs compared to the late swabs for GC LCR (13% difference), GC PCR (13%), and CT TMA (10%), these differences were not statistically significant. Their clinical significance warrants further investigation. Conclusions In clinical settings where both Pap smears and STI testing are performed in adolescents, clinical considerations can influence the order of specimen collection, since neither Pap specimen adequacy nor test performance of NAAT for CT and GC were significantly associated with swab order.