A Randomized Comparison of the 3 Papanicolaou Smear Collection Methods

Summary: The purpose of this study was to compare the effectiveness of 3 cervical smear sampling devices for obtaining acceptable yields of endocervical cells in Papanicolaou smears. In a randomized, controlled clinical trial, we collected 346 smears over a 6-month period, 110 with the Cervex brush, 125 with the cotton swab plus Ayre spatula and 111 with the Cytobrush plus Ayre spatula. The Cytopathology Laboratory, blinded to the Papanicolaou smear method, screened the smears using the Bethesda system guidelines. Statistical analyses were performed using the Pearson X² and analysis of variance tests. There was an increased detection of endocervical cells in the Cytobrush plus Ayre spatula and the Cervex brush methods, compared with the cotton swab plus Ayre spatula group (p=2.39 × 10^-6, p=4.49 × 10^-7 respectively). There was no statistically significant difference between the Cytobrush-spatula and Cervex brush groups (p=0.0779). We concluded that the Cytobrush-Ayre spatula and the Cervex brush sampling methods were equally effective in obtaining endocervical cells in Papanicolaou smears.     

USE OF THE CYTOBRUSH FOR PAPANICOLAOU SMEAR SCREENS IN PREGNANT WOMEN

A prospective, randomized clinical trial was conducted to study the safety and efficacy of the Cytobrush for Papanicolaou smear screens in 252 pregnant women. Two groups—Ayre spatula plus Cytobrush and Ayre spatula plus cotton swab—were compared. There was a higher incidence of spotting with each of the three devices as compared with studies of nonpregnant women. The highest incidence of spotting at time of exam occurred with the Cytobrush; however, this spotting was not clinically significant. Eleven first-trimester women experienced a pregnancy loss; five of these losses were due to a hydatidiform mole or missed abortion that occurred before the exam. Six women (2%) aborted spontaneously compared with a 10% incidence reported in the literature. It was concluded that all three devices are safe for use in pregnancy. In addition, the most adequate screen for retrieval of squamous epithelial cells was found to be the Ayre spatula, while the Cytobrush proved most effective for retrieval of endocervical epithelial cells.     

Cytological screening--the technique of cytological specimen taking and its influence on the quality of the method

The aim of our research work was to evaluate if the way of taking material influence the quality of the Pap smear test. 2300 patients were examined by taking Pap smear test for 7 years period from 2000 till 2007. In 1000 patients endocervical brush /Cytobrush/ was used and after that Ayre spatula for taking ectocervical material. In 1300 patients Ayre spatula was used first and after that endocervical brush applied. The number of the Pap smears contaminated with blood, the Pap smears without endocervical component and the Pap smears with bad fixation were examined. There were more contaminated with blood pap smears in the group where endocervical brush was used first /156 patients vs 100, p = 0.004/. There was no significant difference in the number of bad fixated pap smears, the "thick" pap smears, the inflamated Pap smears in both groups. The quality of the technique for taking pap smears when Ayre spatula is used first and after that endocervical brush is better than the reverse way of obtaining cytological material from the cervix. With this technique we find more squamous intraepithelial lesions.     

A randomized clinical trial comparing the Cytobrush and cotton swab for Papanicolaou smears.

OBJECTIVE: We sought to determine whether use of the Cytobrush/spatula or the cotton swab/spatula is better in obtaining satisfactory Papanicolaou smears as defined by the Bethesda System. METHODS: This 1-year randomized trial was performed at the Los Angeles County + University of Southern California Women's Hospital colposcopy clinic. Participants were all nonpregnant patients referred to the colposcopy clinic for abnormal Papanicolaou smears. The main outcome measurement was the effectiveness in obtaining satisfactory Papanicolaou smears as defined by the Bethesda System. Data were analyzed using the Pearson chi 2 test. RESULTS: The sampling methods had similar abilities to obtain a satisfactory smear (Cytobrush/spatula 63%, cotton swab/spatula 57%; P = .23). Less-than-optimal smears accounted for 28% of the Cytobrush group and 38% of the cotton-swab group. The Cytobrush was superior in its ability to obtain endocervical cells (Cytobrush 80%, cotton swab 60%; P less than .01). Both sampling methods had similar rates of correlation with histologic diagnosis. No complications were associated with either technique. CONCLUSIONS: The Cytobrush/spatula is superior to the cotton swab/spatula in obtaining endocervical cells. There appears to be no difference in each method's ability to obtain satisfactory smears. Application of the Bethesda System results in a significant number of less-than-optimal smears using either technique.     

Should the Cytobrush be used in routine screening for cervical pathology?

In 632 women visiting a family planning clinic, paired cervical smears were taken using a wooden spatula and a Cytobrush. Of the spatula smears 7.8% were unreliable with too little or scanty material to allow a cytologic diagnosis (class 0); 17.7% of spatula smears were inadequate, lacking endocervical cells. Combined spatula/Cytobrush cytology reduced these figures significantly; 4.3% unreliable smears and 3.2% inadequate specimens. Seventy-three (11.6%) of the smears revealed some abnormality, in most cases Papanicolaou class IIIA, suggestive of mild dysplasia. In 10 cases, dysplastic cells were found only in the Cytobrush cytology. It is concluded that the Cytobrush adds to the improvement of smear quality and the accuracy of routine cervical cytology obtained by relatively inexperienced smear takers.     

The quality of the Pap smear.

Three methods of cervical Pap smear have been studied: the classical spatula, the combination of spatula and cytobrush, and the Cervex-Brush. Thirty-two percent of the spatula smears did not provide endocervical cylinder cells. Significantly better results can be achieved by performing the smear with a combination of spatula and cytobrush (11% without cylinder cells), or with Cervex-Brush (15% without cylinder cells). Cervical smears using a spatula alone are therefore discouraged.     

An Evaluation of Cervical Smears Consisting of Spatula and Cytobrush Samples

Analysis of 100 paired spatula and Cytobrush cervical smear samples taken and evaluated by one person showed that the combined smear was excellent for sampling the transformation zone and for detecting lesions. However, care in obtaining and evaluating smears are still vital if false-negative smears are to be eliminated. The greater use of the 2-sample smear is advocated.     

Performance of the Cytobrush in patients at risk for cervical pathology: does it add anything to the wooden spatula?

In 130 high-risk patients for cervical pathology paired smears were obtained with a wooden spatula and a Cytobrush. The Cytobrush was useful in lowering the amount of inadequate smears (2 vs 22%, p less than or equal to 0.01), and detected more abnormal cytology in combination with the spatula compared to the spatula smear alone (27 vs 35%, p less than or equal to 0.05). In 6 cases, adequate false-negative spatula smears, containing endocervical cells, were corrected by the Cytobrush. It is concluded that the Cytobrush is useful in lowering the amount of inadequate smears and false-negative cytology, while there is little evidence of false-positive cytology. The use of the wooden spatula/Cytobrush-combination is recommended in high risk populations.     

Diagnostic value of an abnormal smear in non-pregnant women. Evaluation of positive smear from the surface of the portio obtained by the cottonswab method or by the dry wooden Ayre spatula and the relevance of positive smear from the endocervix and/or from the surface of the portio

During a 3-4 year period, 324 women with a positive smear were registered consecutively and prospectively and divided into two groups according to the design of the investigation. In one group the smear was taken with an Ayre spatula and in the other group with a cotton swab. The purpose of this investigation has been to make a comparison between the endocervical smear and the smear taken from the surface of the portio and at the same time between the samples taken with a dry wooden Ayre spatula and with a cotton swab. No differences were found. The cytological findings have been registered and correlated both with the histological findings by colposcopically directed punch-biopsies and endocervical curettings and with the final histological diagnosis obtained by punch-biopsy, conization or hysterectomy.     

Effect of the sampling sequence on the quality of Papanicolaou smear

The aim of the study was to determine whether the order of cell collection (ie, obtaining either endocervical first or ectocervical cells first) has an effect on the quality of the Papanicolaou smear. 1129 smears were obtained using an Ayre spatula and an endocervical brush. In 564 cases, the endocervical brush was used first, and in 565 cases, the spatula was used first. The number of smears obscured by blood, the smears without endocervical component, and the smears with poor fixation were compared between the two groups. More smears were partially obscured by blood when brush was used first (78, 13.8% compared with 48, 8.5%, P = 0.004). No endocervical component was found in seven (1.2%) smears from the brush-first group compared with five (0.9%) of the spatula-first group, which is an insignificant difference. There were no significant differences in the number of poor-fixated smears, too-thick smears, and satisfactory smears but limited by inflammation between the two methods. The quality of the Papanicolaou smear can be improved by using the Ayre spatula first followed by the endocervical brush. Fewer smears will be contaminated by blood which may result in more squamous intraepithelial lesions being detected.     

The Multispatula; a spatula adjustable to the shape of the individual cervix

The Multispatula, which is adjustable to the specific shape of each individual cervix, was compared with the Ayre spatula in 236 patients. Two smears were taken from each woman, one with the Ayre and one with the Multispatula. The Multispatula had a significantly higher percentage of smears containing endocervical cells than the Ayre spatula. Disadvantages of the Multispatula are its high price and the sharp edges causing somewhat more pain and bleeding. There were major differences in the quality of the smears between the various sample takers.     

The cytological detection of persistent cervical intraepithelial neoplasia after local ablative treatment: a comparison of sampling devices.

OBJECTIVE: To determine whether the cytological detection of persistent cervical intraepithelial neoplasia (CIN) after local ablative treatment is improved by the use of sampling devices other than the Ayre's spatula. DESIGN: A randomized controlled study. SETTING: Lothian Area Colposcopy Clinic. SUBJECTS: 856 patients who had received local therapy (CO2 laser or cold coagulation) for CIN II or III between 9 and 30 months earlier. INTERVENTION: Each patient had three consecutive cervical smears taken, one with the Ayre's spatula, one with either the Aylesbury, the Rocket or the Multispatula device, and finally one with the Cytobrush. The allocation of which spatula and the order of the first two was randomized. Each patient had a colposcopic examination immediately after the smears were taken. MAIN OUTCOME MEASURES: A comparison of the detection of histologically proven persistent CIN by the Ayre's spatula with the detection of persistent disease by alternative sampling devices. RESULTS: Of the 856 patients 130 had histologically proven persistent CIN. Another 98 had suspicious findings on colposcopy but punch biopsies reported as histologically normal. Of the remaining patients with normal colposcopy 130 were randomly selected to form a control group. The cervical smears from these 358 women were reported. Significantly fewer Ayre's samples contained endocervical cells than Aylesbury samples (47% vs 59%, difference 12%; 95% CI 3%-21%; P less than 0.001), Rocket samples (47% vs 67%; difference 20%, 95% CI; 12%-32%; P less than 0.001) or Multispatula samples (47% vs 76%; difference 29%, 95% CI 19-38%; P less than 0.001). When punch biopsies contained CIN, dyskaryotic cells were seen in 10% of Ayre's samples, 4.3% of Aylesbury samples, 8.3% of Rocket samples, and in no smear taken with the Multispatula. Obtaining a third smear with the Cytobrush did not substantially improve the detection rate of dyskaryosis. Neither the order of use of the spatulas, the form of initial treatment nor the size of the transformation zone had any apparent effect on the cytological detection of persistent CIN. CONCLUSIONS: We recommend that surveillance of patients who have received local ablative therapy for CIN should be by both cytology and colposcopy, and that cytological samples should be obtained using the Ayre's spatula.     

Comparison of cervical smears secured with different instruments

BACKGROUND: In this presentation we have compared the results from cytologic samples obtained with the cervical brush and Ayre's wooden spatula, against samples obtained with Acellon Combi. METHODS: One thousand cervical smears were collected. This was a cross-sectional study, where it was decided randomly to use cervical brush for sampling of the endocervix and Ayre's wooden spatula for exocervix or Acellon Combi for both. RESULTS: The combination of the cervical brush and the wooden spatula yielded an acceptable quantity of columnar cells in 71.6% of the cases, during both endocervical and exocervical sampling, while the Acellon Combi yielded an acceptable quantity in 61.7% of the cases (p<0.01). The combination of brush/spatula yielded an acceptable quantity of squamous cells from samples of endocervix and exocervix in 87.5% cases, while with the Acellon device amounted to 77.4% (p<0.001). Highly significant differences in the state of cellular preservation of samples from endocervix obtained with cervical brush technique were found upon comparison to Acellon group. CONCLUSIONS: Henceforth, we believe that the use of the cervical brush and the Ayre wooden spatula increases the quantity and preservation of the cells retrieved during cervical smears compared to Acellon Combi.     

Controlled evaluation of implementing the Cytobrush technique to improve Papanicolaou smear quality

The effect of introducing the Cytobrush Cell Collector for endocervical sampling on the quality of Papanicolaou smears was evaluated using a quasi-experimental design. Baseline evaluation of the Ayre spatula-cotton swab method in two patient groups showed that only 61.8-61.9% of smears contained endocervical cells. Replacing the cotton swab with the Cytobrush in the intervention group improved endocervical cell yields to 82.0% (P less than .001). This improvement was not due to group differences in patient factors previously related to endocervical cell yields, eg, parity, use of oral contraceptives, pregnancy, previous cervical procedures, and menopausal status. An increase in the proportion of Papanicolaou smears showing dysplasia or cancer (class III or higher) was associated with use of the Cytobrush (P less than .05). Subsequent introduction of the Cytobrush to the control group resulted in a similar significant improvement in cell yields to 82.5% (P less than .001). Greater use of methods such as the Cytobrush Cell Collector in the primary care setting can improve cervical cancer screening by reducing the number of false-negative Papanicolaou smears resulting from inadequate endocervical cell sampling.     

Spatula/cytobrush vs. spatula/cotton swab detection of cervical condylomatous lesions

Human papillomavirus is widely implicated as a primary etiologic factor in cervical carcinoma. This study compared the sampling accuracy of the modified Ayre spatula/Zelsmyr cytobrush versus the modified Ayre spatula/cotton swab in the detection of cervical lesions with koilocytotic features. The histologic categories consisted of koilocytotic lesions (flat condylomas) with minimal cellular atypia and cervical intraepithelial neoplasia (CIN) I, II and III with surface koilocytes showing cellular atypia (atypical koilocytosis). Using the spatula/cytobrush there was 88% concurrence (118/134 cases) between the cytologic/histologic diagnosis of flat condyloma and CIN with atypical koilocytosis. Using the spatula/swab there was a cytologic/histologic concurrence of 68% (71/104 cases). Statistical analysis confirmed the difference between the two techniques to be significant. In addition, a higher percentage of CIN II and III lesions with koilocytotic features was detected with the spatula/cytobrush--54% (19/35 cases) as compared to 30% (14/46 cases) for the spatula/swab. The results of this study support the use of the spatula/cytobrush in the detection of cervical lesions with koilocytotic features.     

Comparison of the ThinPrep monolayer technique and conventional cervical Pap smears in a high-risk population using the Munich II nomenclature

OBJECTIVE: In this prospective study using the Munich II nomenclature for cervical cytology. Pap smear results obtained by the ThinPrep monolayer technique and those obtained by the conventional method were compared. METHODS: Pap smears were obtained from 1,000 women using an Ayre spatula/endocervical brush combination. Following transfer of the cell sample onto a slide, the same collection devices were rinsed in a liquid medium and processed using ThinPrep-2000 processor (split-sample technique). RESULTS: Specimen inadequacies due to drying artefacts, cell overlap or low number of epithelial cells were rare with both methods without any significant differences. However, ThinPrep slides were significantly less often compromised by red or white blood cells or by cytolysis. In contrast, endocervical cells were missing in 11.6% of slides compared to only 2.3% in conventional Pap smears. ThinPrep yielded results of unknown significance (Pap III) significantly less often (4.2 vs 6.3%). CONCLUSIONS: ThinPrep slides are less frequently compromised by blood components or cytolysis. Inconclusive results of Pap III are slightly less frequent when using ThinPrep. However, there is a significant percentage of slides lacking the endocervical component. Using a combination of spatula and cytobrush, this may not necessarily be due to non-representative cell sampling.     

Laser conization: follow-up in patients with cervical intraepithelial neoplasia in the cone margin

Combination laser conization was performed in 469 patients for the treatment of cervical intraepithelial neoplasia (CIN). In 58 cases (12.4%), CIN was located in the margins of the cone. Fifty-one patients with involvement of the margins were evaluated by cytologic examination, using the Ayre spatula and the Cytobrush, and by cervical biopsy and endocervical curettage (ECC). In six cases, the histologic evaluation was positive, and in three of these cases, the cytology was positive too. Hysterectomy was performed in five cases, but in only one case was a significant lesion demonstrated in the uterus. These results justify expectant, conservative management of patients treated with combination laser conization. Follow-up based on colposcopy and cytology seems sufficient.     

Improving the quality of cervical screening

OBJECTIVE: To compare the adequacy of cervical cytology sampling by a newly designed cervical cell sampler (the implement) with a commonly used, extended tip cervical scraper, namely the Jordan's spatula, by assessing the quality of cervical smears obtained. DESIGN: Prospective randomised controlled trial, with the approval of the local Ethics Committee after informing the Medical Devices Agency in the UK. SETTING: Colposcopy Clinic in a District General NHS Trust Hospital in London. POPULATION: Women attending the Colposcopy Clinic and having a good command of the English language (to avoid any misinterpretation of the information and enabling them to give informed consent) were invited to take part. Two hundred and twenty patients were recruited. METHODS: The women were randomised into two groups, each of them having two smears at the same time, half of them having their first smear with the Jordan's spatula and the other half having the first smear with the new implement. MAIN OUTCOME MEASURE: Good quality smears, assessed by evidence of effective sampling of the transformation zone, including immature metaplastic cells and also endocervical cells. RESULTS: Fifty-four percent of smears taken by the new implement showed good quality smears, compared with 37% taken by Jordan's spatula, a statistically significant result with P value <0.001. CONCLUSION: A larger number of good quality smears, judged by evidence of sampling of transformation zone and presence of endocervical cells, were obtained with the new implement. The difference was statistically significant. This would enhance the ability to detect dyskaryosis and increase adequate smear rates, reducing unnecessary recall of patients for repeat smears.     

Sampling devices for the Papanicolaou test]

Smear quality is related to the experience of the sample taker and also to the screening instrument used. Most Authors concur that both an endocervical and an ectocervical specimen must be collected to assure adequate sampling of the transitional zone. The cytobrush alone is effective mainly for endocervical sampling while the Ayre spatula alone is effective mainly for ectocervical sampling; the cotton swab is ineffective for both endocervical and ectocervical sampling. Values and failure of the sampling devices are described.     

The Inadequacies of Instruments Used for Cervical Screening

Cervical cytology has a high false negative rate, especially for adenocarcinoma and its precursors. This study compares the traditional spatula with the cytobrush. Both the modified Ayre spatula and the cytobrush were found to be inadequate in a significant number of patients with known cytological atypia. It is concluded that inadequate sampling instruments make a contribution to false negative rates and that brush cytology is superior to rigid instrument cytology in routine cervical screening.