Controlled trial of a new cervical spatula.

A wooden spatula was designed to scrape the varied distribution of epithelial abnormalities of the cervix as seen at colposcopy. The efficiency of the spatula in obtaining dyskaryotic cells and improving the cellular quality of smears was compared with that of the Ayre spatula in a controlled trial. More than 17,000 smears were taken from women aged 14-86 years by more than 200 smear takers from 74 centres. Twenty two per cent more dyskaryotic smears were obtained with the trial spatula, and the cellular quality of the smears was improved in all age groups. Although it was associated with a slightly increased risk of bleeding, 83% of users preferred the trial spatula.     

The Cervex: an ectocervical brush sampler

The performance of a new ectocervical brush sampler--the Cervex--was compared with the Ayre spatula in 280 paired cervical smears. The Cervex smears were superior in quality of spread, transformation zone sampling in all degrees of cervical patency and in detection of histologically proven epithelial abnormalities, with a false negative rate of 10.9% compared with 20% for the Ayre. Improvement in predictive value was noted in atrophic samples, with increased cellularity and transformation zone representation. Difficulty has been encountered in obtaining adequate samples from the older woman and from those with iatrogenic scarring of the cervix. Although two-sampler techniques may be used, submission of high quality pan-cervical material from a single sampler onto one slide is economically and organizationally attractive. The Cervex seems capable of producing such samples and deserves further evaluation for routine screening.     

Cervical smears following laser treatment. Comparison of Cervex brush versus Cytobrush-Ayre spatula sampling

For 802 women at initial follow-up after laser treatment of cervical lesions, 421 smears prepared using the Cervex brush were compared with 381 smears prepared using the combination of a Cytobrush plus an Ayre spatula. The smears were graded for adequacy, the presence of endocervical or metaplastic cells and the presence and degree of epithelial abnormalities. Endocervical or metaplastic cells were seen more often in Cytobrush-Ayre spatula smears (94.5%) as compared with Cervex brush smears (88.8%; P = .004). Also, the number of samples classed as inadequate was significantly greater with Cervex brush smears (4.0%) than with Cytobrush-Ayre spatula smears (0.3%; P = .0003). The number of smears showing dysplasia was too small to detect realistic differences between the two sampling methods. These findings suggest that, in women who have had laser treatment of the cervix, Cytobrush plus Ayre spatula sampling produces better-quality smears than does Cervex brush sampling, with regard to both adequacy and the presence of endocervical cells.     

The effects of different sampling techniques on smear quality and the diagnosis of cytological abnormalities in cervical screening

A major cause of false‐negative cervical smears is sampling error. We examined the results obtained with three different instruments in 126 608 smears from general practitioners. The spatula/brush combination yielded the highest proportion of smears showing cytological abnormalities, and the Cervex brush the lowest. Although not a randomized study, this paper highlights the shortcomings of the Cervex brush. We postulate a mechanical deficiency. Diagnostic accuracy rather than a high proportion of good quality smears should dictate the choice of instrument.     

Analysis of five sampling methods for the preparation of cervical smears

The quality of the cervical smear, a decisive factor in the efficacy of population screening, can depend on the sampling method utilized. An analysis was made of the performance of five sample takers in a screening program, each of whom had made approximately 5,000 smears, and of the five sampling methods each had used: spatula alone (method A), Cytobrush plus spatula (method B), Cytopick (method C), cotton swab plus spatula (method D) and Cervex brush (method E). The differences between the sample takers and the sampling methods were significant in both the detection of grade III cervical intraepithelial neoplasia (CIN III) (P less than .01) and in the production of smears containing endocervical cells (EC+) (P less than .018). The data obtained firmly establish the importance of the presence of endocervical cells for smear adequacy. The results of this study indicate that (1) method B (Cytobrush plus spatula) and method C (Cytopick) give superior results in the preparation of EC+ smears and in the detection of CIN III and thus should be used in population screening programs, and (2) methods A and D should not be used for cervical cytologic sampling in such programs.     

Relation between sampling device and detection of abnormality in cervical smears: a meta-analysis of randomised and quasi-randomised studies.

OBJECTIVE: To assess the diagnostic yield of different sampling devices used in cervical screening. DESIGN: Meta-analysis of randomised and quasi-randomised studies. SETTING: All randomised and quasi-randomised studies comparing the yield of cytological or histological abnormalities when two or more different sampling devices were used. SUBJECTS: 85,000 patients included in 29 studies reported in 28 papers. MAIN OUTCOME MEASURES: Pooled relative risk and 95% confidence interval of the yield of mild dysplasia or worse in smears recovered by each sampling method versus each other method with which it was compared; sensitivity or positive predictive value, or both, of cytological versus histological results in six studies from which sufficient data were available. RESULTS: There were no substantial differences in the yield of cytological abnormalities between the Ayre spatula, the Cytobrush, and the cotton swab used alone. There were also no substantial differences in the yield of cytological abnormalities between the extended tip spatula, the Ayre spatula combined with the Cytobrush or cotton swab, or the Cervex brush. The Ayre spatula, Cytobruah, or cotton swab used alone generally performed significantly worse than the combinations, the extended tip spatula, or the Cervex brush. There were no substantial differences in sensitivity or positive predictive value between the sampling methods. CONCLUSIONS: These results support the use of either the extended tip spatula, a combination of any spatula plus the Cytobrush or cotton swab, or the Cervex brush for cervical screening.     

Efficacy of cotton-tipped applicators for obtaining cells from the uterine cervix for Papanicolaou smears

A study was made of the efficacy of two techniques for the preparation of Papanicolaou smears. In one technique ("swab-spatula technique"), a scraping of the endocervix with a saline-moistened cotton-tipped applicator was combined with a scraping of the ectocervix with a plastic spatula. In the second technique ("swab technique"), the endocervix and ectocervix were scraped with only a saline-moistened cotton-tipped applicator. The swab technique produced more inadequate smears with a scanty cellular yield (24/408 = 6%) than did the swab-spatula technique (9/361 = 3%). The swab technique also produced higher false-negative rates (60% for CIN I, 42% for CIN II, 16% for CIN III, 20% for invasive cancer, and 32% overall) as compared with those of the swab-spatula technique (27% for CIN I, 29% for CIN II, 14% for CIN III, 0% for invasive cancer and 18% overall). Because of the higher rates of inadequate samples and false negativity in smears prepared by cotton-tipped applicators alone, it is recommended that the spatula not be omitted in taking cervical samples for the preparation of Papanicolaou smears for the detection of dysplasia or cancer. This study also reflects a poor performance of a cervical cancer detection system in the setting of a major medical school and suggests the need for instruction and periodic evaluation of the performance of the staff taking the smears. This study also substantiates doubt on the value of a second recent smear as a follow-up procedure for cervical dysplasia.     

Adequacy of cervical cytology sampling with the Cervex brush and the Aylesbury spatula: a population based randomised controlled trial.

OBJECTIVE: To compare the adequacy of cervical cytology sampling with two sampling instruments commonly used in primary care-namely, the Aylesbury spatula and the Cervex brush. DESIGN: Pair matched, population based randomised controlled trial. SETTING: 86 general practices and family planning clinics in Greater Manchester. SUBJECTS: 15 882 cervical smears taken from women aged 20-64 years as part of the national cervical screening programme. INTERVENTIONS: Participating centres were allocated to sample with either the Cervex brush or the Aylesbury spatula. MAIN OUTCOME MEASURE: Inadequate smear rate. RESULTS: 5.4% and 5.5% (433/8086 and 426/7796) of smears taken with the Cervex brush and the Aylesbury spatula respectively were reported as inadequate (odds ratio 0.95; 95% confidence interval 0.74 to 1.22). CONCLUSION: The Cervex brush offers no advantage over the Aylesbury spatula in reducing inadequate smear rates in the primary care setting.     

Comparison of spatula and nonspatula methods for cervical sampling

A comparison between nonspatula (cotton swab and Cytobrush) cervical sampling methods and spatula (wooden Ayre spatula and plastic extended-tip Szalay Cyto-Spatula) sampling methods was made in 109 cases. Based on the presence of endocervical cells, there were statistically significant qualitative differences between the non-spatula methods as well as between the spatula methods, but not between the Cytobrush and Cyto-Spatula smears or the cotton swab and Ayre spatula smears. In all kinds of inflammatory lesions, the spatula samples were more accurate and diagnostic than the nonspatula ones. In all cases of cervical intraepithelial neoplasia and in most cases of squamous metaplasia, the Cyto-Spatula sample was the most accurate. It is concluded that the Szalay Cyto-Spatula method is superior to the other cervical sampling methods because it provides well-preserved cells from both the endocervix and the ectocervix in one smear. The Cytobrush should be used in conjunction with spatula sampling (combination method) for effective sampling of the cervix. 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.     

Consequences of the introduction of combined spatula and Cytobrush sampling for cervical cytology. Improvements in smear quality and detection rates

One of the most important yardsticks for evaluating sampling for the detection of premalignant and malignant cervical lesions is the percentage of smears that contain cells from the transformation zone. Until February 1985, all smears made by around 500 different general practitioners were taken with a modified Ayre spatula. In the period February to October 1985, 24,496 smears of spatula samples and 5,716 smears prepared by combined spatula-Cytobrush sampling were analyzed. With the introduction of the combined spatula-Cytobrush method, the rate of smears containing cells from the transformation zone (adequate smears) rose from 84% to 98%. With the spatula-alone method, there were large differences between the rates of adequate smears from the various doctors; with the combined spatula-Cytobrush method, all participating doctors were without exception highly successful. The positive cytology rate was significantly higher in the combined spatula-Cytobrush smears (0.75%) as compared with the spatula-alone smears (0.38%). There was also a change in the diagnostic pattern in that more premalignant changes of the glandular epithelium of the endocervix were detected. One case of early invasive adenocarcinoma of the endocervix, in which the combined spatula-Cytobrush smears was positive and the repeat spatula-alone smear made by the gynecologist was negative, is discussed in detail. We anticipate that, with the large-scale introduction of the Cytobrush sampling method, fewer repeat smears will be required and, in addition, the observed relative increase of endocervical adenocarcinoma of the endocervix will be halted. In addition, there will be fewer false-negative smears.     

Aylesbury and cervitula spatulas: a comparative study to assess the adequacy of cervical smears

OBJECTIVE: To assess whether the Aylesbury (Pharmaceutical Enterprises Ltd., Pinelands, Capetown, South Africa) or Cervitula spatula (Harwill Medical, Capetown, South Africa) is more effective for adequate cervical smears in obstetric and gynecology patients. STUDY DESIGN: The Cervitula spatula was compared with the Aylesbury spatula by taking a total of 160 smears, which were examined cytologically. This consisted of 40 obstetric and 40 gynecology patients. The sequence in which the spatiulas were used was determined by computer randomization. Our main outcome criterion was whether both ectocervical and endocervical cells were present, thus making the smear adequate. Our numbers were too small to draw conclusions on the cytologic abnormalities detected between the two spatulas. RESULTS: The Cervitula was more effective for the identification of endocervical cells in obstetric patients (P = .0008). When combining the obstetric and gynecology groups, the Cervitula was also better in obtaining endocervical cells, but this did not reach statistical significance (P = .016). CONCLUSION: Pap smear sampling with the Cervitula reduces the number of cases without endocervical cells, which would constitute an inadequate smear, requiring unnecessary recall of patients for repeat smears.     

Comparison of Cytobrush sampling, spatula sampling and combined Cytobrush-spatula sampling of the uterine cervix

Since the introduction of the Cytobrush for sampling the uterine cervix, some practitioners have ceased taking a concomitant cervical scraping using a spatula. To examine whether Cytobrush sampling alone is adequate for the diagnosis of cervical lesions, the Cytobrush and spatula samples in 444 smears (most with original diagnoses of at least mild dysplasia) were analyzed separately for the presence of diagnostic cells, endocervical cells and squamous cells. Of the 412 smears showing pathologic findings (mild to severe dysplasia or worse), diagnostic cells were present in 400 Cytobrush samples and in 369 spatula samples; the combination of both samples thus gave a 3% gain in correct diagnoses as compared to use of the Cytobrush samples alone. Another 18 smears would have been underdiagnosed based only on the Cytobrush samples. Endocervical cells were present in 95.3% of the Cytobrush samples and 83.8% of the spatula samples; squamous cells were present in 93.9% of the Cytobrush samples and 96.8% of the spatula samples. Analysis confirmed that it is important that the smear should contain both endocervical and squamous cells. A positive relationship between the absence of squamous cells in the Cytobrush sample and the probability of a false-negative assessment was suggested. It thus seems inadvisable to replace the combination sampling method by Cytobrush sampling alone, which may lead to a false-negative diagnosis.     

An assessment of partial rescreening as an internal quality control method for cervical smears

Partial screening was performed on 10 800 cervical smears, comprising 8640 filed negative and unsatisfactory smears and 2160 newly received smears prior to conventional screening. Each slide was screened for 30 s and those considered abnormal were reviewed by standard screening. Partial screening led to the detection of 27 additional infections and 44 additional cytological abnormalities. These detection rates are better than those obtained with the traditional method of rescreening only a proportion of smears. Amongst the smears partially screened before conventional screening, partial screening detected 37-66% of infections and 22-71% of cytological abnormalities. We recommend the use of partial rescreening of all negatively reported smears as a method of internal quality control in cervical cytology laboratories.     

Relationship between the diagnosis of epithelial abnormalities and the composition of cervical smears

The significance of endocervical columnar cells as a high-quality parameter of cervical smears was studied. In a cohort of women with two successive screenings, the consistency of the cellular composition of the cervical smears and the relation between the cellular composition of the smears and the frequency of the diagnosis of abnormal epithelial changes was investigated. At the first screening, a significantly higher number of epithelial abnormalities was found in smears with endocervical columnar cells than in smears without endocervical columnar cells. A significantly higher number of abnormal epithelial changes was found on the second screening in smears from women whose smears from the first screening did not contain endocervical columnar cells than in smears from women whose smears from the first screening did contain endocervical columnar cells. The presence of endocervical cells should be considered a very important indicator of the quality of cervical smears. The chance of missing an abnormal epithelial change is increased in smears without endocervical columnar cells. When endocervical columnar cells are absent, the smear should be considered to be of unreliable quality and a repeat smear should be taken after a short interval, unless the absence of columnar cells can be satisfactorily explained.     

Pap smear quality parameters of 3 sampling devices used by auxiliary nurse midwives on symptomatic rural Indian women

OBJECTIVE: To determine whether auxiliary nurse midwives (ANMs) could make good-quality Pap smears after focused training and to determine which sampling device is most effective in their hands in field practice areas. STUDY DESIGN: In a downstaging cervical cancer screening program, 394 symptomatic rural Indian women between the ages of 35 and 60 were identified by the ANMs in 2 villages, with a total population of 14,747, and were invited to have a smear taken. Two hundred of these symptomatic women responded. The ANMs were educated to render information on screening for cervical cancer and to take smears with 3 sampling devices--Ayre spatula, modified spatula (with extended tip) and Cytobrush (Medscand AB, Malm?, Sweden). The smears were evaluated for 6 adequacy parameters. Smears made by gynecologists were used as controls. To establish the superiority of a method, chi2 tests were used. RESULTS: All smears made by the ANMs could be used to render a cytologic diagnosis. The adequacy parameters of all the smears made by ANMs at least matched those of the gynecologists. The best results were obtained with modified spatula (with extended tip) and combination of Cytobrush with modified spatula. CONCLUSION: Since only 50% of symptomatic rural women came for Pap testing, we conclude it is not easy to motivate women for such testing, even if a large-scale educational effort is made. ANMs can be taught to take reasonably good qualisuperior sampling device for ANMs is ty Pap smears. The superior sampling device for ANMs is the modified spatula (with extended tip).     

Comparative evaluation of seven cell collection devices for cervical smears

OBJECTIVE: To compare the most commonly used cervical sampling devices. STUDY DESIGN: We examined seven cytology sampling devices (Cytobrush, Cervex brush, Szalay spatula, Papex spatula, WrGKK spatula [main social security agency in Vienna], cotton swab and loop). Eight hundred smears were assessed for even distribution of cells, percentage of slide surface covered with cells, and presence and number of endocervical cells. RESULTS: Even distribution of cells was best with the WrGKK spatula. Percentage of slide surface covered with evaluable cells was best with the Cytobrush. Highest ranking for the presence of endocervical cells was found for the Cytobrush. Cotton swabs and loop showed inferior results in all categories. CONCLUSION: The use of cervical cell sampling devices showing the best cytologic results improves the interpretation and validity of cervical smears. Our results suggest that cotton swabs and loops should not be used for cervical cell sampling.     

Rapid pre-screening of cervical smears as a method of internal quality control in a cervical screening programme

Objective:  To evaluate the performance of rapid pre-screening (RPS) as a method of internal quality control in the cytopathological examination of cervical smears for cervical cancer screening.
Methods:  The sample consisted of 6135 cervical smears submitted to RPS and routine screening (RS) methods. The smears classified as negative in RPS and RS were considered final diagnoses, and were not, therefore, submitted to any additional review. The smears identified as suspect or unsatisfactory according to RPS were analysed separately by two different cytologists irrespective of the diagnosis reached in RS. Smears considered abnormal or unsatisfactory at RS were also reviewed. When both cytologists issued concordant diagnoses, this was considered the final diagnosis. Discordant results were analysed by a third cytologist and a consensus meeting was held to define the final diagnosis.
Results:  Taking abnormalities detected by RS as the denominator, RPS had a sensitivity of 63.0% for the detection of all abnormal smears and 96.7% for high grade squamous intraepithelial lesion (HSIL). When compared with the final diagnosis, sensitivity of RPS for all abnormal smears was 74.9% and for HSIL 95.0%. Of the 529 abnormal smears confirmed in the final diagnosis, 2.15% were detected only by the RPS.
Conclusion:  RPS is an effective alternative method of internal quality control with high sensitivity for the detection of more severe lesions. It also permits monitoring of the laboratory rate of false-negative results, and allows constant evaluation of the performance both of the pre-screening and RS cytologists.     

Diagnostic accuracy of squamous cervical lesions studied in spatula-cytobrush smears

The cytologically positive cases found in 25,300 cervical smears of spatula samples and 6,168 smears prepared by combined spatula-Cytobrush sampling were analyzed. The diagnostic accuracy (the correlation between the cytologic and histologic diagnoses) was the same for both types of sampling. As to the histologic diagnosis, the rates of severe dysplasia, carcinoma in situ and squamous carcinoma in the spatula-Cytobrush group were more than twice as high as in the spatula group. In the spatula group, the majority of abnormal cells was of the mature type. In the spatula-Cytobrush group, the majority of smears contained a mixture of immature and mature abnormal cells. The more immature lesions, which are often located higher in the endocervical canal, seem to be better sampled by the Cytobrush. The results indicate that the Cytobrush reaches areas that a spatula cannot reach, resulting in a higher diagnostic efficiency.     

A comparison between the Accu-Pap device and the extended-tip wooden Ayre spatula for cervical cytology sampling

The wooden Ayre spatula with an extended endocervical tip was compared with both designs of the plastic Accu-Pap sampler in two series of 100 consecutive patients to compare their adequacy in obtaining samples for cervical cytology. There was no significant advantage noted in the smears taken by either spatula. In terms of the sequence of smears, the second smear generally contained more endocervical cells and less often showed an absence of diagnostic cells.     

Evaluation of PAPNET-assisted cervical rescreening

Evaluation of PAPNET-assisted cervical rescreening
We have compared the results of targeted manual rescreening of 1211 randomly selected smears with the results of PAPNET-assisted rescreening of 1613 cervical smears, containing at least 6.3% low-grade squamous intraepithelial lesion (SIL). PAPNET diagnosis and the targeted rescreening diagnosis were compared with the initial report, issued on the corresponding smear. Reproducibility scores for inadequacy, presence of endocervical and endometrial cells, specific infections and squamous cell abnormalities were determined. The reproducibility scores for the diagnosis of inadequate smears and specific infections were lower with the PAPNET-assisted rescreening. The detection of squamous cell abnormalities was excellent for both methods (>0.95), with a higher detection rate for false-negative smears with the PAPNET testing system.