The diagnostic reliability of urinary cytology: a retrospective study.

The aim of this study was twofold. The first aim was to estimate the diagnostic reliability of urinary cytology for detection and management of urothelial neoplasms by using a specific preserving fluid for sample collection, and the liquid-based thin layer method for specimen preparation, the estimate was based on the correlation between the cytological findings of 10,000 non-hospitalized patients, and their histological diagnoses. A second aim was to compare the reliability of two instruments for thin-layer preparation, i.e., TP2000, TP3000, capable of processing the specimens at very different rates. The preservation of cell structure is ameliorated by the procedure of sample collection and treatment here described. This allows a more accurate reading of LBC slides as shown by: (a) the significant concordance between cytological and histological diagnosis (92%); (b) the significant number of low-grade urothelial carcinomas (20.5%) revealed by urinary cytology and validated by histologic diagnosis; (c) the low rate (8%) of misjudgement of cytological diagnosis reached in this study. The quality of performances of the two instruments tested for thin-layer preparation, i.e., TP2000 and TP3000, is statistically comparable. We recommend the procedure that makes use of preserving fluid for sample collection (cytolyt™) and treatment (preservcyt ™) as here described. We also recommend the use of thin-layer method for specimen preparation since it allows a more uniform distribution of the cells on the support with reduction of overlapping phenomena. Finally, economic considerations suggest the preferential use of Thin Prep 3000.

External quality assurance in cervical/vaginal cytology: Interlaboratory agreement in the Emilia-Romagna region of Italy.

OBJECTIVE: To evaluate the diagnostic agreement between seven cervical/vaginal cytology laboratories participating in the first external quality assurance (EQA) scheme developed in Italy. STUDY DESIGN: Between 1991 and 1993, 110 cytologic smears were selected and classified by a committee and circulated and reported on by the laboratories according to the 1988 Bethesda System. Agreement was evaluated with the kappa statistic. Systematic disagreement was assessed by means of the Wilcoxon signed rank test. RESULTS: Interlaboratory kappa values varied between .01 and .29 (group score, .11) for sample adequacy and between .53 and .78 (group score, .67) for epithelial abnormalities. The lowest specific kappa values were observed for the three classes of sample adequacy (unsatisfactory, .07; less than optimal [LTO], .10; satisfactory [SAT], .14) and for the class of atypical cells of undetermined significance (ACUS), (.29). As compared with the study committee, 5/7 laboratories showed a systematic (P<.01) tendency to undercall sample adequacy. Agreement on epithelial abnormalities was also analyzed according to the pattern of adequacy reported by paired laboratories (LTO/LTO, LTO/SAT, SAT/SAT). As compared with smears designated SAT/SAT, those classified as LTO/SAT were associated with lower specific kappa values for agreement on the presence of carcinoma and ACUS and with equal or greater values for agreement on the other classes, suggesting an arbitrary use of notations of LTO inversely related to the severity of epithelial lesions. CONCLUSION: EQA schemes, as applied to cervical/vaginal cytology, can shed light on major deficiencies in specific diagnostic areas.

HPV typing of cervical squamous lesions by in situ HPV DNA hybridization: influence of HPV type and therapy on the follow-up of low-grade squamous cervical disease.

Papanicolaou (Pap)-stained cervical specimens from 160 squamous lesions were processed for the detection of human papillomavirus (HPV) DNA by an in situ hybridization (ISH) assay. Three biotinylated HPV DNA probes were employed, each containing HPV genotypes 6/11, HPV genotypes 16/18, or HPV genotypes 31/35/51. The HPV etiology of 86 lesions was ascertained (53.8%). In 74 out of 135 (58.8%) HPV-typed low-grade squamous intraepithelial lesions (SILs), HPV 6/11 was found in nine (6.6%), HPV 16/18 in 46 (34.2%), and HPV 31/35/51 in 19 lesions (14.1%); in 11 out of 18 HPV-typed high-grade SILs (61.1%), seven lesions (38.9%) were typed for HPV 16/18 and four (22.2%) for HPV 31/35/51. Of seven invasive carcinomas, only one (14.3%) reacted with the HPV 16/18 DNA probe. A cohort of 124 low-grade SILs were followed cytologically for a year. The results of this study are discussed in light of HPV type association and therapy.

Human papillomavirus DNA detection in Papanicolaou-stained cervical smears with a nonradioactive, in situ hybridization assay.

Archived Papanicolaou-stained cervical smears from women with different cervical pathologies were processed for human papillomavirus (HPV) DNA detection and typing with an in situ hybridization (ISH) assay that employed commercial biotinylated HPV DNA probes. Two HPV DNA probes were utilized: one included HPV genotypes 6/11 and the other, 16/18. The method yielded positive results for HPV DNA 6/11 in 5 cases with condylomata acuminata (100%) and in 2 of 47 with flat warty lesions (4.2%), whereas HPV DNA 16/18 was detected in 29/47 of the latter group (61.7%). In cases with cervical intraepithelial III or invasive squamous cell carcinoma the yield was lower: positive results for HPV DNA 16/18 were obtained in only one of the five cases with one or the other cervical pathology (20%). An analysis of the results showed that the sensitivity of the assay correlated with evidence in the Papanicolaou specimens of pathognomonic cell injury from HPV infection. In the presence of such cytologic features, HPV DNA typing was possible in 37/52 cases (65.4%). In view of the modest difficulty and relatively quick execution of the nonradioactive ISH assay, the authors believe that Papanicolaou cervical smears with cytologic changes of HPV infection could be processed by this method in order to acquire information on the HPV type or types involved in the cervical infection.

Detection of Chlamydia trachomatis in Papanicolaou-stained cervical smears: control study by in situ hybridization.

Ninety-one Papanicolaou-stained vaginopancervical smears were destained and subjected to in situ hybridization with Chlamydia trachomatis DNA probe. At cytologic examination (Pap test), 71 smears showed changes suggestive of chlamydial infection, while remaining 20 were negative. At the control by in situ hybridization, the results of Pap test were confirmed in 85 out of 91 cases, two false-positive and four false-negative cases being detected. The sensitivity and specificity of Pap test, compared with in situ hybridization, were 95% and 89%, respectively. Like some recent reports, the present study confirms the reliability of Pap test in the detection of Chlamydia trachomatis and its possible relevant role in reducing the diffusion of the infection, when properly applied to mass-screening program.

Chlamydia trachomatis infections in asymptomatic women. Results of a study employing different staining techniques.

A total of 300 cervical smears randomly collected from asymptomatic women in a mass-screening program for the detection of cervical carcinoma was investigated for Chlamydia trachomatis infection by the use of Papanicolaou and immunofluorescence staining. Features of chlamydial infection detected in 18 cases by Papanicolaou-stained smears were confirmed in 11 cases with immunofluorescence; not a single case that was negative in the Papanicolaou-stained smears was positive by immunofluorescence. The presence of Chlamydia in the Papanicolaou-stained smears in ten cases, including two cases that were negative by immunofluorescence, was also proven by either immunoperoxidase staining or in situ hybridization. On the other hand, either immunoperoxidase or in situ hybridization gave false-negative results in two of the ten cases. Therefore, the combined use of different techniques demonstrated that false-negative results occurred with all techniques, except with Papanicolaou-stained smears, whose sensitivity is apparently the highest.