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Summary of Contents for Hologic ThinPrep 2000
- Page 1 Instructions For Use MAN-02060-001 Rev. 005 page 1 of 14...
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Page 2: Intended Use
ThinPrep sample vial is then capped, labeled, and sent to a laboratory equipped with a ThinPrep 2000 Processor. At the laboratory, the PreservCyt sample vial is placed into a ThinPrep 2000 Processor and a gentle dispersion step breaks up blood, mucus, non-diagnostic debris, and thoroughly mixes the cell sample. - Page 3 PreservCyt Solution for collection, transport, storage, and preparation of specimens for use in those systems. The PreservCyt Solution component of the ThinPrep 2000 System is also an alternative collection and transport medium for gynecologic specimens tested with the Roche Diagnostics COBAS AMPLICOR CT/NG assay.
- Page 4 PRECAUTIONS Specific processing steps must be followed before and during use of the ThinPrep 2000 processor if planning to perform Chlamydia trachomatis and Neisseria gonorrhoeae testing, using the Roche Diagnostics COBAS AMPLICOR CT/NG test, on the residual specimen after a slide has been prepared using a ThinPrep 2000 processor.
- Page 5 PreservCyt Solution. At the laboratory, the PreservCyt sample vial was placed into a ThinPrep 2000 Processor and a slide was then prepared from the patient’s sample. ThinPrep and conventional Pap smear slides were examined and diagnosed independently.
- Page 6 CLINICAL STUDY RESULTS The diagnostic categories of The Bethesda System were used as the basis of the comparison between conventional and ThinPrep findings from the clinical study. The diagnostic classification data and ® statistical analyses for all clinical sites are presented in Tables 2 through 11. Cases with incorrect paperwork, patient’s age less than 18 years, cytologically unsatisfactory slides, or patients with a hysterectomy were excluded from this analysis.
- Page 7 Table 5: Two Category Diagnostic Classification Table, ASCUS/AGUS and More Severe Diagnoses ASCUS/AGUS+ TOTAL ThinPrep 5224 5593 ASCUS/ 1154 AGUS+ TOTAL 5680 1067 6747 The diagnostic data analysis from the sites is summarized in Table 6 and 7. When the p-value is significant (p < 0.05), the method favored is indicated in the tables.
- Page 8 The reference diagnosis was the more severe diagnosis from either of the ThinPrep or conventional Pap slides as determined by the independent pathologist. The number of slides diagnosed as abnormal at each site, compared to the reference diagnosis of the independent pathologist, provides the proportion of LSIL or more severe lesions (Table 8) and the proportion of ASCUS/AGUS or more severe lesions (Table 9).
- Page 9 Table 10 below shows the summary for all sites of the descriptive diagnosis for all Bethesda System categories. Table 10: Summary of Descriptive Diagnosis Descriptive Diagnosis ThinPrep Conventional Number of Patients: 6747 Benign Cellular Changes: 1592 23.6 1591 23.6 Infection: Trichomonas Vaginalis Candida spp.
- Page 10 ® vial, without first making a conventional Pap smear. This specimen collection technique is the intended use for the ThinPrep 2000 System. Tables 15 and 16 present the split sample and direct to vial results. Table 12: Summary of Specimen Adequacy Results...
- Page 11 Table 14: Specimen Adequacy Results by Site Site Cases Thin Con- Thin Con- Thin Con- Prep vent. Prep vent. Prep vent. SBLB SBLB UNSAT UNSAT Cases Cases Cases Cases Cases Cases 1,386 1092 1178 1,668 1530 1477 1,093 1,046 1,049 All Sites 7,223 5656...
- Page 12 Following initial FDA approval of the ThinPrep System, Hologic conducted a multi-site direct-to-vial clinical study to evaluate the ThinPrep 2000 System versus conventional Pap smear for the detection of High Grade Squamous Intraepithelial and more severe lesions (HSIL+). Two types of patient groups were enrolled in the trial from ten (10) leading academic hospitals in major metropolitan areas throughout the United States.
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Page 13: Materials Required
Multiple peer-reviewed publications report on the improved ability of the ThinPrep 2000 System to detect glandular disease versus the conventional Pap smear. Although these studies do not consistently address sensitivity of different Pap testing... - Page 14 9. Wang N, Emancipator SN, Rose P, Rodriguez M, Abdul-Karim FW. Histologic follow-up of atypical endocervical cells. Liquid-based, thin-layer preparation vs. conventional Pap smear. Acta Cytol 2002; 46: 453-7 TECHNICAL SERVICE AND PRODUCT INFORMATION For technical service and assistance related to use of the ThinPrep 2000 System, contact Hologic: Telephone: 1-800-442-9892 Fax: 1-508-229-2795 For international or toll-free blocked calls, please contact 1-508-263-2900.
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