MAN-02060-001 Rev. 005 page 1 of 14
Instructions For Use
Page 1: ...MAN 02060 001 Rev 005 page 1 of 14 Instructions For Use...
Page 2: ...ThinPrep Pap Test Filter during the collection process in order to prevent the cellular presentation from being too scant or too dense A thin layer of cells is then transferred to a glass slide in a...
Page 3: ...by cytotechnologists and pathologists who have been trained to evaluate ThinPrep prepared slides by Hologic or by organizations or individuals designated by Hologic Supplies used in the ThinPrep 2000...
Page 4: ...o C 59o F and 30o C 86o F and tested within 6 weeks of collection PreservCyt Solution with cytologic sample intended for CT NG testing using the Roche Diagnostics COBAS AMPLICOR CT NG test must be sto...
Page 5: ...ositive slides from all sites in a blinded fashion to provide a further objective review of the results LABORATORY AND PATIENT CHARACTERISTICS Cytology laboratories at three screening centers designat...
Page 6: ...Prep NEG 5224 295 3 60 11 0 0 5593 ASCUS 318 125 2 45 7 0 0 497 AGUS 13 2 3 0 1 0 1 20 LSIL 114 84 0 227 44 0 0 469 HSIL 11 15 0 35 104 2 0 167 SQ CA 0 0 0 0 0 1 0 1 GL CA 0 0 0 0 0 0 0 0 TOTAL 5680 5...
Page 7: ...and was statistically equivalent at two sites Table 7 Results by Site ASCUS AGUS and More Severe Lesions Site Cases ThinPrep ASCUS Convent ASCUS Increased Detection p Value Method Favored S1 1 336 117...
Page 8: ...ive by Independent Pathologist ThinPrep Positive Conventional Positive p Value Method Favored S1 50 33 25 0 170 Neither S2 65 48 33 0 042 ThinPrep S3 77 54 33 0 001 ThinPrep H1 116 102 81 0 001 ThinPr...
Page 9: ...c undetermined LSIL HSIL Carcinoma Glandular Cell Benign Endometrial cells in Postmenopausal Women Atypical Glandular Cells AGUS favor reactive favor neoplastic undetermined Endocervical Adenocarcinom...
Page 10: ...actory 5656 78 3 5101 70 6 Satisfactory for Evaluation but Limited by Air Drying Artifact Thick Smear Endocervical Component Absent Scant Squamous Epithelial Component Obscuring Blood Obscuring Inflam...
Page 11: ...ECC s Conventional SBLB no ECC s Conventional SBLB no ECC s S1 1 386 237 17 1 162 11 7 S2 1 668 104 6 2 73 4 4 S3 1 093 145 13 3 84 7 7 H1 1 046 229 21 9 115 11 0 H2 1 049 305 29 1 150 14 3 H3 981 12...
Page 12: ...her group made up of patients representative of a referral population enrolled at the time of colposcopic examination The ThinPrep specimens were collected prospectively and compared against a histori...
Page 13: ...ONCLUSIONS The ThinPrep 2000 System is as effective as the conventional Pap smear in a variety of patient populations and may be used as a replacement for the conventional Pap smear method for the det...
Page 14: ...otes detection of glandular lesions of the endocervix Diagn Cytopathol 2000 23 19 22 6 Carpenter AB Davey DD ThinPrep Pap Test Performance and biopsy follow up un a university hospital Cancer Cytopath...
