MAN-04008-001 Rev. 001 Page 17 of 27
Table 18: Laboratory ThinPrep 5000 Diagnosis vs. Laboratory ThinPrep 2000 Diagnosis for First
Pair of Cytotechnologist/Pathologist (Combined Sites)
Lab
ThinPrep
5000
Diagnosis
Lab ThinPrep 2000 Diagnosis
UNSAT NILM ASC-US AGUS LSIL ASC-H HSIL Cancer Total
UNSAT 31 9 1 1 42
NILM 9 624 32 2 4 3 2 676
ASC-US 3 23 59 3 33 10 1 132
AGUS 1 5 7 1 3 3 20
LSIL 6 19 1 111 9 14 160
ASC-H 6 7 2 9 27 12 63
HSIL 2 12 16 109 2 141
Cancer 3 23 26
Total 44 673 119 16 170 66 144 28 1260
Reference Diagnosis by Adjudication Review
After all slides in the study were reviewed, all ThinPrep 2000 and ThinPrep 5000 slides were subject to an
adjudication review. Adjudication was done at a facility that was not one of the study sites conducting the study.
Slides for adjudication were evenly divided between three (3) adjudication panels each consisting of one (1)
cytotechnologist and three (3) independent pathologists. Each adjudication panel was blinded to the original
review diagnosis for all slides and each independent pathologist within each panel was also blinded to other
adjudicator’s diagnoses for all slides. Adjudication consensus agreement was obtained for each slide reviewed.
Consensus agreement was achieved when at least two (2) of the three (3) pathologists from a panel rendered an
identical diagnosis. In cases where consensus agreement was not achieved the panel members were brought
together at a multi-head microscope to review the slides together and come to a consensus diagnosis. For each
specimen, an adjudicated diagnosis for the ThinPrep 2000 slide and an adjudicated diagnosis for the ThinPrep
5000 slide were obtained.
Table 19: Adjudicated ThinPrep 5000 Diagnosis vs. Adjudicated ThinPrep 2000 Diagnosis
(Combined Sites)
Adjudicated
ThinPrep
5000
Diagnosis
Adjudicated ThinPrep 2000 Diagnosis
UNSAT NILM ASC-US AGUS LSIL ASC-H HSIL Cancer Total
UNSAT 14 8 1 23
NILM 12 696 39 8 9 2 4 770
ASC-US 33 48 4 26 7 4 122
AGUS 4 1 6 4 3 18
LSIL 12 20 135 3 10 180
ASC-H 7 4 2 6 7 11 37
HSIL 7 1 9 8 66 1 92
Cancer 2 16 18
Total 26 760 119 21 185 28 101 20 1260
For each specimen, the Reference Diagnosis (RD) was considered as the most abnormal diagnosis from the
adjudicated diagnoses of the ThinPrep 2000 and ThinPrep 5000 slides. In the study, there were 22 Cancer, 124
HSIL, 39 ASC-H, 202 LSIL, 23 AGUS, 120 ASC-US, and 696 NILM specimens. Thirty-four (34) specimens
had UNSAT either with ThinPrep 2000 or with ThinPrep 5000 or with both. Clinical sensitivity and specificity
(e.g., with reference to a histological diagnosis) cannot be measured in this study which relied on cytological
examination alone. Instead, laboratory positive and negative diagnoses by both methods, ThinPrep 5000 and
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