Hologic Genius, Operator'S Manual

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Genius™ Digital Diagnostics System Instructions for Use English AW-22963-001 Rev. 001 3-2021 11/13
The study calculated the average cell count generated by the Genius Cervical AI algorithm
for each case across the three runs on each of the three Digital Imagers in the study. The
intra-instrument %CV in the study was 0.6%. The inter-instrument %CV in the study was 2.7%.
The study also estimated the systematic bias of the cell count generated by the Genius
Cervical AI algorithm as compared to the manual count, at a count of 5000 cells, the clinical
threshold for diagnosis. In the Bethesda System
1
, specimens with fewer than 5000 cells are
considered unsatisfactory for screening. The count bias in the study was 528, with a 95% CI
of -323 to 1379.
The results of the study demonstrate that the cell counts generated by the Genius Cervical
AI algorithm are comparable to a manual cell count performed by a cytotechnologist.
CONCLUSIONS
•
89.3% of abnormal slides have OOIs matching or exceeding the TIS-assisted review result.
•
On average, there are 6.8 OOIs that match or exceed the TIS-assisted result for abnormal
slides.
•
The standard deviation of number of matching OOIs is 1.3, for abnormal slides.
•
Endocervical component (ECC) is detected in the OOI gallery at an equal or higher rate
than in TIS-assisted reviews.
•
Trichomonas is detected in the OOI gallery at an equal or higher rate than in TIS-assisted
reviews.
•
Candida is detected in the OOI gallery at an equal or higher rate than in TIS-assisted
reviews.
•
Coccobacilli are detected in the OOI gallery at an equal or higher rate than in TIS-assisted
reviews.
•
The Genius Digital Diagnostics System provides cell counts adequate for determining if
specimen adequacy is sufficient for evaluating patient cases.
The data from the studies conducted on the Genius Digital Diagnostics System demonstrate that
the Genius Digital Diagnostics System, when used with the Genius Cervical AI algorithm, is
effective for assisting in cervical cancer screening of ThinPrep® Pap test slides, imaged on the
Genius Digital Imager for the presence of atypical cells, cervical neoplasia, including its precursor
lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial
Lesions), and carcinoma as well as all other cytological criteria, including adenocarcinoma, as
defined by The Bethesda System for Reporting Cervical Cytology
1
.