We report on the testing of a prototype of an electronic device for the detection of cervix cancer and its precursors, known as the Polarprobe. The device monitors three aspects of the cervix tissue; two relate to optical properties and the other to dielectric characteristics. The response to tissue stimulation takes the form of an energy pattern which, in conjunction with spectroscopic discriminants, can be digitized to prepare an algorithm. The pattern algorithms are sufficiently characteristic to be afforded names which correspond to tissue states recognizable as normal or abnormal by the clinician. On a tissue observation basis the previously established recognition algorithms derived from 106 volunteers produced assessments which related strongly to colposcopy/histology diagnoses obtained on 77 additional volunteers. This concordance between colposcopy/histology and Polarprobe diagnoses on this primary analysis subgroup ranged from 85% on low-grade intraepithelial abnormalities, and 90% on high-grade cervical intraepithelial squamous neoplasia, to 99% on invasive cancer. An extrapolation of these results suggests false-positive/false-negative rates in the order of 10% are achievable with the current Polarprobe device.

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We report on the results from a multicenter trial for a real time optoelectronic device as an adjunct to the Pap smear for cervical screening. TruScreen (Polartechnics Limited, Sydney, Australia) is an automated device which measures the response to optical and electrical stimulation of the cervix and returns a screening result in real time. Analysis was performed on a group of 651 subjects recruited at 10 centers. Cytology and histology analyses were performed by centralized laboratories, with the cytology classification performed according to the Bethesda 2001 system. The sensitivities for histologically confirmed CIN 2/3 lesions by TruScreen, Pap, and TruScreen/Pap combined were 70% (95% CI: 67-74), 69% (CI: 65-72), and 93% (CI: 91-95), respectively. For histologically reported CIN 1, the sensitivities of the TruScreen, Pap, and combined test were 67% (CI: 63-70), 45% (CI: 41-49), and 87% (CI: 84-89). The improvement in sensitivity for the combined test compared to the Pap smear alone was significant (P = 0.002). Because TruScreen and cytology detect partly different but overlapping groups of CIN cases, the adjunctive combination provides very high CIN detection rates.

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