H ealth care professionals encounter multiple dilemmas with the surveillance, diagnosis, and management of women with cervical neoplasia. An imperfect screening test, a lengthy Papanicolaou (Pap) smear collection to notification interval, and a substantial patient noncompliance rate with recommended practices may all adversely impact the screening process [1][2][3][4][5][6][7][8]. Cervical neoplasia is suspected from an abnormal screening Pap smear or positive triage test for oncogenic human papillomavirus (HPV) DNA that is localized and detected by specific epithelial features noted during colposcopic examination of the lower genital tract. The diagnosis is confirmed by histologic results obtained from sampling the ectocervix and endocervical canal, when deemed necessary [9]. When results from these evaluations are considered collectively, optimal management ensues. Most of the tests involve a subjective appraisal that varies considerably and depends on specimen or anatomic variation, as well as evaluator expertise. Thus, diagnoses may be influenced adversely by technical issues and are not made consistently at an expert level; the diagnoses also are not always reproducible.
AbstractObjective. To determine the ability of Multimodal Hyperspectral Imaging (MHI) to noninvasively detect, localize and diagnose cervical neoplasia.Materials and Methods. The cervical epithelium was interrogated by MHI using tissue fluorescence and reflectance measurements after the probe was placed on the ectocervix. A Papanicolaou smear was taken, and a colposcopic examination was performed and cervical histologic specimens were collected, when indicated. MHI and Pap smear sensitivity and specificity data were compared with colposcopic and histologic results.Results. Nineteen patients had CIN2 or higher, 30 had CIN1, 34 had benign cellular changes or metaplasia, and 28 were normal by both Pap smear and colposcopic examination. At equal specificity (70%) for both tests, the sensitivity of MHI was 97%, compared to 72% for the Pap smear.Conclusion. MHI detected cervical cancer precursors at a rate greater than that obtained by a simultaneously collected Pap smear.
Application of continuous vacuum pressure on skin perforated with tiny micropores created by a focused beam from a low-cost laser system can result in access to a clear, transdermal body fluid (TDF) for the continuous measurement of glucose in vivo. Two clinical studies were performed to assess the feasibility of this approach. In the first study, 56 diabetic subjects were porated on either the arm or abdomen, and glucose was measured in their TDF using a custom assay system contained in a patch that was affixed to the skin above the poration site. The continuous readings of glucose in TDF were compared with fingerstick blood measured every half-hour over a 2-day period, resulting in 1,167 paired data points that yielded a correlation of 0.8745 with 97.75% of the readings in the Clarke Error Grid A and B zones. In a second study, 187 diabetic and 65 nondiabetic subjects had glucose measurements from their TDF made using a commercially available glucose strip and meter. A total of 4,059 data pairs (discrete TDF and capillary blood) were collected over a 2-day period, resulting in a correlation of 0.946 with 99% of the readings in the Clarke Error Grid A and B zones. These studies indicate that TDF drawn through micropores in the stratum corneum of the skin potentially can provide a lesser invasive and continuous method of measuring glucose in diabetic individuals.
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