Efficacy of a real time optoelectronic device (TruScreen™) in detecting cervical intraepithelial pathologies: a prospective observational study

Özgü, Emre; Yıldız, Yunus; Özgü, Burçin Salman; Öz, Murat; Danışman, Nuri; Güngör, Tayfun

doi:10.5152/jtgga.2015.15199

Cited by 10 publications

(9 citation statements)

References 13 publications

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“…demonstrated a 67.4% sensitivity for TruScreen™ and an 87.9% for conventional cytology in detections with a histological confirmation of CINs. [ 17 ] In 2014, the use of TruScreen™ as the screening procedure for detecting CC resulted in an 86.1% sensitivity and 35% specificity, demonstrating a greater sensitivity than the gold standard, which is the PAP, with instantaneous results and without the need for interpretation by cytopathology, which has the additional disadvantage of being operator-dependent. [ 18 ]…”

Section: Discussionmentioning

confidence: 99%

“…This is, to our knowledge, the first study conducted in Mexico and Latin America in which we can observe that for the detection of high-grade intraepithelial lesions, TruScreen™ demonstrated low sensitivity and high specificity compared with conventional cytology, with a high NPV. The impact of this study lies in the possible diagnostic usefulness of the TruScreen™ in not having to wait for the result of the PAP and in the fact that the results can be similar to those obtained by conventional cytology, in which the sensitivity can be similarly low, reaching 51.5%, as shown in a study performed in the U.S. with more than 47,000 patients submitted to a conventional cytology,[ 17 ] and the advantages of diminishing the need of a pathological report and establishing a protocol of treatment from the first clinical assessment prior to an abnormal result for the opto-electronic device. The greatest impact of the latter would be in primary care-level services, where a high percentage of patients who have a screening test, such as conventional cytology, do not return for the results or the results take a long time to be delivered.…”

Section: Onclusionsmentioning

confidence: 93%

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Cervicouterine cancer screening – TruScreen™ vs. conventional cytology: Pilot study

Salazar-Campos

González-Enciso²,

Díaz-Molina

et al. 2018

J Cytol

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Introduction:Cervicouterine cancer (CC) is a health problem worldwide and is the fourth most common cancer in women, with a greater proportion of individuals affected by advanced stages of the disease in developing countries.Objective:To determine the sensitivity and specificity of the TruScreen™ opto-electronic device vs. conventional cytology in CC screenings.Methodology:This is a prospective observational study that included individuals who presented for the first time at the Dysplasia Clinic of the Instituto Nacional de Cancerología from March 1 through April 30, 2016, and those referred due to abnormal conventional cytology. The patients were evaluated with the TruScreen™ device, conventional cytology, colposcopy and, if necessary, cervical biopsy. The results were analyzed by descriptive statistics as well as the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the TruScreen™, using conventional cytology as the standard.Results:Thirty-two patients were included who met the inclusion criteria. The average age of the patients was 40 years (range, 23–61 years). For the diagnosis of high-grade intraepithelial lesions, the TruScreen™ device showed a 43% sensitivity, a 92% specificity, a PPV of 60%, and a NPV of 85%, whereas evaluation via cervical biopsy exhibited a 33% sensitivity, an 86% specificity, a 33% PPV, and an 86% NPV. The Kappa agreement index of the TruScreen™ with the colposcopies was 0.70.Conclusions:TruScreen™ demonstrated low sensitivity and high specificity compared with conventional cytology, which had a high NPV.

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Section: Discussionmentioning

confidence: 99%

Section: Onclusionsmentioning

confidence: 93%

Cervicouterine cancer screening – TruScreen™ vs. conventional cytology: Pilot study

Salazar-Campos

González-Enciso²,

Díaz-Molina

et al. 2018

J Cytol

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“…TruScreen (TS) is a non-invasive diagnostic method for CIN with immediate and automatically generated results [13]. Briefly, it detects and analyzes cervical tissues through optoelectronic signals emitted from the tip of the device.…”

Section: Introductionmentioning

confidence: 99%

Significant specificity of TruScreen in cervical cytology of ASC and LSIL women with incomplete cervical transformation zone type during COVID-19 post-pandemic in China: a prospective study

Yang,

He,

Xiao

et al. 2024

Preprint

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Objective: To evaluate the efficacy of TruScreen (TS) detecting cervical intraepithelial neoplasia (CIN) in cytology of atypical squamous cells (ASC) and low-grade squamous intraepithelial lesion (LSIL) women during COVID-19 post-pandemic. Design: Prospective, single-center study. Setting: Changsha, China. Population: ASC and LSIL women from December 2020 to May 2021. Methods: Participants underwent TS, colposcopy examination and biopsy in turn. Diagnostic value of TS, high-risk human papillomavirus (hrHPV) and TS combined with hrHPV were compared. Differences of TS regarding cervical transformation zone (TZ) type and menopause, correlations between TS and p16, Ki-67 were assessed. Main outcome measures: Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and area under curve (AUC) for diagnostic value. Spearman coefficient for correlation. Results: A total of 483 patients were enrolled. Specificity of TS detecting CIN1+, CIN2+, CIN3+ were 77.1% (95% CI, 70.4%-82.7%), 66.7% (95% CI, 61.5%-71.5%), 62.7% (95% CI, 57.8%-67.4%) and all were significantly higher than hrHPV test (P<0.001). TS had a high sensitivity (68.0% vs 52.0%, P>0.05) and significantly higher specificity (70.0% vs 48.5%, P<0.05) and NPV (89.6% vs 73.3%, P<0.05) in women with incomplete cervical TZ type (II and III) than TZ type I in detection of CIN2+. Conclusion: TS is an effective triage screening method for cervical cytology of ASC and LSIL women during COVID-19 post-pandemic, especially for incomplete cervical TZ type women. Funding: Supported by National Natural Science Foundation Project of China (81771546) and Hunan Science and Technology Innovation Project (2020SK53404). Keywords: TruScreen; Cervical cancer screening; Cervical transformation zone; CIN; COVID-19.

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“…However, at present, most of the studies on cervical cancer screening by TS have been based on small sample clinical patients, and the evaluation of the screening effect of TS has shown wide differences in different studies. Some studies showed that the effect of TS is consistent with that of cytology, but some studies show that its screening effect is not as good as that of cytology [10][11][12]. So in the real world, is there any difference in the detection rate of cervical lesion between TS and human papillomavirus (HPV) test and Liquid-based cytology (LBC) test which currently used in the project area of NCCSPRA?…”

Section: Introductionmentioning

confidence: 99%

Comparison of the detection rate of cervical lesion with TruScreen, LBC test and HPV test: A Real-world study based on population screening of cervical cancer in rural areas of China

et al. 2020

PLoS ONE

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Background and objective China carries a heavy burden of cervical cancer and has an alarmingly low cervical cancer screening rate. In order to achieve the goal of cervical cancer elimination, there is an urgent need for suitable methods and strategies in China. Materials and methods A total 9972 woman who received cervical cancer screening services of National Cervical Cancer Screening Program in Rural Areas (NCCSPRA) in 8 project counties participated in this study. TruScreen, HPV test and LBC test were performed in all participants. A total of 1945women had one or more than one positive or abnormal screening results of the above three screening tests subsequently received colposcopy. The detection rate of CIN2+ between the three tests were compared. Results No matter what kind of screening method is used, the CIN2+ detection rate in the eastern regions was much higher than that in the central and western regions. The total detection rate of CIN2+ in HPV group was highest (0.73%), following in LBC group (0.44%) and TS group (0.31%). There was statistically significant difference in the total detection rate of CIN2+ between TS and HPV groups, LBC and HPV groups, respectively. There was no statistical difference in the total detection rate of CIN2+ between TS and LBC screening groups. Moreover, except for the eastern regions, there was no statistical difference in the detection rate of CIN2+ between TS group and the other two groups in central and western regions. Conclusion If it can meet the requirements of the laboratory and personnel, HPV test seems to be the preferred method for cervical cancer screening in rural areas of China. The characteristics of minimal training requirements, simple operation, real-time results obtained without the collection of cervical cell samples and the help of laboratory equipment and cytologists of TS make it ideal for cervical cancer screening in low-resource regions.

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Efficacy of a real time optoelectronic device (TruScreen™) in detecting cervical intraepithelial pathologies: a prospective observational study

Cited by 10 publications

References 13 publications

Cervicouterine cancer screening – TruScreen™ vs. conventional cytology: Pilot study

Cervicouterine cancer screening – TruScreen™ vs. conventional cytology: Pilot study

Significant specificity of TruScreen in cervical cytology of ASC and LSIL women with incomplete cervical transformation zone type during COVID-19 post-pandemic in China: a prospective study

Comparison of the detection rate of cervical lesion with TruScreen, LBC test and HPV test: A Real-world study based on population screening of cervical cancer in rural areas of China

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