Fluorescence colposcope with TMTP1-PEG4-ICG is comparable to the conventional colposcope in identifying cervical precancerous lesions: A randomized controlled trial.

OBJECTIVE: To compare the diagnostic efficiency of a fluorescence colposcope with TMTP1-PEG4-ICG dye versus a conventional colposcope with acetic acid and Lugol's iodine in identifying cervical precancerous lesions. METHODS: In all, 218 women with abnormal cervical cancer screening results including cytology and/or human papillomavirus (HPV) test were involved in the randomized controlled trial. Patients in the fluorescence colposcope group had TMTP1-PEG4-ICG dye applied to the cervix uteri before colposcopy. Patients in the conventional colposcope group were routinely administered acetic acid and Lugol's iodine to stain the cervix uteri. Two to four cervical sites per patient were taken out for biopsy. The diagnostic efficiency of fluorescence colposcopy and conventional colposcopy was calculated on a per-patient and per-site basis. χ2 test or Fisher exact test was used. RESULTS: A total of 194 patients and the corresponding 662 cervical sites were included in the final analysis. There was no statistically significant difference in the diagnostic efficiency between the two groups both on a per-patient and a per-site basis, including accuracy, sensitivity, specificity, positive predictive value, and negative predictive value. CONCLUSIONS: The fluorescence colposcope with TMTP1-PEG4-ICG dye was comparable to the conventional colposcope in identifying cervical precancerous lesions.

Can portable Colposcopes Replace Standard-of-care Colposcopes? A Crossover Trial of Two Portable Colposcopes with a Standard-of-Care Video Colposcope.

BACKGROUND: Screen positive women need to be triaged by colposcopy which is a major challenge in low-middle income countries. Portable colposcopes may overcome many challenges, reduce referrals and enable a single visit approach. This study assessed the performance of portable colposcopes and potential to reduce referral. METHOD: This crossover randomised study enrolled women aged 25 to 65 years with abnormal screening result or cervical symptoms. All women underwent visual inspection with acetic acid (VIA), HPV test, colposcopy with two portable colposcopes (Gynocular®, Gynius, Sweden, and Pocket® transvaginal colposcope, Duke University, NC, USA) and a standard video colposcope, and biopsy. Colposcopic Swede score agreement between portable and video colposcopes, as well as agreement of Swede score with histology were calculated for each device. The potential impact of portable colposcopes in a single visit approach was assessed based on the final diagnosis. RESULTS: Among 250 subjects, 27(10.80%) had high-grade cervical intraepithelial neoplasia (CIN2+) lesions. Swede scores for Pocket and Gynocular colposcopes were similar to video colposcope in 248 (99.20%) and 247 (98.80%) subjects, respectively (agreement scores 0.9969 and 0.9954, respectively). At a Swede score cut-off of ≥5, all three devices had identical sensitivity, specificity, positive and negative predictive value of 96.30%, 92.30%, 60.50% and 99.50,. Ablative treatment offered at field setting would result in optimal treatment in 52.0% and 85.1% cases when screened with VIA and HPV test respectively; using Pocket colposcope could improve this to 94.0% and 95.9%, respectively. Overtreatment and referral rates reduced from 46.8% and 12.4% to 4.8% and 6.0%, respectively, when VIA test is followed by triage with pocket colposcope. These outcomes were comparable to screening with HPV followed by colposcopy triage. CONCLUSIONS: Pocket colposcope performed comparably to the video colposcope. Used by healthcare providers in the field setting, they can augment the results of VIA significantly.

Absence of lower genital tract lesions among women of reproductive age infected with Schistosoma mansoni: A cross-sectional study using a colposcope in Western Kenya.

BACKGROUND: Female genital schistosomiasis (FGS) constitutes four different lesions known to be caused by Schistosoma haematobium ova deposited in the genital tract. Schistosoma mansoni ova may also be found in the genital tract. However, it is not known if S. mansoni causes lower genital tract lesions characteristic of FGS. METHODOLOGY: This study was conducted in 8 villages along the shores of Lake Victoria, western Kenya. Stool and urine samples, collected from women of reproductive age on three consecutive days, were analysed for S. mansoni and S. haematobium infection. S. mansoni positive and S. haematobium negative willing participants, aged 18-50 years were invited to answer a questionnaire (demographics, symptoms), undergo a gynaecological examination and cytology specimen collection by an FGS expert. PRINCIPAL FINDINGS: Gynaecologic investigations were conducted in 147 S. mansoni-positive women who had a mean infection intensity of 253.3 epg (95% CI: 194.8-311.9 epg). Nearly 90% of them used Lake Victoria as their main water source. None were found to have cervicovaginal grainy sandy patches or rubbery papules. Homogenous yellow patches were found in 12/147 (8.2%) women. Women with homogenous yellow patches were significantly older (47 years) than the rest (34 years, p = 0.001). No association was found between intensity of S. mansoni infection and homogenous yellow patches (p = 0.70) or abnormal blood vessels (p = 0.14). S. mansoni infection intensity was not associated with genital itch, bloody or malodorous vaginal discharge. CONCLUSION: S. mansoni infection was neither associated with lower genital tract lesions nor symptoms typically found in women with FGS.

Clinical application of the 2011 IFCPC colposcope terminology.

BACKGROUND: Colposcopy offers an accurate way to the diagnose of cervical precancerous lesions. However, the diagnostic accuracy of colposcopy is unsatisfied. This study was to evaluate colposcopic accuracy according to the 2011 International Federation of Cervical Pathology and Colposcopy (IFCPC) terminology. METHODS: A retrospective cohort study was performed in 1,838 patients who underwent colposcopy in Shandong Qianfoshan Hospital, Cheeloo College of Medicine, Shandong University from October 2013 to April 2018. Using conization or cervical biopsy pathology as the gold standard, the agreement between colposcopic diagnosis and pathologic diagnosis was calculated, and correlations between variables were analyzed. RESULTS: As an authoritative and widely used terminology for colposcopy diagnosis, the 2011 IFCPC terminology has certain clinical practicality and diagnostic accuracy. However, some signs such as mosaic, punctation, sharp border, inner border sign and ridge sign had high specificity but unsatisfactory sensitivity, which limited the diagnostic value. Therefore, we discussed the Lugol's staining, a very common sign in colposcopy, and analyzed the diagnostic significance of bright yellow staining in low-grade squamous intraepithelial lesion (LSIL) and mustard yellow staining in high-grade squamous intraepithelial lesion (HSIL). The results showed that mustard yellow may be a valuable indicator in the diagnosis of HSIL. CONCLUSION: The 2011 IFCPC colposcope terminology has standardized interpretations of the colposcopic findings and improved the accuracy of colposcopy diagnosis. The aceto-white epithelium still has important diagnostic value; however, the value of a few signs is needed to be discussed and new signs are expected to be discovered. Although the significance of Lugol's staining was diminishing, mustard yellow might be a valuable indicator for the diagnosis of HSIL.

Endocervical microglandular hyperplasia: Colposcopic aspects, physiopathology and differential diagnosis.

Endocervical microglandular hyperplasia (MGH) is a reactive type of glandular lesion that may be confused with endocervical adenocarcinoma from the macroscopic and the colposcopic findings, as well as from a histological. Differential diagnosis is very important. Here, we report a case of a 21 years-old women with a challenging differential diagnosis in the colposcopy and a MGH as histological finding.

Feasibility and safety study of a high resolution wide field-of-view scanning endoscope for circumferential intraluminal intestinal imaging.

Global anal cancer incidence is increasing. High resolution anoscopy (HRA) currently screens for anal cancer, although the definitive test remains unknown. To improve on intraluminal imaging of the anal canal, we conducted a first-in-human study to determine feasibility and safety of a high-resolution, wide field-of-view scanning endoscope. Fourteen patients, under an IRB-approved clinical study, underwent exam under anesthesia, HRA, and imaging with the experimental device. HRA findings were photographed using an in-line camera attached to the colposcope and compared with the scanning endoscope images. Patients were followed up within 2 weeks of the procedure. The imaging device is inserted into the anal canal and the intraluminal surface is digitally photographed in 10 s and uploaded to a computer monitor for review. Ten patients completed imaging with the device. Three patients were not imaged due to severe anal stenosis. One patient was not imaged due to technical device malfunction. The device images were compared to the HRA images. No adverse event attributable to the device was reported. The intraluminal scanning endoscope can be used for circumferential anal canal imaging and is safe for clinical use. Future clinical studies are needed to evaluate the performance of this device.

Design and implementation of a portable colposcope Mueller matrix polarimeter.

SIGNIFICANCE: Mueller matrix polarimetry can provide useful information about the function and structure of the extracellular matrix. A portable and low-cost system could facilitate the clinical assessment of cervical anomalies in low-resource settings. AIM: We introduce a low-cost snapshot Mueller matrix polarimeter that does not require external power, has no moving parts, and can acquire a full Mueller matrix in ∼1 s, to conduct a feasibility study for cervical imaging in the low-resource setting. APPROACH: A snapshot system based on two sets of Savart plates, a ring illuminator with polarizing elements (generating four polarization states), and one camera is introduced. Stokes vectors are formulated to recover the polarization properties of the sample. Then, using Mueller matrix decomposition, the depolarization and retardance information is extracted. RESULTS: We report the results on 16 healthy individuals (out of 22 patients imaged), whose Pap smear showed no malignant findings from mobile clinics in rural region of Mysore, India. The depolarization and retardance information was in agreement with previous reports. CONCLUSIONS: We introduce an imaging system and conducted a feasibility study on healthy individuals. This work could futurely translate into diagnostic applications to provide a quantitative platform in the clinical environment (e.g., cervical cancer screening).

Combining multiple contrasts for improving machine learning-based classification of cervical cancers with a low-cost point-of-care Pocket colposcope.

We apply feature-extraction and machine learning methods to multiple sources of contrast (acetic acid, Lugol's iodine and green light) from the white Pocket Colposcope, a low-cost point of care colposcope for cervical cancer screening. We combine features from the sources of contrast and analyze diagnostic improvements with addition of each contrast. We find that overall AUC increases with additional contrast agents compared to using only one source.

Colposcopio para para el examen de alteraciones himeneales en casos de abuso sexual / Colposcope for the examination of hymenal alterations in cases of sexual abuse

INTRODUCCIÓN: Este documento técnico se realiza a solicitud del Instituto Nacional de Salud del Niño - San Borja. A. Cuadro clínico: En los últimos años, las denuncias por delitos sexuales han ido aumentando en su mayoría en menores de edad. El peritaje de víctimas de abuso sexual es un proceso difícil para la víctima, que no sólo tiene que relatar un episodio traumático, sino que se tiene que someter a una serie de pruebas físicas y de laboratorio. Usualmente para evaluar el himen, especialmente en casos pediátricos, se utiliza la visualización directa con la ayuda de una lupa (x40). Este proceso, si bien es inocuo, se tiene que repetir en cada peritaje durante el proceso legal asociado al abuso sexual. Sin embargo, existen tecnologías que podrían hacer grabaciones del examen para que no deba ser repetido por la víctima. B. Tecnología sanitaria: El colposcopio es un dispositivo usado para la evaluación de los genitales femeninos. La magnificación del colposcopio hace mucho más preciso la identificación de anormalidades en los genitales internos tanto como externos. El colposcopio viene acompañado de cámara fotográfica o cámara de video que permite la grabación del examen de alteraciones del himen en el caso de abuso sexual. OBJETIVO: Evaluar la eficacia y seguridad, así como documentos relacionados a la decisión de cobertura del colposcopio para examen de alteraciones himeneales en casos de abuso sexual. METODOLOGÍA: Se realizó una búsqueda en las principales bases de datos bibliográficas: MEDLINE, LILACS, COCHRANE, así como en buscadores genéricos de Internet incluyendo Google Scholar y TRIPDATABASE. Adicionalmente, se hizo una búsqueda dentro de la información generada por las principales instituciones internacionales de ginecología y agencias de tecnologías sanitarias que realizan revisiones sistemáticas (RS), evaluación de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC). RESULTADOS: No se encontraron ensayos clínicos, revisiones sistemáticas de ECAs, evaluaciones de tecnología sanitaria ni evaluaciones económicas que evaluaran la tecnología de interés. Se identificaron cuatro estudios comparativos diagnósticos y cuatro GPC. CONCLUSIONES: • Si bien los estudios no coinciden en que la colposcopía brindaría beneficios en el diagnóstico de alteraciones himeneales en niñas con sospecha de abuso sexual, las GPC recabadas mencionan la importancia de un proceso de documentación adecuado por razones legales y para evitar la reevaluación de pacientes. No se encontraron evaluaciones de tecnología sanitaria que evaluaran la tecnología de interés.

An Update on the Current Role of High Resolution Anoscopy in Patients With Anal Dysplasia.

The incidence of anal squamous cell carcinoma (ASCC) in the U.S. is increasing, particularly in immunocompromised patients. Preventative screening is used to monitor precancerous dysplasia known as anal intraepithelial neoplasia (AIN), which can progress to ASCC. High Resolution Anoscopy (HRA) is one screening procedure that uses a colposcope with acetic acid and Lugol's iodine solution to visualize the anal epithelium for AIN. HRA has offered potential in managing AIN, but as more evidence emerges it is unclear whether HRA provides definitive benefit. This narrative review updates readers on the efficacy of HRA in screening AIN, compares HRA to other techniques, compares the use of HRA in various high-risk populations, and offers practical information on the use of HRA. Keyword searches were conducted using MEDLINE, Web of Science, and Cochrane Library. Current literature is mixed regarding the utility of HRA. Further randomized controlled trials are needed to definitively assess the role of HRA.

Development of Algorithms for Automated Detection of Cervical Pre-Cancers With a Low-Cost, Point-of-Care, Pocket Colposcope.

GOAL: In this paper, we propose methods for (1) automatic feature extraction and classification for acetic acid and Lugol's iodine cervigrams and (2) methods for combining features/diagnosis of different contrasts in cervigrams for improved performance. METHODS: We developed algorithms to pre-process pathology-labeled cervigrams and extract simple but powerful color and textural-based features. The features were used to train a support vector machine model to classify cervigrams based on corresponding pathology for visual inspection with acetic acid, visual inspection with Lugol's iodine, and a combination of the two contrasts. RESULTS: The proposed framework achieved a sensitivity, specificity, and accuracy of 81.3%, 78.6%, and 80.0%, respectively, when used to distinguish cervical intraepithelial neoplasia (CIN+) relative to normal and benign tissues. This is superior to the average values achieved by three expert physicians on the same data set for discriminating normal/benign cases from CIN+ (77% sensitivity, 51% specificity, and 63% accuracy). CONCLUSION: The results suggest that utilizing simple color- and textural-based features from visual inspection with acetic acid and visual inspection with Lugol's iodine images may provide unbiased automation of cervigrams. SIGNIFICANCE: This would enable automated, expert-level diagnosis of cervical pre-cancer at the point of care.

Portable Pocket colposcopy performs comparably to standard-of-care clinical colposcopy using acetic acid and Lugol's iodine as contrast mediators: an investigational study in Peru.

OBJECTIVE: Our goal was to develop a tele-colposcopy platform for primary-care clinics to improve screening sensitivity and access. Specifically, we developed a low-cost, portable Pocket colposcope and evaluated its performance in a tertiary healthcare centre in Peru. DESIGN AND SETTING: Images of the cervix were captured with a standard-of-care and Pocket colposcope at la Liga Contra el Cáncer in Lima, Peru. POPULATION: Two hundred Peruvian women with abnormal cytology and/or human papillomavirus positivity were enrolled. METHODS: Images were collected using acetic acid and Lugol's iodine as contrast agents. Biopsies were taken as per standard-of-care procedures. MAIN OUTCOME MEASURES: After passing quality review, images from 129 women were sent to four physicians who provided a diagnosis for each image. RESULTS: Physician interpretation of images from the two colposcopes agreed 83.1% of the time. The average sensitivity and specificity of physician interpretation compared with pathology was similar for the Pocket (sensitivity = 71.2%, specificity = 57.5%) and standard-of-care (sensitivity = 79.8%, specificity = 56.6%) colposcopes. When compared with a previous study where only acetic acid was applied to the cervix, results indicated that adding Lugol's iodine as a secondary contrast agent improved the percent agreement between colposcopes for all pathological categories by up to 8.9% and the sensitivity and specificity of physician interpretation compared with pathology by over 6.0 and 9.0%, respectively. CONCLUSIONS: The Pocket colposcope performance was similar to that of a standard-of-care colposcope when used to identify precancerous and cancerous lesions using acetic acid and Lugol's iodine during colposcopy examinations in Peru. TWEETABLE ABSTRACT: The Pocket colposcope performance was similar to that of a standard-of-care colposcope when identifying cervical lesions.

Cryotherapy for Intra- and Perianal High-Grade Squamous Intraepithelial Lesions in HIV-Positive Men who have Sex with Men.

BACKGROUND: Available treatment options for anal high-grade squamous intraepithelial lesions (HSIL) in HIV-positive men who have sex with men (MSM) are limited by low response rates and frequent recurrences. Cryotherapy is an established therapeutic option for several pre-malignant skin disorders. METHODS: This retrospective, non-randomized study included HIV-positive MSM who received intra- and/or perianal HSIL cryotherapy treatment between 30 December 2008 and 23 April 2015. Cryotherapy was applied in sessions 4-6 weeks apart for a maximum of five sessions. Patients received a follow-up high-resolution anoscopy (HRA) to assess treatment response. Complete and partial treatment responders were followed-up after 6 months and then every 6-12 months to investigate recurrent HSILs. RESULTS: Of 64 patients [median age 48 years; interquartile range (IQR) 42-56] included in the study, six were lost to follow-up. In total, 35 (60%) of 58 patients responded to treatment. Of 64 patients, 31 (48%) reported one or more side effects, of which anal pain or tenderness and mild blood loss were reported most frequently. A total of 19 patients who responded to cryotherapy were adequately followed-up for over 18 months, of whom 13 (68%) had recurrent HSILs. CONCLUSION: Cryotherapy is capable of clearing HSIL in HIV-positive MSM, and treatment success rates are comparable with those reported for current treatment modalities. The treatment is well tolerated, and side effects are relatively mild. Future studies should therefore compare the efficacy and tolerability of cryotherapy with those of current treatment modalities in randomized controlled trials.

In vivo imaging of uterine cervix with a Mueller polarimetric colposcope.

Mueller polarimetric imaging enables the detection and quantification of modifications of the collagen fibers in the uterine cervix due to the development of a precancerous lesion. This information is not accessible through the use of the classic colposcope, a low magnification microscope used in current practice for cervical cancer screening. However, the in vivo application of Mueller polarimetric imaging poses an instrumental challenge: the device should be sufficiently compact, while still being able to perform fast and accurate acquisition of Mueller matrices in real-world conditions. In this study, the first wide field Mueller Polarimetric Colposcope (MPC) for the in vivo analysis of uterine cervix is presented. The MPC has been fabricated by grafting a miniaturized Mueller polarimetric imager on a classic colposcope. This new imaging tool performs the fast acquisition of Mueller polarimetric images, thus eliminating any blurring effects due to patient movements. It can be easily used by a practitioner with little change to their existing practice. Finally, the MPC was tested in vivo on a number of patients in the field.

International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope.

OBJECTIVE: Barriers to cervical cancer screening in low-resource settings include lack of accessible, high-quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low-cost, intravaginal, optical cervical imaging device, the point-of-care tampon (POCkeT) colposcope and evaluated whether its performance is comparable with a standard-of-care colposcope. MATERIALS AND METHODS: There were 2 protocols, which included 44 and 18 patients. For the first protocol, white-light cervical images were collected in vivo, blinded by device, and sent electronically to 8 physicians from high-, middle-, and low-income countries. For the second protocol, green-light images were also collected and sent electronically to the highest performing physician from the first protocol who has experience in both a high- and low-income country. For each image, physicians completed a survey assessing cervix characteristics and severity of precancerous lesions. Corresponding pathology was obtained for all image pairs. RESULTS: For the first protocol, average percent agreement between devices was 70% across all physicians. The POCkeT and standard-of-care colposcope images had 37% and 51% agreement with pathology for high-grade squamous intraepithelial lesions (HSILs), respectively. Investigation of HSIL POCkeT images revealed decreased visibility of vascularization and lack of contrast in lesion margins. After changes were made for the second protocol, the 2 devices achieved similar agreement to pathology for HSIL lesions (55%). CONCLUSIONS: Based on the exploratory study, physician interpretation of cervix images acquired using a portable, low-cost POCkeT colposcope was comparable to a standard-of-care colposcope.

Design of a Novel Low Cost Point of Care Tampon (POCkeT) Colposcope for Use in Resource Limited Settings.

INTRODUCTION: Current guidelines by WHO for cervical cancer screening in low- and middle-income countries involves visual inspection with acetic acid (VIA) of the cervix, followed by treatment during the same visit or a subsequent visit with cryotherapy if a suspicious lesion is found. Implementation of these guidelines is hampered by a lack of: trained health workers, reliable technology, and access to screening facilities. A low cost ultra-portable Point of Care Tampon based digital colposcope (POCkeT Colposcope) for use at the community level setting, which has the unique form factor of a tampon, can be inserted into the vagina to capture images of the cervix, which are on par with that of a state of the art colposcope, at a fraction of the cost. A repository of images to be compiled that can be used to empower front line workers to become more effective through virtual dynamic training. By task shifting to the community setting, this technology could potentially provide significantly greater cervical screening access to where the most vulnerable women live. The POCkeT Colposcope's concentric LED ring provides comparable white and green field illumination at a fraction of the electrical power required in commercial colposcopes. Evaluation with standard optical imaging targets to assess the POCkeT Colposcope against the state of the art digital colposcope and other VIAM technologies. RESULTS: Our POCkeT Colposcope has comparable resolving power, color reproduction accuracy, minimal lens distortion, and illumination when compared to commercially available colposcopes. In vitro and pilot in vivo imaging results are promising with our POCkeT Colposcope capturing comparable quality images to commercial systems. CONCLUSION: The POCkeT Colposcope is capable of capturing images suitable for cervical lesion analysis. Our portable low cost system could potentially increase access to cervical cancer screening in limited resource settings through task shifting to community health workers.

Evaluation of the accuracy in detecting cervical lesions by nurses versus doctors using a stationary colposcope and Gynocular in a low-resource setting.

OBJECTIVES: Evaluation of the performance of VIA (visual inspection with acetic acid) trained nurses to learn colposcopy and the Swede score method to detect cervical lesions by using stationary colposcope or a portable, hand-held colposcope; the Gynocular, as compared to doctors. DESIGN: A crossover randomised clinical trial. SETTING: The Colposcopy Clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh. PARTICIPANTS: 932 women attending the clinic as either screening naïve for VIA screening (404) or women referred as VIA positive (528) from other VIA screening centres in the Dhaka region. INTERVENTION: VIA trained nurses were trained on-site in colposcopy and in the Swede score systematic colposcopy method. The Swede score grade cervical acetowhiteness, margins plus surface. vessel pattern, lesion size and iodine staining. The women were randomised to start the examination by either a stationary colposcope or the Gynocular. Swede scores were first obtained by a nurse and the same patient was equally evaluated by a doctor. PRIMARY AND SECONDARY OUTCOME MEASURES: Agreement between nurses and doctors in Swede scores was evaluated using the weighted κ statistic for the Gynocular and standard colposcope. The ability to predict CIN 2+ (CIN 2, CIN 3 and invasive cervical cancer) using Swede scores was evaluated using receiver-operating characteristic curves. RESULTS: The Swede scores obtained by nurses and doctors using the Gynocular and stationary colposcope showed high agreement with a κ statistic of 0.858 and 0.859, respectively, and no difference in detecting cervical lesions in biopsy. Biopsy detected CIN 2+ in 39 (4.2%) women. CONCLUSIONS: Our study showed that VIA nurses can perform colposcopy. There was no significant differences compared to doctors in detecting cervical lesions by stationary colposcope or the Gynocular using the Swede score system. Swede scores obtained by nurses using the Gynocular could offer an accurate cervical diagnostic approach in low resource settings. TRIAL REGISTRATION NUMBER: ISRCTN53264564.

Performance of a low cost magnifying device, Magnivisualizer, versus colposcope for detection of pre-cancer and cancerous lesions of uterine cervix.

OBJECTIVE: To assess the performance of a low cost magnifying device (Magnivisualizer) compared to a standard optical colposcope for detection of precancerous and cancerous lesions of the uterine cervix. METHODS: A total of 659 consecutive symptomatic women attending a gynecologic outpatient clinic underwent unaided visual inspection followed by cytology, visual inspection of the cervix using 5% acetic acid (VIA), and VIA under magnification (VIAM) with the Magnivisualizer. All women, independently of test results, were referred for colposcopic examination. Colposcopic-directed biopsies were obtained from all positive lesions and compared to positive VIAM cases. RESULTS: The detection rate for VIA positive lesions was 12% (134/659), while it was 29% for VIAM positive lesions (191/659). The sensitivities of detection of cervical intraepithelial neoplasia (CIN) 2 and higher lesions were 61.7% for VIA, 88.3% for VIAM, and 86.7% for colposcopy, with a specificity of 58.5% for VIA, 55.8% for VIAM, and 90.4% for colposcopy. The performance of colposcopy and VIAM was moderate (κ, 0.48; 95% confidence interval [CI], 0.41 to 0.54) for detection of CIN 1 and higher lesions and excellent (κ, 0.87; 95% CI, 0.82 to 0.94) for detection of CIN 2 and higher lesions. CONCLUSION: In low resource settings, where colposcopic facilities are not available at the community level, a simple low-cost, handheld Magnivisualizer can be considered a valid option for detection of cervical precancerous and cancerous lesions. However, it cannot replace traditional colposcopy because it has a low specificity that results in many unnecessary biopsies.