In vivo optical cellular diagnosis for uterine cervical or vaginal intraepithelial neoplasia using flexible gastrointestinal endocytoscopy -a prospective pilot study-

Abstract Backgrouund For patients with any kind of atypical squamous intraepithelial lesion of the uterine cervix or vagina, colposcopy and punch biopsy are common procedures for histological determination following cytology. However, colposcopy-guided biopsy does not provide a high level of diagnostic accuracy. The aim of this study was to determine the usefulness of optical biopsy in vivo using endocytoscopy compared with conventional procedures using colposcopy. Methods Between May 2018 and March 2019, patients who were scheduled for cervical conization or mapping biopsies of the vagina were prospectively enrolled. Endocytoscopy was performed by senior endoscopists prior to scheduled procedures, and endocytoscopic images and biopsy samples were taken from the most prominent site and surrounding area of the cervical or vaginal lesions. The collection process of images was randomized and anonymous, and three doctors separately evaluated the images according to the ECA classification. ECA 4 and 5 are indicative of endoscopic malignancy. The primary endpoint was diagnostic accuracy (benign or malignant: cervical intraepithelial neoplasia (CIN) 3 or vaginal intraepithelial neoplasia (VAIN) 3 or worse) of cell images at the most prominent site in each patient. Results A total of 28 consecutive patients were enrolled. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of endocytoscopic images were 95.0% (84.8–98.6%), 87.5% (61.9–96.5%), 95.0% (84.8–98.6%), 87.5% (61.9–96.5%) and 92.9% (78.2–98.0%), respectively. Inter-observer agreement among three reviewers was 0.78 (0.08–9.88, P < 0.01). On the other hand, the accuracy of colposcopy-guided biopsy was 74.1% (64.0–84.0%). Conclusions Optical cell diagnosis of cervical or vaginal intraepithelial neoplasia using endocytoscopy provides a high level of diagnostic accuracy. Trial registration The study was registered with the UMIN database (ID: 000031712). UMIN000031712. Registered 16 March 2017,

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In vivo optical cellular diagnosis for uterine cervical or vaginal intraepithelial neoplasia using flexible gastrointestinal endocytoscopy -a prospective pilot study-

10.21203/rs.3.rs-58036/v2 ◽

2020 ◽

Author(s):

Shoko Ono ◽

Ayako Nozaki ◽

Kana Matsuda ◽

Emi Takakuwa ◽

Naoya Sakamoto ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Predictive Value ◽

Intraepithelial Neoplasia ◽

Observer Agreement ◽

Optical Biopsy ◽

Optical Cell ◽

Guided Biopsy ◽

Vaginal Intraepithelial Neoplasia ◽

High Level

Abstract Background For patients with any kind of atypical squamous intraepithelial lesion of the uterine cervix or vagina, colposcopy and punch biopsy are common procedures for histological determination following cytology. However, colposcopy-guided biopsy does not provide a high level of diagnostic accuracy. The aim of this study was to determine the usefulness of optical biopsy in vivo using endocytoscopy compared with conventional procedures using colposcopy.Methods Between May 2018 and March 2019, patients who were scheduled for cervical conization or mapping biopsies of the vagina were prospectively enrolled. Endocytoscopy was performed by senior endoscopists prior to scheduled procedures, and endocytoscopic images and biopsy samples were taken from the most prominent site and surrounding area of the cervical or vaginal lesions. The collection process of images was randomized and anonymous, and three doctors separately evaluated the images according to the ECA classification. ECA 4 and 5 are indicative of endoscopic malignancy. The primary endpoint was diagnostic accuracy (benign or malignant: cervical intraepithelial neoplasia (CIN) 3 or vaginal intraepithelial neoplasia (VAIN) 3 or worse) of cell images at the most prominent site in each patient.Results A total of 28 consecutive patients were enrolled. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of endocytoscopic images were 95.0% (84.8-98.6%), 87.5% (61.9-96.5%), 95.0% (84.8-98.6%), 87.5% (61.9-96.5%) and 92.9% (78.2-98.0%), respectively. Inter-observer agreement among three reviewers was 0.78 (0.08-9.88, P < 0.01). On the other hand, the accuracy of colposcopy-guided biopsy was 74.1% (64.0-84.0%).Conclusions Optical cell diagnosis of cervical or vaginal intraepithelial neoplasia using endocytoscopy provides a high level of diagnostic accuracy. Trial registration The study was registered with the UMIN database (ID: 000031712).UMIN000031712. Registered 16 March 2017, https://rctportal.niph.go.jp/detail/um?trial_id=UMIN000031712

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In vivo optical cellular diagnosis for uterine cervical or vaginal intraepithelial neoplasia using flexible gastrointestinal endocytoscopy - a prospective pilot study-

10.21203/rs.3.rs-58036/v1 ◽

2020 ◽

Author(s):

Shoko Ono ◽

Ayako Nozaki ◽

Kana Matsuda ◽

Emi Takakuwa ◽

Naoya Sakamoto ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Predictive Value ◽

Intraepithelial Neoplasia ◽

Observer Agreement ◽

Optical Biopsy ◽

Optical Cell ◽

Guided Biopsy ◽

Vaginal Intraepithelial Neoplasia ◽

High Level

Abstract BackgrouundFor patients with any kind of atypical squamous intraepithelial lesion of the uterine cervix or vagina, colposcopy and punch biopsy are common procedures for histological determination following cytology. However, colposcopy-guided biopsy does not provide a high level of diagnostic accuracy. The aim of this study was to determine the usefulness of optical biopsy in vivo using endocytoscopy compared with conventional procedures using colposcopy.MethodsBetween May 2018 and March 2019, patients who were scheduled for cervical conization or mapping biopsies of the vagina were prospectively enrolled. Endocytoscopy was performed by senior endoscopists prior to scheduled procedures, and endocytoscopic images and biopsy samples were taken from the most prominent site and surrounding area of the cervical or vaginal lesions. The collection process of images was randomized and anonymous, and three doctors separately evaluated the images according to the ECA classification. ECA 4 and 5 are indicative of endoscopic malignancy. The primary endpoint was diagnostic accuracy (benign or malignant: cervical intraepithelial neoplasia (CIN) 3 or vaginal intraepithelial neoplasia (VAIN) 3 or worse) of cell images at the most prominent site in each patient.ResultsA total of 28 consecutive patients were enrolled. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of endocytoscopic images were 95.0% (84.8-98.6%), 87.5% (61.9-96.5%), 95.0% (84.8-98.6%), 87.5% (61.9-96.5%) and 92.9% (78.2-98.0%), respectively. Inter-observer agreement among three reviewers was 0.78 (0.08-9.88, P < 0.01). On the other hand, the accuracy of colposcopy-guided biopsy was 74.1% (64.0-84.0%).ConclusionsOptical cell diagnosis of cervical or vaginal intraepithelial neoplasia using endocytoscopy provides a high level of diagnostic accuracy.Trial registrationThe study was registered with the UMIN database (ID: 000031712).UMIN000031712. Registered 16 March 2017, https://rctportal.niph.go.jp/detail/um?trial_id=UMIN000031712

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Optical Biopsy for Esophageal Squamous Cell Neoplasia by Using Endocytoscopy

10.21203/rs.3.rs-1100881/v1 ◽

2021 ◽

Author(s):

Yoshihiko Shimoda ◽

Yuichi Shimizu ◽

Hiroaki Takahashi ◽

Satoshi Okahara ◽

Takakazu Miyake ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Prospective Study ◽

Squamous Cell ◽

Predictive Value ◽

Narrow Band Imaging ◽

High Risk Group ◽

Optical Biopsy ◽

Esophageal Tumor ◽

Multicenter Prospective Study

Abstract Background Endocytoscopy (ECS) enables microscopic observation in vivo for the gastrointestinal mucosa; however, there has been no prospective study in which the diagnostic accuracy of ECS for lesions that have not yet undergone histological diagnosis was evaluated. We conducted a surveillance study for patients in a high-risk group of esophageal squamous cell carcinoma (ESCC) and evaluated the in vivo histological diagnostic accuracy of ECS. Methods This study was a multicenter prospective study. We enrolled 197 patients in the study between September 1, 2019 and November 30, 2020. The patients first underwent white light imaging and narrow band imaging, and ultra-high magnifying observation was performed if there was a lesion suspected to be an esophageal tumor. Endoscopic submucosal dissection (ESD) was later performed for lesions that were diagnosed to be ESCC by ECS without biopsy. We analyzed the diagnostic accuracy of ECS for esophageal tumorous lesions. Results ESD was performed for 37 patients (41 lesions) who were diagnosed as having ESCC by ECS, and all of them were histopathologically diagnosed as having ESCC. The sensitivity (95% confidence interval (CI)) was 97.6% (87.7%-99.7%), specificity was 100% (92.7%-100%), diagnostic accuracy was 98.9% (94.0%-99.8%), positive predictive value (PPV) was 100% (91.4%-100%) and negative predictive value (NPV) was 98.0% (89.5%-99.7%). Conclusions ECS has a high diagnostic accuracy and there were no false positives in cases diagnosed and resected as ESCC. Optical biopsy by using ECS for esophageal lesions is considered to be sufficient in clinical practice.

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Development of HPV 16/18 E6 oncoprotein paper-based nanokit for enhanced detection of HPV 16/18 E6 oncoprotein in cervical cancer screening

10.1101/2020.04.29.20084459 ◽

2020 ◽

Author(s):

Lucy Muthoni Mwai ◽

Mutinda C. Kyama ◽

Caroline W. Ngugi ◽

Edwin Walong

Keyword(s):

Cervical Cancer ◽

Gold Nanoparticles ◽

Cancer Screening ◽

Diagnostic Accuracy ◽

Predictive Value ◽

Intraepithelial Neoplasia ◽

Hpv 16 ◽

Middle Income ◽

Middle Income Countries ◽

E6 Oncoprotein

AbstractCervical cancer caused mainly by high risk human papillomavirus (HPV) 16 and 18 strains is the second most prevalent cancer of women in Kenya. It is often diagnosed late when treatment is difficult due to very low percentage of women attending screening thus, mortalities remain high. The most available tests in low-and-middle-income countries (LMICs) have relatively low specificity, low sensitivity, require a laboratory setting and huge technical and financial support not readily available. HPV 16/18 E6 oncoprotein has been identified as a potential biomarker in a more specific early diagnosis of cervical cancer. This retrospective cross-sectional study developed a paper-based nanokit with enhanced detection of HPV 16/18 E6 oncoprotein for cervical cancer screening. The HRP labelled antibodies HPV 16 E6/18 E6-HRP (CP15) passively conjugated to citrate stabilized 20nm gold nanoparticles were evaluated for immune sensing mechanism using a recombinant viral HPV E6 protein. The diagnostic accuracy was evaluated using 50 tissue lysates from formalin fixed paraffin embedded cervical biopsy, including control (n=10), Mild Dysplasia (n=10), Cervical intraepithelial neoplasia 3 (CIN3) (n=10), Cervical intraepithelial neoplasia 4 (CIN4) (n=10) and invasive carcinoma (n=10). The molecular technique used was dot blot molecular assay. A positive result was generated by catalytic oxidation of peroxidase enzyme on 3,3’,5,5’-Tetramethylbenzidine (TMB) substrate. The gold nanoparticles were used to enhance the signal produced by peroxidase activity of horseradish peroxidase (HRP) enzyme giving a more sensitive assay as compared to use of non-conjugated antibody. This study provides a significantly high and reliable diagnostic accuracy for precancerous and cancerous lesions with a sensitivity of 90%, a specificity of 90%, a likelihood ratio for positive and negative tests as 9:1 and 1:9 respectively, a Positive Predictive Value of 97.3% and a Negative Predictive Value of 69.2%. This study avails a sensitive, rapid test using paper-based nanotechnology which can be utilised in community-based screening outreaches particularly in low- and middle-income countries.

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Association Between 45° Flexion Anteroposterior Elbow Radiographs and Diagnostic Accuracy of Capitellum Osteochondritis Dissecans

The American Journal of Sports Medicine ◽

10.1177/03635465211027178 ◽

2021 ◽

pp. 036354652110271

Author(s):

Michael G. Saper ◽

Viviana Bompadre ◽

Gregory A. Schmale ◽

Sarah Menashe ◽

Monique Burton ◽

...

Keyword(s):

Diagnostic Accuracy ◽

Osteochondritis Dissecans ◽

Predictive Value ◽

Interobserver Reliability ◽

Intraobserver Reliability ◽

Control Group ◽

Level Of Evidence ◽

Level Of Confidence ◽

High Level ◽

Sensitivity Specificity

Background: An anteroposterior (AP) radiograph of the elbow in 45° of flexion has been suggested to increase the diagnostic accuracy of capitellum osteochondritis dissecans (OCD). Purpose: To assess the diagnostic performance, inter- and intraobserver reliability, and confidence level for identifying capitellum OCD using plain radiographs (AP, lateral, and 45° flexion AP). Study Design: Cohort study (Diagnosis); Level of evidence, 3. Methods: This was a retrospective study of pediatric and adolescent patients with capitellum OCD and a control group. Six independent clinicians who were blinded to the official radiologists’ reports reviewed images on 2 separate occasions, 1 week apart. A 5-point Likert scale was used to assess the clinicians’ level of confidence. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were calculated for individual and combinations of radiographic views. Inter- and intraobserver reliability was determined using Cohen kappa (κ) coefficients. Results: A total of 28 elbows (mean age, 12.5 ± 2 years) were included. There were no differences in age ( P = .18), sex ( P = .62), or laterality ( P > .999) between groups. There were marked variations in the diagnostic accuracy between views: sensitivity (AP, 85.1; lateral, 73.2; 45° flexion AP, 91.7), specificity (AP, 89.3; lateral, 91.7; 45° flexion AP, 91.1), PPV (AP, 88.8; lateral, 89.8; 45° flexion AP, 91.1), NPV (AP, 85.7; lateral, 77.4; 45° flexion AP, 91.6), and accuracy (AP, 87.2; lateral, 82.4; 45° flexion AP, 91.4). Standard radiographs (AP and lateral views) failed to diagnose capitellum OCD in 4.8% of cases. The sensitivity of the 3 combined views was 100%. Confidence intervals in the clinicians’ diagnostic assessments were similar for each view (AP, 4.0; lateral, 4.0; and 45° flexion AP, 4.1). Interobserver reliability was substantial for AP and lateral views (κ = 0.65 and κ = 0.60, respectively) but highest for the 45° flexion AP radiographs (κ = 0.72). Intraobserver reliability for the 45° flexion AP view was moderate to almost perfect (κ = 0.45 to 0.93). Conclusion: The 45° flexion AP view can detect capitellum OCD with excellent accuracy, a high level of confidence, and substantial interobserver agreement. When added to standard AP and lateral radiographs, the 45° flexion AP view aids in the identification of capitellum OCD.

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Comparative analysis of cerebrospinal fluid adenosine deaminase levels in infective meningitis of different aetiologies

International Journal of Contemporary Pediatrics ◽

10.18203/2349-3291.ijcp20170718 ◽

2017 ◽

Vol 4 (2) ◽

pp. 608

Author(s):

Mohsin Rashid ◽

Sheikh Mushtaq ◽

Junaid Manzoor ◽

Javaid Ahmad Bhat ◽

Shilakha Chaman ◽

...

Keyword(s):

Cerebrospinal Fluid ◽

Diagnostic Accuracy ◽

Adenosine Deaminase ◽

Aseptic Meningitis ◽

Predictive Value ◽

Cost Effective ◽

Systemic Lupus Erythematosis ◽

Pyogenic Meningitis ◽

Tubercular Meningitis ◽

High Level

Background: Meningitis can be caused by bacteria, viruses, parasites, and fungi as well as by non-infectious conditions including inflammatory disorders (e.g., systemic lupus erythematosis or Kawasaki disease) and neoplasia (e.g., leukemic meningitis). The objective of this study were to study cerebrospinal fluid (CSF) adenosine deaminase (ADA) levels in infective meningitis of different aetiologies. And to assess the role of cerebrospinal fluids (CSF) adenosine deaminase (ADA) levels in differentiating tubercular from non-tubercular meningitis.Methods: The study was conducted on 70 patients of meningitis at Postgraduate Department of Paediatrics, in G. B. Pant Hospital, an associated hospital of Government Medical College Srinagar. Out of 70 patients included in the study 27 cases were Aseptic Meningitis (AM), 14 cases partially treated pyogenic -meningitis (PTM), 19 cases pyogenic meningitis (PM), and 10 cases were tubercular meningitis (TBM). ADA activity of CSF was quantified by colorimetry.Results: In our study we observed a significant high level of ADA 30.0±3.2U/L (20.0, 54.0) among the tubercular meningitis (TBM) patients and its respective level among Aseptic Meningitis (AM), was 8.1±0.3U/L (4.0, 11.5), partially treated pyo -meningitis (PTM) was 7.6±0.4U/L (5.0, 11.0), pyogenic meningitis (PM) was 11.6±0.5U/L (8.0, 14.5). In total Non-TBM ADA level was 9.1±0.3U/L (4.0, 14.5) units/liter. At cut off of > or equal to 10U/L sensitivity was 100% specificity66.67% positive predictive value33.33% negative predictive value of 100% diagnostic accuracy 71.43%. At a higher cut off of > or equal to 12U/L sensitivity was 100% and specificity increased to 81.67% positive predictive value 47.62% negative predictive value100% diagnostic accuracy was 84.29%.Conclusions: The sensitivity and specificity of CSF ADA activity is markedly high in differentiating TBM from non-TBM. Hence CSF ADA activity may be used as a simple, cost-effective and reliable test for early diagnosis of TBM.

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Accuracy of Magnetometer-Guided Sentinel Lymphadenectomy after Intraprostatic Injection of Superparamagnetic Iron Oxide Nanoparticles in Prostate Cancer: The SentiMag Pro II Study

10.20944/preprints201911.0017.v1 ◽

2019 ◽

Author(s):

Alexander Winter ◽

Svenja Engels ◽

Philipp Goos ◽

Marie-Christin Süykers ◽

Stefan Gudenkauf ◽

...

Keyword(s):

Prostate Cancer ◽

Iron Oxide ◽

High Risk ◽

Diagnostic Accuracy ◽

Iron Oxide Nanoparticles ◽

Predictive Value ◽

Superparamagnetic Iron Oxide ◽

Superparamagnetic Iron Oxide Nanoparticles ◽

Oxide Nanoparticles

Targeted radioisotope-guided sentinel lymph node dissection (sLND) has shown high diagnostic accuracy in prostate cancer (PCa). To overcome the downsides of the radioactive tracers, magnetometer-guided sLND using superparamagnetic iron oxide nanoparticles (SPIONs) was successfully applied in PCa. This prospective study (SentiMag Pro II, DRKS00007671) determined the diagnostic accuracy of magnetometer-guided sLND in intermediate- and high-risk PCa. Fifty intermediate- or high-risk PCa patients (PSA≥10 ng/ml and/or Gleason score ≥7; median PSA 10.8 ng/ml, IQR 7.4–19.2 ng/ml) were enrolled. After intraprostatic SPIONs injection a day earlier, patients underwent magnetometer-guided sLND and eLND, followed by radical prostatectomy. SLNs were detected in vivo and in ex vivo samples. Diagnostic accuracy of sLND was assessed using eLND as the reference. SLNs were detected in all patients (detection rate 100%), with 447 SLNs (median 9, IQR 6–12) being identified and 966 LNs (median 18, IQR 15-23) being removed. Thirty-six percent (18/50) of patients had LN metastases (median 2, IQR 1–3). Magnetometer-guided sLND had 100% sensitivity, 97.0% specificity, 94.4% positive predictive value, 100% negative predictive value, 0.0% false negative rate, and 3.0% additional diagnostic value (LN metastases only in SLNs outside the eLND template). In vivo, one positive SLN/LN-positive patient was missed, resulting in a sensitivity of 94.4%. In conclusion, this new magnetic sentinel procedure has high accuracy for nodal staging in intermediate- and high-risk PCa. The reliability of intraoperative SLN detection using this magnetometer system requires verification in further multicentric studies.

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Accuracy of Magnetometer-Guided Sentinel Lymphadenectomy after Intraprostatic Injection of Superparamagnetic Iron Oxide Nanoparticles in Prostate Cancer: The SentiMag Pro II Study

Cancers ◽

10.3390/cancers12010032 ◽

2019 ◽

Vol 12 (1) ◽

pp. 32 ◽

Cited By ~ 3

Author(s):

Alexander Winter ◽

Svenja Engels ◽

Philipp Goos ◽

Marie-Christin Süykers ◽

Stefan Gudenkauf ◽

...

Keyword(s):

Lymph Node ◽

Iron Oxide ◽

High Risk ◽

Diagnostic Accuracy ◽

Lymph Node Dissection ◽

Predictive Value ◽

Superparamagnetic Iron Oxide ◽

Oxide Nanoparticles ◽

Node Dissection

Radioisotope-guided sentinel lymph node dissection (sLND) has shown high diagnostic reliability in prostate (PCa) and other cancers. To overcome the limitations of the radioactive tracers, magnetometer-guided sLND using superparamagnetic iron oxide nanoparticles (SPIONs) has been successfully used in PCa. This prospective study (SentiMag Pro II, DRKS00007671) determined the diagnostic accuracy of magnetometer-guided sLND in intermediate- and high-risk PCa. Fifty intermediate- or high-risk PCa patients (prostate-specific antigen (PSA) ≥ 10 ng/mL and/or Gleason score ≥ 7; median PSA 10.8 ng/mL, IQR 7.4–19.2 ng/mL) were enrolled. After the intraprostatic SPIONs injection a day earlier, patients underwent magnetometer-guided sLND and extended lymph node dissection (eLND, followed by radical prostatectomy. SLNs were detected in in vivo and in ex vivo samples. Diagnostic accuracy of sLND was assessed using eLND as the reference. SLNs were detected in all patients (detection rate 100%), with 447 sentinel lymph nodes SLNs (median 9, IQR 6–12) being identified and 966 LNs (median 18, IQR 15–23) being removed. Thirty-six percent (18/50) of patients had LN metastases (median 2, IQR 1–3). Magnetometer-guided sLND had 100% sensitivity, 97.0% specificity, 94.4% positive predictive value, 100% negative predictive value, 0.0% false negative rate, and 3.0% additional diagnostic value (LN metastases only in SLNs outside the eLND template). In vivo, one positive SLN/LN-positive patient was missed, resulting in a sensitivity of 94.4%. In conclusion, this new magnetic sentinel procedure has high accuracy for nodal staging in intermediate- and high-risk PCa. The reliability of intraoperative SLN detection using this magnetometer system requires verification in further multicentric studies.

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Utilizing fourth-generation endocytoscopy and the ‘enlarged nuclear sign’ for in vivo diagnosis of early gastric cancer

Endoscopy International Open ◽

10.1055/a-0957-2866 ◽

2019 ◽

Vol 07 (08) ◽

pp. E1002-E1007 ◽

Cited By ~ 2

Author(s):

Mary Raina Angeli Abad ◽

Haruhiro Inoue ◽

Haruo Ikeda ◽

Anastassios Manolakis ◽

Enrique Rodriguez de Santiago ◽

...

Keyword(s):

Gastric Cancer ◽

Early Gastric Cancer ◽

Diagnostic Accuracy ◽

Cancer Diagnosis ◽

Kappa Statistic ◽

Observer Agreement ◽

Fourth Generation ◽

Well Differentiated ◽

Sensitivity Specificity

Abstract Background and study aims Fourth-generation endocytoscopy is an ultra-high magnification endoscopic technique designed to provide excellent quality in vivo histologic assessment of gastrointestinal lesions. This study aims to evaluate the diagnostic accuracy of endocytoscopy in early gastric cancer diagnosis. Patients and methods A single-center, retrospective analysis of prospectively collected data from all gastric endocytoscopic examinations was conducted. Two expert endoscopists, blinded to white-light and narrow-band imaging findings as well as histopathologic diagnosis, independently reviewed and diagnosed all endocytoscopic images. A newly recognized “enlarged nuclear sign” was detected, and its implication in early gastric cancer diagnosis was evaluated. The diagnostic performance of fourth-generation endocytoscopy was assessed while using the gold standard histopathology as a reference. Results Forty-three patients (mean age±SD, 72.6 ± 12.1 years; 31 males) were enrolled. Based on histopathology, 23 had well-differentiated adenocarcinomas, four adenomas, and 16 non-neoplastic lesions. The sensitivity, specificity, and accuracy of fourth-generation endocytoscopy for gastric cancer diagnosis were 87.0 % (95 % CI: 67.9 – 95.5), 80.0 % (95 % CI: 58.4 – 91.9), and 83.7 % (95 % CI: 70.0 – 91.9) by endoscopist A; and 91.3 % (95 % CI: 73.2 – 97.6), 75.0 % (95 % CI: 53.1 – 88.8), and 83.7 % (95 % CI: 70.0 – 91.9) by endoscopist B. The inter-observer agreement, Kappa statistic = 0.71 (95 % CI: 0.50 – 0.93), was good. The sensitivity, specificity, and accuracy of the enlarged nuclear sign for early gastric cancer diagnosis were 87.0 % (95 % CI: 67.9 – 95.5), 95.0 % (95 % CI: 76.4 – 99.1), and 90.7 % (95 % CI: 78.4 – 96.3) by endoscopist A; and 82.6 % (95 % CI: 62.9 – 93.0), 85.0 % (95 % CI: 64.0 – 94.8), and 83.7 % (95 % CI: 70.0 – 91.9) by endoscopist B. The inter-observer agreement, Kappa statistic = 0.68 (95 % CI: 0.51 – 0.89) was good. Conclusion: Fourth-generation endocytoscopy appears to aid in the diagnosis of early gastric cancer, particularly well-differentiated adenocarcinomas, due to its good diagnostic accuracy and identification of the “enlarged nuclear sign,” and deserves further evaluation in future studies.

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High diagnostic accuracy of automated rapid Strep A test reduces antibiotic prescriptions for children in the United Arab Emirates

BMC Pediatrics ◽

10.1186/s12887-021-02516-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Salama Bin Hendi ◽

Zainab A. Malik ◽

Amar Hassan Khamis ◽

Fadil Y. A. Al-Najjar

Keyword(s):

Diagnostic Accuracy ◽

United Arab Emirates ◽

Predictive Value ◽

High Sensitivity ◽

Signs And Symptoms ◽

Throat Culture ◽

Clinical Criteria ◽

Variable Sensitivity ◽

High Level ◽

Sensitivity Specificity

Abstract Background Diagnosis of Group A Streptococcus (GAS) pharyngitis in children is hindered by variable sensitivity of clinical criteria and rapid Strep A tests (SAT), resulting in reliance on throat cultures as the gold standard for diagnosis. Delays while awaiting culture reports result in unnecessary antibiotic prescriptions among children, contributing to the spread of antimicrobial resistance (AMR). Methods Diagnostic accuracy study of an automated SAT (A-SAT) in children up to 16 years of age presenting to an emergency room with signs and symptoms of pharyngitis between March and June 2019. Paired throat swabs for A-SAT and culture were collected. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for A-SAT were calculated. Results Two hundred and ninety-one children were included in this study. 168 (57.7%) were boys and the mean age was 4.2 years. A-SAT was positive in 94 (32.3%) and throat culture was positive in 90 (30.9%) children. A-SAT and throat culture results showed a high level of consistency in our cohort. Only 6 (2%) children had inconsistent results, demonstrating that the A-SAT has a high sensitivity (98.9%), specificity (97.5%), PPV (94.7%) and NPV (99.5%) for the diagnosis of GAS pharyngitis in children. Only 92 (32%) children were prescribed antibiotics while the vast majority (68%) were not. Conclusions A-SAT is a quick and reliable test with diagnostic accuracy comparable to throat culture. Its widespread clinical use can help limit antibiotic prescriptions to children presenting with pharyngitis, thus limiting the spread of AMR.

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