Diagnostic accuracy of ELISA kits for measurement of rabies antibodies: A systematic review and meta-analysis

2021 ◽  
Author(s):  
Weiping Ling ◽  
Suhail A R Doi ◽  
Colleen L Lau ◽  
Deborah J Mills ◽  
Polychronis Kostoulas ◽  
...  
Keyword(s):  
Systematic Review ◽  
Diagnostic Accuracy ◽  
Immunosorbent Assay ◽  
Gold Standard ◽  
Meta Analysis ◽  
Inhibition Test ◽  
Enzyme Linked Immunosorbent Assay ◽  
Antibody Levels ◽  
Fluorescent Focus

Rapid fluorescent focus inhibition test (RFFIT) is considered the gold standard for measuring rabies antibody levels; however, enzyme-linked immunosorbent assay (ELISA) is cheaper, faster, and more widely available. This meta-analysis revealed that at a cut-off point of 0.5 EU/mL, ELISA has a sensitivity of 95.6% (95%CI:67.7–99.6%) and specificity of 95.4% (95%CI:67.0–99.5%).

scholarly journals Limited Diagnostic Capacities of Two Commercial Assays for the Detection of Leptospira Immunoglobulin M Antibodies in Laos

2006 ◽  
Vol 13 (10) ◽  
pp. 1166-1169 ◽  
Author(s):  
Stuart D. Blacksell ◽  
Lee Smythe ◽  
Rattanaphone Phetsouvanh ◽  
Michael Dohnt ◽  
Rudy Hartskeerl ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Immunosorbent Assay ◽  
Gold Standard ◽  
Agglutination Test ◽  
Immunoglobulin M ◽  
Microscopic Agglutination Test ◽  
Enzyme Linked Immunosorbent Assay ◽  
Diagnostic Utility

ABSTRACT The diagnostic utility of immunochromatographic (Leptotek) and enzyme-linked immunosorbent assay (ELISA; Panbio) tests for the detection of Leptospira immunoglobulin M antibodies was assessed in febrile adults admitted in Vientiane, Laos. Both tests demonstrated poor diagnostic accuracy using admission serum (Leptotek sensitivity of 47.3% and specificity of 75.5%: ELISA sensitivity of 60.9% and specificity of 65.6%) compared to the Leptospira “gold standard” microscopic agglutination test.

scholarly journals Diagnostic Accuracy of COVID-19 Antibody Tests Authorized by FDA Philippines: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 3 (4) ◽  
pp. 283-301
Author(s):  
Carmel Reina R. Chua ◽  
Esther Delle E. De los Santos ◽  
Karla Veronica H. Escasa ◽  
Richmond Louis G. Estolas ◽  
Junnealyn Feliciano ◽  
...  
Keyword(s):  
Systematic Review ◽  
Diagnostic Accuracy ◽  
Random Effects ◽  
Meta Analysis ◽  
Characteristic Curve ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serological Tests ◽  
Random Effects Models ◽  
Specificity And Sensitivity ◽  
Antibody Tests

Introduction: Coronavirus Disease (COVID-19) is a highly infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) which has infected many people all over the world. One of the best ways to lessen its spread is through early detection and diagnosis. Various serological tests are now being used as a surveillance tool in the detection of antibodies as a response to SARS-CoV-2. The aim of this study is to evaluate the diagnostic accuracy and performance of the available COVID-19 antibody tests authorized by the Food and Drug Administration (FDA) Philippines that make use of Enzyme-Linked Immunosorbent Assay (ELISA), Chemiluminescence Immunoassay (CLIA) and Lateral Flow Immunoassay (LFIA). Method: Complete published journal articles relevant to the diagnostic accuracy of the three antibody tests were collected using trusted medical journal search engines. The quality of journals was assessed using QUADAS-2 to determine the risk of bias and assess the applicability judgments of diagnostic accuracy studies. Forest plots were used to summarize the performance of LFIA, ELISA and CLIA according to their specificity and sensitivity in detecting various antibodies. Pooled sensitivity and specificity were also done using bivariate random-effects models with its log-likelihood, a corresponding chi-square test statistic, and area under the summary Receiver-Operating Characteristic curve to see the potential heterogeneity in the data and to assess the diagnostic accuracy of the COVID-19 antibody tests. Results: Bivariate random-effects model and areas under the sROC curve were used to evaluate the diagnostic accuracy of COVID-19 antibody tests. The pooled sensitivity in detecting IgG based on CLIA, ELISA, and LFIA were 81.7%, 58.7%, and 74.3% respectively, with an overall of 72.0%. For IgM detection, LFIA has a higher pooled sensitivity of 69.6% than CLIA with 61.0%. Overall, the pooled sensitivity is 68.5%. In IgA detection, only ELISA based test was included with a pooled sensitivity of 84.8%. Lastly, pooled sensitivities for combined antibodies based on ELISA and LFIA were 89.0% and 81.6% respectively, with an overall of 82.5%. On the other hand, all tests excluding ELISA-IgA displayed high pooled specificities with a range of 94.0% to 100.0%. Diagnostic accuracies of the test in detecting IgG, IgM, and combined antibodies were found out to be almost perfect based on the computed area under the sROC with values of 0.973, 0.953, and 0.966, respectively. Conclusion: In this systematic review and meta-analysis, existing evidence on the diagnostic accuracy of antibody tests for COVID-19 were found to be characterized by high risks of bias, consistency in the heterogeneity of sensitivities, and consistency in the homogeneity of high specificities except in IgA detection using ELISA. The bivariate random-effects models showed that there are no significant differences in terms of sensitivity among CLIA, ELISA and LFIA in detecting IgG, IgM, and combined antibodies at a 95% confidence interval. Nonetheless, CLIA, ELISA and LFIA were found to have excellent diagnostic accuracies in the detection of IgG, IgM and combined antibodies as reflected by their AUC values. Doi: 10.28991/SciMedJ-2021-0304-1 Full Text: PDF

scholarly journals Diagnostic Accuracy of Ambulatory Devices in Detecting Atrial Fibrillation: Systematic Review and Meta-analysis

10.2196/26167 ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. e26167
Author(s):  
Tien Yun Yang ◽  
Li Huang ◽  
Shwetambara Malwade ◽  
Chien-Yi Hsu ◽  
Yang Ching Chen
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Diagnostic Accuracy ◽  
Likelihood Ratio ◽  
Systematic Reviews ◽  
Subgroup Analysis ◽  
Gold Standard ◽  
Meta Analysis ◽  
Automatic Interpretation ◽  
Sensitivity Specificity

Background Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide. Early diagnosis of AF is crucial for preventing AF-related morbidity, mortality, and economic burden, yet the detection of the disease remains challenging. The 12-lead electrocardiogram (ECG) is the gold standard for the diagnosis of AF. Because of technological advances, ambulatory devices may serve as convenient screening tools for AF. Objective The objective of this review was to investigate the diagnostic accuracy of 2 relatively new technologies used in ambulatory devices, non-12-lead ECG and photoplethysmography (PPG), in detecting AF. We performed a meta-analysis to evaluate the diagnostic accuracy of non-12-lead ECG and PPG compared to the reference standard, 12-lead ECG. We also conducted a subgroup analysis to assess the impact of study design and participant recruitment on diagnostic accuracy. Methods This systematic review and meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. MEDLINE and EMBASE were systematically searched for articles published from January 1, 2015 to January 23, 2021. A bivariate model was used to pool estimates of sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), and area under the summary receiver operating curve (SROC) as the main diagnostic measures. Study quality was evaluated using the quality assessment of diagnostic accuracy studies (QUADAS-2) tool. Results Our search resulted in 16 studies using either non-12-lead ECG or PPG for detecting AF, comprising 3217 participants and 7623 assessments. The pooled estimates of sensitivity, specificity, PLR, NLR, and diagnostic odds ratio for the detection of AF were 89.7% (95% CI 83.2%-93.9%), 95.7% (95% CI 92.0%-97.7%), 20.64 (95% CI 10.10-42.15), 0.11 (95% CI 0.06-0.19), and 224.75 (95% CI 70.10-720.56), respectively, for the automatic interpretation of non-12-lead ECG measurements and 94.7% (95% CI 93.3%-95.8%), 97.6% (95% CI 94.5%-99.0%), 35.51 (95% CI 18.19-69.31), 0.05 (95% CI 0.04-0.07), and 730.79 (95% CI 309.33-1726.49), respectively, for the automatic interpretation of PPG measurements. Conclusions Both non-12-lead ECG and PPG offered high diagnostic accuracies for AF. Detection employing automatic analysis techniques may serve as a useful preliminary screening tool before administering a gold standard test, which generally requires competent physician analyses. Subgroup analysis indicated variations of sensitivity and specificity between studies that recruited low-risk and high-risk populations, warranting future validity tests in the general population. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42020179937; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=179937

scholarly journals Latex Agglutination Turbidimetric Immunoassay Versus Enzyme-Linked Immunosorbent Assay for Helicobacter pylori: An Observational Study.

2020 ◽  
Author(s):  
Yoshitaka Tokai ◽  
Junko Fujisaki ◽  
Naoki Ishizuka ◽  
Hiroki Osumi ◽  
Ken Namikawa ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Diagnostic Accuracy ◽  
Sensitivity And Specificity ◽  
Immunosorbent Assay ◽  
Latex Agglutination ◽  
Concordance Rate ◽  
Enzyme Linked Immunosorbent Assay ◽  
H Pylori ◽  
Antibody Levels ◽  
Turbidimetric Immunoassay

Abstract Background: Helicobacter pylori antibody levels in the blood are currently measured using an enzyme-linked immunosorbent assay (ELISA). In April 2016, FUJIFILM Wako Pure Chemical Corporation launched the “L-type Wako Helicobacter pylori antibody J” test, which is based on the latex agglutination turbidimetric immunoassay. In this study, we investigated the usefulness of the Wako test. Methods: We measured H. pylori antibody levels using both ELISA and Wako tests in 180 patients who underwent esophagogastroduodenoscopy at our hospital between September 2017 and February 2019. Ninety patients had H. pylori infections. We calculated the diagnostic accuracy, sensitivity, and specificity of each test and the concordance rate between the two tests. If the lower limits of 90% confidence intervals (CI) for each diagnostic validity exceeded the 85% threshold, the usefulness of the diagnostic test was confirmed. Results: Diagnostic accuracy, sensitivity, and specificity were 94.4% (90% CI; 90.8–97.0%), 94.4% (90% CI; 88.7–97.8%), and 94.4% (90% CI; 88.7–97.8%), respectively, using the Wako test, and 94.4% (90% CI; 90.8–97.0%), 88.9% (90% CI; 81.9–93.8%), and 100% (90% CI; 96.0–100%), respectively, using ELISA. The concordance rate between the two tests was high (κ = 0.8444). Conclusions: We confirmed the usefulness of the Wako test, especially when screening for H. pylori infection, due to its high sensitivity.Trial registration: We retrospectively registered the data of this study.

scholarly journals Serological profiling of rabies antibodies by enzyme-linked immunosorbent assay and its comparative analysis with rapid fluorescent focus inhibition test in mouse model

2019 ◽  
Vol 12 (1) ◽  
pp. 126-130 ◽  
Author(s):  
Ashis Debnath ◽  
Dinesh C. Pathak ◽  
Narayan Ramamurthy ◽  
Gulam Mohd ◽  
A. B. Pandey ◽  
...  
Keyword(s):  
Vero Cell ◽  
Rabies Virus ◽  
Immunosorbent Assay ◽  
Disease Transmission ◽  
Regression Line ◽  
Rabies Vaccine ◽  
Inhibition Test ◽  
Enzyme Linked Immunosorbent Assay ◽  
Mice Model ◽  
Fluorescent Focus

Aim: In this study, we have used enzyme-linked immunosorbent assay (ELISA) as an alternative test to replace the cumbersome rapid fluorescent focus inhibition test (RFFIT) to ascertain the immune status of immunized mice against rabies virus. Materials and Methods: Rabies is a devastating disease worldwide caused by rabies virus. Proper usage of pre- or post-exposure rabies vaccine can prevent the disease transmission. In this study, mice were immunized with Vero cell-adapted inactivated rabies vaccine. RFFIT was used as a test to determine the serum neutralizing titers in infected/vaccinated mice. Seroprofiling of mice sera was done in vitro by ELISA. Results: Twenty-one days post-immunization, both ELISA and RFFIT assays indicated similar antibody levels in mice sera that were immunized with Vero cell-adapted inactivated rabies vaccine. Both the tests were correlated, and the linearity was verified by the regression line (R2=0.979). Conclusion: In this study, we profiled the serological status of Vero cell-adapted inactivated rabies vaccine through ELISA in mice model that correlated well with the OIE gold standard test RFFIT.

scholarly journals Diagnostic Accuracy of Ambulatory Devices in Detecting Atrial Fibrillation: Systematic Review and Meta-analysis (Preprint)

2020 ◽  
Author(s):  
Tien Yun Yang ◽  
Li Huang ◽  
Shwetambara Malwade ◽  
Chien-Yi Hsu ◽  
Yang Ching Chen
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Diagnostic Accuracy ◽  
Likelihood Ratio ◽  
Systematic Reviews ◽  
Subgroup Analysis ◽  
Gold Standard ◽  
Meta Analysis ◽  
Automatic Interpretation ◽  
Sensitivity Specificity

BACKGROUND Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide. Early diagnosis of AF is crucial for preventing AF-related morbidity, mortality, and economic burden, yet the detection of the disease remains challenging. The 12-lead electrocardiogram (ECG) is the gold standard for the diagnosis of AF. Because of technological advances, ambulatory devices may serve as convenient screening tools for AF. OBJECTIVE The objective of this review was to investigate the diagnostic accuracy of 2 relatively new technologies used in ambulatory devices, non-12-lead ECG and photoplethysmography (PPG), in detecting AF. We performed a meta-analysis to evaluate the diagnostic accuracy of non-12-lead ECG and PPG compared to the reference standard, 12-lead ECG. We also conducted a subgroup analysis to assess the impact of study design and participant recruitment on diagnostic accuracy. METHODS This systematic review and meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. MEDLINE and EMBASE were systematically searched for articles published from January 1, 2015 to January 23, 2021. A bivariate model was used to pool estimates of sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), and area under the summary receiver operating curve (SROC) as the main diagnostic measures. Study quality was evaluated using the quality assessment of diagnostic accuracy studies (QUADAS-2) tool. RESULTS Our search resulted in 16 studies using either non-12-lead ECG or PPG for detecting AF, comprising 3217 participants and 7623 assessments. The pooled estimates of sensitivity, specificity, PLR, NLR, and diagnostic odds ratio for the detection of AF were 89.7% (95% CI 83.2%-93.9%), 95.7% (95% CI 92.0%-97.7%), 20.64 (95% CI 10.10-42.15), 0.11 (95% CI 0.06-0.19), and 224.75 (95% CI 70.10-720.56), respectively, for the automatic interpretation of non-12-lead ECG measurements and 94.7% (95% CI 93.3%-95.8%), 97.6% (95% CI 94.5%-99.0%), 35.51 (95% CI 18.19-69.31), 0.05 (95% CI 0.04-0.07), and 730.79 (95% CI 309.33-1726.49), respectively, for the automatic interpretation of PPG measurements. CONCLUSIONS Both non-12-lead ECG and PPG offered high diagnostic accuracies for AF. Detection employing automatic analysis techniques may serve as a useful preliminary screening tool before administering a gold standard test, which generally requires competent physician analyses. Subgroup analysis indicated variations of sensitivity and specificity between studies that recruited low-risk and high-risk populations, warranting future validity tests in the general population. CLINICALTRIAL PROSPERO International Prospective Register of Systematic Reviews CRD42020179937; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=179937

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