scholarly journals Antibody Tests in Detecting SARS-CoV-2 Infection: A Meta-Analysis

Diagnostics ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. 319 ◽  
Author(s):  
Panagiota I. Kontou ◽  
Georgia G. Braliou ◽  
Niki L. Dimou ◽  
Georgios Nikolopoulos ◽  
Pantelis G. Bagos
Keyword(s):  
Gold Standard ◽  
Diagnostic Tests ◽  
Meta Analysis ◽  
High Specificity ◽  
Enzyme Linked Immunosorbent Assay ◽  
Lower Sensitivity ◽  
Serological Tests ◽  
Bivariate Method ◽  
Acid Test ◽  
Antibody Tests

The emergence of Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 made imperative the need for diagnostic tests that can identify the infection. Although Nucleic Acid Test (NAT) is considered to be the gold standard, serological tests based on antibodies could be very helpful. However, individual studies are usually inconclusive, thus, a comparison of different tests is needed. We performed a systematic review and meta-analysis in PubMed, medRxiv and bioRxiv. We used the bivariate method for meta-analysis of diagnostic tests pooling sensitivities and specificities. We evaluated IgM and IgG tests based on Enzyme-linked immunosorbent assay (ELISA), Chemiluminescence Enzyme Immunoassays (CLIA), Fluorescence Immunoassays (FIA), and the Lateral Flow Immunoassays (LFIA). We identified 38 studies containing data from 7848 individuals. Tests using the S antigen are more sensitive than N antigen-based tests. IgG tests perform better compared to IgM ones and show better sensitivity when the samples were taken longer after the onset of symptoms. Moreover, a combined IgG/IgM test seems to be a better choice in terms of sensitivity than measuring either antibody alone. All methods yield high specificity with some of them (ELISA and LFIA) reaching levels around 99%. ELISA- and CLIA-based methods perform better in terms of sensitivity (90%–94%) followed by LFIA and FIA with sensitivities ranging from 80% to 89%. ELISA tests could be a safer choice at this stage of the pandemic. LFIA tests are more attractive for large seroprevalence studies but show lower sensitivity, and this should be taken into account when designing and performing seroprevalence studies.

scholarly journals Antibody tests in detecting SARS-CoV-2 infection: a meta-analysis

2020 ◽  
Author(s):  
Panagiota I Kontou ◽  
Georgia G Braliou ◽  
Niki L Dimou ◽  
Georgios Nikolopoulos ◽  
Pantelis G Bagos
Keyword(s):  
Diagnostic Tests ◽  
Point Of Care ◽  
Meta Analysis ◽  
High Specificity ◽  
Enzyme Linked Immunosorbent Assay ◽  
Lower Sensitivity ◽  
Serological Tests ◽  
Bivariate Method ◽  
Acid Test ◽  
Antibody Tests

SummaryBackgroundWith the emergence of SARS-CoV-2 and the associated Coronavirus disease 2019 (COVID-19), there is an imperative need for diagnostic tests that can identify the infection. Although Nucleic Acid Test (NAT) is considered to be the gold standard, serological tests based on antibodies could be very helpful. However, individual studies measuring the accuracy of the various tests are usually underpowered and inconsistent, thus, a comparison of different tests is needed.MethodsWe performed a systematic review and meta-analysis following the PRISMA guidelines. We conducted the literature search in PubMed, medRxiv and bioRxiv. For the statistical analysis we used the bivariate method for meta-analysis of diagnostic tests pooling sensitivities and specificities. We evaluated IgM and IgG tests based on Enzyme-linked immunosorbent assay (ELISA), Chemiluminescence Enzyme Immunoassays (CLIA), Fluorescence Immunoassays (FIA) and the point-of-care (POC) Lateral Flow Immunoassays (LFIA) that are based on immunochromatography.FindingsIn total, we identified 38 eligible studies that include data from 7,848 individuals. The analyses showed that tests using the S antigen are more sensitive than N antigen-based tests. IgG tests perform better compared to IgM ones, and show better sensitivity when the samples were taken longer after the onset of symptoms. Moreover, irrespective of the method, a combined IgG/IgM test seems to be a better choice in terms of sensitivity than measuring either antibody type alone. All methods yielded high specificity with some of them (ELISA and LFIA) reaching levels around 99%. ELISA- and CLIA-based methods performed better in terms of sensitivity (90-94%) followed by LFIA and FIA with sensitivities ranging from 80% to 86%.InterpretationELISA tests could be a safer choice at this stage of the pandemic. POC tests (LFIA), that are more attractive for large seroprevalence studies show high specificity but lower sensitivity and this should be taken into account when designing and performing seroprevalence studies.FundingNone

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 Multiple Indirect ELISAs for Serological Detection of SARS-CoV-2 Antibodies

2020 ◽  
Author(s):  
Abdullah Algaissi ◽  
Mohamed A. Alfaleh ◽  
Sherif Hala ◽  
Turki S. Abujamel ◽  
Sawsan S. Alamari ◽  
...  
Keyword(s):  
Antibody Response ◽  
Large Scale ◽  
Disease Onset ◽  
High Specificity ◽  
Epidemiological Studies ◽  
Cross Reactivity ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serological Tests ◽  
Specificity And Sensitivity ◽  
Novel Coronavirus

As the coronavirus disease 2019 (COVID-19), which is caused by the novel coronavirus SARS-CoV-2, continues to spread rapidly around the world, there is an urgent need for validated serological assays to evaluate viral specific antibody responses in COVID-19 patients or recovered individuals. In this study, we established and used indirect Enzyme Linked Immunosorbent Assay (ELISA)-based serological tests to study the antibody response in COVID-19 patients. In order to validate the assays, we determined the cut-off values, sensitivity and specificity of the developed assays using sera collected from COVID-19 patients in Saudi Arabia at different time points after disease onset, as well as sera that are seropositive to other human CoVs; namely MERS-CoV, hCoV-OC43, hCoV-NL63, hCoV-229E, and hCoV-HKU1. The SARS-CoV-2 S1 subunit of the spike glycoprotein and nucleocapsid (N) ELISAs that we developed here not only showed high specificity and sensitivity, but also did not show any cross-reactivity with other CoVs. We also showed that all RT-PCR confirmed COVID-19 patients included in our study developed both virus specific IgM and IgG as early as one week after the onset of disease. The availability of these validated assays will enable us to determine the nature and duration of the antibody response mounted in response to SARS-CoV-2 infection. It will also allow conducting large-scale epidemiological studies to determine evidence of previous exposure to the virus and assess the true extent of virus spread within communities.

scholarly journals Performance of an Immunochromatographic Test (ICT) in Comparison to Some Commonly Used Serological Tests for the Diagnosis of Brucellosis in Dromedary Camels (Camelus dromedarius)

2019 ◽  
Vol 7 (12) ◽  
pp. 591
Author(s):  
Serhan ◽  
Khan ◽  
Gasim ◽  
Alketbi ◽  
De Massis ◽  
...  
Keyword(s):  
Small Ruminants ◽  
Control Measures ◽  
Camelus Dromedarius ◽  
Enzyme Linked Immunosorbent Assay ◽  
Lower Sensitivity ◽  
Immunochromatographic Test ◽  
Dromedary Camels ◽  
Serological Tests ◽  
Significant Difference ◽  
Fluorescence Polarization Assay

Serological tests may represent an essential tool for the diagnosis of camel brucellosis; however, concerns arise in the scientific community regarding the direct transposition from cattle and small ruminants without adequate validation. The present study was made to compare four serological tests for the diagnosis of brucellosis in dromedary camels (Camelus dromedarius). In terms of sensitivity, our results show that the Immunochromatographic Test (ICT) shows the higher value of sensitivity, 98.67% (95% Confidence Level (C.L): 94.36%–99.99%), followed by the Fluorescence Polarization Assay (FPA) with 95.05% (95% C.L: 88.23%–99.51%), then the Competitive Enzyme-Linked Immunosorbent Assay (c-ELISA) with 94.94% (95% C.L: 88.25%–99.45%) and, finally, the Rose Bengal Test (RBT) with 68.95% (95% C.L: 56.55%–80.69%), which is the only test showing a significantly lower sensitivity compared to the others. On the other hand, our study revealed no significant difference in terms of specificity between all the tests under study, with a range from 99.06% (95% C.L: 98.34%–99.64%) for the ICT to 99.92% (95% C.L: 99.64%–100%) for the RBT. The ICT was found to be comparable in terms of sensitivity and specificity with the most commonly used tests for camel brucellosis. The results of the present study are of paramount importance for designing surveillance and control measures for brucellosis in camel populations.

Meta-analysis for the comparison of two diagnostic tests to a common gold standard: A generalized linear mixed model approach

2016 ◽  
Vol 27 (5) ◽  
pp. 1410-1421 ◽  
Author(s):  
Annika Hoyer ◽  
Oliver Kuss
Keyword(s):  
Gold Standard ◽  
Diagnostic Tests ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Meta Analysis ◽  
Roc Curves ◽  
Generalized Linear Mixed Model ◽  
Screening Methods ◽  
Bivariate Model ◽  
Mixed Model Approach

Meta-analysis of diagnostic studies is still a rapidly developing area of biostatistical research. Especially, there is an increasing interest in methods to compare different diagnostic tests to a common gold standard. Restricting to the case of two diagnostic tests, in these meta-analyses the parameters of interest are the differences of sensitivities and specificities (with their corresponding confidence intervals) between the two diagnostic tests while accounting for the various associations across single studies and between the two tests. We propose statistical models with a quadrivariate response (where sensitivity of test 1, specificity of test 1, sensitivity of test 2, and specificity of test 2 are the four responses) as a sensible approach to this task. Using a quadrivariate generalized linear mixed model naturally generalizes the common standard bivariate model of meta-analysis for a single diagnostic test. If information on several thresholds of the tests is available, the quadrivariate model can be further generalized to yield a comparison of full receiver operating characteristic (ROC) curves. We illustrate our model by an example where two screening methods for the diagnosis of type 2 diabetes are compared.

Performance of the ASAS classification criteria for axial and peripheral spondyloarthritis: a systematic literature review and meta-analysis

2017 ◽  
Vol 76 (5) ◽  
pp. 886-890 ◽  
Author(s):  
Alexandre Sepriano ◽  
Roxana Rubio ◽  
Sofia Ramiro ◽  
Robert Landewé ◽  
Désirée van der Heijde
Keyword(s):  
Literature Review ◽  
Systematic Literature Review ◽  
Meta Analysis ◽  
High Specificity ◽  
Classification Criteria ◽  
Lower Sensitivity ◽  
Likelihood Ratios ◽  
Random Effects Models ◽  
Asas Classification Criteria ◽  
Peripheral Spondyloarthritis

ObjectiveTo summarise the evidence on the performance of the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial spondyloarthritis (axSpA) (also imaging and clinical arm separately), peripheral (p)SpA and the entire set, when tested against the rheumatologist's diagnosis (‘reference standard’).MethodsA systematic literature review was performed to identify eligible studies. Raw data on SpA diagnosis and classification were extracted or, if necessary, obtained from the authors of the selected publications. A meta-analysis was performed to obtain pooled estimates for sensitivity, specificity, positive and negative likelihood ratios, by fitting random effects models.ResultsNine papers fulfilled the inclusion criteria (N=5739 patients). The entire set of the ASAS SpA criteria yielded a high pooled sensitivity (73%) and specificity (88%). Similarly, good results were found for the axSpA criteria (sensitivity: 82%; specificity: 88%). Splitting the axSpA criteria in ‘imaging arm only’ and ‘clinical arm only’ resulted in much lower sensitivity (30% and 23% respectively), but very high specificity was retained (97% and 94% respectively). The pSpA criteria were less often tested than the axSpA criteria and showed a similarly high pooled specificity (87%) but lower sensitivity (63%).ConclusionsAccumulated evidence from studies with more than 5500 patients confirms the good performance of the various ASAS SpA criteria as tested against the rheumatologist's diagnosis.

scholarly journals Diagnostic tests for amoebic liver abscess: comparison of enzyme - linked immunosorbent assay (Elisa) and counterimmunoelectrophoresis (CIE)

1996 ◽  
Vol 29 (1) ◽  
pp. 27-32 ◽  
Author(s):  
Marcos I. Restrepo ◽  
Zoraida Restrepo ◽  
Consuelo López Elsa Villareal ◽  
Aura Aguirre ◽  
Marcos Restrepo
Keyword(s):  
Liver Abscess ◽  
Immunosorbent Assay ◽  
Diagnostic Tests ◽  
Amoebic Liver Abscess ◽  
Enzyme Linked Immunosorbent Assay ◽  
Elisa Method ◽  
Serological Tests ◽  
Negative Results ◽  
Intestinal Amoebiasis ◽  
Higher Sensitivity

The liver abscess is the most frequent extraintestinal complication of intestinal amoebiasis: its diagnosis is suggested by the clinical picture but it must be confirmed by paraclinic tests. Themost stringent diagnosis requires identification of E. histolytica. But this is possible only in a few cases. Serological tests greatly improve the diagnosis of this severe complication of amoebiasis. We compared the Enzyme Linfed Immunosorbent Assay and the Counterimmunoeletrophoresis techniques. Both techniques were used to detect amoebic antibodies in 50 control patients, 30 patients with liver abscess and 30 patients with intestinal amoebiasis. All the sera from control patients gave negative results iin both techniques. When analysing the sera from patients with intestinal amoebiasis, 10% of them were positive by ELISA but non by CIE. The sera of patients with liver abscess, we found that 90% were positive by the ELISA method and 66.6% by the CIE technique. In patients with amoebic liver abscess, the results showed that the ELISA was more sensitive than the CIE, as it presented a higher sensitivity (100%) than that of the CIE technique (66%).

scholarly journals Comparison of Weil Felix Test and ELISA with the Gold Standard IFA for the Diagnosis of Scrub Typhus in Clinically Suspected Cases of Scrub Typhus at a Tertiary Care Hospital in Tamil Nadu

2021 ◽  
Vol 8 (21) ◽  
pp. 1722-1725
Author(s):  
Anisha Elizabeth Jacob ◽  
Marina Thomas ◽  
v Appalaraju
Keyword(s):  
Gold Standard ◽  
Tamil Nadu ◽  
Scrub Typhus ◽  
Fluorescent Antibody ◽  
Tertiary Care ◽  
Antibody Test ◽  
Enzyme Linked Immunosorbent Assay ◽  
Care Hospital ◽  
Serological Tests ◽  
Cross Sectional

BACKGROUND Scrub typhus is a febrile disease, the clinical diagnosis of which is difficult due to its vague symptoms. Scrub typhus is diagnosed mainly via serological tests. Sensitivity of Weil Felix was found to be poor, but the specificity of Weil Felix was variable in different studies. Enzyme linked immunosorbent assay (ELISA) IgM is known to be a sensitive test, but its specificity was variable in different studies. Therefore, in this study we have compared these two tests with the gold standard IFA. METHODS The study was performed as a cross-sectional study. Among the suspected scrub typhus cases, fifty consecutive IFA scrub typhus positive and fifty consecutive IFA negative samples were taken for comparison of Weil Felix and ELISA tests. The indirect fluorescent antibody test (IFA) was taken as the gold standard. RESULTS The sensitivity of ELISA and Weil Felix at a titre of 1 : 160 was found to be 96 % and 40 % respectively. The specificity of ELISA and Weil Felix at 1 : 160 and was found to be 88 % and 94 % respectively. CONCLUSIONS Scrub typhus should be kept in mind as a possible diagnosis in acute febrile illnesses. Weil - Felix was found to have a good specificity but low sensitivity. Hence, if the results by Weil Felix are negative, scrub typhus cannot be ruled out and may require further testing. ELISA showed good sensitivity making it a preferable screening test but is not highly specific and confirmation with IFA may be required when feasible. KEYWORDS Scrub Typhus, ELISA, Weil Felix, IFA, Laboratory Diagnosis

scholarly journals The role of rapid diagnostic point of care IgG/IgM antibody tests in the diagnosis of SARS-CoV-2 infection

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Nishita Tripathi ◽  
Keyword(s):  
Nucleic Acid ◽  
Point Of Care ◽  
Clinical Importance ◽  
Antibody Test ◽  
High Specificity ◽  
Nucleic Acid Amplification ◽  
Serological Tests ◽  
Nucleic Acid Amplification Tests ◽  
Igm Antibody ◽  
Antibody Tests

Background: Current testing of symptomatic patients for SARS-CoV-2 involves the use of nucleic acid amplification tests, also known as genetic, RNA or PCR to detect viral RNA. The initial use of point-of-care (POC) antibody tests, also known as serological tests in the management of SARS-CoV-2 infection was limited. In this review, we determine the significance of POC antibody serological tests and explore their possible role in the diagnosis and management of patients infected with SARS-CoV-2 virus. Methods: A literature search was conducted in Google Scholar, PubMed, and Embase, and supplemented by searching the Center for Disease Control (CDC), and the Infectious Diseases Society of America (IDSA) websites. We identified 7 articles published in the last 6 months pertaining to the keywords. The sensitivity and specificity of the IgG/IgM antibody tests obtained from these studies were compared and used to determine the clinical importance of the rapid diagnostic antibody test in SARS-CoV-2 infection. Results: Through the literature review, it was found that POC diagnostic antibody tests can be used as an adjuvant with the nucleic acid amplification tests in determining both active and post-exposure antibodies. These rapid antibody IgG/IgM tests had high sensitivity, the ability of a test to correctly identify those with the disease, and high specificity, the ability of the test to correctly identify those without the disease. Conclusion: Emerging studies indicate the importance of POC antibody serological testing as an important diagnostic tool in the current SARS-CoV-2 pandemic. Considering the limitations of the molecular methods of testing, POC antibody tests can help reduce dependency on the molecular assays of testing when used in conjunction with them.

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