scholarly journals A systematic and meta-analysis review on the diagnostic accuracy of antibodies in the serological diagnosis of COVID-19.

2020 ◽  
Author(s):  
Arthur Vengesai ◽  
Herald Midzi ◽  
Maritha Kasambala ◽  
Hamlet Mutandadzi ◽  
Tariro L. Mduluza-Jok ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Data Extraction ◽  
Meta Analysis ◽  
Characteristic Curve ◽  
Test Accuracy ◽  
Summary Receiver Operating Characteristic ◽  
Serological Tests ◽  
Bivariate Model ◽  
Prevalence Studies

Abstract Background: Serological testing based on different antibody types are an alternative method being used to diagnose SARS-CoV-2 and has the potential of having higher diagnostic accuracy compared to the current gold standard rRT-PCR. Therefore, the objective of this review was to evaluate the diagnostic accuracy of IgG and IgM based point-of-care (POC) lateral flow immunoassay (LFIA), chemiluminescence enzyme immunoassay (CLIA), fluorescence enzyme-linked immunoassay (FIA) and ELISA systems that detect SARS-CoV-2 antigens.Method: A systematic literature search was carried out in PubMed, Medline complete and MedRxiv. Studies evaluating the diagnostic accuracy of serological assays for SARS-CoV-2 were eligible. Study selection and data-extraction were performed by two authors independently. QUADAS-2 checklist tool was used to assess the quality of the studies. The bivariate model and the hierarchical summary receiver operating characteristic curve model were performed to evaluate the diagnostic accuracy of the serological tests. Subgroup meta-analysis analyses was performed to explore the heterogeneity. Results: The pooled sensitivity for IgG, IgM and IgG-IgM based LFIA tests were 0.5856, 0.4637 and 0.6886, respectively compared to rRT-PCR method. The pooled sensitivity for IgG and IgM based CLIA tests were 0.9311 and 0.8516, respectively compared to rRT-PCR. The pooled sensitivity the IgG, IgM and IgG-IgM based ELISA tests were 0.8292, 0.8388 and 0.8531 respectively compared to rRT-PCR. All tests displayed high specificities ranging from 0.9693 to 0.9991. Among the evaluated tests, IgG based CLIA expressed the highest sensitivity signifying its accurate detection of the largest proportion of infections identified by rRT-PCR. ELISA and CLIA tests performed better in terms of sensitivity compared to LFIA. IgG based tests performed better compared to IgM except for the ELISA. Conclusions: We report that IgG-IgM based ELISA tests have the best overall diagnostic test accuracy. 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 independently. Given the poor performances of the current LFIA devices there is need for more research on the development of highly sensitivity and specific POC LFIA that are adequate for most individual patient applications and attractive for large sero-prevalence studies.Systematic review registration: PROSPERO Registration Number is: CRD42020179112

scholarly journals A systematic and meta-analysis review on the diagnostic accuracy of antibodies in the serological diagnosis of COVID-19

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Arthur Vengesai ◽  
Herald Midzi ◽  
Maritha Kasambala ◽  
Hamlet Mutandadzi ◽  
Tariro L. Mduluza-Jokonya ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Data Extraction ◽  
Meta Analysis ◽  
Characteristic Curve ◽  
Test Accuracy ◽  
Summary Receiver Operating Characteristic ◽  
Serological Tests ◽  
Bivariate Model ◽  
Prevalence Studies

Abstract Background Serological testing based on different antibody types are an alternative method being used to diagnose SARS-CoV-2 and has the potential of having higher diagnostic accuracy compared to the current gold standard rRT-PCR. Therefore, the objective of this review was to evaluate the diagnostic accuracy of IgG and IgM based point-of-care (POC) lateral flow immunoassay (LFIA), chemiluminescence enzyme immunoassay (CLIA), fluorescence enzyme-linked immunoassay (FIA) and ELISA systems that detect SARS-CoV-2 antigens. Method A systematic literature search was carried out in PubMed, Medline complete and MedRxiv. Studies evaluating the diagnostic accuracy of serological assays for SARS-CoV-2 were eligible. Study selection and data-extraction were performed by two authors independently. QUADAS-2 checklist tool was used to assess the quality of the studies. The bivariate model and the hierarchical summary receiver operating characteristic curve model were performed to evaluate the diagnostic accuracy of the serological tests. Subgroup meta-analysis was performed to explore the heterogeneity. Results The pooled sensitivity for IgG (n = 17), IgM (n = 16) and IgG-IgM (n = 24) based LFIA tests were 0.5856, 0.4637 and 0.6886, respectively compared to rRT-PCR method. The pooled sensitivity for IgG (n = 9) and IgM (n = 10) based CLIA tests were 0.9311 and 0.8516, respectively compared to rRT-PCR. The pooled sensitivity the IgG (n = 10), IgM (n = 11) and IgG-IgM (n = 5) based ELISA tests were 0.8292, 0.8388 and 0.8531 respectively compared to rRT-PCR. All tests displayed high specificities ranging from 0.9693 to 0.9991. Amongst the evaluated tests, IgG based CLIA expressed the highest sensitivity signifying its accurate detection of the largest proportion of infections identified by rRT-PCR. ELISA and CLIA tests performed better in terms of sensitivity compared to LFIA. IgG based tests performed better compared to IgM except for the ELISA. Conclusions We report that IgG-IgM based ELISA tests have the best overall diagnostic test accuracy. 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 independently. Given the poor performances of the current LFIA devices, there is a need for more research on the development of highly sensitivity and specific POC LFIA that are adequate for most individual patient applications and attractive for large sero-prevalence studies. Systematic review registration PROSPERO CRD42020179112

scholarly journals A Systematic and Meta-Analysis Review on the Diagnostic Accuracy of Antibodies in the Serological Diagnosis of COVID-19.

2020 ◽  
Author(s):  
Arthur Vengesai ◽  
Herald Midzi ◽  
Maritha Kasambala ◽  
Hamlet Mutandadzi ◽  
Tariro L. Mduluza-Jok ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Meta Analysis ◽  
Characteristic Curve ◽  
Test Accuracy ◽  
Rt Pcr ◽  
Summary Receiver Operating Characteristic ◽  
Serological Tests ◽  
Bivariate Model ◽  
Prevalence Studies

Abstract Background: Serological testing based on different antibody types are an alternative method being used to diagnose SARS-CoV-2 and has the potential of having higher diagnostic accuracy compared to the current gold standard RT-PCR. Therefore, the objective of this review was to evaluate the diagnostic accuracy of IgG and IgM based Point-of-care (POC) lateral flow immunoassays (LFIA), chemiluminescence enzyme immunoassay (CLIA), fluorescence enzyme-linked immunoassay (FIA) and ELISA systems that detect SARS-CoV-2 antigens.Method: A systematic literature search was carried out in PubMed, Medline complete and MedRxiv. Studies evaluating the diagnostic accuracy of serological assays for SARS-CoV-2 were eligible. Study selection and data-extraction were done by two authors independently. QUADAS-2 checklist tool was used to assess the quality of the studies. The bivariate model and the hierarchical summary receiver operating characteristic curve model were performed to evaluate the diagnostic accuracy of the serological tests. Subgroup meta-analysis analyses was performed to explore the heterogeneity. Results: The pooled sensitivity for IgG, IgM and IgG-IgM based LFIA tests were 0.5856, 0.4637 and 0.6886 respectively compared to RT-PCR method. The pooled sensitivity for IgG and IgM based CLIA tests were 0.9311 and 0.8516 respectively compared to RT-PCR. The pooled sensitivity the IgG, IgM and IgG-IgM based ELISA tests were 0.8292, 0.8388 and 0.8531 respectively compared to RT-PCR. All tests displayed high specificities ranging from 0.9693 to 0.9991. Among the evaluated tests, IgG based CLIA expressed the highest sensitivity signifying its accurate detection of the largest proportion of infections identified by RT-PCR. ELISA and CLIA tests performed better in terms of sensitivity compared to LFIA. IgG based tests performed better compared to IgM ones expect for the ELISA. Conclusions: We report that IgG-IgM based ELISA tests have the best overall diagnostic test accuracy. 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 independently. Given the poor performances of the current LFIA devices there is need for more research on the development of highly sensitivity and specific POC LFIA that are adequate for most individual patient applications and attractive for large sero-prevalence studies.Systematic review registration: PROSPERO Registration Number is: CRD42020179112

scholarly journals Comparison of Centor and McIsaac scores in primary care: a meta-analysis over multiple thresholds

2020 ◽  
Vol 70 (693) ◽  
pp. e245-e254 ◽  
Author(s):  
Brian H Willis ◽  
Dyuti Coomar ◽  
Mohammed Baragilly
Keyword(s):  
Primary Care ◽  
Point Of Care ◽  
Data Extraction ◽  
Meta Analysis ◽  
Test Accuracy ◽  
Summary Receiver Operating Characteristic ◽  
Cross Sectional ◽  
Multiple Thresholds ◽  
The Difference ◽  
Point Of Care Tests

BackgroundCentor and McIsaac scores are both used to diagnose group A beta-haemolytic streptococcus (GABHS) infection, but have not been compared through meta-analysis.AimTo compare the performance of Centor and McIsaac scores at diagnosing patients with GABHS presenting to primary care with pharyngitis.Design and settingA meta-analysis of diagnostic test accuracy studies conducted in primary care was performed using a novel model that incorporates data at multiple thresholds.MethodMEDLINE, EMBASE, and PsycINFO were searched for studies published between January 1980 and February 2019. Included studies were: cross-sectional; recruited patients with sore throats from primary care; used the Centor or McIsaac score; had GABHS infection as the target diagnosis; used throat swab culture as the reference standard; and reported 2 × 2 tables across multiple thresholds. Selection and data extraction were conducted by two independent reviewers. QUADAS-2 was used to assess study quality. Summary receiver operating characteristic (SROC) curves were synthesised. Calibration curves were used to assess the transferability of results into practice.ResultsTen studies using the Centor score and eight using the McIsaac score were included. The prevalence of GABHS ranged between 4% and 44%. The areas under the SROC curves for McIsaac and Centor scores were 0.7052 and 0.6888, respectively. The P-value for the difference (0.0164) was 0.419, suggesting the SROC curves for the tests are equivalent. Both scores demonstrated poor calibration.ConclusionBoth Centor and McIsaac scores provide only fair discrimination of those with and without GABHS, and appear broadly equivalent in performance. The poor calibration for a positive test result suggests other point-of-care tests are required to rule in GABHS; however, with both Centor and McIsaac scores, a score of ≤0 may be sufficient to rule out infection.

The role of serum periostin in the diagnosis of asthma: A meta-analysis

2020 ◽  
Vol 41 (4) ◽  
pp. 240-247
Author(s):  
Lei Yang ◽  
Qingtao Zhao ◽  
Shuyu Wang
Keyword(s):  
Diagnostic Accuracy ◽  
Meta Analysis ◽  
Characteristic Curve ◽  
False Negative ◽  
Summary Receiver Operating Characteristic ◽  
True Negative ◽  
Negative Results ◽  
Noninvasive Biomarker ◽  
Sensitivity Specificity ◽  
Serum Periostin

Background: Serum periostin has been proposed as a noninvasive biomarker for asthma diagnosis and management. However, its accuracy for the diagnosis of asthma in different populations is not completely clear. Methods: This meta-analysis aimed to evaluate the diagnostic accuracy of periostin level in the clinical determination of asthma. Several medical literature data bases were searched for relevant studies through December 1, 2019. The numbers of patients with true-positive, false-positive, false-negative, and true-negative results for the periostin level were extracted from each individual study. We assessed the risk of bias by using Quality Assessment of Diagnostic Accuracy Studies 2. We used the meta-analysis to produce summary estimates of accuracy. Results: In total, nine studies with 1757 subjects met the inclusion criteria. The pooled estimates of sensitivity, specificity, and diagnostic odds ratios for the detection of asthma were 0.58 (95% confidence interval [CI], 0.38‐0.76), 0.86 (95% CI, 0.74‐0.93), and 8.28 (95% CI, 3.67‐18.68), respectively. The area under the summary receiver operating characteristic curve was 0.82 (95% CI, 0.79‐0.85). And significant publication bias was found in this meta‐analysis (p = 0.39). Conclusion: Serum periostin may be used for the diagnosis of asthma, with moderate diagnostic accuracy.

scholarly journals Accuracy of Contrast Extravasation on Computed Tomography for Diagnosing Severe Pelvic Hemorrhage in Pelvic Trauma Patients: A Meta-Analysis

Medicina ◽  
2021 ◽  
Vol 57 (1) ◽  
pp. 63
Author(s):  
Sung Nam Moon ◽  
Jung-Soo Pyo ◽  
Wu Seong Kang
Keyword(s):  
Computed Tomography ◽  
Meta Analysis ◽  
Characteristic Curve ◽  
Pelvic Trauma ◽  
Test Accuracy ◽  
Trauma Patients ◽  
Positive Finding ◽  
Summary Receiver Operating Characteristic ◽  
Contrast Extravasation ◽  
Pelvic Hemorrhage

Background and objective: The early detection of underlying hemorrhage of pelvic trauma has been a critical issue. The aim of this study was to systematically determine the diagnostic accuracy of computed tomography (CT) for detecting severe pelvic hemorrhage. Materials and Methods: Relevant articles were obtained by searching PubMed, EMBASE, and Cochrane databases through 28 November 2020. Diagnostic test accuracy results were reviewed to obtain the sensitivity, specificity, diagnostic odds ratio, and summary receiver operating characteristic curve of CT for the diagnosis in pelvic trauma patients. The positive finding on CT was defined as the contrast extravasation. As the reference standard, severe pelvic hemorrhage was defined as an identification of bleeding at angiography or by direct inspection using laparotomy that required hemostasis by angioembolization or surgery. A subgroup analysis was performed according to the CT modality that is divided by the number of detector rows. Result: Thirteen eligible studies (29 subsets) were included in the present meta-analysis. Pooled sensitivity of CT was 0.786 [95% confidence interval (CI), 0.574–0.909], and pooled specificity was 0.944 (95% CI, 0.900–0.970). Pooled sensitivity of the 1–4 detector row group and 16–64 detector row group was 0.487 (95% CI, 0.215–0.767) and 0.915 (95% CI, 0.848–0.953), respectively. Pooled specificity of the 1–4 and 16–64 detector row groups was 0.956 (95% CI, 0.876–0.985) and 0.906 (95% CI, 0.828–0.951), respectively. Conclusion: Multi-detector CT with 16 or more detector rows has acceptable high sensitivity and specificity. Extravasation on CT indicates severe hemorrhage in patients with pelvic trauma.

scholarly journals The diagnostic accuracy of isothermal nucleic acid point-of-care tests for human coronaviruses: A systematic review and meta-analysis

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Pakpoom Subsoontorn ◽  
Manupat Lohitnavy ◽  
Chuenjid Kongkaew
Keyword(s):  
Systematic Review ◽  
Diagnostic Accuracy ◽  
Diagnostic Test ◽  
Point Of Care ◽  
Meta Analysis ◽  
Isothermal Amplification ◽  
Diagnostic Test Accuracy ◽  
Test Accuracy ◽  
Index Test ◽  
Point Of Care Tests

AbstractMany recent studies reported coronavirus point-of-care tests (POCTs) based on isothermal amplification. However, the performances of these tests have not been systematically evaluated. Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy was used as a guideline for conducting this systematic review. We searched peer-reviewed and preprint articles in PubMed, BioRxiv and MedRxiv up to 28 September 2020 to identify studies that provide data to calculate sensitivity, specificity and diagnostic odds ratio (DOR). Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) was applied for assessing quality of included studies and Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) was followed for reporting. We included 81 studies from 65 research articles on POCTs of SARS, MERS and COVID-19. Most studies had high risk of patient selection and index test bias but low risk in other domains. Diagnostic specificities were high (> 0.95) for included studies while sensitivities varied depending on type of assays and sample used. Most studies (n = 51) used reverse transcription loop-mediated isothermal amplification (RT-LAMP) to diagnose coronaviruses. RT-LAMP of RNA purified from COVID-19 patient samples had pooled sensitivity at 0.94 (95% CI: 0.90–0.96). RT-LAMP of crude samples had substantially lower sensitivity at 0.78 (95% CI: 0.65–0.87). Abbott ID Now performance was similar to RT-LAMP of crude samples. Diagnostic performances by CRISPR and RT-LAMP on purified RNA were similar. Other diagnostic platforms including RT- recombinase assisted amplification (RT-RAA) and SAMBA-II also offered high sensitivity (> 0.95). Future studies should focus on the use of un-bias patient cohorts, double-blinded index test and detection assays that do not require RNA extraction.

scholarly journals Diagnostic Test Accuracy of the 4AT for Delirium Detection: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 17 (20) ◽  
pp. 7515 ◽  
Author(s):  
Eunhye Jeong ◽  
Jinkyung Park ◽  
Juneyoung Lee
Keyword(s):  
Systematic Review ◽  
Diagnostic Test ◽  
Healthcare Professionals ◽  
Meta Analysis ◽  
Diagnostic Test Accuracy ◽  
Test Accuracy ◽  
Summary Receiver Operating Characteristic ◽  
Bivariate Model ◽  
Data Synthesis

Under-recognition of delirium is an international problem. For the early detection of delirium, a feasible and valid screening tool for healthcare professionals is needed. This study aimed to present a scientific reason for using the 4 ‘A’s Test (4AT) through a systematic review and meta-analysis of studies on the diagnostic test accuracy. We systematically searched articles in the EMBASE, MEDLINE, CINAHL, and PsycINFO databases and selected relevant articles on the basis of the predefined inclusion criteria. The quality of the included articles was evaluated using the Quality Assessment of the Diagnostic Accuracy Studies-2 tool. We estimated the pooled values of diagnostic test accuracy by employing the bivariate model and the hierarchical summary receiver operating characteristic (HSROC) model in data synthesis. A total of 3729 patients of 13 studies were included in the analysis. The pooled estimates of sensitivity and specificity of the 4AT were 81.5% (95% confidence interval: 70.7%, 89.0%) and 87.5% (79.5%, 92.7%), respectively. Given the 4AT’s evidence of accuracy and practicality, we suggest healthcare professionals to utilize this tool for routine screening of delirium. However, for detecting delirium in the dementia population, further work is required to evaluate the 4AT with other cut-off points or scoring methods in order for it to be more sensitive and specific.

scholarly journals Diagnostic and prognostic implications of parafibromin immunohistochemistry in parathyroid carcinomaT

2019 ◽  
Vol 39 (4) ◽  
Author(s):  
Jung-Soo Pyo ◽  
Won Jin Cho
Keyword(s):  
Parathyroid Adenoma ◽  
Diagnostic Test ◽  
Meta Analysis ◽  
Characteristic Curve ◽  
Disease Free Survival ◽  
Diagnostic Test Accuracy ◽  
Parathyroid Hyperplasia ◽  
Test Accuracy ◽  
Summary Receiver Operating Characteristic ◽  
Prognostic Implications

Abstract The aim of the present study was to elucidate the diagnostic and prognostic implications of parafibromin immunohistochemistry (IHC) in parathyroid carcinoma (PC). We performed a meta-analysis to examine the rate of loss of parafibromin expression from 18 eligible studies. In addition, a diagnostic test accuracy review was conducted to investigate the diagnostic role of parafibromin in PC. The rates of loss of parafibromin expression were 0.522 (95% CI: 0.444–0.599), 0.291 (95% CI: 0.207–0.391), 0.027 (95% CI: 0.011–0.064), and 0.032 (95% CI: 0.008–0.119) in PC, atypical parathyroid adenoma (APA), parathyroid adenoma (PA), and parathyroid hyperplasia, respectively. In the diagnostic test accuracy review for diagnosis of PC, the pooled sensitivity and specificity of parafibromin IHC was 0.53 (95% CI: 0.46–0.59) and 0.96 (95% CI: 0.95–0.97), respectively. The diagnostic odds ratio and the area under curve on summary receiver operating characteristic curve was 25.31 (95% CI: 8.91–71.87) and 0.7954, respectively. In addition, the meta-analysis demonstrated that loss of parafibromin expression was significantly correlated with worse disease-free survival (hazard ratio: 2.832; 95% CI: 1.081–7.421). Loss of parafibromin IHC expression was significantly higher in PC than in APA, PA, and parathyroid hyperplasia. Parafibromin IHC could be useful for diagnosis and prediction of prognosis of PC in daily practice.

Usefulness of Nasal Endoscopy for Diagnosing Patients With Chronic Rhinosinusitis: A Meta-Analysis

2019 ◽  
Vol 34 (2) ◽  
pp. 306-314
Author(s):  
Do Hyun Kim ◽  
Youngjun Seo ◽  
Kyung Min Kim ◽  
Seoungmin Lee ◽  
Se Hwan Hwang
Keyword(s):  
Diagnostic Accuracy ◽  
Chronic Rhinosinusitis ◽  
Sensitivity And Specificity ◽  
Meta Analysis ◽  
Characteristic Curve ◽  
False Negative ◽  
Nasal Endoscopy ◽  
Summary Receiver Operating Characteristic ◽  
True Negative ◽  
Endoscopic Score

Background We evaluated the accuracy of nasal endoscopy in diagnosing chronic rhinosinusitis (CRS) compared with paranasal sinus computed tomography (CT). Methods Two authors independently searched the 5 databases (PubMed, SCOPUS, Embase, the Web of Science, and the Cochrane database) up to March 2019. For all included studies, we calculated correlation coefficients between the endoscopic and CT scores. We extracted data on true-positive and false-positive and true-negative and false-negative results. Methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool (version 2). Results We included 16 observational or retrospective studies. A high correlation ( r = .8543; 95% confidence interval [CI] [0.7685–0.9401], P < .0001, I2 = 76.58%) between endoscopy and CT in terms of the diagnostic accuracy for CRS was apparent. The odds ratio (Lund–Kennedy endoscopic score ≥1) was 7.915 (95% CI [4.435–14.124]; I2 = 28.361%). The area under the summary receiver operating characteristic curve was 0.765. The sensitivity and specificity were 0.726 (95% CI [0.584–0.834]) and 0.767 (95% CI [0.685–0.849]), respectively. However, high interstudy heterogeneity was evident given the different endoscopic score thresholds used (Lund–Kennedy endoscopic score ≥1 vs 2). In a subgroup analysis of studies using a Lund–Kennedy endoscopic score threshold ≥2, the area under the summary curve was 0.881, and the sensitivity and specificity were 0.874 (95% CI [0.783–0.930]) and 0.793 (95% CI [0.366–0.962]), respectively. Conclusion Nasal endoscopy is a useful diagnostic tool; the Lund–Kennedy score was comparable with that of CT.

scholarly journals Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

BMJ ◽  
2020 ◽  
pp. m2516 ◽  
Author(s):  
Mayara Lisboa Bastos ◽  
Gamuchirai Tavaziva ◽  
Syed Kunal Abidi ◽  
Jonathon R Campbell ◽  
Louis-Patrick Haraoui ◽  
...  
Keyword(s):  
Systematic Review ◽  
Diagnostic Accuracy ◽  
Sensitivity And Specificity ◽  
Symptom Onset ◽  
Serological Test ◽  
Point Of Care ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Serological Tests ◽  
Immunoglobulin Class

AbstractObjectiveTo determine the diagnostic accuracy of serological tests for coronavirus disease-2019 (covid-19).DesignSystematic review and meta-analysis.Data sourcesMedline, bioRxiv, and medRxiv from 1 January to 30 April 2020, using subject headings or subheadings combined with text words for the concepts of covid-19 and serological tests for covid-19.Eligibility criteria and data analysisEligible studies measured sensitivity or specificity, or both of a covid-19 serological test compared with a reference standard of viral culture or reverse transcriptase polymerase chain reaction. Studies were excluded with fewer than five participants or samples. Risk of bias was assessed using quality assessment of diagnostic accuracy studies 2 (QUADAS-2). Pooled sensitivity and specificity were estimated using random effects bivariate meta-analyses.Main outcome measuresThe primary outcome was overall sensitivity and specificity, stratified by method of serological testing (enzyme linked immunosorbent assays (ELISAs), lateral flow immunoassays (LFIAs), or chemiluminescent immunoassays (CLIAs)) and immunoglobulin class (IgG, IgM, or both). Secondary outcomes were stratum specific sensitivity and specificity within subgroups defined by study or participant characteristics, including time since symptom onset.Results5016 references were identified and 40 studies included. 49 risk of bias assessments were carried out (one for each population and method evaluated). High risk of patient selection bias was found in 98% (48/49) of assessments and high or unclear risk of bias from performance or interpretation of the serological test in 73% (36/49). Only 10% (4/40) of studies included outpatients. Only two studies evaluated tests at the point of care. For each method of testing, pooled sensitivity and specificity were not associated with the immunoglobulin class measured. The pooled sensitivity of ELISAs measuring IgG or IgM was 84.3% (95% confidence interval 75.6% to 90.9%), of LFIAs was 66.0% (49.3% to 79.3%), and of CLIAs was 97.8% (46.2% to 100%). In all analyses, pooled sensitivity was lower for LFIAs, the potential point-of-care method. Pooled specificities ranged from 96.6% to 99.7%. Of the samples used for estimating specificity, 83% (10 465/12 547) were from populations tested before the epidemic or not suspected of having covid-19. Among LFIAs, pooled sensitivity of commercial kits (65.0%, 49.0% to 78.2%) was lower than that of non-commercial tests (88.2%, 83.6% to 91.3%). Heterogeneity was seen in all analyses. Sensitivity was higher at least three weeks after symptom onset (ranging from 69.9% to 98.9%) compared with within the first week (from 13.4% to 50.3%).ConclusionHigher quality clinical studies assessing the diagnostic accuracy of serological tests for covid-19 are urgently needed. Currently, available evidence does not support the continued use of existing point-of-care serological tests.Study registrationPROSPERO CRD42020179452.

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