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

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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Rapid diagnostic test for antenatal syphilis screening in low-income and middle-income countries: a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2017-018132 ◽

2018 ◽

Vol 8 (2) ◽

pp. e018132 ◽

Cited By ~ 5

Author(s):

Carmen Phang Romero Casas ◽

Marrissa Martyn-St James ◽

Jean Hamilton ◽

Daniel S Marinho ◽

Rodolfo Castro ◽

...

Keyword(s):

Systematic Review ◽

High Risk ◽

Diagnostic Accuracy ◽

Pregnant Women ◽

Sensitivity And Specificity ◽

Methodological Quality ◽

Meta Analysis ◽

Risk Of Bias ◽

Antenatal Clinics

ObjectivesTo undertake a systematic review and meta-analysis to evaluate the test performance including sensitivity and specificity of rapid immunochromatographic syphilis (ICS) point-of-care (POC) tests at antenatal clinics compared with reference standard tests (non-treponemal (TP) and TP tests) for active syphilis in pregnant women.MethodsFive electronic databases were searched (PubMed, EMBASE, CRD, Cochrane Library and LILACS) to March 2016 for diagnostic accuracy studies of ICS test and standard reference tests for syphilis in pregnant women. Methodological quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies). A bivariate meta-analysis was undertaken to generate pooled estimates of diagnostic parameters. Results were presented using a coupled forest plot of sensitivity and specificity and a scatter plot.ResultsThe methodological quality of the five included studies with regards to risk of bias and applicability concern judgements was either low or unclear. One study was judged as high risk of bias for patient selection due to exclusion of pregnant women with a previous history of syphilis, and one study was judged at high risk of bias for study flow and timing as not all patients were included in the analysis. Five studies contributed to the meta-analysis, providing a pooled sensitivity and specificity for ICS of 0.85 (95% CrI: 0.73 to 0.92) and 0.98 (95% CrI: 0.95 to 0.99), respectively.ConclusionsThis review and meta-analysis observed that rapid ICS POC tests have a high sensitivity and specificity when performed in pregnant women at antenatal clinics. However, the methodological quality of the existing evidence base should be taken into consideration when interpreting these results.PROSPERO registration numberCRD42016036335.

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Diagnostic Accuracy of Confocal Laser Endomicroscopy for the Diagnosis of Oral Squamous Cell Carcinoma: A Systematic Review and Meta-Analysis

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph182312390 ◽

2021 ◽

Vol 18 (23) ◽

pp. 12390

Author(s):

Sneha Sethi ◽

Xiangqun Ju ◽

Richard M. Logan ◽

Paul Sambrook ◽

Robert A. McLaughlin ◽

...

Keyword(s):

Systematic Review ◽

Squamous Cell Carcinoma ◽

Diagnostic Accuracy ◽

Sensitivity And Specificity ◽

Meta Analysis ◽

High Sensitivity ◽

Risk Of Bias ◽

Confocal Laser Endomicroscopy ◽

Confocal Laser ◽

Likelihood Ratios

Background: Advances in treatment approaches for patients with oral squamous cell carcinoma (OSCC) have been unsuccessful in preventing frequent recurrences and distant metastases, leading to a poor prognosis. Early detection and prevention enable an improved 5-year survival and better prognosis. Confocal Laser Endomicroscopy (CLE) is a non-invasive imaging instrument that could enable an earlier diagnosis and possibly help in reducing unnecessary invasive surgical procedures. Objective: To present an up to date systematic review and meta-analysis assessing the diagnostic accuracy of CLE in diagnosing OSCC. Materials and Methods. PubMed, Scopus, and Web of Science databases were explored up to 30 June 2021, to collect articles concerning the diagnosis of OSCC through CLE. Screening: data extraction and appraisal was done by two reviewers. The quality of the methodology followed by the studies included in this review was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. A random effects model was used for the meta-analysis. Results: Six studies were included, leading to a total number of 361 lesions in 213 patients. The pooled sensitivity and specificity were 95% (95% CI, 92–97%; I2 = 77.5%) and 93% (95% CI, 90–95%; I2 = 68.6%); the pooled positive likelihood ratios and negative likelihood ratios were 10.85 (95% CI, 5.4–21.7; I2 = 55.9%) and 0.08 (95% CI, 0.03–0.2; I2 = 83.5%); and the pooled diagnostic odds ratio was 174.45 (95% CI, 34.51–881.69; I2 = 73.6%). Although risk of bias and heterogeneity is observed, this study validates that CLE may have a noteworthy clinical influence on the diagnosis of OSCC, through its high sensitivity and specificity. Conclusions: This review indicates an exceptionally high sensitivity and specificity of CLE for diagnosing OSCC. Whilst it is a promising diagnostic instrument, the limited number of existing studies and potential risk of bias of included studies does not allow us to draw firm conclusions. A conclusive inference can be drawn when more studies, possibly with homogeneous methodological approach, are performed.

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Diagnostic accuracy of focused deep venous, lung, cardiac and multiorgan ultrasound in suspected pulmonary embolism: a systematic review and meta-analysis

Thorax ◽

10.1136/thoraxjnl-2021-216838 ◽

2021 ◽

pp. thoraxjnl-2021-216838

Author(s):

Casper Falster ◽

Niels Jacobsen ◽

Karen Ehlers Coman ◽

Mikkel Højlund ◽

Thomas Agerbo Gaist ◽

...

Keyword(s):

Systematic Review ◽

Pulmonary Embolism ◽

Diagnostic Accuracy ◽

Sensitivity And Specificity ◽

Meta Analysis ◽

Risk Of Bias ◽

Endobronchial Ultrasound ◽

Cochrane Library ◽

Suspected Pulmonary Embolism ◽

Reference Test

ObjectiveTo determine the diagnostic accuracy of point-of-care ultrasound in suspected pulmonary embolism.DesignSystematic review and meta-analysis.Data sourcesMEDLINE, Embase, CINAHL and Cochrane library were searched on 2 July 2020 with no restrictions on the date of publication. Subject headings or subheadings combined with text words for the concepts of pulmonary embolism, ultrasound and diagnosis were used.Eligibility criteria and data analysisEligible studies reported sensitivity and specificity of deep venous, lung, cardiac or multiorgan ultrasound in patients with suspected pulmonary embolism, using an adequate reference-test. Prospective, cross-sectional and retrospective studies were considered for eligibility. No restrictions were made on language. Studies were excluded if a control group consisted of healthy volunteers or if transesophageal or endobronchial ultrasound was used. Risk of bias was assessed using quality assessment of diagnostic accuracy studies-2. Meta-analysis of sensitivity and specificity was performed by construction of hierarchical summary receiver operator curves. I2 was used to assess the study heterogeneity.Main outcome measuresThe primary outcome was overall sensitivity and specificity of reported ultrasound signs, stratified by organ approach (deep venous, lung, cardiac and multiorgan). Secondary outcomes were stratum-specific sensitivity and specificity within subgroups defined by pretest probability of pulmonary embolism.Results6378 references were identified, and 70 studies included. The study population comprised 9664 patients with a prevalence of pulmonary embolism of 39.9% (3852/9664). Risk of bias in at least one domain was found in 98.6% (69/70) of included studies. Most frequently, 72.8% (51/70) of studies reported >24 hours between ultrasound examination and reference test or did not disclose time interval at all. Level of heterogeneity ranged from 0% to 100%. Most notable ultrasound signs were bilateral compression of femoral and popliteal veins (22 studies; 4708 patients; sensitivity 43.7% (36.3% to 51.4%); specificity 96.7% (95.4% to 97.6%)), presence of at least one hypoechoic pleural-based lesion (19 studies; 2134 patients; sensitivity 81.4% (73.2% to 87.5%); specificity 87.4% (80.9% to 91.9%)), D-sign (13 studies; 1579 patients; sensitivity 29.7% (24.6% to 35.4%); specificity 96.2% (93.1% to 98.0%)), visible right ventricular thrombus (5 studies; 995 patients; sensitivity 4.7% (2.7% to 8.1%); specificity 100% (99.0% to 100%)) and McConnell’s sign (11 studies; 1480 patients; sensitivity 29.1% (20.0% to 40.1%); specificity 98.6% (96.7% to 99.4%)).ConclusionSeveral ultrasound signs exhibit a high specificity for pulmonary embolism, suggesting that implementation of ultrasound in the initial assessment of patients with suspected pulmonary embolism may improve the selection of patients for radiation imaging.PROSPERO registration numberCRD42020184313.

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Performance of the cuff leak test in adults in predicting post-extubation airway complications: a systematic review and meta-analysis

Critical Care ◽

10.1186/s13054-020-03358-8 ◽

2020 ◽

Vol 24 (1) ◽

Author(s):

Akira Kuriyama ◽

Jeffrey L. Jackson ◽

Jun Kamei

Keyword(s):

Systematic Review ◽

Diagnostic Accuracy ◽

Airway Obstruction ◽

Sensitivity And Specificity ◽

Meta Analysis ◽

Risk Of Bias ◽

Cochrane Library ◽

Leak Test ◽

Airway Complications ◽

Cuff Leak

Abstract Background Clinical practice guidelines recommend performing a cuff leak test in mechanically ventilated adults who meet extubation criteria to screen those at high risk for post-extubation stridor. Previous systematic reviews demonstrated excellent specificity of the cuff leak test but disagreed with respect to sensitivity. We conducted a systematic review and meta-analysis to assess the diagnostic accuracy of the cuff leak test for predicting post-extubation airway complications in intubated adult patients in critical care settings. Methods We searched Medline, EMBASE, Scopus, ISI Web of Science, the Cochrane Library for eligible studies from inception to March 16, 2020, without language restrictions. We included studies that examined the diagnostic accuracy of cuff leak test if post-extubation airway obstruction after extubation or reintubation was explicitly reported as the reference standard. Two authors in duplicate and independently assessed the risk of bias using the Quality Assessment for Diagnostic Accuracy Studies-2 tool. We pooled sensitivities and specificities using generalized linear mixed model approach to bivariate random-effects meta-analysis. Our primary outcomes were post-extubation airway obstruction and reintubation. Results We included 28 studies involving 4493 extubations. Three studies were at low risk for all QUADAS-2 risk of bias domains. The pooled sensitivity and specificity of cuff leak test for post-extubation airway obstruction were 0.62 (95% CI 0.49–0.73; I2 = 81.6%) and 0.87 (95% CI 0.82–0.90; I2 = 97.8%), respectively. The pooled sensitivity and specificity of the cuff leak test for reintubation were 0.66 (95% CI 0.46–0.81; I2 = 48.9%) and 0.88 (95% CI 0.83–0.92; I2 = 87.4%), respectively. Subgroup analyses suggested that the type of cuff leak test and length of intubation might be the cause of statistical heterogeneity of sensitivity and specificity, respectively, for post-extubation airway obstruction. Conclusions The cuff leak test has excellent specificity but moderate sensitivity for post-extubation airway obstruction. The high specificity suggests that clinicians should consider intervening in patients with a positive test, but the low sensitivity suggests that patients still need to be closely monitored post-extubation.

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Deep learning for pulmonary embolism detection on computed tomography pulmonary angiogram: a systematic review and meta-analysis

Scientific Reports ◽

10.1038/s41598-021-95249-3 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Shelly Soffer ◽

Eyal Klang ◽

Orit Shimon ◽

Yiftach Barash ◽

Noa Cahan ◽

...

Keyword(s):

Systematic Review ◽

Pulmonary Embolism ◽

Deep Learning ◽

Sensitivity And Specificity ◽

Meta Analysis ◽

Risk Of Bias ◽

Future Research ◽

Learning Models ◽

Summary Receiver Operating Characteristic ◽

Pulmonary Angiogram

AbstractComputed tomographic pulmonary angiography (CTPA) is the gold standard for pulmonary embolism (PE) diagnosis. However, this diagnosis is susceptible to misdiagnosis. In this study, we aimed to perform a systematic review of current literature applying deep learning for the diagnosis of PE on CTPA. MEDLINE/PUBMED were searched for studies that reported on the accuracy of deep learning algorithms for PE on CTPA. The risk of bias was evaluated using the QUADAS-2 tool. Pooled sensitivity and specificity were calculated. Summary receiver operating characteristic curves were plotted. Seven studies met our inclusion criteria. A total of 36,847 CTPA studies were analyzed. All studies were retrospective. Five studies provided enough data to calculate summary estimates. The pooled sensitivity and specificity for PE detection were 0.88 (95% CI 0.803–0.927) and 0.86 (95% CI 0.756–0.924), respectively. Most studies had a high risk of bias. Our study suggests that deep learning models can detect PE on CTPA with satisfactory sensitivity and an acceptable number of false positive cases. Yet, these are only preliminary retrospective works, indicating the need for future research to determine the clinical impact of automated PE detection on patient care. Deep learning models are gradually being implemented in hospital systems, and it is important to understand the strengths and limitations of these algorithms.

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A systematic review and meta-analysis of the diagnostic accuracy of point-of-care tests used to establish the presence of peripheral arterial disease in people with diabetes

Journal of Vascular Surgery ◽

10.1016/j.jvs.2020.11.030 ◽

2020 ◽

Author(s):

Pasha Normahani ◽

Chira Mustafa ◽

Joseph Shalhoub ◽

Alun H. Davies ◽

John Norrie ◽

...

Keyword(s):

Systematic Review ◽

Peripheral Arterial Disease ◽

Diagnostic Accuracy ◽

Point Of Care ◽

Meta Analysis ◽

Arterial Disease ◽

Peripheral Arterial ◽

Point Of Care Tests

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Psoriatic arthritis screening: a systematic review and meta-analysis

Rheumatology ◽

10.1093/rheumatology/key314 ◽

2018 ◽

Vol 58 (4) ◽

pp. 692-707 ◽

Cited By ~ 12

Author(s):

Nicolas Iragorri ◽

Glen Hazlewood ◽

Braden Manns ◽

Vishva Danthurebandara ◽

Eldon Spackman

Keyword(s):

Systematic Review ◽

Psoriatic Arthritis ◽

Sensitivity And Specificity ◽

Screening Tool ◽

Meta Analysis ◽

Risk Of Bias ◽

Screening Tools ◽

Screening Questionnaire ◽

Psa Screening ◽

Early Psoriatic Arthritis

Abstract Objective To systematically review the accuracy and characteristics of different questionnaire-based PsA screening tools. Methods A systematic review of MEDLINE, Excerpta Medical Database, Cochrane Central Register of Controlled Trials and Web of Science was conducted to identify studies that evaluated the accuracy of self-administered PsA screening tools for patients with psoriasis. A bivariate meta-analysis was used to pool screening tool-specific accuracy estimates (sensitivity and specificity). Heterogeneity of the diagnostic odds ratio was evaluated through meta-regression. All full-text records were assessed for risk of bias with the QUADAS 2 tool. Results A total of 2280 references were identified and 130 records were assessed for full-text review, of which 42 were included for synthesis. Of these, 27 were included in quantitative syntheses. Of the records, 37% had an overall low risk of bias. Fourteen different screening tools and 104 separate accuracy estimates were identified. Pooled sensitivity and specificity estimates were calculated for the Psoriatic Arthritis Screening and Evaluation (cut-off = 44), Psoriatic Arthritis Screening and Evaluation (47), Toronto Psoriatic Arthritis Screening (8), Psoriasis Epidemiology Screening Tool (3) and Early Psoriatic Arthritis Screening Questionnaire (3). The Early Psoriatic Arthritis Screening Questionnaire reported the highest sensitivity and specificity (0.85 each). The I2 for the diagnostic odds ratios varied between 76 and 90.1%. Meta-regressions were conducted, in which the age, risk of bias for patient selection and the screening tool accounted for some of the observed heterogeneity. Conclusions Questionnaire-based tools have moderate accuracy to identify PsA among psoriasis patients. The Early Psoriatic Arthritis Screening Questionnaire appears to have slightly better accuracy compared with the Toronto Psoriatic Arthritis Screening, Psoriasis Epidemiology Screening Tool and Psoriatic Arthritis Screening and Evaluation. An economic evaluation could model the uncertainty and estimate the cost-effectiveness of PsA screening programs that use different tools.

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Comparative accuracy of pleural fluid unstimulated interferon-gamma and adenosine deaminase for diagnosing pleural tuberculosis: A systematic review and meta-analysis

PLoS ONE ◽

10.1371/journal.pone.0253525 ◽

2021 ◽

Vol 16 (6) ◽

pp. e0253525

Author(s):

Ashutosh Nath Aggarwal ◽

Ritesh Agarwal ◽

Sahajal Dhooria ◽

Kuruswamy Thurai Prasad ◽

Inderpaul Singh Sehgal ◽

...

Keyword(s):

Systematic Review ◽

Diagnostic Accuracy ◽

Adenosine Deaminase ◽

Pleural Fluid ◽

Sensitivity And Specificity ◽

Interferon Gamma ◽

Meta Analysis ◽

Paired Data ◽

Ifn Γ ◽

Meta Regression

Objective We compared diagnostic accuracy of pleural fluid adenosine deaminase (ADA) and interferon-gamma (IFN-γ) in diagnosing tuberculous pleural effusion (TPE) through systematic review and comparative meta-analysis. Methods We queried PubMed and Embase databases to identify studies providing paired data for sensitivity and specificity of both pleural fluid ADA and IFN-γ for diagnosing TPE. We used hierarchical summary receiver operating characteristic (HSROC) plots and HSROC meta-regression to model individual and comparative diagnostic performance of the two tests. Results We retrieved 376 citations and included 45 datasets from 44 publications (4974 patients) in our review. Summary estimates for sensitivity and specificity for ADA were 0.88 (95% CI 0.85–0.91) and 0.91 (95% CI 0.89–0.92), while for IFN-γ they were 0.91 (95% CI 0.89–0.94) and 0.96 (95% CI 0.94–0.97), respectively. HSROC plots showed consistently greater diagnostic accuracy for IFN-γ over ADA across the entire range of observations. HSROC meta-regression using test-type as covariate yielded a relative diagnostic odds ratio of 2.22 (95% CI 1.68–2.94) in favour of IFN-γ, along with better summary sensitivity and specificity figures. No prespecified subgroup variable significantly influenced the summary diagnostic accuracy estimates. Conclusion Pleural fluid IFN-γ estimation has better diagnostic accuracy than ADA estimation for diagnosis of TPE.

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Accuracy of Anti-GBM Antibodies in Diagnosing Anti-Glomerular Basement Membrane Disease: A Systematic Review and Meta-Analysis

American Journal of Nephrology ◽

10.1159/000518362 ◽

2021 ◽

pp. 1-8

Author(s):

Akihiro Shiroshita ◽

Yasuhiro Oda ◽

Seiji Takenouchi ◽

Noboru Hagino ◽

Yuki Kataoka

Keyword(s):

Systematic Review ◽

High Risk ◽

Basement Membrane ◽

Diagnostic Accuracy ◽

Cohort Studies ◽

Quality Assessment ◽

Sensitivity And Specificity ◽

Glomerular Basement Membrane ◽

Case Control ◽

Risk Of Bias

Background: The sensitivity and specificity of anti-glomerular basement membrane (GBM) antibodies have not been systematically analyzed. In this systematic review, we aimed to evaluate the diagnostic accuracy of anti-GBM antibodies for anti-GBM disease. Summary: Potential studies were searched using MEDLINE, Embase, the Cochrane Library, and the International Clinical Trials Registry Platform based on the index test and target condition. The inclusion criteria were prospective or retrospective cohort studies or case-control studies assessing the sensitivity and specificity of anti-GBM antibodies, and the reference standard was clinical diagnosis including biopsy results. The exclusion criteria were review articles, case reports, animal studies, and in vitro studies. Quality assessment was conducted based on the Quality Assessment of Diagnostic Accuracy Studies-2. The pooled estimates of sensitivity and specificity were calculated using a bivariate random-effects model. The overall quality was evaluated using the Grades of Recommendation, Assessment, Development, and Evaluation. Six studies (1,691 patients) and 11 index tests were included in our systematic review. A high risk of bias and concerns regarding the applicability of patient selection were noted because of the case-control design in 67% of the included studies. The pooled sensitivity and specificity were 93% (95% CI: 84–97%) and 97% (95% CI: 94–99%), respectively. The certainty of evidence was low because of the high risk of bias and indirectness. Key Messages: Anti-GBM antibodies may exhibit high sensitivity and specificity in the diagnosis of anti-GBM disease. Further cohort studies are needed to confirm their precise diagnostic accuracy and compare diagnostic accuracies among different immunoassays.

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