A systematic review and meta-analysis of the accuracy of SARS-COV-2 IGM and IGG tests in individuals with COVID-19

Macedo, Ana; Prestes, Gabriele da Silveira; Colonetti, Tamy; Cândido, Ana Cláudia Rodrigues; Uggioni, Maria Laura Rodrigues; Gomes, Ariane; Silva, Fábio Rosa; Ceretta, Luciane Bisognin; Grande, Antônio José; Rosa, Maria Inês da

doi:10.1016/j.jcv.2022.105121

Cited by 8 publications

(9 citation statements)

References 62 publications

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“…A systematic review and meta‐analysis of SARS‐CoV‐2 serological assay performance found that the overall sensitivity of commercial assays was 91% (IC95:85–94) after 15 days of infection regardless of the technique used. 5 The pre‐Omicron sensitivities of the Abbott S and Wantaï assays were 100%, 9 while those of the Roche and Abbott N assays were 97.9% and 96%, respectively, for patients infected for 15 days. 12 , 13 This indicates that these assays are less sensitive for detecting anti‐Omicron antibodies than for detecting antibodies induced by ancestral strains.…”

Section: Discussionmentioning

confidence: 99%

“…Using these assays, the detection rate after infection with an ancestral D614G strain (control panel) ranged from 96.8% to 100% for anti‐S antibodies; it was 87.1% for anti‐N antibodies. A systematic review and meta‐analysis of SARS‐CoV‐2 serological assay performance found that the overall sensitivity of commercial assays was 91% (IC95:85–94) after 15 days of infection regardless of the technique used 5 . The pre‐Omicron sensitivities of the Abbott S and Wantaï assays were 100%, 9 while those of the Roche and Abbott N assays were 97.9% and 96%, respectively, for patients infected for 15 days 12,13 .…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, Omicron‐specific antibodies could bind less efficiently to the ancestral SARS‐CoV‐2 antigens. While many commercial assays have been evaluated, 4 , 5 data regarding their capacity to detect antibodies induced by Omicron SARS‐CoV‐2 infections are lacking.…”

Section: Introductionmentioning

confidence: 99%

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Current immunoassays and detection of antibodies elicited by Omicron SARS‐CoV‐2 infection

Migueres

Chapuy‐Regaud

Miédougé

et al. 2022

Journal of Medical Virology

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The present study aimed to determine whether current commercial immunoassays are adequate for detecting anti‐Omicron antibodies. We analyzed the anti‐SARS‐CoV‐2 antibody response of 23 unvaccinated individuals 1–2 months after an Omicron infection. All blood samples were tested with a live virus neutralization assay using a clinical Omicron BA.1 strain and four commercial SARS‐CoV‐2 immunoassays. We assessed three anti‐Spike immunoassays (SARS‐CoV‐2 IgG II Quant [Abbott S], Wantaï anti‐SARS‐CoV‐2 antibody ELISA [Wantaï], Elecsys Anti‐SARS‐CoV‐2 S assay [Roche]) and one anti‐Nucleocapsid immunoassay (Abbott SARS‐CoV‐2 IgG assay [Abbott N]). Omicron neutralizing antibodies were detected in all samples with the live virus neutralization assay. The detection rate of the Abbott S, Wantai, Roche, and Abbott N immunoassays were 65.2%, 69.6%, 86.9%, and 91.3%, respectively. The sensitivities of Abbott S and Wantai immunoassays were significantly lower than that of the live virus neutralization assay (p = 0.004, p = 0.009; Fisher's exact test). Antibody concentrations obtained with anti‐S immunoassays were correlated with Omicron neutralizing antibody concentrations. These data provide clinical evidence of the loss of performance of some commercial immunoassays to detect antibodies elicited by Omicron infections. It highlights the need to optimize these assays by adapting antigens to the circulating SARS‐CoV‐2 strains.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Current immunoassays and detection of antibodies elicited by Omicron SARS‐CoV‐2 infection

Migueres

Chapuy‐Regaud

Miédougé

et al. 2022

Journal of Medical Virology

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“…A literature search was conducted in electronic databases, including PubMed, Google Scholar, Scopus, and Cochrane, to identify relevant studies. The search strategy was developed using appropriate Medical Subject Headings (MeSH) terms and keywords related to COVID-19, PCR testing, serology testing, diagnostic accuracy, sensitivity and specificity 6 . Boolean operators (AND, OR) were used to combine search terms effectively.…”

Section: Methodsmentioning

confidence: 99%

Comparative Analysis of COVID-19 Serological testing methods to Polymerase Chain Reaction: A systematic review and meta-analysis

Chisompola,

Maleti,

Tembo

et al. 2024

Preprint

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Background Accurate and reliable diagnosis of COVID 19 is essential for effective disease management and public health interventions. SARS CoV 2 antibody/antigen tests play a crucial role in identifying covid 19 infections and assessing immunity in populations. This systematic review aimed to evaluate the sensitivity, specificity, and accuracy of SARS CoV 2 antibody tests in diagnosing COVID 19. Method A comprehensive systematic review of the literature was conducted using prominent scientific databases, including PubMed, Google Scholar, Cochrane, and Scopus to search studies published from January 2020 to May 2023. The review followed the PRISMA DTA framework to ensure transparency and rigor in the selection and evaluation of studies. The QUADAS 2 tool was utilized to assess study quality and risk of bias. This review was registered on PROSPERO (registration number CRD 42023445695). Results The pooled sensitivity of SARS CoV 2 antibody/antigen tests was found to be 73% (95% CI: 60 to 86), with individual studies reporting a wide range from 30% to 100%. The pooled specificity was 98% (95% CI: 97 to 100), with values ranging from 85.9% to 100%. The pooled accuracy was 88%, showing variation from 50% to 100% across different studies. Conclusion This review highlights the moderate to high sensitivity and specificity of SARS CoV 2 antibody/antigen tests for COVID-19 diagnosis. The substantial variability in test performance necessitates the standardization of testing protocols and further research to improve accuracy and reliability. These findings offer valuable insights for clinical decision making and the formulation of effective public health strategies related to COVID 19 diagnosis.

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“…Hundreds of tests have been developed for the detection of SARS-CoV-2 antibodies, including commercially available high-throughput automated tests for the use in clinical laboratories. However, the performances several months after symptom onset are not well described [ 1 , 2 , 13 ]. Few studies have evaluated the tests in clinically relevant study populations including contacts of PCR-positive patients [ 14 ], health care workers (HCWs) at high risk of SARS-CoV-2 infection [ 15 ], or in patients with mild symptoms or asymptomatic individuals.…”

Section: Introductionmentioning

confidence: 99%

The Performances of Three Commercially Available Assays for the Detection of SARS-CoV-2 Antibodies at Different Time Points Following SARS-CoV-2 Infection

Syre

Obreque

Dalen

et al. 2022

Viruses

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The aim of this study was to evaluate the performances of three commercially available antibody assays for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies at different time points following SARS-CoV-2 infection. Sera from 536 cases, including 207 SARS-CoV-2 PCR positive, were tested for SARS-CoV-2 antibodies with the Wantai receptor binding domain (RBD) total antibody assay, Liaison S1/S2 IgG assay and Alinity i nucleocapsid IgG assay and compared to a two-step reference ELISA (SARS-CoV-2 RBD IgG and SARS-CoV-2 spike IgG). Diagnostic sensitivity, specificity, predictive values and Cohen’s kappa were calculated for the commercial assays. The assay’s sensitivities varied greatly, from 68.7% to 95.3%, but the specificities remained high (96.9%–99.1%). The three tests showed good performances in sera sampled 31 to 60 days after PCR positivity compared to the reference ELISA. The total antibody test performed better than the IgG tests the first 30 days and the nucleocapsid IgG test showed reduced sensitivity two months or more after PCR positivity. Hence, the test performances at different time points should be taken into consideration in clinical practice and epidemiological studies. Spike or RBD IgG tests are preferable in sera sampled more than two months following SARS-CoV-2 infection.

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A systematic review and meta-analysis of the accuracy of SARS-COV-2 IGM and IGG tests in individuals with COVID-19

Cited by 8 publications

References 62 publications

Current immunoassays and detection of antibodies elicited by Omicron SARS‐CoV‐2 infection

Current immunoassays and detection of antibodies elicited by Omicron SARS‐CoV‐2 infection

Comparative Analysis of COVID-19 Serological testing methods to Polymerase Chain Reaction: A systematic review and meta-analysis

The Performances of Three Commercially Available Assays for the Detection of SARS-CoV-2 Antibodies at Different Time Points Following SARS-CoV-2 Infection

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