Comparison of three automatic chemiluminescent immunoassays for monitoring dynamic profile of SARS‐CoV‐2 IgG and IgM

Dou, Xiaowei; Wang, Enyun; Hu, Jiwen; Zong, Zhi‐Hong; Jiang, Runze; Wang, Mengmeng; Kan, Lijuan; Zhang, Xiuming

doi:10.1002/jcla.23681

Cited by 6 publications

(6 citation statements)

References 21 publications

(32 reference statements)

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“…However, due to some limitations in nucleic acid testing, such as long detection cycle, expensive reagents and high requirements for sampling, and technicians and laboratory conditions, many COVID‐19 cases are not diagnosed accurately and timely. 6 , 7 Up to now, 369 cases of asymptomatic infection in China were still under medical observation, including 352 cases imported from abroad. 8 Therefore, there is an urgent need to explore a rapid, simple, and feasible method for the diagnosis and screening of COVID‐19 patients, especially the asymptomatic cases.…”

Section: Introductionmentioning

confidence: 99%

Dynamic changes of IgM and IgG antibodies in asymptomatic patients as an effective way to detect SARS‐CoV‐2 infection

Shen

Zhu

et al. 2021

Clinical Laboratory Analysis

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Background: COVID-19 has become a global pandemic, and close contacts and asymptomatic patients are worthy of attention.Methods: A total of 1844 people in close contacts with 76 COVID-19 patients were investigated, and nasopharyngeal swabs and venous blood were collected for centralized medical quarantine observation. Real-time fluorescence was used to detect SARS-CoV-2 nucleic acid in nasopharyngeal swabs of all close contacts, and the colloidal gold method was used to detect serum-specific antibodies. Levels of IgM-and IgG-specific antibodies were detected quantitatively through chemiluminescence from the first nucleic acid turned negative date (0 week) and on weekly intervals of ≤1 week, 1-2 weeks, 2-3 weeks, 3-4 weeks, 4-5 weeks, 5-6 weeks, and 6-7 weeks. Results:The total positive rate of the colloidal gold method (88.5%, 23/26) was significantly higher (χ 2 = 59.182, p < 0.001) than that of the healthy control group (2.0%, 1/50). There was significant difference in IgG concentration at different time points (0-7 weeks) after negative nucleic acid conversion (χ 2 = 14.034, p = 0.029). Serum IgG levels were significantly higher at weekly time points of 4-5 weeks (Z = −2.399, p = 0.016), 5-6 weeks (Z = −2.049, p = 0.040), and 6-7 weeks (Z = −2.197, p = 0.028) compared with 1-2 weeks after negative nucleic acid conversion. However, there was no significant difference (χ 2 = 4.936, p = 0.552) in IgM concentration between time points tested (0-7 weeks) after negative nucleic acid conversion. The positive rates of IgM and IgG in asymptomatic patients (χ 2 = 84.660, p < 0.001) were significantly higher than those in the healthy control group (χ 2 = 9.201, p = 0.002) within 7 weeks of negative nucleic acid conversion. Conclusions:The IgG concentration in asymptomatic cases remained at a high level after nucleic acid turned negative. Nucleic acid detection combined with IgM and IgG antibody detection is an effective way to screen asymptomatic infections. How to cite this article: Li P, Shen G, Zhu Z, et al. Dynamic changes of IgM and IgG antibodies in asymptomatic patients as an effective way to detect SARS-CoV-2 infection.

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Section: Introductionmentioning

confidence: 99%

Dynamic changes of IgM and IgG antibodies in asymptomatic patients as an effective way to detect SARS‐CoV‐2 infection

Shen

Zhu

et al. 2021

Clinical Laboratory Analysis

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“…This study is a systematic review and meta-analysis of published articles about the diagnostic accuracy of COVID-19 antibody tests namely Enzyme-Linked Immunosorbent Assay (ELISA), Chemiluminescence Immunoassay (CLIA), and Lateral Flow Immunoassay (LFIA) [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22].…”

Section: Methodsmentioning

confidence: 99%

“…Consequently, the researchers excluded three (3) articles that did not provide absolute data for specificity and sensitivity and another three (3) articles that did not use the gold standard RT-PCR to diagnose COVID-19. After keen assessment and screening done by the researchers, a total of nineteen (19) journal articles [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] were found appropriate to be included in this systematic review and quantitative or meta-analysis.…”

Section: Study Selectionmentioning

confidence: 99%

“…It includes the authors of the nineteen ( 19) studies [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] that were included, along with its Rapid Diagnostic Test Identification (RDT-ID), the brands of the antibody test kits used per study, manufacturer, the types of assays namely LFIA, CLIA, and ELISA, and the type of antibody tested such as IgM, IgG, IgA, or Combined. Table 3 shows the summary of characteristics of the nineteen ( 19) studies [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] included for this systematic review and meta-analysis. Displayed above is the author of each study with his corresponding Rapid Diagnostic Test Identification (RDT-ID) patterned in Table 2.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Data available in a publicly accessible repository: The data presented in this study are openly available in Elsevier at https://doi.org/10.1016/j.jcv.2020.104645 [4]; Elsevier at https://doi.org/10.1016/j.jviromet.2020.114060 [5]; ASM Journals at https://doi.org/10.1128/JCM.01361-20 [6]; Wiley Online Library at https://doi.org/10.1002/jmv.26060 [7]; Springer at https://doi.org/10.1007/s10096-020-04092-3 [8]; International Journal of Infectious Diseases at https:// doi.org/ 10.1016/j.ijid.2020.10.008 [9]; Frontiers at https://doi.org/10.3389/fcimb.2020.00479 [10]; ASM Journals at https://doi.org/10.1128/JCM.02342-20 [11]; Wiley Online Library at https://doi.org/10.1002/jcla.23681 [12]; German Medical Science at https://doi.org/10.3205/dgkh000363, [13]; International Journal of Infectious at https://doi.org/ 10.1016/j.ijid.2020.12.003 [14]; Wiley Online Library at https://doi.org/10.1002/jmv.26060 [15]; Elsevier at https:// doi.org/10.1016/j.jcv.2020.104413, [16]; International Journal of Infectious Diseases at https://doi.org/10.1016/j.ijid. 2020.12.017 [17]; The Lancet at https://doi.org/10.1016/S2213-2600(20)30315-5 [18]; Pathology Journal at https:// doi.org/10.1016/j.pathol.2020.09.007, [19]; Frontiers at https://doi.org/10.3389/fcimb.2020.00470, [20]; PLOS One at https://doi.org/10.1371/journal.pone.0246536 [21]; Elsevier at https://doi.org/10.1016/j.diagmicrobio.2020.115248 [22].…”

Section: Fundingmentioning

confidence: 99%

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

Santos

Escasa

et al. 2021

SciMed. J.

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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

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Blood group O is associated with post-COVID-19 syndrome in outpatients with a low comorbidity index

Díaz-Salazar

Navas

Sainz-Maza

et al. 2022

Infectious Diseases

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Comparison of three automatic chemiluminescent immunoassays for monitoring dynamic profile of SARS‐CoV‐2 IgG and IgM

Cited by 6 publications

References 21 publications

Dynamic changes of IgM and IgG antibodies in asymptomatic patients as an effective way to detect SARS‐CoV‐2 infection

Dynamic changes of IgM and IgG antibodies in asymptomatic patients as an effective way to detect SARS‐CoV‐2 infection

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

Blood group O is associated with post-COVID-19 syndrome in outpatients with a low comorbidity index

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