Performance verification of anti-SARS-CoV-2-specific antibody detection by using four chemiluminescence immunoassay systems
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Abstract
The purpose of the current study was to evaluate the analytical performance of seven kits for detecting IgM/IgG antibodies against coronavirus (SARS-CoV-2) by using four chemiluminescence immunoassay systems.
Methods
Fifty patients diagnosed with SARS-CoV-2 infection and 130 controls without coronavirus infection from the General Hospital of Chongqing were enrolled in the current retrospective study. Four chemiluminescence immunoassay systems, including seven IgM/IgG antibody detection kits for SARS-CoV-2 (A_IgM, A_IgG, B_IgM, B_IgG, C_IgM, C_IgG and D_Ab), were employed to detect antibody concentrations. The chi-square test, the receiver operating characteristic (ROC) curve and Youden’s index were determined to verify the cut-off value of each detection system.
Results
The repeatability verification results of the A, B, C and D systems are all qualified. D_Ab performed best (92% sensitivity and 99.23% specificity), and B_IgM performed worse than the other systems. Except for the A_IgM and C_IgG systems, the optimal diagnostic thresholds and cut-off values of the other kits and their recommendations are inconsistent with each other. B_IgM had the worst AUC, and C_IgG had the best diagnostic accuracy. More importantly, the B_IgG system had the highest false-positive rate for testing patients with AIDS, tumours and pregnancies. The A_IgM system test showed the highest false-positive rates among elderly individuals over 90 years old. COVID-2019 IgM/IgG antibody test systems exhibit performance differences.
Conclusions
The Innodx Biotech Total Antibody serum diagnosis kit is the most reliable detection system for anti-SARS-CoV-2 antibodies, which can be used together with nucleic acid tests as an alternative method for SARS-CoV-2 detecting.
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SciScore for 10.1101/2020.04.27.20074849: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable Sample Collection: 50 serum samples from patients with SARS-CoV-2 diagnosed in January 2020 and 130 serum samples from patients with other conditions including 20 late pregnancy women, 20 patients with solid tumors, 20 patients with AIDS, 21 patients over 90 years old and 49 normal controls were enrolled from the Immunology Department of the Laboratory Department of Chongqing General Hospital (The Third Hospital) from late February to March 2020. Table 2: Resources
Antibodies Sentences Resources ) IgM antibody detection kit (Referred to A_IgM, batch … SciScore for 10.1101/2020.04.27.20074849: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable Sample Collection: 50 serum samples from patients with SARS-CoV-2 diagnosed in January 2020 and 130 serum samples from patients with other conditions including 20 late pregnancy women, 20 patients with solid tumors, 20 patients with AIDS, 21 patients over 90 years old and 49 normal controls were enrolled from the Immunology Department of the Laboratory Department of Chongqing General Hospital (The Third Hospital) from late February to March 2020. Table 2: Resources
Antibodies Sentences Resources ) IgM antibody detection kit (Referred to A_IgM, batch number: G202002415), and S/CO (Sample CutOff value) ≥ 1.0 denoted to be positive. IgMsuggested: NoneReagents include the 2019-nCoV IgM antibody detection kit (Referred to B_IgM, batch number: 271200201), and S/CO≥1.0 AU/ml denoted to be positive. 2019-nCoV IgMsuggested: None2019-nCoV IgG antibody detection kit (Referred to B_IgG, batch number: 2722000101), and S/CO≥1.0 AU/ml denoted to be positive. 2019-nCoV IgGsuggested: NoneSARS-CoV-2 IgG antibody detection kit (Referred to C_IgG, batch number: 20200202), and S/CO ≥ 10 AU/ml denoted to be positive. SARS-CoV-2 IgGsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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