tetano
Editor, Senior Moderator
Ann Clin Biochem
. 2020 Sep 22;4563220963847.
doi: 10.1177/0004563220963847. Online ahead of print.
ANNALS EXPRESS: Performance verification of COVID-19-specific antibody detection by using four chemiluminescence immunoassay systems
Yafang Wan[SUP] 1 [/SUP], Zhijie Li[SUP] 1 [/SUP], Kun Wang[SUP] 1 [/SUP], Tian Li[SUP] 1 [/SUP], Pu Liao[SUP] 1 [/SUP]
Affiliations
Abstract
Objectives: 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 cutoff 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 cutoff 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 D-Ab serum diagnosis kit is the most reliable detection system for anti-SARS-CoV-2 antibodies, which can be used as an alternative method for nucleic acid testing.
Keywords: Analytical systems; Statistics.
. 2020 Sep 22;4563220963847.
doi: 10.1177/0004563220963847. Online ahead of print.
ANNALS EXPRESS: Performance verification of COVID-19-specific antibody detection by using four chemiluminescence immunoassay systems
Yafang Wan[SUP] 1 [/SUP], Zhijie Li[SUP] 1 [/SUP], Kun Wang[SUP] 1 [/SUP], Tian Li[SUP] 1 [/SUP], Pu Liao[SUP] 1 [/SUP]
Affiliations
- PMID: 32961061
- DOI: 10.1177/0004563220963847
Abstract
Objectives: 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 cutoff 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 cutoff 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 D-Ab serum diagnosis kit is the most reliable detection system for anti-SARS-CoV-2 antibodies, which can be used as an alternative method for nucleic acid testing.
Keywords: Analytical systems; Statistics.