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. 2022 Nov 17;2022(11):CD013652. doi: 10.1002/14651858.CD013652.pub2

Gao 2020b [C].

Study characteristics
Patient Sampling See main entry for this study for characteristics and QUADAS‐2 assessment (Gao 2020b [A])
Patient characteristics and setting See main entry for this study for characteristics and QUADAS‐2 assessment (Gao 2020b [A])
Index tests Gao 2020b [C] is test [C] from the following entry:
Test name: [A] CLIA; [B] GICA; [C] ELISA
Manufacturer: Beier Bioengineering Company (Beijing, China)
Ab targets: IgG and IgM
Antigens used: spike (S) and nucleocapsid (N) proteins of 2019‐nCoV
Test method: [A] CLIA; [B] GICA; [C] ELISA
Timing of samples: [1] early stage (1‐7 days pso) 10/37 samples (27%), [2] middle stage (8‐14 days pso) 13/37 samples (35%); [3] late stage (14‐24 days pso) 14/37 samples (38%)
Samples used: serum
Test operators: laboratory staff
Definition of test positivity:
[A] samples with an concentration ≥ 8 arbitrary unit (AU)/mL were considered positive.
[B] Visible line
[C] The absorbance at 450 nm (A450 nm) of each well was determined and the cut‐off value was 0.10 + A negative control. A value > cut‐off value was considered a positive result.
Blinded to reference standard: NR
Threshold predefined:
[A] samples with an concentration ≥ 8 arbitrary unit (AU)/mL were considered positive.
[B] Positive results showed the appearance of both control line and testing line.
[C] The absorbance at 450 nm (A450 nm) of each well was determined and the cut‐off value was 0.10 + A negative control. A value > cut‐off value was considered a positive result.
Target condition and reference standard(s) See main entry for this study for characteristics and QUADAS‐2 assessment (Gao 2020b [A])
Flow and timing See main entry for this study for characteristics and QUADAS‐2 assessment (Gao 2020b [A])
Comparative  
Notes