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

Lippi 2020 [B].

Study characteristics
Patient Sampling See main entry for this study for characteristics and QUADAS‐2 assessment (Lippi 2020 [A])
Patient characteristics and setting See main entry for this study for characteristics and QUADAS‐2 assessment (Lippi 2020 [A])
Index tests 2 tests were evaluated; this entry (Lippi 2020 [B]) refers to test [B] in the list below
Test name:
[A] MAGLUMI 2019‐nCoV IgG and IgM (2 indirect tests)
[B] Anti‐SARS‐CoV‐2 IgA and IgG ELISA
Manufacturer:
[A] SNIBE – Shenzhen New Industries Biomedical Engineering Co., Ltd, Shenzhen, China
[B] Euroimmun AG, Lübeck, Germany
Ab targets: [A] IgM or IgG ; [B] IgA or IgG
Antigens used: [A] CoV‐S (spike) and e CoV‐N (nucleocapsid); [B] NR
Test method: [A] CLIA (CLIAs); [B] ELISA
Timing of samples: NR
Samples used: blood, serum or plasma
Test operators: NR
Definition of test positivity:
[A] ≥ 1.10 AU/mL
[B] ≥ 1.1 (absorbance of patient sample/absorbance of calibrator)
Blinded to reference standard: NR
Threshold predefined: yes by manufacturer
Target condition and reference standard(s) See main entry for this study for characteristics and QUADAS‐2 assessment (Lippi 2020 [A])
Flow and timing See main entry for this study for characteristics and QUADAS‐2 assessment (Lippi 2020 [A])
Comparative  
Notes