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 |
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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 |