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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Scientific literature on COVID-19 Test Methods and Devices - detail

Evaluation of three immunochromatographic tests for rapid detection of antibodies against SARS-CoV-2

Detection Principle
ImmunoAssay-Antibody
Target
IgM, IgG
Testing Method Category
LFIA
Testing Method
kits (Sienna, Wondfo, Prometheus)
Testing Method - Additional Info
Wondfo, SARS-CoV-2 Antibody Test (Lateral flow method). (Luogang District, Guangzhou, China); T&D Diagnostics, Sienna, 2019-nCoV IgG/IgM Rapid Test Cassette (Halifax, Nova Scotia, Canada); Prometheus Bio Inc., 2019-nCoV IgG/IgM Test Cassette (Zhejiang, China).
Reported Performance
Sensitivity: 64.4% (Sienna), 45.2% (Wondfo), 75.5% (Prometheus), 36.6% (Sienna, 0-7 dpo), 18.8% (Wondfo, 0-7 dpo), 68.6% (Prometheus, 0-7 dpo), 81.3% (Sienna, 8-14 dpo), 74.1% (Wondfo, 8-14 dpo), 90.9% (Prometheus, 8-14 dpo), 100% (Sienna, >15 dpo), 83.3% (Wondfo, >15 dpo), 100% (Prometheus, >15 dpo); specificity: 75% (Sienna), 81.8% (Wondfo), 12.5% (Prometheus); PPV: 85.5% (Sienna), 80.5% (Wondfo), 51.4% (Prometheus); NPV: 47.8% (Sienna), 47.4% (Wondfo), 29.4% (Prometheus); accuracy: 67.6% (Sienna), 59% (Wondfo), 47.2% (Prometheus)
Sample Size
145 samples
Peer-reviewed
yes

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