Reference | Assay and target | Number of patients/samples | Index test; comparator (if applicable) |
Sensitivity | |||
Cassaniti et al (2020)17 | LFIA, VivaChek POC | n=50 patients (suspected cases only) | IgM/IgG: 18.4% |
Dohla et al (2020)18 | IgM/IgG POC test | n=49 | IgM/IgG: 36.4% (95% CI 17.2 to 59.3) |
Jin et al (2020)20 | CLIA (N and spike proteins) | n=27 | IgM: 48.1% (13/27) IgG: 88.9% (24/27) |
Li et al (2020)21 | Colloidal gold | Population not clear | IgM: 78.7% IgG: 73.0% IgM/IgG: 87.6% |
Li et al (2020)22 | LFIA, Jiangsu Medomics POC | n=525 specimens | IgM/IgG: 88.66% |
Spicuzza et al (2020)24 | LFIA (spike) | n=37 | IgG/IgM: 82.6% |
Shen et al (2020)23 | Colloidal gold (NR) | n=150 | IgM/IgG: 71.1% (95% CI 0.609 to 0.797) |
Xiang et al (2020)11 | ELISA (NR) | n=66 | IgM: 77.3% (51/66) IgG: 83.3% (55/66) |
Xu et al (2020)33 | Fully automated assay (NR) | n=205 patients | IgM: 70.24% (144/205) IgG: 96.10% (197/205) |
Zhao et al (2020)12 | ELISA (spike for IgM and Ab; N for IgG) | n=173 samples | IgM: 82.7% (143/173) IgG: 64.7% (112/173) Ab: 93.1% (161/173) RT-PCR: 67.1%* (112/?) |
Specificity | |||
Cassaniti et al (2020)17 | LFIA, VivaChek POC | n=50 (suspected cases only) | IgM/IgG: 91.7% |
Li et al (2020)21 | Colloidal gold | Population not clear | IgM: 98.2% IgG: 99.3% IgM/IgG: 98.2% |
Li et al (2020)22 | LFIA, Jiangsu Medomics POC | n=525 specimens | IgM/IgG: 90.63% |
Liu et al (2020)10 | ELISA (spike) | n=100 healthy controls | IgM: 100% (0/100) IgG: 100% (0/100) IgM and/or IgG: 100% (0/100) |
Xu et al (2020)33 | Fully automated assay (NR) | n=79 patients | IgM: 96.20% (76/79) IgG: 92.41% (73/79) |
Zhao et al (2020)12 | ELISA (spike for IgM and Ab; N for IgG) | Not clear | Total Ab: 99.1% (211/213) IgM: 98.6% (210/213) IgA: 99.0% (195/197) |
Jin et al (2020)20 | CLIA (N and spike proteins) | n=33 | IgM: 100% (33/33) IgG: 90.9% (30/33) |
Xiang et al (2020)11 | ELISA (NR) | n=60 | IgM: 100% (60/60) IgG: 95.0% (57/60) |
Dohla et al (2020)18 | IgM/IgG POC test | n=49 | IgM/IgG: 88.9% (95% CI 70.8 to 97.7) |
Spicuzza et al (2020)24 | LFIA (spike) | n=37 | IgG/IgM 92.9% |
Hoffman et al (2020)19 | LFIA (NR) | n=124 (controls) | IgM: 100% (0/124) IgG: 99.2% (1/124) |
Shen et al (2020)23 | Colloidal gold (NR) | n=150 | IgM/IgG: 96.2% (95% CI 0.859 to 0.993) |
CLIA, chemiluminescent immunoassay; LFIA, lateral flow immunoassay; NR, details not reported.