Table 4

Diagnostic accuracy outcomes for antibody tests

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