ObjectiveTo analyze the diagnostic efficacy of colloidal gold immunochromatography assay (GICA) in detection of SARS-CoV-2.MethodsUsing GICA detection kits from three different manufacturers, 33 serum samples were collected from 12 patients with SARS-CoV-2 infection at different time and 45 serum samples from 45 patients without SARS-CoV-2 infection were collected from West China Hospital of Sichuan University from January to February, 2020.ResultsThe sensitivity, specificity, positive predictive value and negative predictive value of the three GICA reagents were 66.7% - 90.9%, 73.3% - 100.0%, 71.4% - 100.0% and 80.4% - 91.7% respectively. The rates of missed diagnosis and misdiagnosis were 9.1% - 33.3% and 0 - 26.7%, respectively. The positive rate decreased with titer increasing. The interference factors mainly included human immunodeficiency virus infection, high rheumatoid factor blood samples, and hemolysis.ConclusionClinical laboratories should pay attention to the differences in the detection ability and potential cross-reaction of different reagents, or use a combination of multiple antibodies.
