Clinical Accuracy of Instrument-Read SARS-CoV-2 Antigen Rapid Diagnostic Tests (Ag-IRRDTs)

Figure 5

Forest diagrams for 5 different brands of Ag-IRRDTs. With the pooled diagnostic odds ratio DOR = 353.097, 95% CI: [322.423–386.688] and tests for equality of sensitivities and for specificities all show that heterogeneity of datasets for major Ag-IRRDT manufacturers is high. Although Shenzen Bioeasy FIA demonstrated the highest sensitivity value over 87%, the number of studies using this test and their pooled sample size (3, 410) were low. Note that its 95% CIs have the widest ranges for both sensitivity and specificity parameters. LumiraDX demonstrated a sensitivity of 81.8% with larger number of studies and samples (10 and 4,697, respectively) with relatively narrow ranges of CIs. Surveillance studies were included in Quidel Sofia and SD Biosensor Standard F Quidel Sofia showed highest specificity value. (Values are displayed in two-digit accuracy).