Table 2 Performance of HC-FIA with respect to clinical diagnosis or RT–qPCR (as ground truths)

From: Rapid lateral flow immunoassay for the fluorescence detection of SARS-CoV-2 RNA

  

Sensitivity

Specificity

Total consistency rate

κ

Positive consistency rate (%)

95% CI (%)

Negative consistency rate (%)

95% CI (%)

Consistency rate (%)

95% CI (%)

HC-FIA/clinical diagnosis

Throat swabs

87.69

83.08–92.30

95.01

92.82–97.20

92.53

90.38–94.68

0.8323

Sputum

91.94

85.16–98.72

92.41

86.57–98.25

92.20

87.77–96.63

0.8419

All samples

88.61

84.57–92.65

94.92

92.85–96.99

92.69

90.72–94.66

0.8393

HC-FIA/RT–qPCR

Throat swabs

100

99.85–100

99.26

98.43–100

99.49

98.92–100

0.9883

Sputum

100

99.74–100

98.73

96.26–100

99.29

97.90–100

0.9856

All samples

100

99.87–100

99.18

98.38–99.98

99.46

98.93–99.99

0.9879

  1. Positive consistency rate = true positive (TP)/(TP + false negative (FN)); negative consistency rate = (true negative (TN)/(TN + false positive (FP)); total consistency rate = (TP + TN)/(TP + TN + FP + FN).