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. 2022 Aug 25;43(1):31–45. doi: 10.1007/s10875-022-01354-x

Table 2.

Performance of QFN and serology assay at the suppliers’ thresholds compared to neutralization in non-infected individuals after the second dose

Neutralization (PRNT50 ≥ 20)
19A Alpha Beta Delta
Sensitivity (95% CI)

  QFN Ag1 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag2 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag1 + 2 (IFNγ ≥ 0.25 IU/ml)

  Serology (IgG ≥ 8.5 BAU/ml)

1.00 (0.93–1.00)

0.98 (0.90–1.00)

1.00 (0.93–1.00)

1.00 (0.93–1.00)

0.98 (0.90–1.00)

0.96 (0.88–0.99)

0.98 (0.90–1.00)

1.00 (0.93–1.00)

1.00 (0.91–1.00)

1.00 (0.91–1.00)

1.00 (0.91–1.00)

1.00 (0.90–1.00)

0.96 (0.87–0.99)

0.94 (0.84–0.98)

0.96 (0.87–0.99)

1.00 (0.93–1.00)

Specificity (95% CI)

  QFN Ag1 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag2 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag1 + 2 (IFNγ ≥ 0.25 IU/ml)

  Serology (IgG ≥ 8.5 BAU/ml)

0.58 (0.32–0.81)

0.50 (0.25–0.75)

0.58 (0.32–0.81)

0.00 (0.00–0.24)

0.55 (0.28–0.79)

0.45 (0.21–0.72)

0.55 (0.28–0.79)

0.00 (0.00–0.26)

0.24 (0.12–0.42)

0.25 (0.13–0.43)

0.24 (0.12–0.42)

0.00 (0.00–0.12)

0.33 (0.15–0.58)

0.25 (0.10–0.50)

0.31 (0.14–0.56)

0.00 (0.00–0.20)

PPV (95% CI)

  QFN Ag1 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag2 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag1 + 2 (IFNγ ≥ 0.25 IU/ml)

  Serology (IgG ≥ 8.5 BAU/ml)

0.92 (0.82–0.96)

0.90 (0.80–0.95)

0.92 (0.82–0.96)

0.81 (0.70–0.89)

0.92 (0.82–0.96)

0.90 (0.80–0.95)

0.92 (0.82–0.96)

0.83 (0.71–0.90)

0.63 (0.50–0.74)

0.64 (0.52–0.75)

0.63 (0.50–0.74)

0.56 (0.43–0.67)

0.83 (0.72–0.91)

0.80 (0.68–0.88)

0.81 (0.70–0.89)

0.76 (0.64–0.85)

NPV (95% CI)

  QFN Ag1 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag2 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag1 + 2 (IFNγ ≥ 0.25 IU/ml)

  Serology (IgG ≥ 8.5 BAU/ml)

1.00 (0.65–1.00)

0.86 (0.49–0.99)

1.00 (0.65–1.00)

/

0.86 (0.49–0.99)

0.71 (0.36–0.95)

0.86 (0.49–0.99)

/

1.00 (0.65––1.00)

1.00 (0.65–1.00)

1.00 (0.65–1.00)

/

0.71 (0.36–0.95)

0.57 (0.25–0.84)

0.71 (0.36–0.95)

/

Fisher’s exact test

  QFN Ag1 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag2 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag1 + 2 (IFNγ ≥ 0.25 IU/ml)

  Serology (IgG ≥ 8.5 BAU/ml)

p < 0.0001 (****)

p < 0.0001 (****)

p < 0.0001 (****)

p > 0.9999 (ns)

p < 0.0001 (****)

p < 0.0009 (***)

p < 0.0001 (****)

p > 0.9999 (ns)

p = 0.0020 (**)

p = 0.0015 (**)

p = 0.0020 (**)

p > 0.9999 (ns)

p = 0.0053 (**)

p = 0.0532 (ns)

p = 0.0074 (**)

p > 0.9999 (ns)

Agreement

  QFN Ag1 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag2 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag1 + 2 (IFNγ ≥ 0.25 IU/ml)

  Serology (IgG ≥ 8.5 BAU/ml)

92.4%

89.4%

92.4%

81.0%

90.9%

87.9%

90.9%

82.5%

66.7%

68.2%

66.7%

55.6%

81.8%

77.3%

80.3%

76.2%

Cohen’s kappa (95% CI)

  QFN Ag1 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag2 (IFNγ ≥ 0.15 IU/ml)

  QFN Ag1 + 2 (IFNγ ≥ 0.25 IU/ml)

  Serology (IgG ≥ 8.5 BAU/ml)

0.70 (0.45–0.94)

0.58 (0.30–0.85)

0.70 (0.45–0.94)

0.00 (0.00–0.00)

0.62 (0.34–0.89)

0.49 (0.19–0.79)

0.62 (0.34–0.89)

0.00 (0.00–0.00)

0.26 (0.09–0.43)

0.28 (0.10–0.45)

0.26 (0.09–0.43)

0.00 (0.00–0.00)

0.36 (0.09–0.64)

0.24 (0.00–0.48)

0.34 (0.07–0.60)

0.00 (0.00–0.00)

QFN QuantiFERON SARS-CoV-2 Starter Set®, IgG G-immunoglobulins, PPV positive predictive value, NPV negative predictive value, / data not available.