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Table 2 LFA performance in terms of sensitivity and specificity

From: Evaluation of serological lateral flow assays for severe acute respiratory syndrome coronavirus-2

IgG lateral flow assay performance Manufacturer N TP TN FP FN sensitivity specificity PPV NPV sensitivity_CI95 specificity_CI95 PPV_CI95 NPV_CI95
API 112 52 56 0 4 0.929 1 1 0.933 (0.853–1) (0.991–1) (0.99–1) (0.861–1)
API (v2) 112 52 56 0 4 0.929 1 1 0.933 (0.853–1) (0.991–1) (0.99–1) (0.861–1)
BioHit 110 52 50 4 4 0.929 0.926 0.929 0.926 (0.853–1) (0.847–1) (0.853–1) (0.847–1)
BTNX 110 48 56 0 6 0.889 1 1 0.903 (0.796–0.982) (0.991–1) (0.99–1) (0.821–0.985)
Camtech 111 48 55 0 8 0.857 1 1 0.873 (0.756–0.958) (0.991–1) (0.99–1) (0.783–0.963)
CareHealth 112 53 53 3 3 0.946 0.946 0.946 0.946 (0.878–1) (0.878–1) (0.878–1) (0.878–1)
Cellex 112 53 52 4 3 0.946 0.929 0.93 0.945 (0.878–1) (0.853–1) (0.855–1) (0.876–1)
Edinburgh 108 47 51 2 8 0.855 0.962 0.959 0.864 (0.753–0.957) (0.901–1) (0.893–1) (0.768–0.96)
Genobio 111 42 56 0 13 0.764 1 1 0.812 (0.643–0.885) (0.991–1) (0.988–1) (0.713–0.911)
InTec 111 49 54 1 7 0.875 0.982 0.98 0.885 (0.779–0.971) (0.938–1) (0.931–1) (0.797–0.973)
KHB 112 53 54 2 3 0.946 0.964 0.964 0.947 (0.878–1) (0.906–1) (0.906–1) (0.88–1)
Lumiquick 111 54 53 3 1 0.982 0.946 0.947 0.981 (0.938–1) (0.878–1) (0.88–1) (0.935–1)
Oranoxis 110 40 55 0 15 0.727 1 1 0.786 (0.6–0.854) (0.991–1) (0.988–1) (0.683–0.889)
OZO 112 43 54 2 13 0.768 0.964 0.956 0.806 (0.649–0.887) (0.906–1) (0.885–1) (0.704–0.908)
Phamatech 95 38 47 0 10 0.792 1 1 0.825 (0.667–0.917) (0.989–1) (0.987–1) (0.718–0.932)
Ray Biotech 112 43 56 0 13 0.768 1 1 0.812 (0.649–0.887) (0.991–1) (0.988–1) (0.713–0.911)
Ray Biotech (v2) 111 51 55 0 5 0.911 1 1 0.917 (0.827–0.995) (0.991–1) (0.99–1) (0.839–0.995)
U2U 112 43 56 0 13 0.768 1 1 0.812 (0.649–0.887) (0.991–1) (0.988–1) (0.713–0.911)
Vivachek 111 52 55 1 3 0.945 0.982 0.981 0.948 (0.876–1) (0.938–1) (0.935–1) (0.882–1)
Zhuhai Livzon 109 47 54 0 8 0.855 1 1 0.871 (0.753–0.957) (0.991–1) (0.989–1) (0.779–0.963)
IgM lateral flow assay performance Manufacturer N TP TN FP FN sensitivity specificity PPV NPV sensitivity_CI95 specificity_CI95 PPV_CI95 NPV_CI95
API 112 27 56 0 29 0.482 1 1 0.659 (0.342–0.622) (0.991–1) (0.981–1) (0.552–0.766)
API (v2) 112 51 55 1 5 0.911 0.982 0.981 0.917 (0.827–0.995) (0.938–1) (0.934–1) (0.839–0.995)
BioHit 110 54 49 5 2 0.964 0.907 0.915 0.961 (0.906–1) (0.82–0.994) (0.835–0.995) (0.898–1)
BTNX 110 48 53 3 6 0.889 0.946 0.941 0.898 (0.796–0.982) (0.878–1) (0.867–1) (0.812–0.984)
Camtech 111 42 52 3 14 0.75 0.945 0.933 0.788 (0.628–0.872) (0.876–1) (0.849–1) (0.682–0.894)
CareHealth 112 50 56 0 6 0.893 1 1 0.903 (0.803–0.983) (0.991–1) (0.99–1) (0.821–0.985)
Cellex 112 31 56 0 25 0.554 1 1 0.691 (0.415–0.693) (0.991–1) (0.984–1) (0.584–0.798)
Edinburgh 108 29 49 4 26 0.527 0.925 0.879 0.653 (0.386–0.668) (0.845–1) (0.753–1) (0.539–0.767)
Genobio 111 31 52 4 24 0.564 0.929 0.886 0.684 (0.424–0.704) (0.853–1) (0.766–1) (0.573–0.795)
InTec 111 43 54 1 13 0.768 0.982 0.977 0.806 (0.649–0.887) (0.938–1) (0.921–1) (0.704–0.908)
KHB 112 31 55 1 25 0.554 0.982 0.969 0.688 (0.415–0.693) (0.938–1) (0.893–1) (0.58–0.796)
Lumiquick 111 37 56 0 18 0.673 1 1 0.757 (0.54–0.806) (0.991–1) (0.986–1) (0.653–0.861)
Oranoxis 110 48 55 0 7 0.873 1 1 0.887 (0.776–0.97) (0.991–1) (0.99–1) (0.8–0.974)
OZO 112 13 54 2 43 0.232 0.964 0.867 0.557 (0.113–0.351) (0.906–1) (0.662–1) (0.453–0.661)
Phamatech 95 38 46 1 10 0.792 0.979 0.974 0.821 (0.667–0.917) (0.927–1) (0.911–1) (0.712–0.93)
Ray Biotech 112 40 55 1 16 0.714 0.982 0.976 0.775 (0.587–0.841) (0.938–1) (0.917–1) (0.671–0.879)
Ray Biotech (v2) 111 47 55 0 9 0.839 1 1 0.859 (0.734–0.944) (0.991–1) (0.989–1) (0.766–0.952)
U2U 112 13 56 0 43 0.232 1 1 0.566 (0.113–0.351) (0.991–1) (0.962–1) (0.463–0.669)
Vivachek 111 51 55 1 4 0.927 0.982 0.981 0.932 (0.849–1) (0.938–1) (0.934–1) (0.859–1)
Zhuhai Livzon 109 46 54 0 9 0.836 1 1 0.857 (0.729–0.943) (0.991–1) (0.989–1) (0.763–0.951)
Combined IgG + IgM performance Manufacturer N TP TN FP FN sensitivity specificity PPV NPV sensitivity_CI95 specificity_CI95 PPV_CI95 NPV_CI95
API 112 36 56 0 20 0.643 1 1 0.737 (0.509–0.777) (0.991–1) (0.986–1) (0.631–0.843)
API (v2) 112 51 56 0 5 0.911 1 1 0.918 (0.827–0.995) (0.991–1) (0.99–1) (0.841–0.995)
BioHit 110 53 50 4 3 0.946 0.926 0.93 0.943 (0.878–1) (0.847–1) (0.855–1) (0.871–1)
BTNX 110 47 56 0 7 0.87 1 1 0.889 (0.771–0.969) (0.991–1) (0.989–1) (0.803–0.975)
Camtech 111 44 55 0 12 0.786 1 1 0.821 (0.67–0.902) (0.991–1) (0.989–1) (0.722–0.92)
CareHealth 112 51 56 0 5 0.911 1 1 0.918 (0.827–0.995) (0.991–1) (0.99–1) (0.841–0.995)
Cellex 112 46 55 1 10 0.821 0.982 0.979 0.846 (0.712–0.93) (0.938–1) (0.927–1) (0.751–0.941)
Edinburgh 108 35 51 2 20 0.636 0.962 0.946 0.718 (0.5–0.772) (0.901–1) (0.86–1) (0.606–0.83)
Genobio 111 39 56 0 16 0.709 1 1 0.778 (0.58–0.838) (0.991–1) (0.987–1) (0.675–0.881)
InTec 111 46 54 1 10 0.821 0.982 0.979 0.844 (0.712–0.93) (0.938–1) (0.927–1) (0.747–0.941)
KHB 112 39 56 0 17 0.696 1 1 0.767 (0.567–0.825) (0.991–1) (0.987–1) (0.663–0.871)
Lumiquick 111 40 56 0 15 0.727 1 1 0.789 (0.6–0.854) (0.991–1) (0.988–1) (0.687–0.891)
Oranoxis 110 43 55 0 12 0.782 1 1 0.821 (0.664–0.9) (0.991–1) (0.988–1) (0.722–0.92)
OZO 112 19 56 0 37 0.339 1 1 0.602 (0.206–0.472) (0.991–1) (0.974–1) (0.497–0.707)
Phamatech 95 36 47 0 12 0.75 1 1 0.797 (0.617–0.883) (0.989–1) (0.986–1) (0.686–0.908)
Ray Biotech 112 41 56 0 15 0.732 1 1 0.789 (0.607–0.857) (0.991–1) (0.988–1) (0.687–0.891)
Ray Biotech (v2) 111 48 55 0 8 0.857 1 1 0.873 (0.756–0.958) (0.991–1) (0.99–1) (0.783–0.963)
U2U 112 22 56 0 34 0.393 1 1 0.622 (0.256–0.53) (0.991–1) (0.977–1) (0.516–0.728)
Vivachek 111 52 55 1 3 0.945 0.982 0.981 0.948 (0.876–1) (0.938–1) (0.935–1) (0.882–1)
Zhuhai Livzon 109 45 54 0 10 0.818 1 1 0.844 (0.707–0.929) (0.991–1) (0.989–1) (0.747–0.941)
  1. N Total number of valid assays; TP True Positive; TN True Negative; FP False Positive; FN False Negative; PPV Positive Predictive Value; NPV Negative Predictive Value; CI95: 95% confidence interval