Table 2 LFA performance in terms of sensitivity and specificity

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)