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Table 4 Details of specimens discrepant from the TP reference result in two or more assays

From: Laboratory evaluation of four HIV/syphilis rapid diagnostic tests

WHO N°

Origin

INSTI Multiplex HIV-1/HIV-2/Syphilis antibody test

DPP HIV/Syphilis Assay

SD Bioline HIV/Syphilis Duo

Multiplo rapid TP/HIV Antibody test

Reference Results TP

Reference result for HIV

Vitros Syphilis TPA assay

TP particle agglutination (TTPA)

RPR

RecomLine Treponema IgM

Reference result for TP

Initial

Final

Initial

Final

Initial

Final

Initial

Final

S/CO

Result

 

Result

   

Initial result not correct in all four RDTs

 WHO3–0008

South America

FN

FN

FN

FN

FN

FN

FN

FN

11,60

R

160

R

N

NT

Positive

Negative

 140,017

Africa

FN

FN

FN

FN

FN

FN

FN

FN

11,80

R

640

R

N

NT

Positive

Negative

 140,020

Africa

FN

FN

FN

FN

FN

FN

FN

FN

8,50

R

320

R

N

NT

Positive

Negative

 140,087

Africa

FN

FN

FN

FN

FN

FN

FN

FN

22,00

R

320

R

N

NT

Positive

Negative

 140,127

Africa

FN

FN

FN

FN

FN

FN

FN

FN

20,90

R

320

R

N

NT

Positive

Negative

 140,148

Europe

FN

FN

FN

FN

FN

FN

FN

FN

7,97

R

160

R

N

NT

Positive

HIV-1 positive

 140,150

Europe

FN

FN

FN

FN

FN

FN

FN

FN

4,65

R

160

R

N

NT

Positive

HIV-1 positive

 140,176

Europe

FN

FN

FN

FN

FN

FN

FN

FN

11,60

R

1280

R

N

NT

Positive

HIV-1 positive

 140,179

United States

FN

FN

FN

FN

FN

FN

FN

FN

5,83

R

160

R

N

NT

Positive

HIV-1 positive

 140,180

Europe

FN

FN

FN

FN

FN

FN

FN

FN

5,79

R

320

R

N

NT

Positive

HIV-1 positive

 140,207

Europe

FN

FN

FN

FN

FN

FN

FN

FN

36,40

R

640

R

N

NT

Positive

HIV-1 positive

 140,215

Africa

FN

FN

FN

FN

FN

FN

FN

FN

13,20

R

160

R

N

NT

Positive

HIV-1 positive

 140,231

Asia

FN

FN

FN

FN

FN

FN

FN

FN

5,97

R

80

R

N

NT

Positive

HIV-1 positive

 991,126

Africa

FN

FN

FN

FN

FN

FN

FN

FN

5,16

R

160

R

N

NT

Positive

HIV-1 positive

Initial result not correct in three RDTs and one indeterminate result

 140,016

Africa

FN

FN

FN

FN

IND

OK

FN

FN

19,50

R

640

R

N

NT

Positive

Negative

 140,037

Africa

FN

FN

FN

FN

IND

OK

FN

FN

44,40

R

640

R

R

NT

Positive

Negative

 140,107

Africa

FN

FN

FN

FN

IND

IND

FN

FN

24,90

R

640

R

N

NT

Positive

Negative

 140,109

Africa

FN

FN

FN

FN

IND

IND

FN

FN

18,30

R

320

R

R

NT

Positive

Negative

 140,209

Europe

FN

FN

FN

OK

IND

FN

FN

FN

29,10

R

320

R

N

NT

Positive

HIV-1 positive

Initial result not correct in two RDTs and two indeterminate results

 140,006

Africa

FN

FN

IND

IND

IND

OK

FN

FN

59,80

R

640

R

N

NT

Positive

Negative

 140,170

Europe

FN

FN

IND

FN

IND

OK

FN

FN

14,40

R

160

R

N

NT

Positive

HIV-1 positive

 140,208

Europe

FN

FN

IND

FN

IND

OK

FN

FN

40,90

R

640

R

N

NT

Positive

HIV-1 positive

Initial result not correct in tree RDTs

 140,009

Africa

FN

FN

FN

OK

OK

OK

FN

FN

54,80

R

1280

R

N

NT

Positive

Negative

 140,149

Europe

OK

OK

FN

FN

FN

FN

FN

FN

42,60

R

320

R

N

NT

Positive

HIV-1 positive

 991,110

Africa

FN

FN

FN

FN

FN

FN

OK

OK

8,68

R

80

R

N

NT

Positive

HIV-1 positive

Initial result not correct in two RDTs and one indeterminate result

 140,085

Africa

FN

FN

IND

FN

OK

OK

FN

FN

7,90

R

160

R

N

NT

Positive

Negative

 140,091

Africa

FN

FN

OK

OK

IND

IND

FN

IND

31,50

R

640

R

N

NT

Positive

Negative

 140,146

Europe

FN

FN

IND

IND

OK

OK

FN

FN

19,30

R

80

R

N

NT

Positive

HIV-1 positive

 140,160

Europe

OK

OK

IND

FN

FN

FN

FN

FN

425,00

R

5120

R

N

NT

Positive

HIV-1 positive

 140,167

Europe

FN

FN

OK

OK

IND

FN

FN

FN

27,10

R

640

R

N

NT

Positive

HIV-1 positive

 140,192

Europe

FN

FN

IND

OK

OK

OK

FN

FN

15,00

R

320

R

N

NT

Positive

HIV-1 positive

Initial result not correct in two RDTs

 140,056

Africa

FN

FN

OK

OK

OK

OK

FN

FN

33,00

R

640

R

N

NT

Positive

Negative

 140,111

Africa

FN

FN

OK

OK

OK

OK

FN

FN

57,00

R

640

R

N

NT

Positive

Negative

 140,133

Africa

FN

FN

OK

OK

OK

OK

FN

IND

61,40

R

640

R

N

NT

Positive

Negative

 140,134

Africa

FN

FN

OK

OK

OK

OK

FN

FN

46,80

R

1280

R

N

NT

Positive

Negative

 140,140

Europe

FN

OK

OK

OK

OK

OK

FN

FN

35,40

R

320

R

N

NT

Positive

HIV-1 positive

 140,141

Africa

FN

OK

OK

OK

OK

OK

FN

FN

64,80

R

320

R

N

NT

Positive

HIV-1 positive

 140,152

Europe

FN

FN

OK

OK

OK

OK

FN

FN

18,20

R

160

R

N

NT

Positive

HIV-1 positive

 140,174

Europe

FN

FN

OK

OK

OK

OK

IND

FN

29,30

R

320

R

R

NT

Positive

HIV-1 positive

 140,219

Europe

FN

FN

OK

OK

OK

OK

FN

FN

41,50

R

640

R

N

NT

Positive

HIV-1 positive

 140,223

Europe

FN

FN

OK

OK

OK

OK

FN

IND

42,50

R

640

R

N

NT

Positive

HIV-1 positive

 140,230

South America

FN

FN

OK

OK

OK

OK

FN

FN

53,60

R

320

R

N

NT

Positive

HIV-1 positive

 WHO3–0586

Africa

FR

FR

OK

OK

OK

OK

FR

FR

0,02

NR

–

NR

N

Negative

Negative

HIV-1 positive

  1. ITG specimens obtained through the ITM clinic; FR false reactive, FN false non-reactive, OK result is concordant with the reference result, IND indeterminate result, S/CO sample signal/cut-off, OD/CO optical density/cut-off, R reactive, NR non-reactive, NT not tested, N negative