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Table 2 Change in panel detection score and clean negative false positivity rate for voluntarily and compulsorily resubmitted products (rounds 1–8)

From: A review of the WHO malaria rapid diagnostic test product testing programme (2008–2018): performance, procurement and policy

Product

Catalogue number

Type of submission

First test

Last test

Change between first and last test

Met all WHO procurement criteria

Rd

Pf PDS (%)

Pv PDS (%)

FP (%)

Rd

Pf PDS (%)

Pv PDS (%)

FP (%)

Pf PDS (%)

Pv PDS (%)

FP (%)

1st test

Last test

Advanced Quality™ One Step Malaria Pf Test

ITP11002TC1/TC40

C

1

57.0

N/A

16.1

5

53.0

N/A

7.7

− 4.0

N/A

− 8.4

No

No

Advanced Quality™ One Step Malaria Pf Test

ITP11002TC1/TC40

V

5

53.0

N/A

7.7

7

93.0

N/A

0.4

40.0

N/A

− 7.3

No

Yes

Advanced Quality™ One Step Malaria (Pf/Pv) Tri-line Test (whole blood)

ITP11003 TC40

V

3

86.9

0.0

18.5

7

92.0

97.1

0.4

5.1

97.1

− 18.1

No

Yes

Advantage Mal Card

IR221025

C

1

62.0

100.0

4.2

5

30.0

94.3

0.4

− 32.0

− 5.7

− 3.8

No

No

Advantage P.f. Malaria Card

IR016025

C

1

97.5

N/A

0.0

5

89.0

N/A

0.0

− 8.5

N/A

0.0

Yes

Yes

Advantage Pan Malaria Card

IR013025

C

1

72.2

100.0

1.8

5

77.0

100.0

0.4

4.8

0.0

− 1.4

No

Yes

Asan Easy Test® Malaria Pf/Pan Ag

AM4650-K

V

5

81.0

34.3

0.4

7

88.0

100.0

1.3

7.0

65.7

0.9

No

Yes

BIONOTE MALARIA P.f. Ag Rapid Test Kit

RG19-11

V

3

85.9

N/A

2.0

6

88.0

N/A

0.5

2.1

N/A

− 1.5

Yes

Yes

BIONOTE MALARIA P.f & Pan Ag Rapid Test Kit

RG19-08

V

3

93.9

88.6

3.0

6

83.0

68.6

0.5

− 10.9

− 20.0

− 2.5

Yes

No

BioTracer™ Malaria P.f/PAN Rapid Card

17,012

V

5

77.0

77.1

0.4

7

96.0

97.1

0.9

19.0

20.0

0.5

Yes

Yes

CareStart™ Malaria HRP2 (Pf)

RMOM-02571b

C

1

98.7

N/A

2.4

5

91.0

N/A

0.9

− 7.7

N/A

− 1.5

Yes

Yes

CareStart™ Malaria HRP2 (Pf)

RMOM-02571b

V

5

91.0

N/A

0.9

8

92.0

N/A

0.0

1.0

N/A

− 0.9

Yes

Yes

CareStart™ Malaria HRP2/pLDH Pf

RMPM-02571e

C

2

98.0

N/A

3.0

6

91.0

N/A

0.0

− 7.0

N/A

− 3.0

Yes

Yes

CareStart™ Malaria HRP2/pLDH Pf

RMPM-02571e

V

6

91.0

N/A

0.0

8

96.0

N/A

0.0

5.0

N/A

0.0

Yes

Yes

CareStart™ Malaria HRP2/pLDH (Pf/PAN) COMBO

RMRM-02571d

C

1

97.5

90.0

3.0

5

90.0

94.3

0.4

− 7.5

4.3

− 2.6

Yes

Yes

CareStart™ Malaria HRP2/pLDH (Pf/PAN) COMBO

RMRM-02571d

V

5

90.0

94.3

0.4

8

87.0

94.3

0.0

− 3.0

0.0

− 0.4

Yes

Yes

CareStart Malaria HRP2/pLDH (Pf/Pv) COMBO

RMVM-02571a

V

2

90.0

90.0

0.5

8

87.0

100.0

0.0

− 3.0

10.0

− 0.5

Yes

Yes

CareStart Malaria HRP2/pLDH (Pf/VOM) COMBO

RMWM-02571c

V

2

89.0

80.0

0.5

4

89.8

91.2

0.0

0.8

11.2

− 0.5

Yes

Yes

CareStart Malaria HRP2/pLDH (Pf/VOM) COMBO

RMWM-02571c

C

4

89.8

91.2

0.0

8

87.0

100.0

0.0

− 2.8

8.8

0.0

Yes

Yes

CareStart™ Malaria pLDH (PAN)

G0111

C

1

92.4

100.0

6.6

5

84.0

88.6

0.0

− 8.4

− 11.4

− 6.6

Yes

Yes

CareStart™ Malaria Pf/PAN (pLDH) Ag RDT

RMLM-05071f

C

3

88.9

91.4

0.5

7

73.0

0.0

1.7

− 15.9

− 91.4

− 0.5

Yes

No

CareStart™ Malaria Pf/PAN (pLDH) Ag RDT

RMLM-05071f

V

7

73.0

0.0

1.7

8

83.0

97.1

1.0

10.0

97.1

− 0.7

No

Yes

CareStart™ Malaria Screen RDT

RMAM-05071 g

C

3

86.9

88.6

2.5

7

93.0

94.3

0.0

6.1

5.7

− 2.5

Yes

Yes

CareStart™ Malaria Pf (HRP2/pLDH) Ag Combo 3-line RDT

RMSM-XXX7X

V

7

94.0

N/A

0.4

8

82.0

N/A

0.5

− 12.0

N/A

0.1

Yes

Yes

diagnosticks—Malaria (Pf)Cassette WB

KMFC6001

V

2

59.0

N/A

7.0

5

88.0

N/A

0.9

29.0

N/A

− 6.1

No

Yes

EzDx™ Malaria Pan/Pf Rapid Test Detection kit

RK MAL 001

V

4

76.5

11.8

3.5

6

78.0

88.6

1.4

1.5

76.8

− 2.1

No

Yes

Falcivax Rapid Test for Malaria Pv/Pf (device)

503010025j

V

2

92.0

45.0

4.5

8

95.0

100.0

0.5

3.0

55.0

− 3.0

No

Yes

First Response® Malaria Ag Combo (pLDH/HRP2)

I16FRC30

V

1

100.0

75.0

3.6

5

85.0

74.3

0.0

− 15.0

− 0.7

− 3.6

Yes

No

First Response Malaria Ag P. falciparum (HRP2) Card

I13FRC30

C

1

100.0

N/A

3.0

5

95.0

N/A

0.4

− 5.0

N/A

− 2.6

Yes

Yes

First Response® Malaria Ag. P.f./P.v. Card test

PI19FRC25

V

6

85.0

71.4

0.5

8

94.0

100.0

1.0

9.0

28.6

0.5

No

Yes

FirstSign™—ParaView (Pan + Pf) Malaria Test

2101 CB-25

V

2

85.0

80.0

25.5

4

87.8

61.8

2.6

2.8

− 18.2

− 22.9

No

No

Humasis Malaria P.f/Pan Antigen Test

AMAL-7025

V

4

100.0

0.0

97.8

5

90.0

91.4

0.9

− 10.0

91.4

− 96.9

No

Yes

ICT Malaria Dual Test

ML03

V

3

78.8

60.0

0.5

7

85.0

31.4

1.3

6.2

− 28.6

0.8

No

No

ICT Malaria Pf Cassette Test

ML01

V

1

82.3

N/A

0.6

3

86.9

N/A

0.0

4.6

N/A

− 0.6

Yes

Yes

ICT Malaria Pf Cassette Test

ML01

C

3

86.9

N/A

0.0

7

94.0

N/A

1.7

7.1

N/A

1.7

Yes

Yes

ICT Malaria Combo Cassette Test

ML02

V

1

86.1

0.0

0.6

4

76.5

5.9

0.4

− 9.6

5.9

− 0.2

No

No

IMMUNOQUICK® MALARIA falciparum

0502_K25

C

1

91.1

N/A

0.6

5

72.0

N/A

5.1

− 19.1

N/A

4.5

Yes

No

Malaria pf (HRP II)/(PAN-LDH) Antigen Detection Test

MFV-124R

V

1

77.2

30.0

9.5

3

95.0

0.0

5.5

17.8

− 30.0

− 4.0

No

No

Malaria pf (pLDH)/PAN-pLDH Test Device

MFV-124

V

3

2.0

5.7

0.0

5

41.0

8.6

81.3

39.0

2.9

81.3

No

No

Malaria P.f./Pan Rapid Test Cassette

IMPN-402

V

7

69.0

71.4

0.9

8

63.0

91.4

0.5

− 6.0

20.0

− 0.4

No

No

Malaria Rapid Combo/Clearview® Malaria Combo

VB11

V

1

87.3

10.0

7.7

3

82.8

5.7

3.5

− 4.5

− 4.3

− 4.2

No

No

Malaria Rapid Dual/Clearview® Malaria Dual Test

VB20

V

1

76.0

5.0

10.1

5

89.0

60.0

12.7

13.0

55.0

2.6

No

No

Malaria Rapid Pf/Clearview®Malaria Pf

VB01

V

1

68.4

N/A

0.6

5

84.0

N/A

5.1

15.6

N/A

4.5

No

Yes

Malascan™ Device—Rapid test for Malaria Pf/Pan

50,402,025

V

1

63.3

0.0

5.4

3

82.8

57.1

1.0

19.5

57.1

− 4.4

No

No

Maleriscan® Malaria P.f/PAN (Pv, Pm, Po) 3 Line Antigen Test

MAT-PF/PAN-50

V

4

84.7

0.0

1.3

5

84.0

62.9

3.0

− 0.7

62.9

1.7

No

No

NanoSign Malaria Pf/Pan Ag

RMAP10

V

3

77.8

0.0

0.5

4

92.9

97.1

0.4

15.1

97.1

− 0.1

No

Yes

One Step Malaria Pf Test (Cassette)

522,352

V

2

37.0

N/A

0.5

4

94.9

N/A

1.3

57.9

N/A

0.8

No

Yes

One Step Malaria P.f Test

W37-C

V

3

60.6

N/A

0.0

7

93.0

N/A

0.0

32.4

N/A

0.0

No

Yes

One Step Malaria P.f/P.v Whole Blood Test

W056-C

V

5

87.0

28.6

2.1

7

92.0

65.7

1.3

5.0

37.1

− 0.8

No

Yes

One Step Malaria P.F/P.V Test (Cassette)

523,352

V

4

50.0

0.0

1.3

5

92.0

100.0

77.1

42.0

100.0

75.8

No

No

Onsite Pf Ag Rapid Test

R0114C

V

2

59.0

N/A

0.0

6

75.0

N/A

0.0

16.0

N/A

0

No

Yes

Onsite Malaria Pf/Pan Malaria Ag Rapid Test

R0113C

V

2

63.0

20.0

0.0

6

78.0

85.7

0.0

15.0

65.7

0

No

Yes

Onsite Malaria Pf/Pv Ag Rapid Test

R0112C

V

2

61.0

75.0

0.5

6

74.0

80.0

0.0

13.0

5.0

− 0.5

No

No

OptiMAL-IT

710,024

V

1

36.7

95.0

0.0

3

50.5

97.1

2.0

13.8

2.1

2.0

No

No

Parabank™ Device—Rapid test for Malaria Pan

50,301,025

V

1

1.3

30.0

3.0

3

17.2

62.9

0.5

15.9

32.9

− 2.5

No

No

Paracheck® Pf Device—Rapid test for P. falciparum Malaria (Ver. 3)

302030025 k

V

1

54.4

N/A

1.2

4

95.9

N/A

1.3

41.5

N/A

0.1

No

Yes

Paracheck® Pf Device—Rapid test for P. falciparum Malaria (Ver. 3)

302030025 k

C

4

95.9

N/A

1.3

8

94.0

N/A

3.4

− 1.9

N/A

2.1

Yes

Yes

Paracheck® Pf Dipstick—Rapid test for P. falciparum Malaria (Ver.3)

30,302,025

V

1

74.7

N/A

7.2

4

70.4

N/A

0.9

− 4.3

N/A

− 6.3

No

No

ParaHIT®—f (Device)

551C104-50 h

V

1

39.2

N/A

0.0

3

84.9

N/A

0.0

45.7

N/A

0.0

No

Yes

ParaHIT® - f (Device)

551C104-50 h

C

3

84.9

N/A

0.0

7

77.0

N/A

0.0

− 7.9

N/A

0.0

Yes

Yes

ParaHIT®—f (Dipstick)

551C103-50i

V

1

78.5

N/A

0.6

3

80.8

N/A

2.5

2.3

N/A

1.9

Yes

Yes

ParaHIT®—f (Dipstick)

551C103-50i

C

3

80.8

N/A

2.5

7

74.0

N/A

0.0

− 6.8

N/A

− 2.5

Yes

No

Parascreen™ Device—Rapid test for Malaria Pan/Pf

503030025 l

V

1

50.6

25.0

1.2

8

91.0

94.3

0.5

40.4

69.3

− 0.7

No

Yes

QuickProfileTM Malaria Pf/Pv Antigen Test

71,050

V

6

78.0

25.7

0.0

7

79.0

88.6

22.9

1.0

62.9

22.9

No

No

RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH)

C32RHA25m

V

5

77.0

77.1

4.7

7

91.0

100.0

3.9

14.0

22.9

− 0.8

Yes

Yes

SD BIOLINE Malaria Ag

05FK40

V

1

29.1

50.0

1.8

3

16.2

97.1

0.0

− 12.9

47.1

− 1.8

No

No

SD Bioline Malaria Ag P.f (HRP2/pLDH)

05FK90

V

3

87.9

N/A

2.0

8

90.0

N/A

0.0

2.1

N/A

− 2.0

Yes

Yes

SD BIOLINE Malaria Ag P.f/P.f/P.v

05FK120

V

6

85.0

91.4

0.0

8

89.0

97.1

0.0

4.0

5.7

0.0

Yes

Yes

SD BIOLINE Malaria Ag P.f/Pan

05FK60

V

1

96.2

35.0

1.2

5

94.0

91.4

0.0

− 2.2

56.4

− 1.2

No

Yes

SD Bioline Malaria Ag P.f/P.v

05FK80

C

2

96.0

95.0

3.5

6

92.0

94.3

1.9

− 4.0

− 0.7

− 1.6

Yes

Yes

SD BIOLINE Malaria Antigen

05FK50

C

1

97.5

N/A

2.4

5

95.0

N/A

0.0

− 2.5

N/A

− 2.4

Yes

Yes

Wondfo One Step Malaria Pf/Pan Whole Blood Test

W56-C

V

1

60.8

30.0

6.6

3

37.4

85.7

4.1

− 23.4

55.7

− 2.5

No

No

  1. First and last submissions of the same type are compared
  2. PDS panel detection score, FP false positivity, Rd round, resubmission type: V voluntary, C compulsory, N/A not applicable. The following list is the former product codes which have since been updated as detailed in the table: aG0161/G0161-ET, bG0141/G0141-ET, cG0171/G0171-ET, dG0131/G0131-ET, eG0181/G0181-ET, fG0121, gG0231, h55IC102-10, I5 55IC101-10, j50,300,025, k30301025, l50310025, mC30RHA25
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