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استفاده از تست‌های تشخیصی سریع به منظور تشخیص مالاریا غیر از فالسیپاروم یا پلاسمودیوم ویواکس بدون عارضه در کشورهای آندمی

Information

DOI:
https://doi.org/10.1002/14651858.CD011431Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 18 December 2014see what's new
Type:
  1. Diagnostic
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Infectious Diseases Group

Classified:
  1. No update planned

    Review superseded

    This Cochrane Review has been superseded by Choi 2019 https://doi.org/10.1002/14651858.CD013218

    Assessed: 12 April 2019

Copyright:
  1. Copyright © 2015 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.
  2. This is an open access article under the terms of the Creative Commons Attribution‐Non‐Commercial Licence, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Authors

  • Katharine Abba

    Correspondence to: Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK

    [email protected]

  • Amanda J Kirkham

    Cancer Research UK Clinical Trials Unit, School of Cancer Sciences, University of Birmingham, Birmingham, UK

  • Piero L Olliaro

    UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland

  • Jonathan J Deeks

    Public Health, Epidemiology and Biostatistics, University of Birmingham, Birmingham, UK

  • Sarah Donegan

    Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK

  • Paul Garner

    Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK

  • Yemisi Takwoingi

    Public Health, Epidemiology and Biostatistics, University of Birmingham, Birmingham, UK

Contributions of authors

The review authors jointly developed the protocol. Katharine Abba applied inclusion criteria, oversaw the data extractions and entered the data. Yemisi Takwoingi, Sarah Donegan, Amanda Kirkham and Jon Deeks performed statistical analyses. All review authors contributed to the final manuscript.

Sources of support

Internal sources

  • International Medical University, Malaysia.

    Research grant ID 134/2007

  • Liverpool School of Tropical Medicine, UK.

External sources

  • Department for International Development, UK.

    Research Programme Grant

Declarations of interest

PG is Director of Evidence Building and Synthesis Research Consortium that receives money to increase the number of evidence‐informed decisions by intermediary organizations, including WHO and national decision‐makers that benefit the poor in middle‐ and low‐income countries. PG is the coordinator of a WHO Collaborating Centre for Evidence Synthesis for Infectious and Tropical Diseases; one of the Centre's aims is to help WHO in its role as an infomediary in communicating reliable summaries of research evidence to policy makers, clinicians, teachers, and the public in developing countries.

Acknowledgements

The academic editor for this review was Dr Karen Steingart.

We are grateful to our affiliated institutions and organizations, and to the Department of International Development (DFID), UK for research grants. We acknowledge the referees for their comments. Also, we thank Nicola Mayan and Sally Jackson for helping with data extraction.

The editorial base for the Cochrane Infectious Diseases Group is funded by UKaid from the UK Government for the benefit of developing countries.

Version history

Published

Title

Stage

Authors

Version

2014 Dec 18

Rapid diagnostic tests for diagnosing uncomplicated non‐falciparum or <i>Plasmodium vivax</i> malaria in endemic countries

Review

Katharine Abba, Amanda J Kirkham, Piero L Olliaro, Jonathan J Deeks, Sarah Donegan, Paul Garner, Yemisi Takwoingi

https://doi.org/10.1002/14651858.CD011431

Differences between protocol and review

In the protocol, we considered RDTs for the detection of P. falciparum and nonfalciparum malaria within one Cochrane Review. However, it became apparent during production of the review that such a publication would be very large. For this reason we decided to split results for the different target conditions into two separate Cochrane Reviews.

In the protocol, we stated that in the search for eligible studies we would contact test manufacturers to identify any unpublished studies, handsearch conference proceedings and contact study authors and other experts for information on ongoing and unpublished studies. However, due to the number of citations returned by our search (over 4000) and the large size of the reviews, we did not have the resources to undertake any of these additional search methods, and the methods stated in the review reflect this.

Since the publication of the protocol, we added three additional exclusion criteria relating to study eligibility. We excluded studies if the study authors used active case detection to recruit participants, as we felt the threshold of symptoms leading to testing may be lower than for a self‐selecting sample attending healthcare facilities and that this may influence the findings. We also excluded studies if they did not present sufficient data to allow us to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives, as we considered it would be distracting to the reader to present data on studies that did not contribute to the analyses. Due to resource constraints, we excluded studies if they were written in non‐English languages, or if they did not provide enough information to enable a full assessment of their eligibility for the review.

Keywords

MeSH

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figures and Tables -
Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Forest plot of commercial brands of Type 2 tests for detection of non‐falciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.
Figures and Tables -
Figure 3

Forest plot of commercial brands of Type 2 tests for detection of nonfalciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.

Summary ROC plot of Type 2 tests for detection of non‐falciparum species (verified with microscopy). The black solid circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.
Figures and Tables -
Figure 4

Summary ROC plot of Type 2 tests for detection of nonfalciparum species (verified with microscopy). The black solid circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.

Forest plot of commercial brands of Type 3 tests for detection of non‐falciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.
Figures and Tables -
Figure 5

Forest plot of commercial brands of Type 3 tests for detection of nonfalciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.

Summary ROC plot of Type 3 tests for detection of non‐falciparum species (verified with microscopy). The black solid circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.
Figures and Tables -
Figure 6

Summary ROC plot of Type 3 tests for detection of nonfalciparum species (verified with microscopy). The black solid circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.

Forest plot of commercial brands of Type 4 tests for detection of non‐falciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.
Figures and Tables -
Figure 7

Forest plot of commercial brands of Type 4 tests for detection of nonfalciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.

Summary ROC plot of Type 4 tests for detection of non‐falciparum species (verified with microscopy). The black circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.
Figures and Tables -
Figure 8

Summary ROC plot of Type 4 tests for detection of nonfalciparum species (verified with microscopy). The black circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.

Forest plot of Type 2, Type 3 and Type 4 tests for detection of non‐falciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.
Figures and Tables -
Figure 9

Forest plot of Type 2, Type 3 and Type 4 tests for detection of nonfalciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.

Summary ROC plot comparing Type 2, Type 3 and Type 4 tests for detection of non‐falciparum species (verified with microscopy). The solid circles correspond to the summary estimates of sensitivity and specificity for each test type, and are shown with 95% confidence regions (dotted lines) and 95% prediction regions (dashed lines). The summary points for Type 2 and Type 3 and their 95% confidence regions are identical but the 95% prediction regions differ. The 95% prediction regions illustrate the extent of between study heterogeneity.
Figures and Tables -
Figure 10

Summary ROC plot comparing Type 2, Type 3 and Type 4 tests for detection of nonfalciparum species (verified with microscopy). The solid circles correspond to the summary estimates of sensitivity and specificity for each test type, and are shown with 95% confidence regions (dotted lines) and 95% prediction regions (dashed lines). The summary points for Type 2 and Type 3 and their 95% confidence regions are identical but the 95% prediction regions differ. The 95% prediction regions illustrate the extent of between study heterogeneity.

Summary ROC plot of Type 3 tests for detection of non‐falciparum species (verified with PCR). The solid circles correspond to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.
Figures and Tables -
Figure 11

Summary ROC plot of Type 3 tests for detection of nonfalciparum species (verified with PCR). The solid circles correspond to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.

Forest plot of Pf HRP‐2 and Pv pLDH for detection of P. vivax (verified with microscopy). Studies are ordered by continent, age group and study identifier.
Figures and Tables -
Figure 12

Forest plot of Pf HRP‐2 and Pv pLDH for detection of P. vivax (verified with microscopy). Studies are ordered by continent, age group and study identifier.

Summary ROC plot Pf HRP‐2 and Pv pLDH for detection of P. vivax (verified with microscopy). The black circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.
Figures and Tables -
Figure 13

Summary ROC plot Pf HRP‐2 and Pv pLDH for detection of P. vivax (verified with microscopy). The black circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.

Non‐falciparum species only, microscopy, Type 2, ICT Combo Cassette.
Figures and Tables -
Test 1

Nonfalciparum species only, microscopy, Type 2, ICT Combo Cassette.

Non‐falciparum species only, microscopy, Type 2, ICT Malaria Pf/Pv.
Figures and Tables -
Test 2

Nonfalciparum species only, microscopy, Type 2, ICT Malaria Pf/Pv.

Non‐falciparum species only, microscopy, Type 2, NOW Malaria ICT.
Figures and Tables -
Test 3

Nonfalciparum species only, microscopy, Type 2, NOW Malaria ICT.

Non‐falciparum species only, microscopy, Type 2, Malascan.
Figures and Tables -
Test 4

Non‐falciparum species only, microscopy, Type 2, Malascan.

Non‐falciparum species only, microscopy, Type 2, VIKIA Ag Pf/Pan.
Figures and Tables -
Test 5

Non‐falciparum species only, microscopy, Type 2, VIKIA Ag Pf/Pan.

Non‐falciparum species only, microscopy, Type 2 (All).
Figures and Tables -
Test 6

Nonfalciparum species only, microscopy, Type 2 (All).

Non‐falciparum species only, microscopy, Type 3, Parascreen.
Figures and Tables -
Test 7

Non‐falciparum species only, microscopy, Type 3, Parascreen.

Non‐falciparum species only, microscopy, Type 3, CareStart Pf/Pan.
Figures and Tables -
Test 8

Non‐falciparum species only, microscopy, Type 3, CareStart Pf/Pan.

Non‐falciparum species only, microscopy, Type 3, SD Malaria Antigen Bioline.
Figures and Tables -
Test 9

Non‐falciparum species only, microscopy, Type 3, SD Malaria Antigen Bioline.

Non‐falciparum species only, microscopy, Type 3, First Response Malaria Combo.
Figures and Tables -
Test 10

Non‐falciparum species only, microscopy, Type 3, First Response Malaria Combo.

Non‐falciparum species only, microscopy, Type 3, One Step Malaria Pf/Pan.
Figures and Tables -
Test 11

Non‐falciparum species only, microscopy, Type 3, One Step Malaria Pf/Pan.

Non‐falciparum species only, microscopy, Type 3 (All).
Figures and Tables -
Test 12

Non‐falciparum species only, microscopy, Type 3 (All).

Non‐falciparum species only, microscopy, Type 4, OptiMAL.
Figures and Tables -
Test 13

Nonfalciparum species only, microscopy, Type 4, OptiMAL.

Non‐falciparum species only, microscopy, Type 4, OptiMAL‐IT.
Figures and Tables -
Test 14

Non‐falciparum species only, microscopy, Type 4, OptiMAL‐IT.

Non‐falciparum species only, microscopy, Type 4, Carestart.
Figures and Tables -
Test 15

Non‐falciparum species only, microscopy, Type 4, Carestart.

Non‐falciparum species only, microscopy, Type 4 (All).
Figures and Tables -
Test 16

Non‐falciparum species only, microscopy, Type 4 (All).

Non‐falciparum species only, microscopy, Other Type, Malariagen Malaria.
Figures and Tables -
Test 17

Nonfalciparum species only, microscopy, Other Type, Malariagen Malaria.

Non‐falciparum species only, PCR, Type 3, CareStart Pf/Pan.
Figures and Tables -
Test 18

Non‐falciparum species only, PCR, Type 3, CareStart Pf/Pan.

Non‐falciparum species only, PCR, Type 3, Parascreen.
Figures and Tables -
Test 19

Non‐falciparum species only, PCR, Type 3, Parascreen.

Non‐falciparum species only, PCR, Type 3, One Step Malaria Pf/Pan.
Figures and Tables -
Test 20

Non‐falciparum species only, PCR, Type 3, One Step Malaria Pf/Pan.

Non‐falciparum species only, PCR, Type 3, SD Malaria Antigen Bioline.
Figures and Tables -
Test 21

Non‐falciparum species only, PCR, Type 3, SD Malaria Antigen Bioline.

Non‐falciparum species only, PCR, Type 3 (All).
Figures and Tables -
Test 22

Non‐falciparum species only, PCR, Type 3 (All).

Non‐falciparum species only, PCR, Type 4, OptiMAL (All).
Figures and Tables -
Test 23

Non‐falciparum species only, PCR, Type 4, OptiMAL (All).

P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Carestart Pf/Pv (All).
Figures and Tables -
Test 24

P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Carestart Pf/Pv (All).

P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Biotech Malaria Pf/Pv.
Figures and Tables -
Test 25

P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Biotech Malaria Pf/Pv.

P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Falcivax.
Figures and Tables -
Test 26

P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Falcivax.

P. vivax, microscopy, Pf HRp‐2 and Pv pLDH, Onsite Pf/Pv.
Figures and Tables -
Test 27

P. vivax, microscopy, Pf HRp‐2 and Pv pLDH, Onsite Pf/Pv.

P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Pf/Pv Malaria Device.
Figures and Tables -
Test 28

P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Pf/Pv Malaria Device.

P. vivax, microscopy, Pf HRP‐2 and Pv pLDH (All).
Figures and Tables -
Test 29

P. vivax, microscopy, Pf HRP‐2 and Pv pLDH (All).

P. vivax, PCR, Pf HRP‐2 and Pv pLDH, Falcivax.
Figures and Tables -
Test 30

P. vivax, PCR, Pf HRP‐2 and Pv pLDH, Falcivax.

P. vivax, PCR, Pf HRP‐2 and Pv pLDH, OnSite Pf/Pv.
Figures and Tables -
Test 31

P. vivax, PCR, Pf HRP‐2 and Pv pLDH, OnSite Pf/Pv.

P. vivax, PCR, Pf HRP‐2 and Pv pLDH, Pf/Pv Malaria Device.
Figures and Tables -
Test 32

P. vivax, PCR, Pf HRP‐2 and Pv pLDH, Pf/Pv Malaria Device.

P. vivax, PCR, Pf HRP‐2 and Pv pLDH (All).
Figures and Tables -
Test 33

P. vivax, PCR, Pf HRP‐2 and Pv pLDH (All).

P. vivax, PCR, Type 6, PALUTOP (All).
Figures and Tables -
Test 34

P. vivax, PCR, Type 6, PALUTOP (All).

Summary of findings Performance of RDTs for diagnosis of non‐falciparum or P. vivax malaria

Patients/populations

People presenting with symptoms suggestive of uncomplicated malaria 

Prior testing

None

Settings

Ambulatory healthcare settings in P. vivax,P. malariae or P. ovale malaria endemic areas in Asia, Africa and South America

Index tests

Immunochromatography‐based rapid diagnostic tests (RDTs) for non‐falciparum malaria in the absence of P. falciparum co‐infection, or P. vivax malaria with or without other malaria species 

Reference standard

Conventional microscopy, polymerase chain reaction (PCR)

Importance

Accurate and fast diagnosis allows appropriate and quick treatment for malaria to be provided

Studies

37 unique publications reporting 47 studies (22,862 participants)

Quality concerns

Poor reporting of patient characteristics, sampling method and reference standard methods were common concerns

Test type

Quantity of evidence

Number of evaluations (malaria cases/participants)

Average sensitivity (95% CI)

Average specificity (95% CI)

Prevalence (%)

Consequences in a cohort of 1000

Missed cases

False positives

Target condition (reference standard): non‐falciparum malaria (microscopy)

Type 2

HRP‐2 (P. falciparum specific) and aldolase (pan‐specific)

11 (958/6879)

78% (73% to 82%)

99% (97% to 99%)

5

11

10

15

33

9

30

66

7

Type 3

HRP‐2 (P. falciparum specific) and pLDH (pan‐specific)

23 (1537/11,234)

78% (69% to 84%)

99% (98% to 99%)

5

11

10

15

33

9

30

66

7

Type 4

pLDH (P. falciparum specific) and pLDH (pan‐specific)

10 (986/3831)

89% (79% to 95%)

98% (97% to 99%)

5

6

19

15

17

17

30

33

14

Target condition (reference standard): non‐falciparum malaria (PCR)

Type 3

HRP‐2 (P. falciparum specific) and pLDH (pan‐specific)

5 (300/1639)

81% (72% to 88%)

99% (97% to 99%)

5

10

10

15

29

9

30

57

7

Target condition (reference standard): P.vivax with or without other malaria species (microscopy)

HRP‐2 (P. falciparum specific) and pLDH (P. vivax‐specific)

8 (580/3682)

95% (86% to 99%)

99% (99% to 100%)

5

3

10

15

8

9

30

15

7

Conclusions: The majority of studies evaluated RDTs which are designed to differentiate falciparum malaria from non‐falciparum malaria, but cannot differentiate between different non‐falciparum species or identify non‐falciparum malaria species within a mixed infection. In these types of tests, specificity for non‐falciparum malaria in the absence ofP. falciparum infection was high, but sensitivity was low, tests missing between 11% and 22% of non‐falciparum cases. RDTs which are designed to detect P. vivax specifically, whether alone or part of a mixed infection, were more accurate with tests missing less than 5% of P. vivax cases. This review can help decision‐making about which RDT to use, in combination with other published information about in vitro test performance and stability in the field.

Figures and Tables -
Summary of findings Performance of RDTs for diagnosis of non‐falciparum or P. vivax malaria
Table 1. Types of malaria RDTs by antigen combination and parasite species detected

Type of test

Antigen combinations

Possible results

Type 1

HRP‐2 (P. falciparum specific)

No Pf; Pf; invalid

Type 2

HRP‐2 (P. falciparum specific) and aldolase (pan‐specific)

No malaria; Pf or mixed; Pv, Pf, or Pm; invalid

Type 3

HRP‐2 (P. falciparum specific) and pLDH (pan‐specific)

No malaria; Pf or mixed; Pv, Pf, or Pm; invalid

Type 4

pLDH (P. falciparum specific) and pLHD (pan‐specific)

No malaria; Pf or mixed; Pv, Pf, or Pm; invalid

Type 5

pLDH (P. falciparum specific) and pLHD (P. vivax‐specific)

No malaria; Pf; Pv; Pf and Pv; invalid

Type 6

HRP‐2 (P. falciparum specific), pLHD (pan‐specific) and pLDH (P. vivax specific)

No malaria; Pf and Pv ± Po and/or Pm;  Pf ± Po and/or Pm;  Pv ± Po or Pm; Po or Pm; invalid

Type 7

Aldolase (pan‐specific)

No malaria; Pf, Pv, Po,or Pm; invalid

Other

HRP‐2 (P. falciparum specific) and pLDH (P. vivax specific)

No malaria; Pf; Pv; Pf and Pv; invalid

Figures and Tables -
Table 1. Types of malaria RDTs by antigen combination and parasite species detected
Table 2. Malaria 'zones' by endemic parasite species and type of test appropriate for each

Zone

Endemic malaria parasites

Geographic area

Appropriate test type

1

P. falciparum only or other species almost always as a mixed infection

Most of sub‐Saharan Africa; lowland Papua New Guinea

Tests using HRP‐2 to detect P. falciparum only

(Type 1)

2

Both P. falciparum and P. vivax, most commonly as a single species

 

Asia and the Americas; Ethiopian highlands

 

Combination RDTs which detect all species and distinguish between P. falciparum and P. vivax

(Types 2 to 6)

3

Nonfalciparum only

 

Vivax‐only areas of East Asia and Central Asia; some highland areas elsewhere

Pan‐specific or vivax‐specific RDTs

(Type 7; Pan‐pLDH only; vivax‐pLDH only)

Figures and Tables -
Table 2. Malaria 'zones' by endemic parasite species and type of test appropriate for each
Table 3. Number of studies by RDT type and reference standard

Type of RDT

Number of study cohorts (test evaluations) by reference standard

Microscopy

PCR

Non‐falciparum species in the absence of P. falciparum

Type 2

11 (11)

0 (0)

Type 3

23 (25)

5 (5)

Type 4

10 (11)

1 (1)

Other type

1 (1)

0 (0)

P. vivax

Pf HRP2 and Pv pLDH

8 (9)

2 (3)

Type 6

0 (0)

1 (1)

Figures and Tables -
Table 3. Number of studies by RDT type and reference standard
Table 4. False negatives for non‐falciparum and P. vivax by RDT type

Study

Test 

Number of false negatives

% false negatives indicating 'no malaria'

% false negatives indicating 'P. falciparum'

Type 2 tests

Ashton 2010

ICT Combo

37

22

78

Bell 2001a

ICT Malaria trial 1

16

13

88

Bell 2001b

ICT Malaria trial 2

6

67

33

Fernando 2004

ICT Malaria Pf/Pv

29

100

0

Harani 2006

ICT Malaria Pf/Pv

3

67

33

Singh 2000a

ICT Malaria Pf/Pv

13

62

38

Singh 2010

Malascan

18

67

33

Tjitra 1999

ICT Malaria Pf/Pv

8

75

25

van den Broek 2006

NOW malaria ICT

72

67

33

Wongsrichanalai 2003

ICT Malaria Pf/Pv

9

67

33

van den Broek 2006

OptiMAL‐IT

34

74

26

Median (range)

67 (13 to 100)

33 (0 to 88)

Pooled estimate (95% CI)*

65 (43 to 81)

35 (19 to 57)

Type 3 tests

Ashton 2010

Carestart

37

22

78

Ashton 2010

Parascreen

43

14

86

Bendezu 2010

Parascreen

19

84

16

Bharti 2008

First response

7

100

0

Dev 2004

Diamed OptiMAL

3

100

0

Eibach 2013

CareStart

3

100

0

Elahi 2013

Parascreen

5

60

40

Kosack 2013

SD Bioline

133

89

11

Moges 2012

Carestart

38

89

11

Ratsimbasoa 2007

SD Malaria Antigen Bioline

4

100

0

Singh 2010

Parascreen

13

54

46

Singh 2010

First response

9

33

67

Singh 2010

ParaHIT Total

48

92

8

Trouvay 2013

SD Malaria Ag Pf/Pan

18

78

22

Yan 2013

Pf/Pan Device

24

25

75

Median (range)

84 (14 to 100)

16 (0 to 86)

Pooled estimate (95% CI)

74 (52 to 88)

26 (12 to 48)

Type 4 tests

Andrade 2010

OptiMAL‐IT

0

0

0

Chayani 2004

OptiMAL

3

100

0

Dev 2004

SD Malaria

2

100

0

Kolaczinski 2004

OptiMAL

23

100

0

Metzger 2011

OptiMAL‐IT

30

100

0

Pattanasin 2003

OptiMAL‐IT

26

65

35

Ratsimbasoa 2007

OptiMAL‐IT

2

100

0

Ratsimbasoa 2007

Carestart Malaria

3

33

67

Singh 2003

OptiMAL (field)

0

0

0

Soto Tarazona 2004

OptiMAL

3

100

0

Valecha 2003

OptiMAL

13

77

23

Median (range)

100 (0 to 100)

0 (0 to 67)

Pooled estimate (95% CI)

87 (79 to 92)

13 (8 to 21)

*The pooled estimates of the percentage of false negatives indicating 'no malaria' and the percentage of false negatives indicating 'P. falciparum' were computed by using a random effects logistic regression model for Type 2 and Type 3. A fixed effects logistic regression model was used for Type 4.

This table shows participants with non‐falciparum malaria monoinfection identified by microscopy who were negative by non‐falciparum monoinfection by RDT, by whether the RDT incorrectly identified the participant as not having malaria, or as having P. falciparum malaria.

Figures and Tables -
Table 4. False negatives for non‐falciparum and P. vivax by RDT type
Table 5. Non‐falciparum infections by RDT types verified by microscopy

RDT Type

Study cohort

Participants

Malaria cases

Pooled sensitivity

(95% CI) (%)

Pooled specificity

(95% CI) (%)

Test1

Type 2

11

6879

958

78 (73 to 82)

99 (97 to 99)

P = 0.008

Type 3

23

11,234

1537

78 (69 to 85)

99 (98 to 99)

Type 4

10

3831

986

90 (79 to 95)

98 (97 to 99)

Other type

1

262

12

92 (62 to 100)

95 (92 to 98)

1Likelihood ratio test for evidence of a difference in sensitivity or specificity, or both, between Types 2, 3, and 4.

*Only one test brand (randomly selected) from each cohort is included in the analysis of each type.

Figures and Tables -
Table 5. Non‐falciparum infections by RDT types verified by microscopy
Table 6. Comparisons of RDT types for non‐falciparum infections verified by microscopy

Ratio of sensitivity

(95% CI),

P value for comparison

Ratio of specificity

 (95% CI),

P value for comparison 

 

Type 2

Type 3

Studies (participants)

11 (6879)

23 (11,234)

 

Studies (participants)

Sensitivity  (95% CI)

Specificity  (95% CI)

78 (73 to 82)

99 (97 to 99)

78 (69 to 84)

99 (98 to 99)

Type 2

11 (6879)

78 (73 to 82)

99 (97 to 99)

Type 3

23 (11,234)

78 (69 to 84)

99 (98 to 99)

1.00 (0.89 to 1.12), P = 1.00

1.00 (0.99 to 1.01), P = 0.87

Type 4

10 (3831)

90 (79 to 95)

98 (97 to 99)

0.87 (0.78 to 0.96), P = 0.01

1.00 (0.99 to 1.02), P = 0.52

0.87 (0.76 to 0.99), P = 0.03

1.01 (1.00 to 1.02), P = 0.29

We computed the ratio of sensitivities and specificities by division of the sensitivity and specificity for the column by the sensitivity and specificity for the row. If the ratio of sensitivities is greater than one, the sensitivity of the test for the column is higher than that for the row; if less than one, the sensitivity of the test in the row is higher than in the column. The same applies to the ratio of specificities.

Figures and Tables -
Table 6. Comparisons of RDT types for non‐falciparum infections verified by microscopy
Table Tests. Data tables by test

Test

No. of studies

No. of participants

1 Nonfalciparum species only, microscopy, Type 2, ICT Combo Cassette Show forest plot

1

2383

2 Nonfalciparum species only, microscopy, Type 2, ICT Malaria Pf/Pv Show forest plot

7

3151

3 Nonfalciparum species only, microscopy, Type 2, NOW Malaria ICT Show forest plot

1

246

4 Non‐falciparum species only, microscopy, Type 2, Malascan Show forest plot

1

372

5 Non‐falciparum species only, microscopy, Type 2, VIKIA Ag Pf/Pan Show forest plot

1

727

6 Nonfalciparum species only, microscopy, Type 2 (All) Show forest plot

11

6879

7 Non‐falciparum species only, microscopy, Type 3, Parascreen Show forest plot

14

5407

8 Non‐falciparum species only, microscopy, Type 3, CareStart Pf/Pan Show forest plot

4

3544

9 Non‐falciparum species only, microscopy, Type 3, SD Malaria Antigen Bioline Show forest plot

4

3769

10 Non‐falciparum species only, microscopy, Type 3, First Response Malaria Combo Show forest plot

2

663

11 Non‐falciparum species only, microscopy, Type 3, One Step Malaria Pf/Pan Show forest plot

1

606

12 Non‐falciparum species only, microscopy, Type 3 (All) Show forest plot

23

11234

13 Nonfalciparum species only, microscopy, Type 4, OptiMAL Show forest plot

6

1843

14 Non‐falciparum species only, microscopy, Type 4, OptiMAL‐IT Show forest plot

4

1987

15 Non‐falciparum species only, microscopy, Type 4, Carestart Show forest plot

1

195

16 Non‐falciparum species only, microscopy, Type 4 (All) Show forest plot

10

3831

17 Nonfalciparum species only, microscopy, Other Type, Malariagen Malaria Show forest plot

1

262

18 Non‐falciparum species only, PCR, Type 3, CareStart Pf/Pan Show forest plot

1

178

19 Non‐falciparum species only, PCR, Type 3, Parascreen Show forest plot

2

659

20 Non‐falciparum species only, PCR, Type 3, One Step Malaria Pf/Pan Show forest plot

1

606

21 Non‐falciparum species only, PCR, Type 3, SD Malaria Antigen Bioline Show forest plot

1

196

22 Non‐falciparum species only, PCR, Type 3 (All) Show forest plot

5

1639

23 Non‐falciparum species only, PCR, Type 4, OptiMAL (All) Show forest plot

1

313

24 P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Carestart Pf/Pv (All) Show forest plot

3

2000

25 P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Biotech Malaria Pf/Pv Show forest plot

1

250

26 P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Falcivax Show forest plot

2

710

27 P. vivax, microscopy, Pf HRp‐2 and Pv pLDH, Onsite Pf/Pv Show forest plot

2

710

28 P. vivax, microscopy, Pf HRP‐2 and Pv pLDH, Pf/Pv Malaria Device Show forest plot

1

350

29 P. vivax, microscopy, Pf HRP‐2 and Pv pLDH (All) Show forest plot

8

3682

30 P. vivax, PCR, Pf HRP‐2 and Pv pLDH, Falcivax Show forest plot

1

338

31 P. vivax, PCR, Pf HRP‐2 and Pv pLDH, OnSite Pf/Pv Show forest plot

1

338

32 P. vivax, PCR, Pf HRP‐2 and Pv pLDH, Pf/Pv Malaria Device Show forest plot

1

350

33 P. vivax, PCR, Pf HRP‐2 and Pv pLDH (All) Show forest plot

2

688

34 P. vivax, PCR, Type 6, PALUTOP (All) Show forest plot

1

313

Figures and Tables -
Table Tests. Data tables by test