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MEDLINE

EMBASE

1

Exp Malaria[MeSH]

Exp Malaria [Emtree]

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Exp Plasmodium [MeSH]

Exp Plasmodium [Emtree]

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Malaria ti, ab

Malaria ti, ab

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1 or 2 or 3

1 or 2 or 3

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Exp Reagent kits, diagnostics [MeSH]

Exp Diagnostic procedures [Emtree]

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rapid diagnos* test* ti, ab

rapid diagnos$ test$ ti, ab

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RDT ti, ab

RDT ti, ab

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Dipstick* ti, ab

Dipstick$ ti, ab

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Rapid diagnos* device* ti, ab

Rapid diagnos$ device$ ti, ab

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MRDD ti, ab

MRDD ti, ab

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OptiMal ti, ab

OptiMal ti, ab

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Binax NOW ti, ab

Binax NOW ti, ab

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ParaSight ti, ab

ParaSight ti, ab

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Immunochromatograph* ti, ab

Immunochromatography [Emtree]

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Antigen detection method*

Antigen detection method$

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Rapid malaria antigen test*

Rapid malaria antigen test$

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Combo card test* ti, ab

Combo card test$ ti, ab

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Immunoassay [MeSH]

Immunoassay [Emtree]

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Chromatography [MeSH]

Chromatography [Emtree]

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Enzyme‐linked immunosorbent assay [MeSH]

Enzyme‐linked immunosorbent assay [Emtree]

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Rapid test* ti, ab

Rapid test$ ti, ab

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Card test* ti, ab

Card test$ ti, ab

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Rapid AND (detection* or diagnos*) ti, ab

Rapid AND (detection$ or diagnos$) ti, ab

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5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23

5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23

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4 and 19

4 and 19

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Limit 20 to Humans

Limit 20 to Human

Study ID

First author, year of publication.

Clinical features and settings

Presenting signs and symptoms, previous treatments for malaria, clinical setting.

Participants

Sample size, age, sex, comorbidities or pregnancy, country and locality, P. falciparum malaria endemicity, endemic malaria species, average parasite density in microscopy positive cases.

Study design

Were consecutive patients enrolled retrospectively or prospectively?

Whether the sampling method was consecutive or random, or whether the method was not described but consecutive sampling was most probable.

If the study evaluated more than one RDT, how were tests allocated to individuals, or did each individual receive all the tests?

Target condition

Malaria parasitaemia.

Reference standard

The reference standard test(s) used.

If microscopy was used, who performed it, and where?

If microscopy was used, how many high power fields were looked at?

If microscopy was used, how many observers or repeats were used?

If microscopy was used, how were discrepancies between observers resolved?

Index tests

The parasite species the test was designed to detect, the commercial name, and the type of test. Batch numbers if provided. Transport and storage conditions. Details of the test operators, including any special training provided.

Notes

Source of funding.

Quality indicator

Notes

Was the spectrum of patients representative of the spectrum of patients who will receive the test in practice?

• 'Yes' if the inclusion criteria clearly stipulated people attending an ambulatory healthcare setting with symptoms of malaria, and the sampling method was consecutive or random.

• 'No' if the sample was unrepresentative of people with uncomplicated malaria in general (for example, if the majority of participants also had some other presenting health problem, such as pneumonia). Where a proportion of potential participants were excluded due to recent antimalarial use, well defined comorbidities or pregnancy, the sample could be classed as representative because these groups may also be excluded from testing as normal clinical practice, depending on local policy and practice.

• 'Unclear' if the source or characteristics of participants was not adequately described; or if the sampling method was not described.

Is the reference standard likely to correctly identify the target condition?

• 'Yes' if microscopy was undertaken by experienced microscopists with adequate laboratory facilities. Laboratory facilities were assumed to be adequate unless the study report indicated otherwise. Slides were viewed by at least two independent observers, either for all slides or for those where there are discordant results between the index and the reference test. At least 100 microscopic fields were viewed before declaring a slide negative.

• 'Yes' if reference standard was PCR.

• 'No' if microscopy was undertaken by insufficiently trained individuals, by one individual only, or in a situation with inadequate equipment, or if they viewed less than 100 microscopic fields before declaring negative.

• 'Unclear' if insufficient information was provided.

Is partial verification avoided?

• 'Yes' if all participants who received the index test also received the reference test.

• 'No' if not all the participants who received the index test also received the reference test.

• 'Unclear' if insufficient information was provided to assess this.

If not all participants received the reference test, we reported how many did not.

Is differential verification avoided?

• 'Yes' if the same reference test was used regardless of the index test results.

• 'No' if different reference tests were used depending on the results of the index test.

• 'Unclear' if insufficient information was provided.

If any participants received a different reference test, we reported the reasons stated for this, and how many participants were involved.

Is incorporation avoided? (the index test does not form part of the reference standard)

This should be 'Yes' for all studies, as the reference standard is defined in the inclusion criteria as microscopy or PCR.

Are the reference standard test results blinded?

• 'Yes' if the person undertaking the reference test did not know the results of the index tests, if the two tests were carried out in different places, or it was clear that the reference test was undertaken and the results recorded before the index test.

• 'No' if the same person performed both tests, or the results of the index tests were known to the person undertaking the reference tests.

• 'Unclear' if insufficient information was provided.

Are the index test results blinded?

• 'Yes' if the person undertaking the index test did not know the results of the reference tests, or if the two tests were carried out in different places, or it was clear that the index test was undertaken and the results recorded before the reference test.

• 'No' if the same person performed both tests, or the results of the index tests were known to the person undertaking the reference tests.

• 'Unclear' if insufficient information was provided.

Were uninterpretable results reported?

• 'Yes' if the paper stated whether there were any uninterpretable or invalid results, and how those were handled; for example whether they were repeated until a valid result was obtained, or excluded from the analysis.

• 'No' if the number of participants presented in the analysis did not match the number of participants originally enrolled in the study, and insufficient explanation was provided for any discrepancy.

• 'Unclear' if uninterpretable or invalid test results were not mentioned, but the number of participants presented in the analysis corresponded to the number of participants reported to be originally recruited into the study, or if insufficient information was given to permit this judgement; for example if the original number of participants recruited into the study was unclear.

We reported how many results were uninterpretable (of the total) and how these were handled in the analysis.

Were any withdrawals explained?

• 'Yes' if it was clear that no participants were excluded from the analysis (the number participants originally enrolled was clearly stated, and corresponded to the number presented in the analysis) or if exclusions were adequately described.

• 'No' if there were participants missing or excluded from the analysis and there was no explanation given; usually where the number of participants reported to have been enrolled and the number presented in the analysis did not correspond.

• 'Unclear' if not enough information was given to assess whether any participants were excluded from the analysis; for example if the original number of participants recruited into the study was unclear.

We reported how many participants were excluded from the analysis.

Study

Sensitivity (true positives/malaria cases) (%)

Difference (95% CI) (%)

P value

Specificity (true negatives/non‐cases) (%)

Difference (95% CI) (%)

P value

Type 2 versus Type 3

Type 2

Type 3

Type 2

Type 3

Ashton 2010

85 (209/246)

85 (209/246)

0 (‐6.3 to 6.3)

P = 1.00

96 (2052/2137)

96 (2060/2137)

0 (‐1.5 to 0.8 )

P = 0.58

Eibach 2013

80 (4/5)

60 (3/5)

20.0 (‐35.4 to 75.4)

P = 1.00

99 (716/722)

99 (718/722)

0 (‐1.1 to 0.6)

P = 0.75

Singh 2010

68 (39/57)

77 (44/57)

‐8.8 (‐25.0 to 7.5)

P = 0.40

98 (308/315)

98 (309/315)

0 (‐2.5 to 1.9)

P = 1.00

Type 2 versus Type 4

Type 2

Type 4

Type 2

Type 4

van den Broek 2006

75 (217/291)

88 (256/292)

‐13.1 (‐19.4 to ‐6.8)

P < 0.001

100 (604/605)

99 (598/604)

0.8 (0 to 1.7)

P = 0.07

Type 3 versus Type 4

Type 3

Type 4

Type 3

Type 4

Dev 2004

71 (5/7)

90 26/29

‐18.2 (‐53.5 to 17.0)

P = 0.24

100 (23/23)

100 (111/111)

0 (Not estimable)

Not estimable

Ratsimbasoa 2007

73 (11/15)

80 (12/15)

‐6.7 (‐36.8 to 23.5)

P = 1.0

98 (175/179)

97 (175/180)

0.50 (‐2.7 to 3.8)

P = 1.0

Test type, RDT brand

Microscopy

PCR

Type 3, CareStart Pf/Pan

4

3544

74 (45 to 91)

99 (96 to 100)

1

179

91 (81 to 97)

100 (97 to 100)

Type 3, Parascreen

14

5407

79 (67 to 88)

98 (98 to 99)

2

659

84 (70 to 92)

99 (97 to 100)

Type 3, One Step Malaria Pf/Pan

1

606

70 (58 to 81)

99 (98 to 100)

1

606

72 (60 to 82)

97 (95 to 98)

Type 3, SD Malaria Antigen Bioline

4

3769

80 (73 to 85)

99 (98 to 100)

1

196

64 (41 to 83)

99 (97 to 100)

Type 4, OptiMAL

6

1843

90 (85 to 93)

98 (97 to 99)

1

313

88 (64 to 99)

98 (96 to 99)