Rapid diagnostic tests for diagnosing uncomplicated <i>P. falciparum</i> malaria in endemic countries

Katharine Abba; Jonathan J Deeks; Piero L Olliaro; Cho‐Min Naing; Sally M Jackson; Yemisi Takwoingi; Sarah Donegan; Paul Garner

doi:10.1002/14651858.CD008122.pub2

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Figure 1

Example map showing P. falciparum malaria endemicities and study locations

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Figure 2

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

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Figure 3

Study results of Type 1 RDTs plotted in ROC space (by RDT brand)

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Figure 4

Forest plot of study results of Type 2, 3 and 5 RDTs (by RDT brand)

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Figure 5

Study results of Type 4 RDTs plotted in ROC space (by RDT brand)

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Figure 6

Summary ROC Plot comparing different RDT types verified with microscopy (points are meta‐analytical estimates, regions are 95% confidence regions, no regions could be computed for Type 2 and 5 due to small numbers of studies)

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Figure 7

Summary ROC Plot comparing HRP‐2‐based and pLDH‐based RDTs across all studies verified with microscopy (points are meta‐analytical estimates, regions are 95% confidence regions)

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Figure 8

Summary estimates of Type 1 RDTs plotted in ROC space (by RDT brand)

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Figure 9

Summary estimates of Type 4 RDTs plotted in ROC space (by RDT brand)

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Figure 10

Study results of Type 2, 3 and 5 RDTs plotted in ROC space (by RDT brand)

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Figure 11

Summary estimates of Type 2 RDTs and study results plotted in ROC space (by RDT brand)

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Figure 12

Summary estimates of Type 3 RDTs and study results plotted in ROC space

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Figure 13

Summary estimates of Type 5 RDTs and study results plotted in ROC space

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Figure 14

Paired comparison of Type 1 and Type 4 RDTs. Connecting lines link the direct comparison of pairs of tests in each study.

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Figure 15

Paired comparison of HRP‐2‐based tests and pLDH‐based tests. Connecting lines link the direct comparison of pairs of tests in each study.

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Test 1

Paracheck‐Pf.

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Test 2

ParaSight‐F.

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Test 3

ICT Malaria Pf.

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Test 4

ParaHIT‐F.

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Test 5

PATH.

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Test 6

Determine Malaria Pf.

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Test 7

Rapid Test Malaria.

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Test 8

Diaspot Malaria.

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Test 9

New Pf‐1 mini.

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Test 10

Hexagon Malaria.

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Test 11

Type 1 (All).

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Test 12

CareStart Malaria Pf/Pan.

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Test 13

ICT Malaria Pf/Pv.

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Test 14

NOW malaria ICT.

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Test 15

Type 2 (All).

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Test 16

SD Malaria Antigen Bioline.

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Test 17

First Response Malaria.

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Test 18

OptiMAL/ OptiMAL 48.

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Test 19

Parascreen.

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Test 20

Type 3 (All).

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Test 21

OptiMAL‐IT.

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Test 22

Parabank.

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Test 23

Type 4 (All).

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Test 24

Carestart Pf/Pv.

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Test 25

ParaSight Pf/Pv.

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Test 26

Type 5 (All).

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Test 27

HRP‐2 based tests.

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Test 28

pLDH based tests.

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Test 29

Type 1 (paired comparison with Type 4).

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Test 30

Type 4 (paired comparison with Type 1).

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Test 31

PCR adjusted microscopy, Type 1, Paracheck‐PF (All).

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Test 32

PCR adjusted microscopy, Type 4, Parabank (All).

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Test 33

PCR, Type 1, ParaSight‐F.

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Test 34

PCR, Type 1, ParaHIT‐F.

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Test 35

PCR, Type 1 (All).

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Test 36

PCR, Type 3, SD Malaria Antigen (All).

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Test 37

HRP‐2 based tests paired data.

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Test 38

pLDH based tests paired data.

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Test 71

PCR, Type 6, PALUTOP (All).

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Test 72

PCR, Type 4, OptiMAL‐IT (All).

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Summary of findings New Summary of results table

What is the diagnostic accuracy of Rapid Diagnostic Tests for detecting malaria? What are the best types of tests?
Patients/populations	People presenting with symptoms suggestive of uncomplicated malaria
Prior testing	None
Settings	Ambulatory healthcare settings in P. falciparum malaria endemic areas in Asia, Africa and South America
Index tests	Immunochromatography‐based rapid diagnostic tests for P. falciparum malaria
Reference standard	Conventional microscopy or PCR
Importance	Accurate and fast diagnosis allows appropriate and quick treatment for malaria to be provided
Studies	Consecutive series of patients; 74 studies presented 111 test evaluations based on 60,396 patient test results
Quality concerns	Poor reporting of patient characteristics, sampling method and reference standard methods were common concerns
Test types	Quantity of evidence	Brands (studies)	Average pooled results	Consequences in a cohort of 1000
				P. falciparum prevalence	Missed cases	Overtreated non‐cases
HRP‐2 antibody‐based tests compared with microscopy
Type 1 HRP‐2 (P. falciparum specific)	71 evaluations 40,062 participants 11,966 malaria cases	Paracheck‐Pf (27), ParaSight (17), ICT Malaria Pf (16), ParaHIT‐F (4), PATH (2), Determine Malaria Pf (1), Rapid Test Malaria (1), Diaspot Malaria (1), New mini‐Pf (1), and Hexagon Malaria (1)	sens = 94.8% (93.1% to 96.1%)	30%	16	34
			spec = 95.2% (93.2% to 96.7%)	50%	26	24
Type 2 HRP‐2 (P. falciparum specific) and aldolase (pan‐specific)	8 evaluations 3397 participants 790 malaria cases	ICT Malaria Pf/Pv (6) and NOW ICT Malaria (2)	sens = 96.0% (94.0% to 97.3%)	30%	12	33
			spec = 95.3% (87.3% to 98.3%)	50%	20	24
Type 3 HRP‐2 (P. falciparum specific) and pLDH (pan‐specific)	5 evaluations 958 participants 330 malaria cases	SD Malaria Antigen Bioline (2), Parascreen (2), and First Response Malaria (1)	sens = 99.5% (71.0% to 100.0%)	30%	12	62
			spec = 90.6% (80.5% to 95.7%)	50%	20	44
pLDH antibody‐based tests compared with microscopy
Type 4 pLDH (P. falciparum specific) and pLDH (pan‐specific)	17 evaluations 13,010 participants 4274 malaria cases	OptiMAL (10), OptiMAL‐IT(3), Parabank (2) and Carestart Malaria Pf/Pan (2)	sens = 91.5% (84.7% to 95.3%)	30%	26	9
			spec = 98.7% (96.9% to 99.5%)	50%	43	7
Type 5 pLDH (P. falciparum specific) and pLDH (P. vivax‐specific)	3 evaluations 1777 participants 400 malaria cases	Carestart Pf/Pv (2), and ParaSight Pf/Pv (1)	sens = 98.4% (95.1% to 99.5%)	30%	5	18
			spec = 97.5% (93.5% to 99.1%)	50%	8	13
Comparisons
Comparison	Comparison type	Quantity of evidence and overall finding	Sensitivity		Specificity
Type 1 vs Type 4	All studies	65 Type 1 vs 16 Type 4 Overall significant difference in accuracy P = 0.009	Type 1 3.3% more sensitive than Type 4 (P = 0.20)		Type 4 3.5% more specific than Type 1 (P < 0.001)
	Within studies	7 comparative studies No overall significant difference in accuracy P = 0.26	Type 1 2.5% more sensitive than Type 4 (P = 0.51)		Type 4 2.9% more specific than Type 1 (P = 0.31)
HRP‐2 vs pLDH	All studies	75 HRP‐2 vs 19 pLDH Overall significant difference in accuracy P = 0.01	HRP‐2 1.8% more sensitive than pLDH (P = 0.34)		pLDH 3.3% more specific than HRP‐2 (P = 0.01)
	Within studies	9 comparative studies No overall significant difference in accuracy P = 0.35	HRP‐2 0.8% more sensitive than pLDH (P = 0.60)		pLDH 2.3% more specific than HRP‐2 (P = 0.22)

Summary of findings New Summary of results table

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Table 1. Types of malaria RDTs by antibody combination and parasite species detected

Type of Test	Antibody 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 and/or Pm; invalid
Type 3	HRP‐2 (P. falciparum specific) and pLDH (pan‐specific)	No malaria; Pf or mixed; Pv, Pf and/or Pm; invalid
Type 4	pLDH (P. falciparum specific) and pLDH (pan‐specific)	No malaria; Pf or mixed; Pv, Pf and/or Pm; invalid
Type 5	pLDH (P. falciparum specific) and pLDH (P. vivax‐specific)	No malaria; Pf; Pv; Pf and Pv; invalid
Type 6	HRP‐2 (P. falciparum specific), pLDH (pan‐specific) and pLDH (P. vivax specific)	No malaria; Pf and Pv =/‐ Po and/or Pm; Pf +/‐ Po and/or Pm; Pv +/‐ Po and/or Pm; Po and/or Pm; invalid
Type 7	Aldolase (pan‐specific)	No malaria; Pf, Pv, Po and/or Pm; invalid
Pf P. falciparum; Pv P. vivax; Pm P. malariae; Po P .ovale

Table 1. Types of malaria RDTs by antibody combination and parasite species detected

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Table 2. Malaria 'zones' by endemic parasite species and RDT type 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	Non‐falciparum 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)

Table 2. Malaria 'zones' by endemic parasite species and RDT type appropriate for each

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Table 3. Number of studies verifying each RDT type with reference standard

Type of RDT	Number of study cohorts (test evaluations if different) by reference standard
Type of RDT	Microscopy	PCR	PCR‐adjusted microscopy
Type 1	65 (71)	2	1
Type 4	16 (17)	1	0
Type 2	8	0	0
Type 3	5	1	1
Type 5	3	0	0
Type 6	0	1	0

Table 3. Number of studies verifying each RDT type with reference standard

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Table 4. Methodological quality by RDT type

Test type	Test evaluations	Representative spectrum	Adequate reference standard	Blinded reference standard	Blinded index test
Type 1	71	38 (54%)	18 (25%)	44 (62%)	50 (70%)
Type 2	8	2 (25%)	4 (50%)	6 (75%)	7 (88%)
Type 3	5	4 (80%)	2 (40%)	4 (80%)	4 (80%)
Type 4	17	9 (53%)	5 (29%)	10 (59%)	12 (71%)
Type 5	3	1 (33%)	3 (100%)	2 (67%)	3 (100%)

Test for difference between types		P = 0.54	P = 0.05	P = 0.93	P = 0.84

Table 4. Methodological quality by RDT type

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Table 5. RDT types and brands verified with microscopy

RDT Brand	Study cohorts (n)	Patients (n)	P. falciparum cases (n)	Pooled sensitivity (95% CI)	Pooled specificity (95% CI)	Test¹
Type 1 Brands
Paracheck‐Pf	27	22,319	6929	93.2 (89.7, 95.6)	95.6 (92.8, 97.3)	P = 0.15
ParaSight‐F	17	12,521	3261	94.1 (89.9, 96.6)	94.6 (90.4, 96.8)
ICT Malaria‐Pf	16	2955	1200	97.6 (95.5, 98.8)	94.5 (90.5, 96.9)
ParaHIT‐F	4	1119	192	92.3 (74.9, 98.0)	98.9 (94.9, 99.8)
Determine Malaria‐Pf	1	526	262	98.2 (85.4, 99.8)	86.8 (35.1, 98.8)
PATH	2	378	180	96.6 (83.8, 99.3)	93.3 (68.6, 98.9)
Rapid Test Malaria	1	306	36	97.8 (70.1, 100.0)	96.1 (65.6, 99.7)
DiaSpot Malaria	1	153	63	71.8 (23.1, 95.6)	82.6 (27.3, 98.4)
Hexagon Malaria	1	119	32	100.0 (.)	65.7 (13.4, 96.0)
New Pf‐1 mini	1	10	6	100.0 (0, 100.0)	100.0 (.)
Combined²	65	40,062	11,966	94.8 (93.1, 96.1)	95.2 (93.2, 96.7)
Type 2 Brands
ICT Malaria Pf/Pv	6	2255	600	96.0 (93.6, 97.5)	95.6 (86.1, 98.7)	P = 1.0
Now Malaria ICT	2	1142	190	96.0 (91.6, 98.1)	94.1 (66.6, 99.2)	P = 1.0
Combined	8	3397	790	96.0 (94.0, 97.3)	95.3 (87.3, 98.3)
Type 3 (too few studies to stratify by brand)
Combined	5	958	330	99.5 (71.0, 100.0)	90.6 (80.5, 95.7)
Type 4 Brands
OptiMAL	10	3393	833	90.1 (86.3, 92.9)	99.3 (98.0, 99.8)	P = 0.009
Carestart Pf/Pan	2	537	240	97.8 (94.1, 99.2)	92.2 (72.4, 98.1)
OptiMAL‐IT	3	1356	280	87.4 (79.9, 92.4)	97.0 (88.4, 99.3)
Parabank	2	7918	2992	87.9 (82.0, 92.0)	98.8 (90.9, 99.9)
Combined³	16	13,010	4274	91.5 (84.7, 95.3)	98.7 (96.9, 99.5)
Type 5 Brands (too few studies to stratify by brand)
Combined⁴	3	1777	400	98.4 (95.1, 99.5)	97.5 (93.5, 99.1)
1 Likelihood ratio test for evidence of a difference between brands. 2 65 study cohorts evaluated 71 different tests. Only one test (selected randomly) from each cohort is included in the combined analysis. 3 16 study cohorts evaluated 17 different tests. Only one test (selected randomly) from each cohort is included in the overall analysis. 4 HSROC model fitted assuming no correlation between sensitivity and specificity.

Table 5. RDT types and brands verified with microscopy

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Table 6. Comparison of antibody and RDT types verified with microscopy

	Number of studies	Number of patients	*Number of P. falciparum* cases**	Pooled sensitivity (95% CI)	Pooled specificity (95% CI)	Test ¹
*Antibody‐based test: indirect comparison (using all studies)*
HRP‐2 based	75	43,307	12,857	95.0 (93.5, 96.2)	95.2 (93.4, 96.6)
pLDH based	19	14,787	4674	93.2 (88.0, 96.2)	98.5 (96.7, 99.4)
Ratio				0.98 (0.94, 1.02), P = 0.34	1.03 (1.02, 1.05), P < 0.001	P = 0.01
*Antibody‐based test: direct comparison (using only studies that directly compared the two)*
HRP‐2 based	9	10,626	3672	95.6 (90.0, 98.1)	95.8 (84.7, 98.9)
pLDH based	9	10,623	3672	94.8 (84.1, 98.2)	98.1 (87.8, 99.7)
Ratio				0.99 (0.94, 1.04) P = 0.60	1.02 (0.98, 1.07), P = 0.22	P = 0.35
*Test type: indirect comparison (using all studies of Type 1 and 4)*
Type 1	65	40,062	11,966	94.8 (93.0, 96.1)	95.2 (93.2, 96.7)
Type 4	16	1,3010	4274	91.5 (84.7, 95.3)	98.7 (96.9, 99.5)
Ratio				0.96 (0.91, 1.02), P = 0.20	1.04 (1.02, 1.06), P < 0.001	P = 0.009
*Test type: direct comparison (using only comparative studies of Type 1 and 4)*
Type 1	7	9764	3433	94.5 (88.6, 97.4)	95.7 (72.2, 99.5)
Type 4	7	9761	3433	92.0 (85.7, 94.8)	98.6 (80.0, 99.9)
Ratio				0.97 (0.87, 1.09), P = 0.51	1.03 (0.95, 1.11), P = 0.31	P = 0.26
¹Likelihood ratio test for evidence of a difference between test accuracy estimates between antigen and RDT types.

Table 6. Comparison of antibody and RDT types verified with microscopy

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Table 7. Investigations of heterogeneity between studies of Type 1 RDTs

	Number of studies	Number of patients	*Number of P. falciparum* cases**	Pooled sensitivity (95% CI)	Pooled specificity (95% CI)	Test ¹
*Age*
Mixed ages	29	23,967	7536	93.8 (90.6, 96.0)	94.2 (90.7, 96.5)	P = 0.41
Children only	9	2261	907	94.1 (87.2, 97.4)	93.4 (84.6, 97.3)
Not stated	27	13,834	3523	95.9 (93.4, 97.5)	96.2 (93.7, 97.8)
*Endemicity*
Low	51	29,305	7671	95.1 (93.1, 96.6)	95.9 (94.1, 97.2)	P = 0.22
High	10	1824	806	93.7 (87.0, 97.1)	89.6 (78.3, 95.3)
Mixed	4	8933	3489	93.2 (81.1, 97.8)	92.5 (76.5, 97.9)
*Adequate reference standard*
No	15	5499	1869	93.7 (88.6, 96.6)	95.5 (91.1, 97.7)	P = 0.34
Unclear	32	13,481	3439	95.4 (92.8, 97.1)	96.2 (93.9, 97.7)
Yes	18	21,082	6658	94.6 (90.9, 96.9)	92.1 (86.0, 95.7)
*Continent*
Africa	39	21,958	7445	94.0 (91.3, 95.9)	93.0 (89.8, 95.3)	P = 0.01
Asia	24	1,5810	4060	96.7 (93.7, 97.8)	96.7 (94.4, 98.1)
South America	2	2294	461	88.7 (61.9, 97.4)	99.4 (96.4, 100.0)
*Continent (South America excluded)*
Africa	39	21,958	7445	94.0 (91.2, 96.0)	93.1 (89.7, 95.3)	P = 0.03
Asia	24	15,810	4060	96.4 (93.7, 97.9)	96.6 (94.0, 98.1)	P = 0.03
¹Likelihood ratio test for model with and without the covariate.

Table 7. Investigations of heterogeneity between studies of Type 1 RDTs

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Table Tests. Data tables by test

Test	No. of studies	No. of participants
1 Paracheck‐Pf Show forest plot	27	22319

2 ParaSight‐F Show forest plot	17	12521

3 ICT Malaria Pf Show forest plot	16	2955

4 ParaHIT‐F Show forest plot	4	1119

5 PATH Show forest plot	2	378

6 Determine Malaria Pf Show forest plot	1	526

7 Rapid Test Malaria Show forest plot	1	306

8 Diaspot Malaria Show forest plot	1	153

9 New Pf‐1 mini Show forest plot	1	10

10 Hexagon Malaria Show forest plot	1	119

11 Type 1 (All) Show forest plot	65	40062

12 CareStart Malaria Pf/Pan Show forest plot	2	537

13 ICT Malaria Pf/Pv Show forest plot	6	2255

14 NOW malaria ICT Show forest plot	2	1142

15 Type 2 (All) Show forest plot	8	3397

16 SD Malaria Antigen Bioline Show forest plot	2	224

17 First Response Malaria Show forest plot	1	291

18 OptiMAL/ OptiMAL 48 Show forest plot	10	3393

19 Parascreen Show forest plot	2	443

20 Type 3 (All) Show forest plot	5	958

21 OptiMAL‐IT Show forest plot	3	1356

22 Parabank Show forest plot	2	7918

23 Type 4 (All) Show forest plot	16	13010

24 Carestart Pf/Pv Show forest plot	2	908

25 ParaSight Pf/Pv Show forest plot	1	869

26 Type 5 (All) Show forest plot	3	1777

27 HRP‐2 based tests Show forest plot	75	43307

28 pLDH based tests Show forest plot	19	14787

29 Type 1 (paired comparison with Type 4) Show forest plot	7	9764

30 Type 4 (paired comparison with Type 1) Show forest plot	7	9761

31 PCR adjusted microscopy, Type 1, Paracheck‐PF (All) Show forest plot	1	7000

32 PCR adjusted microscopy, Type 4, Parabank (All) Show forest plot	1	7000

33 PCR, Type 1, ParaSight‐F Show forest plot	1	520

34 PCR, Type 1, ParaHIT‐F Show forest plot	1	336

35 PCR, Type 1 (All) Show forest plot	2	856

36 PCR, Type 3, SD Malaria Antigen (All) Show forest plot	1	198

37 HRP‐2 based tests paired data Show forest plot	9	10626

38 pLDH based tests paired data Show forest plot	9	10623

71 PCR, Type 6, PALUTOP (All) Show forest plot	1	313

72 PCR, Type 4, OptiMAL‐IT (All) Show forest plot	1	313

Table Tests. Data tables by test

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