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Meta-Analysis
. 2014 Jun 20;2014(6):CD009135.
doi: 10.1002/14651858.CD009135.pub2.

Rapid tests for the diagnosis of visceral leishmaniasis in patients with suspected disease

Affiliations
Meta-Analysis

Rapid tests for the diagnosis of visceral leishmaniasis in patients with suspected disease

Marleen Boelaert et al. Cochrane Database Syst Rev. .

Abstract

Background: The diagnosis of visceral leishmaniasis (VL) in patients with fever and a large spleen relies on showing Leishmania parasites in tissue samples and on serological tests. Parasitological techniques are invasive, require sophisticated laboratories, consume time, or lack accuracy. Recently, rapid diagnostic tests that are easy to perform have become available.

Objectives: To determine the diagnostic accuracy of rapid tests for diagnosing VL in patients with suspected disease presenting at health services in endemic areas.

Search methods: We searched MEDLINE, EMBASE, LILACS, CIDG SR, CENTRAL, SCI-expanded, Medion, Arif, CCT, and the WHO trials register on 3 December 2013, without applying language or date limits.

Selection criteria: This review includes original, phase III, diagnostic accuracy studies of rapid tests in patients clinically suspected to have VL. As reference standards, we accepted: (1) direct smear or culture of spleen aspirate; (2) composite reference standard based on one or more of the following: parasitology, serology, or response to treatment; and (3) latent class analysis.

Data collection and analysis: Two review authors independently extracted data and assessed quality of included studies using the QUADAS-2 tool. Discrepancies were resolved by a third author. We carried out a meta-analysis to estimate sensitivity and specificity of rapid tests, using a bivariate normal model with a complementary log-log link function. We analysed each index test separately. As possible sources of heterogeneity, we explored: geographical area, commercial brand of index test, type of reference standard, disease prevalence, study size, and risk of bias (QUADAS-2). We also undertook a sensitivity analysis to assess the influence of imperfect reference standards.

Main results: Twenty-four studies containing information about five index tests (rK39 immunochromatographic test (ICT), KAtex latex agglutination test in urine, FAST agglutination test, rK26 ICT, and rKE16 ICT) recruiting 4271 participants (2605 with VL) were included. We carried out a meta-analysis for the rK39 ICT (including 18 studies; 3622 participants) and the latex agglutination test (six studies; 1374 participants). The results showed considerable heterogeneity. For the rK39 ICT, the overall sensitivity was 91.9% (95% confidence interval (95% CI) 84.8 to 96.5) and the specificity 92.4% (95% CI 85.6 to 96.8). The sensitivity was lower in East Africa (85.3%; 95% CI 74.5 to 93.2) than in the Indian subcontinent (97.0%; 95% CI 90.0 to 99.5). For the latex agglutination test, overall sensitivity was 63.6% (95% CI 40.9 to 85.6) and specificity 92.9% (95% CI 76.7 to 99.2).

Authors' conclusions: The rK39 ICT shows high sensitivity and specificity for the diagnosis of visceral leishmaniasis in patients with febrile splenomegaly and no previous history of the disease, but the sensitivity is notably lower in east Africa than in the Indian subcontinent. Other rapid tests lack accuracy, validation, or both.

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Conflict of interest statement

Marleen Boelaert, Joris Menten, François Chappuis and Suman Rijal are authors of studies included in this review. There are no other known conflicts of interest.

Figures

1
1
Study flow diagram showing the process of selection of records and studies for the review and for the meta‐analyses
2
2
Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across included studies Footnote Figure 2 represents studies but our quality assessment was done per record. Some of the records include more than one study. Figure 2 shows all the estimates used in this review, including the estimates for primary and sensitivity analyses of the same study.
3
3
Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study Footnote Figure 3 represents studies but our quality assessment was done per record. Some of the records include more than one study. Figure 3 shows all the estimates used in this review, including the estimates for primary and sensitivity analyses of the same study.
4
4
rK39 ICT: forest plot of all the available estimates of sensitivity and specificity (n = 20 studies; 26 sets of estimates) Footnote For studies that use latent class analysis, the counts of true positive, false positive, false negative and true negative results are imputed from the Se and Sp estimates and the overall sample size. The estimates and confidence intervals are subsequently calculated from these imputed values.
5
5
rK39 ICT: summary of sensitivity‐specificity pairs according to the reference standard (n = 20 studies; 26 sets of estimates). The type of reference standard is classified as: (a) parasitology including spleen aspirate – no serology; (b) parasitology not including spleen aspirate – no serology; (c) parasitology and serology; or (d) latent class analysis. The data points that are connected with a line refer to the same data analysed with different reference standards.
6
6
rK39 ICT: basic summary using the bivariate normal model with a complementary log‐log link function. This analysis combines data from all studies without accounting for covariates. The average sensitivity is 91.9% (95% confidence interval: 84.8, to 96.5) and the average specificity is 92.4% (95% confidence interval: 85.6, to 96.8). The confidence region is indicated with a full line, the prediction region with a dotted line.
7
7
rK39 ICT; summary of the heterogeneity assessment through meta‐analysis: sensitivity and specificity estimates by covariates. Rectangles indicate significant differences.
8
8
rK39 ICT: summary of the meta‐regression model with effects for geographic region using the bivariate normal model with a complementary log‐log link function. The sensitivity was significantly lower in East Africa (85.3%; 95% confidence interval: 74.5 to 93.2) than in the Indian subcontinent (97.0%; 95% confidence interval: 90.0 to 99.5). There was no significant difference in specificity: the specificity (95% confidence interval) in East Africa was 91.1% (80.3 to 97.3) and in the Indian subcontinent 90.2% (76.1 to 97.7). The confidence region is indicated with a full line, the prediction region with a dotted line.
9
9
Opinion from seven experts on visceral leishmaniasis regarding the diagnostic accuracy and possible variation of two reference standards: parasitology including spleen aspirate without serology and any combination of parasitology with serology. These expert opinions were used as prior information in a Bayesian statistical model to estimate the diagnostic accuracy of the rK39 ICT.
10
10
rK39 ICT: basic model summary using the bivariate logistic normal model. This analysis combines data from all studies without accounting for covariates. The average sensitivity is 91.9% (95% confidence interval: 83.6, to 96.2) and the average specificity is 92.4% (95% confidence interval: 84.9, to 96.3). The confidence region is indicated with a full line, the prediction region with a dotted line. In this analysis, the prediction intervals are wide: 28.3 to 99.7% for the sensitivity and 31.1 to 99.7% for the specificity.
11
11
rK39 ICT; assessment of reporting bias: funnel plot for log diagnostic odds ratio
12
12
Latex agglutination test: forest plot of all the available estimates of sensitivity and specificity (n = 7 studies; 9 sets of estimates).
13
13
Latex agglutination test: basic summary using the bivariate normal model with a complementary log‐log link function. This analysis combines data from all studies without accounting for covariates. The average sensitivity (95% confidence interval) is 63.6% (40.9 to 85.6) and the average specificity is 92.9% (76.7 to 99.2). The confidence region is indicated with a full line, the prediction region with a dotted line. The 95% prediction intervals are very wide: 16.5% to 99.6% for the sensitivity and 41.3% to 100% for the specificity.
14
14
Latex agglutination test; summary of the heterogeneity assessment through meta‐analysis: sensitivity and specificity estimates by covariates.
1
1. Test
rK39 immunochromatographic test.
2
2. Test
KAtex.
3
3. Test
FAST.
4
4. Test
rK26 immunochromatographic test.
5
5. Test
rK39 Primary Analysis.
6
6. Test
rKE16 immunochromatographic test.

Update of

  • doi: 10.1002/14651858.CD009135

References

References to studies included in this review

Boelaert 2004 ‐ classic {published data only}
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Boelaert 2004 ‐ LCA {published data only}
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Boelaert 2008 ‐ Ethiopia {published data only}
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Boelaert 2008 ‐ India {published data only}
    1. Boelaert M, El‐Safi S, Hailu A, Mukhtar M, Rijal S, Sundar S, et al. Diagnostic tests for kala‐azar: a multi‐centre study of the freeze‐dried DAT, rK39 strip test and KAtex in East Africa and the Indian subcontinent. Transactions of the Royal Society of Tropical Medicine and Hygiene 2008;102(1):32‐40. - PubMed
Boelaert 2008 ‐ Kenya {published data only}
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Boelaert 2008 ‐ Nepal {published data only}
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Boelaert 2008 ‐ Sudan {published data only}
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Chappuis 2005 ‐ InBios {published data only}
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Cota 2013 ‐ composite 1 {published data only}
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Cota 2013 ‐ composite 2 {published data only}
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Diro 2007 {published data only}
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Hailu 2006 {published data only}
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Kilic 2008 {published data only}
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Machado de Assis 2011 {published data only}
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Machado de Assis 2012 {published data only}
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Mbui 2013 {published data only}
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Peruhype‐Magalhaes 2012 {published data only}
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Rijal 2004 {published data only}
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Ritmeijer 2006 {published data only}
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ter Horst 2009 ‐ HIV neg {published data only}
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Toz 2004 {published data only}
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Veeken 2003 ‐ composite {published data only}
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Veeken 2003 ‐ spleen {published data only}
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Vilaplana 2004 {published data only}
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References to studies excluded from this review

Abeijon 2013 {published data only}
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Ahsan 2010 {published data only}
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Akhoundi 2010 {published data only}
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Alam 2008 {published data only}
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Alborzi 2006 {published data only}
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Al‐Nahhas 2003 {published data only}
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Al‐Nahhas 2008 {published data only}
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Amato 2009 {published data only}
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Arya 1997 {published data only}
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Arya 2001 {published data only}
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Attar 2001 {published data only}
    1. Attar ZJ, Chance ML, el‐Safi S, Carney J, Azazy A, El‐Hadi M, et al. Latex agglutination test for the detection of urinary antigens in visceral leishmaniasis. Acta Tropica 2001;78(1):11‐6. - PubMed
Azazy 2004 {published data only}
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Bagchi 1998 {published data only}
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Bern 2000 {published data only}
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Brandonisio 2002 {published data only}
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Canavate 2011 {published data only}
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Carvalho 2003 {published data only}
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Cruz 2006 {published data only}
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de Assis 2008 {published data only}
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Delgado 2001 {published data only}
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Edrissian 2003 {published data only}
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El‐Safi 2003 {published data only}
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Ferreira Dourado 2007 {published data only}
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Gavgani 2008 {published data only}
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Goswami 2003 {published data only}
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Goswami 2007 {published data only}
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Goswami 2012 {published data only}
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Gupta 1994 {published data only}
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Hatam 2009 {published data only}
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Hommel 2001 {published data only}
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Iqbal 2002 {published data only}
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