Field Evaluation of a Rapid Immunochromatographic Assay for Detection of
            <i>Trypanosoma cruzi</i>
            Infection by Use of Whole Blood

Roddy, Paul; Goiri, Javier; Flévaud, Laurence; Palma, Pedro Pablo; Morote, Silvia Carbonell; Lima, Nines; Villa, Luís; Torrico, Faustino; Albajar-Viñas, Pedro

doi:10.1128/jcm.02303-07

Cited by 46 publications

(56 citation statements)

References 17 publications

(20 reference statements)

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“…Agreement between the results of standard serological tests and the tested dipstick was good. This complements the results from other studies testing the same dipstick (5,14,30) or dipsticks from other manufacturers (i.e., Chagas Stat-Pak, Chembio Diagnostics Inc.; SD Bioline Chagas Ab rapid test (Standard Diagnostics); and OnSite Chagas Ab rapid test cassette, CTK Biotech) (4,8,14,20,25,28).…”

supporting

confidence: 70%

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Rapid Detection of Trypanosoma cruzi in Human Serum by Use of an Immunochromatographic Dipstick Test

et al. 2010

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We evaluated a commercially available immunochromatographic dipstick test to detect Trypanosoma cruzi infection in 366 human serum samples with known serological results from Argentina, Ecuador, Mexico, and Venezuela. One hundred forty-nine of 366 (40.7%) and 171/366 (46.7%) samples tested positive by dipstick and serology, respectively. Dipstick sensitivity was calculated to be 84.8% (range between countries, 77.5 to 95%), and specificity was 97.9% (95.9 to 100%).

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supporting

confidence: 70%

“…Immunochromatographic dipstick tests have been developed for a range of tropical diseases, including malaria (31), leishmaniasis (7), and schistosomiasis (3); until recently (4,5,8,14,17,20,25,28,30), none was available for Chagas disease.…”

mentioning

confidence: 99%

Rapid Detection of Trypanosoma cruzi in Human Serum by Use of an Immunochromatographic Dipstick Test

et al. 2010

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“…Recombinant antigens have been employed in rapid tests with promising results (Roddy et al 2008, Verani et al 2009). …”

Section: What Still Needs To Be Done Regarding Diagnosis?mentioning

confidence: 99%

Diagnosis of Chagas disease: what has been achieved? What remains to be done with regard to diagnosis and follow up studies?

Gomes

Lorena

Luquetti

2009

Mem. Inst. Oswaldo Cruz

118

107

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“…The Chagas Stat-Pak assay (on serum) was initially evaluated in multicentric studies conducted in South and Central America, yielding sensitivity and specificity estimates of 98.5 to 100% and 94.8 to 99.9%, respectively (12,17). Two field evaluations of the Chagas Stat-Pak assay (on finger-pricked blood) in Bolivia showed sensitivity and specificity estimates of 93.4 to 94.7 and 97.3 to 99%, respectively (3,18). The lower sensitivity estimates observed in the two latter studies could be caused by the use of blood instead of serum.…”

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confidence: 99%

Validation of a Rapid Immunochromatographic Assay for Diagnosis of Trypanosoma cruzi Infection among Latin-American Migrants in Geneva, Switzerland

et al. 2010

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Chagas' disease is a global public health problem due to the recent exchange of population between Latin America and other regions, including Europe. The recent development of rapid diagnostic tests (RDTs) for Trypanosoma cruzi infection may improve patient access to diagnosis and care worldwide. We evaluated the diagnostic accuracy of the Chagas Stat-Pak RDT in a cohort of undocumented Latin-American migrants living in Geneva, Switzerland. Study participants were enrolled in a primary health care center. The Chagas Stat-Pak test was performed independently on blood and serum samples. A combination of two commercialized enzymelinked immunosorbent assay (ELISA)-based serological tests was used for comparison (reference standard). A total of 999 adults (median age, 36 years) were included in the study; the majority were women (83%) and originally from Bolivia (47%) or Brazil (25%). A total of 125 participants (12.5%) were diagnosed with T. cruzi infection; with the exception of three individuals, all individuals diagnosed with T. cruzi were originally from Bolivia. The sensitivity and specificity of the Chagas Stat-Pak test on blood samples were 95.2% (95% confidence interval [95% CI], 89.2% to 97.9%) and 99.9% (95% CI, 99.3% to 100%), respectively. When the test was performed on serum samples, the sensitivity was 96% (95% CI, 91% to 98.3%), and the specificity was 99.8% (95% CI, 99.2% to 99.9%). The concordance of test results for blood and serum samples was 99.7%. Both negative and positive predictive values were above 98%. The Chagas Stat-Pak is an accurate diagnostic test for T. cruzi infection among Latin-American migrants living in Europe. The mild deficit in sensitivity should be interpreted in light of its ease of use and capacity to provide immediate results, which allow more people at risk to have access to diagnosis and care both in countries where Chagas' disease is endemic and in countries where this disease is not endemic.

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Field Evaluation of a Rapid Immunochromatographic Assay for Detection of Trypanosoma cruzi Infection by Use of Whole Blood

Cited by 46 publications

References 17 publications

Rapid Detection of Trypanosoma cruzi in Human Serum by Use of an Immunochromatographic Dipstick Test

Rapid Detection of Trypanosoma cruzi in Human Serum by Use of an Immunochromatographic Dipstick Test

Diagnosis of Chagas disease: what has been achieved? What remains to be done with regard to diagnosis and follow up studies?

Validation of a Rapid Immunochromatographic Assay for Diagnosis of Trypanosoma cruzi Infection among Latin-American Migrants in Geneva, Switzerland

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