The Trypanosoma cruzi satellite DNA OligoC-TesT and Trypanosoma cruzi kinetoplast DNA OligoC-TesT for diagnosis of Chagas disease: a multi-cohort comparative evaluation study

Koen De Winne; Philippe Büscher; Alejandro O Luquetti; Suelene B N Tavares; Rodrigo A Oliveira; Aldo Solari; Ines Zulantay; Werner Apt; Patricio Diosque; Mercedes Monje Rumi; Nuria Gironès; Manuel Fresno; Rogelio Lopez-Velez; José A Perez-Molina; Begoña Monge-Maillo; Lineth Garcia; Stijn Deborggraeve

doi:10.1371/journal.pntd.0002633

The Trypanosoma cruzi satellite DNA OligoC-TesT and Trypanosoma cruzi kinetoplast DNA OligoC-TesT for diagnosis of Chagas disease: a multi-cohort comparative evaluation study

Koen De Winne, Philippe Büscher, Alejandro O Luquetti, Suelene B N Tavares, Rodrigo A Oliveira, Aldo Solari, Ines Zulantay, Werner Apt, Patricio Diosque, Mercedes Monje Rumi, Nuria Gironès, Manuel Fresno, Rogelio Lopez-Velez, José A Perez-Molina, Begoña Monge-Maillo, Lineth Garcia, Stijn Deborggraeve

Research output: Contribution to journal › A1: Web of Science-article › peer-review

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Abstract

BACKGROUND: The Trypanosoma cruzi satellite DNA (satDNA) OligoC-TesT is a standardised PCR format for diagnosis of Chagas disease. The sensitivity of the test is lower for discrete typing unit (DTU) TcI than for TcII-VI and the test has not been evaluated in chronic Chagas disease patients.

METHODOLOGY/PRINCIPAL FINDINGS: We developed a new prototype of the OligoC-TesT based on kinetoplast DNA (kDNA) detection. We evaluated the satDNA and kDNA OligoC-TesTs in a multi-cohort study with 187 chronic Chagas patients and 88 healthy endemic controls recruited in Argentina, Chile and Spain and 26 diseased non-endemic controls from D.R. Congo and Sudan. All specimens were tested in duplicate. The overall specificity in the controls was 99.1% (95% CI 95.2%-99.8%) for the satDNA OligoC-TesT and 97.4% (95% CI 92.6%-99.1%) for the kDNA OligoC-TesT. The overall sensitivity in the patients was 67.9% (95% CI 60.9%-74.2%) for the satDNA OligoC-TesT and 79.1% (95% CI 72.8%-84.4%) for the kDNA OligoC-Test.

CONCLUSIONS/SIGNIFICANCE: Specificities of the two T. cruzi OligoC-TesT prototypes are high on non-endemic and endemic controls. Sensitivities are moderate but significantly (p = 0.0004) higher for the kDNA OligoC-TesT compared to the satDNA OligoC-TesT.

Original language	English
Journal	PLoS Neglected Tropical Diseases
Volume	8
Issue number	1
Pages (from-to)	e2633
ISSN	1935-2727
DOIs	https://doi.org/10.1371/journal.pntd.0002633
Publication status	Published - 2014

Keywords

Adolescent
Adult
Africa
Aged
Chagas Disease
Cohort Studies
DNA, Kinetoplast
DNA, Satellite
Female
Humans
Male
Middle Aged
Molecular Diagnostic Techniques
Parasitology
Prospective Studies
Sensitivity and Specificity
South America
Trypanosoma cruzi
Young Adult

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De Winne, K., Büscher, P., Luquetti, A. O., Tavares, S. B. N., Oliveira, R. A., Solari, A., Zulantay, I., Apt, W., Diosque, P., Monje Rumi, M., Gironès, N., Fresno, M., Lopez-Velez, R., Perez-Molina, J. A., Monge-Maillo, B., Garcia, L., & Deborggraeve, S. (2014). The Trypanosoma cruzi satellite DNA OligoC-TesT and Trypanosoma cruzi kinetoplast DNA OligoC-TesT for diagnosis of Chagas disease: a multi-cohort comparative evaluation study. PLoS Neglected Tropical Diseases, 8(1), e2633. https://doi.org/10.1371/journal.pntd.0002633

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title = "The Trypanosoma cruzi satellite DNA OligoC-TesT and Trypanosoma cruzi kinetoplast DNA OligoC-TesT for diagnosis of Chagas disease: a multi-cohort comparative evaluation study",

abstract = "BACKGROUND: The Trypanosoma cruzi satellite DNA (satDNA) OligoC-TesT is a standardised PCR format for diagnosis of Chagas disease. The sensitivity of the test is lower for discrete typing unit (DTU) TcI than for TcII-VI and the test has not been evaluated in chronic Chagas disease patients.METHODOLOGY/PRINCIPAL FINDINGS: We developed a new prototype of the OligoC-TesT based on kinetoplast DNA (kDNA) detection. We evaluated the satDNA and kDNA OligoC-TesTs in a multi-cohort study with 187 chronic Chagas patients and 88 healthy endemic controls recruited in Argentina, Chile and Spain and 26 diseased non-endemic controls from D.R. Congo and Sudan. All specimens were tested in duplicate. The overall specificity in the controls was 99.1% (95% CI 95.2%-99.8%) for the satDNA OligoC-TesT and 97.4% (95% CI 92.6%-99.1%) for the kDNA OligoC-TesT. The overall sensitivity in the patients was 67.9% (95% CI 60.9%-74.2%) for the satDNA OligoC-TesT and 79.1% (95% CI 72.8%-84.4%) for the kDNA OligoC-Test.CONCLUSIONS/SIGNIFICANCE: Specificities of the two T. cruzi OligoC-TesT prototypes are high on non-endemic and endemic controls. Sensitivities are moderate but significantly (p = 0.0004) higher for the kDNA OligoC-TesT compared to the satDNA OligoC-TesT.",

keywords = "Adolescent, Adult, Africa, Aged, Chagas Disease, Cohort Studies, DNA, Kinetoplast, DNA, Satellite, Female, Humans, Male, Middle Aged, Molecular Diagnostic Techniques, Parasitology, Prospective Studies, Sensitivity and Specificity, South America, Trypanosoma cruzi, Young Adult",

author = "{De Winne}, Koen and Philippe B{\"u}scher and Luquetti, {Alejandro O} and Tavares, {Suelene B N} and Oliveira, {Rodrigo A} and Aldo Solari and Ines Zulantay and Werner Apt and Patricio Diosque and {Monje Rumi}, Mercedes and Nuria Giron{\`e}s and Manuel Fresno and Rogelio Lopez-Velez and Perez-Molina, {Jos{\'e} A} and Bego{\~n}a Monge-Maillo and Lineth Garcia and Stijn Deborggraeve",

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year = "2014",

doi = "10.1371/journal.pntd.0002633",

language = "English",

volume = "8",

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journal = "PLoS Neglected Tropical Diseases",

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De Winne, K, Büscher, P, Luquetti, AO, Tavares, SBN, Oliveira, RA, Solari, A, Zulantay, I, Apt, W, Diosque, P, Monje Rumi, M, Gironès, N, Fresno, M, Lopez-Velez, R, Perez-Molina, JA, Monge-Maillo, B, Garcia, L & Deborggraeve, S 2014, 'The Trypanosoma cruzi satellite DNA OligoC-TesT and Trypanosoma cruzi kinetoplast DNA OligoC-TesT for diagnosis of Chagas disease: a multi-cohort comparative evaluation study', PLoS Neglected Tropical Diseases, vol. 8, no. 1, pp. e2633. https://doi.org/10.1371/journal.pntd.0002633

The Trypanosoma cruzi satellite DNA OligoC-TesT and Trypanosoma cruzi kinetoplast DNA OligoC-TesT for diagnosis of Chagas disease: a multi-cohort comparative evaluation study. / De Winne, Koen; Büscher, Philippe; Luquetti, Alejandro O et al.
In: PLoS Neglected Tropical Diseases, Vol. 8, No. 1, 2014, p. e2633.

Research output: Contribution to journal › A1: Web of Science-article › peer-review

TY - JOUR

T1 - The Trypanosoma cruzi satellite DNA OligoC-TesT and Trypanosoma cruzi kinetoplast DNA OligoC-TesT for diagnosis of Chagas disease

T2 - a multi-cohort comparative evaluation study

AU - De Winne, Koen

AU - Büscher, Philippe

AU - Luquetti, Alejandro O

AU - Tavares, Suelene B N

AU - Oliveira, Rodrigo A

AU - Solari, Aldo

AU - Zulantay, Ines

AU - Apt, Werner

AU - Diosque, Patricio

AU - Monje Rumi, Mercedes

AU - Gironès, Nuria

AU - Fresno, Manuel

AU - Lopez-Velez, Rogelio

AU - Perez-Molina, José A

AU - Monge-Maillo, Begoña

AU - Garcia, Lineth

AU - Deborggraeve, Stijn

N1 - FTX

PY - 2014

Y1 - 2014

N2 - BACKGROUND: The Trypanosoma cruzi satellite DNA (satDNA) OligoC-TesT is a standardised PCR format for diagnosis of Chagas disease. The sensitivity of the test is lower for discrete typing unit (DTU) TcI than for TcII-VI and the test has not been evaluated in chronic Chagas disease patients.METHODOLOGY/PRINCIPAL FINDINGS: We developed a new prototype of the OligoC-TesT based on kinetoplast DNA (kDNA) detection. We evaluated the satDNA and kDNA OligoC-TesTs in a multi-cohort study with 187 chronic Chagas patients and 88 healthy endemic controls recruited in Argentina, Chile and Spain and 26 diseased non-endemic controls from D.R. Congo and Sudan. All specimens were tested in duplicate. The overall specificity in the controls was 99.1% (95% CI 95.2%-99.8%) for the satDNA OligoC-TesT and 97.4% (95% CI 92.6%-99.1%) for the kDNA OligoC-TesT. The overall sensitivity in the patients was 67.9% (95% CI 60.9%-74.2%) for the satDNA OligoC-TesT and 79.1% (95% CI 72.8%-84.4%) for the kDNA OligoC-Test.CONCLUSIONS/SIGNIFICANCE: Specificities of the two T. cruzi OligoC-TesT prototypes are high on non-endemic and endemic controls. Sensitivities are moderate but significantly (p = 0.0004) higher for the kDNA OligoC-TesT compared to the satDNA OligoC-TesT.

AB - BACKGROUND: The Trypanosoma cruzi satellite DNA (satDNA) OligoC-TesT is a standardised PCR format for diagnosis of Chagas disease. The sensitivity of the test is lower for discrete typing unit (DTU) TcI than for TcII-VI and the test has not been evaluated in chronic Chagas disease patients.METHODOLOGY/PRINCIPAL FINDINGS: We developed a new prototype of the OligoC-TesT based on kinetoplast DNA (kDNA) detection. We evaluated the satDNA and kDNA OligoC-TesTs in a multi-cohort study with 187 chronic Chagas patients and 88 healthy endemic controls recruited in Argentina, Chile and Spain and 26 diseased non-endemic controls from D.R. Congo and Sudan. All specimens were tested in duplicate. The overall specificity in the controls was 99.1% (95% CI 95.2%-99.8%) for the satDNA OligoC-TesT and 97.4% (95% CI 92.6%-99.1%) for the kDNA OligoC-TesT. The overall sensitivity in the patients was 67.9% (95% CI 60.9%-74.2%) for the satDNA OligoC-TesT and 79.1% (95% CI 72.8%-84.4%) for the kDNA OligoC-Test.CONCLUSIONS/SIGNIFICANCE: Specificities of the two T. cruzi OligoC-TesT prototypes are high on non-endemic and endemic controls. Sensitivities are moderate but significantly (p = 0.0004) higher for the kDNA OligoC-TesT compared to the satDNA OligoC-TesT.

KW - Adolescent

KW - Adult

KW - Africa

KW - Aged

KW - Chagas Disease

KW - Cohort Studies

KW - DNA, Kinetoplast

KW - DNA, Satellite

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Molecular Diagnostic Techniques

KW - Parasitology

KW - Prospective Studies

KW - Sensitivity and Specificity

KW - South America

KW - Trypanosoma cruzi

KW - Young Adult

U2 - 10.1371/journal.pntd.0002633

DO - 10.1371/journal.pntd.0002633

M3 - A1: Web of Science-article

C2 - 24392177

SN - 1935-2727

VL - 8

SP - e2633

JO - PLoS Neglected Tropical Diseases

JF - PLoS Neglected Tropical Diseases

IS - 1

ER -

The Trypanosoma cruzi satellite DNA OligoC-TesT and Trypanosoma cruzi kinetoplast DNA OligoC-TesT for diagnosis of Chagas disease: a multi-cohort comparative evaluation study

Abstract

Keywords

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