Evaluación preliminar de la prueba comercial “Chagas (Trypanosoma cruzi) IgG-ELISA®” en individuos colombianos

Llano, Mónica; Pavía, Paula; Flórez, Astrid Carolina; Cuéllar, Adriana; González, John Mario; Puerta, Concepción J.

doi:10.7705/biomedica.v34i2.1580

Cited by 11 publications

(7 citation statements)

References 42 publications

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“…The 43 selected studies were published between 2010 and 2019, with between 3 and 6 studies being published per year, except for 2015, a year in which there were no publications. 27 articles [9,21,22,24,25,[27][28][29][30][31][32][33][34][35]38,41,42,[44][45][46]48,51,53,55,[57][58][59] evaluated ELISA tests; 14 used RDT [10,23,26,32,37,39,40,43,47,50,52,54,60,61] and 2 [36,56] evaluated both tests (Table 1).…”

Section: Study Featuresmentioning

confidence: 99%

“…This data is presented and analyzed by separated in the present investigation. Six articles did not present sensitivity and specificity data [22,24,25,37,38,51] but were included considering that they indicated true and false positive and negative data. A total of 30,356 participants were reported in the 43 articles (from 56 to 10,284 subjects per study).…”

Section: Study Featuresmentioning

confidence: 99%

“…Of those studies where ELISA tests were assessed, 17 were carried out with in-house tests [21,24,26,28,31,35,38,40,44,46,48,52,53,55,[60][61][62]; 12 were commercial trials [9,22,24,25,30,34,36,42,45,48,55,56], and one article studied an in-house assay and a commercial assay [26]. The brands assessed that were present in more than one study were Architect PLOS NEGLECTED TROPICAL DISEASES PLOS NEGLECTED TROPICAL DISEASES PLOS NEGLECTED TROPICAL DISEASES PLOS NEGLECTED TROPICAL DISEASES Chagas Abbott [9,30,34,36,48,55], ELISA Chagas III BIOSChile [9,36,41], and Chagatest Wiener [9,25].…”

Section: Study Featuresmentioning

confidence: 99%

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Rapid diagnostic tests and ELISA for diagnosing chronic Chagas disease: Systematic revision and meta-analysis

Carrero

Tadger²,

Cuellar³

et al. 2022

PLoS Negl Trop Dis

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Objective To determine the diagnostic validity of the enzyme-linked immunosorbent assay (ELISA) and Rapid Diagnostic Tests (RDT) among individuals with suspected chronic Chagas Disease (CD). Methodology A search was made for studies with ELISA and RDT assays validity estimates as eligibility criteria, published between 2010 and 2020 on PubMed, Web of Science, Scopus, and LILACS. This way, we extracted the data and assessed the risk of bias and applicability of the studies using the QUADAS-2 tool. The bivariate random effects model was also used to estimate the overall sensitivity and specificity through forest-plots, ROC space, and we visually assessed the heterogeneity between studies. Meta-regressions were made using subgroup analysis. We used Deeks’ test to assess the risk of publication bias. Results 43 studies were included; 27 assessed ELISA tests; 14 assessed RDTs; and 2 assessed ELISA and RDTs, against different reference standards. 51.2 % of them used a non-comparative observational design, and 46.5 % a comparative clinical design (“case-control” type). High risk of bias was detected for patient screening and reference standard. The ELISA tests had a sensitivity of 99% (95% CI: 98–99) and a specificity of 98% (95% CI: 97–99); whereas the Rapid Diagnostic Tests (RDT) had values of 95% (95% CI: 94–97) and 97% (95% CI: 96–98), respectively. Deeks’ test showed asymmetry on the ELISA assays. Conclusions ELISA and RDT tests have high validity for diagnosing chronic Chagas disease. The analysis of these two types of evidence in this systematic review and meta-analysis constitutes an input for their use. The limitations included the difficulty in extracting data due to the lack of information in the articles, and the comparative clinical-type design of some studies.

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Section: Study Featuresmentioning

confidence: 99%

Section: Study Featuresmentioning

confidence: 99%

Section: Study Featuresmentioning

confidence: 99%

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Rapid diagnostic tests and ELISA for diagnosing chronic Chagas disease: Systematic revision and meta-analysis

Carrero

Tadger²,

Cuellar³

et al. 2022

PLoS Negl Trop Dis

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“…Considering that the discriminatory capacity of serological tests varies depending on the type of antigen used, as well as the incidence and prevalence of the disease in the region, one of the most important applications of serological diagnostic tests is in their use in endemic areas, where the test must discriminate infected individuals from those who may have other conditions that generate false positives 5 . Although numerous studies have been carried out to evaluate different tests for the detection of specific anti-T. cruzi antibodies, there is no consensus on the choice of a reference technique.…”

Section: Introductionmentioning

confidence: 99%

Diagnostic evaluation of two enzyme-linked immunosorbent assay tests for Trypanosoma cruzi infection in a Colombian population

Carrero

Monroy-Díaz

Tadger-Viloria³

et al. 2022

Infect

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Objective: To evaluate the diagnostic accuracy of two enzyme-linked immunosorbent assay tests to determine Trypanosoma cruzi infection in a Colombian population. Material and methods: Analytical study with case-control design of a diagnostic evaluation. Sensitivity, specificity and diagnostic efficacy of total CHAGATEK ELISA and recombinant CHAGATEK ELISA were determined. Positive predictive value, negative predictive value, and positive and negative likelihood ratios were calculated. The kappa coefficient was found to estimate the concordance between the index and reference tests. The discriminatory capacity of the tests was expressed by the area under the ROC curve. Results: Of the 184 samples included in the study, 99 were negative for T. cruzi and 85 were positive according to the reference tests used. Sensitivity for total and recombinant ELISA was 97.6 % and 98.8 %, respectively; while specificity was 97.0% and 94.9%. The level of concordance of the total and recombinant ELISA was almost perfect and the discriminatory ability of the two tests were good. Conclusions: It was demonstrated that the two tests can confirm and exclude the diagnosis of Chagas disease and have a good diagnostic performance.

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“…Inúmeros estudos (Valázques et al, 2014;Llano et al, 2014;Cancino-Faure et al, 2015;Castro-Sesquen et al, 2016) compararam as técnicas imunológicas com as moleculares na detecção do T. cruzi e os resultados são bastante contraditórios.…”

Section: Adaptado De Who (2012)unclassified

Uso da biologia molecular no diagnóstico da doença de chagas : uma abordagem teórico-experimental com foco em qPCR

Marques¹

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Trypanosoma cruzi infection is a serious public health problem in Latin America, with high morbidity and mortality. About eight to ten million people are infected with the parasite worldwide and one-third will develop the symptoms of Chagas disease. Its diagnosis is mainly based on serological methods that recognize specific antibodies against the parasite. Often, these tests have inconclusive results or false positives due to cross-reaction with antigens from other microorganisms. Development in molecular biology has been changing and improving the diagnosis of Chagas' disease, representing a good alternative to supplement or establish the diagnosis of T. cruzi infection. Thereby, the objective of the current study was to evaluate theoretically and experimentally qPCR protocols used for Chagas disease diagnosis. A systematic review of the literature allowed the identification of experimental conditions (extraction methods, primers, amplifying enzymes, etc) commonly used in scientific articles and the observation that there is no standard procedure established. Thus, different qPCR protocols for T. cruzi identification were experimentally assessed. Specific primers were used for nuclear DNA (nDNA), and mitochondrial DNA (minicircles and maxicircles). The study population was divided into three categoriespositive, negative and doubtful groups -according to the serologic tests. Comparison between serologic and molecular results showed peculiar disagreements, especially when using primers for kDNA minicircle, which may be associated with the integration of these molecules into the host genome. It was established that the best choice for diagnosis T. cruzi active infection is by specific molecular markers to nDNA, which was able to establish infection in inconclusive serological analysis. Our findings reinforce the need of an effective diagnosis that can be used as the gold standard for identification of T. cruzi infection.

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Evaluación preliminar de la prueba comercial “Chagas (Trypanosoma cruzi) IgG-ELISA®” en individuos colombianos

Cited by 11 publications

References 42 publications

Rapid diagnostic tests and ELISA for diagnosing chronic Chagas disease: Systematic revision and meta-analysis

Rapid diagnostic tests and ELISA for diagnosing chronic Chagas disease: Systematic revision and meta-analysis

Diagnostic evaluation of two enzyme-linked immunosorbent assay tests for Trypanosoma cruzi infection in a Colombian population

Uso da biologia molecular no diagnóstico da doença de chagas : uma abordagem teórico-experimental com foco em qPCR

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