Table 1. Qualitative analysis of studies selected (ELISA and RDT assays).
| Ref | Author / year | Type of test | Type of participants | Study area | Index test | Reference test | Study period | Country | Number of sick patients | Number of healthy patients | Total | Sensit. | Specif. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 (19) | Briceño 2010 | ELISA | Healthy patients and participants with chronic CD and lymphoblastogenesis and Chagasic cardiomyopathy or asymptomatic | Endemic area | AgA-ELISA | Bioschile Ingenieria Genetica S.A Kit, BioKIT and Pharmatest (Laboratorios Pharmatest) Immunofluorescence of epimastigotes Indirect hemagglutination and ELISA) |
Not stated | Venezuela | 89 | 477 | 566 | 98.8% | 97%* |
| 2 (30) | Aria 2016 _ a | ELISA | Blood donors Participants who were positive for syphilis, Hepatitis B and C, HIV, HTLV. |
Endemic area | ELISA Chagas test IICS V.1 | Chagatest ELISA recombinant v 3.0 from Wiener. | Not stated | Paraguay | 33 | 23 | 56 | 97% | 91%* |
| Aria 2016 _ b | ELISA Chagas test IICS V.1 | BiosChile Test ELISA | 97% | 95%* | |||||||||
| 4 (52) | Llano 2014 | ELISA | Participants with leishmaniasis and heart disease. Symptomatic and asymptomatic | Endemic and Non- endemic area | Chagas (Trypanosoma cruzi) IgG-ELISA (NovaTec Immunodiagnostica GmbH) | ELISA and IFI No brand reported |
Not stated | Colombia | 78 | 21 | 99 | 96% | 98%* |
| 5 (56) | Bergmann 2013 _a | ELISA | Blood donors from Brazil | Endemic area | Chagatest (Wiener Lab, Argentina). | Immunotransference with TESA antigen (T. cruzi excretor-secretor antigen) No brand reported |
Not stated | Brazil | 122 | 39 | 161 | 99% | 99% / 18%* |
| Bergmann 2013 _b | CHAGATEK (Biolab-Mérieux, Rio de Janeiro, Brazil). | 98% | 75%* | ||||||||||
| Bergmann 2013 _c | EIAgen T. cruzi IgG + IgM (Adaltis, Bologna, Italy) | 99% | 53%* | ||||||||||
| 7 (58) | da Silva 2012_a | ELISA | Participants with Chagas disease, indeterminate form, cardiac disorders, digestive disorders with or without cardiac disorders Healthy participants, without Chagas disease, with other diseases such as HIV, hepatitis C, syphilis, visceral leishmaniasis, tegumentary leishmaniasis |
Endemic area | ELISA home test IgG whole and subclasses Ig G whole: dilution 1:40 |
ELISA and indirect hemagglutination assay IHA No brand reported |
2006 | Brazil | 60 | 54 | 114 | 100% | 100% |
| da Silva 2012_b | ELISA home test IgG Ig G 1: dilution 1:10 |
100% | 90.7% | ||||||||||
| da Silva 2012_c | ELISA home test IgG Ig G 2: dilution 1:10 |
100% | 88,9% | ||||||||||
| da Silva 2012_d | ELISA home test IgG Ig G 3: dilution 1:20 |
95% | 98.1% | ||||||||||
| 8 (59) | Pimenta 2019 _a | ELISA | Individuals in the rural endemic area | Endemic area | ELISA IBMP-8.1 | ELISA and indirect hemagglutination No brand reported |
Not stated | Argentina, Bolivia, Paraguay | 215 | 122 | 337 | 95.3% | 100% |
| Pimenta 2019 _b | ELISA IBMP-8.4 | 100% | 100% | ||||||||||
| 9 (60) | Pierimarchi 2013_a | ELISA | Migrants and blood donors | Endemic and Non- endemic area | ELISA automated using 2 different antigens of T. cruzi. (a recombinant protein and a complete extract of T. cruzi) TcF | In house ELISA, HAI No brand reported BioELISA Chagas, Biokit, Spain (recombinant antigen) Commercial immunomatographic rapid test (Chagas Quick Test, Cypress Diagnostics, Belgium) |
Not stated | Venezuela Italy |
55 | 77 | 132 | 98.1% | 100%* |
| Pierimarchi 2013_b | ELISA automated using 2 different antigens of T. cruzi. (a recombinant protein and a complete extract of T. cruzi) IMT | 96.3% | 100%* | ||||||||||
| 10 (20) | Praast 2011 | ELISA | Blood donors from Germany and patients from Brazil and Guatemala, Bolivia, Argentina and USA | Endemic and Non- endemic area | Abbott Architect Chagas | BioMérieux ELISA cruzi. Wiener Lab test Chagas ELISA recombinant 3.0. Abbott Chagas confirmatory immunoblot assay |
Not stated | Germany | 655 | 9629 | 10284 | 99.8% | 99.9% |
| 12 (8) | Caicedo 2019_a | ELISA | Sera from Instituto Nacional de Salud, public health and department laboratories, blood donors | Endemic area | Test ELISA Chagas III BIOS | ELISA and IFI home test Indirect hemagglutination (Wiener Chagatest HAI) (T. cruzi excretor-secretor antigen) (TESA, bioMérieux Immunoblot) |
2014 to 2016 | Colombia | 256 | 245 | 501 | 99.2% | 97.9% |
| Caicedo 2019_b | Nonconventional methods Synthetic peptides Umelisa Chagas SUMA | 92.5% | 97.5% | ||||||||||
| Caicedo 2019_c | Recombinant antigens Architect System Chagas ARCHI | 98.4% | 97.9% | ||||||||||
| Caicedo 2019_d | BioELISA Chagas BIOKIT | 98% | 94.6% | ||||||||||
| Caicedo 2019_e | Chagatest ELISA recombinant v. 4 WIENER | 98.8% | 97.9% | ||||||||||
| Caicedo 2019_f | T. cruzi AB DIAPRO | 95.7% | 97.1% | ||||||||||
| Caicedo 2019_g | 7.Chagas ELISA IgM + IgG VIRCEL | 99.6% | 97.5% | ||||||||||
| 13 (22) | Caballero 2019_a | ELISA | Blood donors Participants with visceral leishmaniasis, cutaneous and mucocutaneous leishmaniasis, T. rangely, rheumatic fever, toxoplasma, and P. falciparum |
Endemic area | ELISA home test with Burunga genotype | TESA-blot Western blot Chagatest Rec v3.0 Wiener kit |
Not stated | Panama and Brazil | 40 | 113 | 153 | 100% | 82.3% |
| Caballero 2019_b | ELISA home test with MM1 genotype | 100% | 77.8% | ||||||||||
| Caballero 2019_c | ELISA home test with Jose-IMT genotype | 100% | 84.9% | ||||||||||
| Caballero 2019_d | ELISA home test with Y genotype | 100% | 88.4% | ||||||||||
| Caballero 2019_e | ELISA home test with FCI genotype | 100% | 81.4% | ||||||||||
| Caballero 2019_f | ELISA home test with JJ genotype | 100% | 78.7% | ||||||||||
| 15 (24) | Tonelli 2018_a | ELISA | Participants with indeterminate form, chagasic myocarditis, tegumentary leishmaniasis, visceral leishmaniasis | Endemic area | ELISA home test Epitope 1 of B cells derived from the family of Mucin Associated Surface Proteins (MASP) |
ELISA (Gold Analisa, Brazil), IHA (Wiener Lab., Argentina) and IFA (Bio-Manguinhos, Brazil) | Not stated | Brazil | 53 | 70 | 123 | 60.3% | 72.8%* |
| Tonelli 2018_b | ELISA home test Epitope 2 of B cells derived from the family of Mucin Associated Surface Proteins (MASP) |
100% | 97.1%* | ||||||||||
| Tonelli 2018_c | ELISA home test Epitope 3 of B cells derived from the family of Mucin Associated Surface Proteins (MASP) |
100% | 67.1%* | ||||||||||
| Tonelli 2018_d | ELISA home test Combination of epitopes 1, 2 and 3 of B cells derived from the family of Mucin Associated Surface Proteins (MASP) |
100% | 82.8%* | ||||||||||
| Tonelli 2018_e | ELISA home test Combination of epitopes 2 and 3 of B cells derived from the family of Mucin Associated Surface Proteins (MASP) |
100% | 100%* | ||||||||||
| 16 (25) | Pérez 2018 | ELISA | Migrants from Bolivia | Non- endemic area | Architect Chagas | Immunochromatogra-phy tests (ICT) and/or indirect immunofluorescence (IFI) | January 2014-August 2017 | Spain | 307 | 3844 | 4151 | 92.5% | 100% |
| 17 (26) | Peverengo 2018_ a | ELISA | Blood donors | Endemic area | ELISA CP1 [antigens FRA and SAPA (Ags)] |
ELISA (Chagatest ELISA) e IHA (Chagatest IHA) from Wiener Lab (Argentina) IFI |
Not stated | Argentina | 67 | 67 | 134 | 90.2% | 100% |
| Peverengo 2018_ b | CP3, composed of antigenic determinants MAP, TcD y TSSAII / V / VI | 100% | 92.5% | ||||||||||
| Peverengo 2018_ c | CP1+CP3: | 100% | 100% | ||||||||||
| 20 (29) | Mucci 2017 | ELISA | Healthy patients, patients infected with T.cruzi, in the asymptomatic chronic stage of the disease without heart or gastrointestinal compromise, participants with tegumentary leishmaniasis | Endemic area | ELISA with synthesized peptides | ELISA whole, HAI No brand reported |
Not stated | Argentina | 62 | 16 | 78 | 97% | 97% |
| 23 (33) | Neves 2016_a* | ELISA | Serum samples from individuals from CD endemic areas in Pernambuco (Brazil) of the reference laboratory for CD (RLCD, Oswaldo). Cruz Foundation / PE, Brazil) | Endemic area | ELISA of recombinant proteins IBMP8.1 | ELISA recombinant Immuno-ELISA Chagas (Wama Diagnóstica, São Palo, Brazil, batch 14D061), ELISA whole Chagas III (BIOSChile, Ingeniería Genética S.A., Santiago, Chile, batch 1F130525) |
Not stated | Brazil | 280 | 20 | 300 | 98.9% | 100% |
| Neves 2016_b* | IBMP8.2 | 98.2% | 90% | ||||||||||
| Neves 2016_c* | IBMP8.3 | 95.4% | 95% | ||||||||||
| Neves 2016_d* | IBMP8.4 | 99.6% | 100% | ||||||||||
| 24 (34) | Neves 2016_a | ELISA | Sera obtained from the serum bank of a reference laboratory of chagasic participants with cardiac disorders. Non-chagasic participants, blood donors with dengue, filariasis, hepatitis B and C, HIV, HTLV, leishmaniasis, leptospirosis, rubella, measles, schistosomiasis and syphilis |
Endemic area | Immuno-ELISA Chagas (batch 14D061; Wama Diagnóstica, São Paulo, Brazil) and Pathozyme | IFI IFA (Immunocruzi; Biomérieux) Western blot (TESA blot; Biomérieux, Rio de Janeiro, Brazil) |
Not stated | Brazil | 186 | 499 | 685 | 97.3% | 100% |
| Neves 2016_b | Chagas (batch 7042779; Omega Diagnostics, Scotland, UK), recombinant | 99.5% | 99.2% | ||||||||||
| Neves 2016_c | Chagas III (batch 1F130525; BIOSChile, Ingeniería Genética S.A., Santiago, Chile) | 100% | 100% | ||||||||||
| Neves 2016_d | Gold ELISA Chagas (batch CHA132A; Rem, São Paulo | 99.5% | 97% | ||||||||||
| 26 (36) | Reis 2014_a | ELISA | Brazilian chagasic and non-chagasic participants, patients with chagasic heart disease, cutaneous and visceral leishmaniasis | Endemic area | 26_a: ELISA rTc_11623.20 | ELISA recombinant ELISA v. 3.0 kit, Chagatest HAI Wiener Laboratorio Rosario, Argentina IFI Sigma Chemical Company, Missouri, USA Western blot (TESAcruzi, bioMerieux Brazil) |
Not stated | Brazil | 58 | 45 | 103 | 94.8% | 98.2% |
| Reis 2014_b | 26_b: ELISA rTc_N_10421.310 | 89.6% | 94.6% | ||||||||||
| Reis 2014_c | 26_c: combination of a and b | 95.5% | 98.1% | ||||||||||
| 27 (37) | Izquierdo 2013 | ELISA | Migrants and blood donors Participants with visceral leishmaniasis |
Non- endemic area | ELISA chemiluminescent | ELISA whole ELISA ID-PaGIA (DiaMed, Cressier sur Morat, Switzerland) and Chagas Bioelisa Assay (Biokit, Lliçà d’Amunt, Spain) RDT |
Not stated | Spain | 92 | 58 | 150 | 100% | 98.3% |
| 28 (38) | Cervantes 2013 | ELISA | Participants with leishmaniasis, tuberculosis, neurocysticercosis, taeniasis and toxoplasmosis | Endemic area | Dot-ELISA | ELISA whole, western blot No brand reported |
Not stated | Mexico | 96 | 153 | 360 | 97% | 89% |
| 30 (40) | Iborra 2012 | ELISA | Migrants from endemic countries in Latin America | Non- endemic area | Chemiluminescent immunoassay of microparticles (ARCHITECT Chagas Abbott) | ELISA whole T. cruzi ELISA test system; Ortho Clinical Diagnostic, USA) IFI Immunofluor CHAGAS kit; Biocientífica S.A., Buenos Aires, Argentina Discordance: immunochromatogra-phy Onsite Chagas Ab Combo-Cassete (CTK Biotech, Inc. USA). |
Not stated | Spain | 76 | 89 | 165 | 100% | 96.6% |
| 31 (42) | Longhi 2012 | ELISA | Participants with Kalaazar disease, leishmaniasis, lupus erythematosus, non-chagasic cardiomyopathies, schistosomiasis, juvenile diabetes, idiopathic megaesophagus, and South American blastomycosis | Endemic area | ELISA of T. cruzi and recombinant antigens JL7 | ELISA whole, IFI, HAI No brand reported |
Not stated | Brazil | 228 | 108 | 336 | 100% | 95.2% |
| 33 (44) | Hernández 2010_a | ELISA | Patients from La Paz, Bolivia who attended a parasitology laboratory Healthy participants from non-endemic areas such as Germany and Mongolia, and patients with visceral or cutaneous leishmaniasis, syphilis and brucellosis. |
Endemic and Non- endemic area | ELISA of fusion polypeptides TcBCDE | ELISA Wiener Chagatest-ELISA Recombinant version 3.0 (Wiener Laboratorios, Santa Fé, Argentina) | Not stated | Bolivia, Brazil, Spain and other European countries | 76 | 54 | 130 | 98% | 97%* |
| Hernández 2010_b | Patients from Santa Cruz, Bolivia who attended a hospital | ELISA of fusion polypeptides TcBCDE | ELISA Wiener Chagatest-ELISA Recombinant version 3.0 (Wiener Laboratorios, Santa Fé, Argentina) Bioelisa Chagas (Biokit, Barcelona, Spain) ELISA recombinant Chagas Stat-Pak (Chembio Diagnostic Systems, Medford, NY), |
64 | 21 | 85 | 98% | 94% | |||||
| Hernández 2010_c | Patients from Brazil who attended a university hospital | ELISA of fusion polypeptides TcBCDE | IFI HAI Wiener T. cruzi crude extract ELISA (EIE Biomanguinhos; Fiocruz, Rio de Janeiro, Brazil) |
165 | 216 | 381 | 99% | 99% | |||||
| 35 (46) | Dopico 2019_a | ELISA | Serum samples from Latin American pregnant women with toxoplasmosis and Zika. | Non- endemic area | ELISA IBMP 8.1 | ELISA whole ORTHO T. cruzi ELISA Test System (Ortho Clinical Diagnostics Inc., Raritan, USA) ELISA recombinant Bioelisa CHAGAS (Biokit S.A., Barcelona, Spain) or BIO-FLASH Chagas (automated chemiluminescent assay; Biokit S.A., Barcelona, Spain) |
Not stated | Spain | 347 | 331 | 678 | 99.4% | 100% |
| Dopico 2019_b | ELISA IBMP 8.4 | 99.1% | 99.7% | ||||||||||
| 37 (48) | Abras 2016 | ELISA | Participants with leishmaniasis, toxoplasmosis, amoebic liver abscess, malaria, strongyloidiasis, visceral larva migrans, cytomegalovirus, HIV, parvovirus, Epstein Barr, hepatitis B and C, syphilis, and Lyme disease | Non- endemic area | ELISA Chemiluminescent Architect | ELISA whole, recombinant, western blot No brand reported |
January 2009 to December 2012 | Spain | 114 | 200 | 314 | 100% | 97.6% |
| 39 (50) | Berrizbeitia 2012_a | ELISA | Participants with leishmaniasis, ascariasis, strongyloidiasis and trichuriasis | Endemic area | ELISA of epimastigotes secretion/excretion proteins Optic density 0,400 |
ELISA whole, IFI, HAI No brand reported |
Not stated | Venezuela | 50 | 70 | 120 | 100% | 74% |
| Berrizbeitia 2012_b | ELISA of epimastigotes secretion/excretion proteins Optic density 0,500 |
98% | 80% | ||||||||||
| Berrizbeitia 2012_c | ELISA of epimastigotes secretion/excretion proteins Optic density 0,600 |
98% | 88% | ||||||||||
| 40 (51) | Neves 2018_a | ELISA | Healthy and chronic CD patients, participants with leishmaniasis | Endemic area | ELISA of chimeric proteins IBMP 8.1 | ELISA whole and recombinant ELISA Chagas III (batch 1F130525; BIOSChile, Ingeniería Genética S.A., Santiago, Chile) Immuno-ELISA Chagas (batch 14D061; Wama Diagnostica, São Paulo, Brazil) Pathozyme Chagas (Omega Diagnostics, Scotland, United Kingdom) Gold ELISA Chagas (Rem, São Paulo, Brazil) |
Not stated | Brazil, other Latin American countries and the USA | 595 | 526 | 1121 | 96.4% | 99.6% |
| Neves 2018_b | ELISA of chimeric proteins 8.2 | 93.5% | 99.6% | ||||||||||
| Neves 2018_c | ELISA of chimeric proteins 8.3 | 96.8% | 100% | ||||||||||
| Neves 2018_d | ELISA of chimeric proteins 8.4 | 99.4% | 100% | ||||||||||
| 41 (53) | Neves 2017_a | ELISA | Participants positive for dengue, filariasis, Hepatitis B and C, HIV, HTLV, leishmaniasis, leptospirosis, measles, rubella, schistosomiasis and syphilis | Endemic area | ELISA of chimeric proteins IBMP 8.1 | ELISA whole Immuno-ELISA Chagas (Wama Diagnóstica-SP, Brazil, batch 14D061) ELISA Chagas III (BIOSChile, Ingeniería Genética S.A., Santiago, Chile, batch 1F130525) |
Not stated | Brazil, USA, Mexico, Nicaragua, Guatemala, Honduras and Argentina | 825 | 630 | 1455 | 97.4% | 99.4% |
| Neves 2017_b | ELISA of chimeric proteins IBMP 8.2 | 94.3% | 99.6% | ||||||||||
| Neves 2017_c | ELISA of chimeric proteins IBMP 8.3 | 97.9% | 99.9% | ||||||||||
| Neves 2017_d | ELISA of chimeric proteins IBMP 8.4 | 99.3% | 100% | ||||||||||
| 3 (41) | Mendicino 2014_ a | RDT | Study conducted in whole bloods to patients that go to primary care clinics in the rural areas of a province of Argentina with clinical suspicion of CD | Endemic area | WL Check Chagas (Wiener Lab SAIC, Argentina) | Chagatest ELISA, Wiener Lab SAIC IHA (IHA Chagas Poly- chaco, Lemos Laboratory SRL, Argentina) IFI in case of discordance. |
Not stated | Argentina | 64 | 177 | 241 | 87.3% | 98.8%* |
| Mendicino 2014_ b | Study conducted in serum | 67 | 171 | 238 | 95.7% | 100%* | |||||||
| 6 (57) | Acosta 2013_a | RDT | Participants who were positive for toxoplasmosis, syphilis, tuberculosis, rheumatoid factor and hepatitis | Endemic area | Immunochromatogra-phy test for qualitative detection of IgG anti Trypanosoma cruzi | ELISA Chagas test IICS-UNA | Not stated | Paraguay | 97 | 105 | 202 | 97% | 95%* |
| Acosta 2013_b | Immunochromatogra-phy test SD Bioline–Korea |
51 | 43 | 94 | 94% | 100%* | |||||||
| 11 (21) | Lozano 2019 _a | RDT | Inhabitants of the cities Yacuiba and Villa Montes (province of Gran Chaco, department of Tarija) | Endemic area | Chagas Stat-Pak (CSP; Chembio Inc., Medford, USA) | Lysate antigen ELISA from Wiener and recombinant from Wiener Discordance: ELISA (Chagatek, Laboratorio Lemos, Buenos Aires, Argentina) |
April to August 2018 | Bolivia | 304 | 381 | 685 | 97.7% | 97.4%* |
| Lozano 2019 _b | Chagas Detect Plus (CDP; InBIOS International Inc., Seattle, USA) | 98.4% | 87.1%* | ||||||||||
| 14 (23) | Mendicino 2018_ a | RDT | Inhabitants of the northern province of Santa Fe, located in Gran Chaco | Endemic area | RDT A: WL Check Chagas (Wiener Lab SAIC, Argentina) | IHA (IHA Chagas Polychaco, Lemos Laboratory SRL) ELISA (Chagatest ELISA, Wiener Lab SAIC) When results were discordant, IFI was performed with commercial conjugates and smear prepared with epimastigotes of T. cruzi of the strain Tulahuen 0.10 |
Not stated | Argentina | 42 | 64 | 106 | 90.5% | 100%* |
| Mendicino 2018_ b | RDT B: SD BiolineChagasAb Rapid (Standard Diagnostics Inc., Korea) | 97.6% | 93.8%* | ||||||||||
| 19 (28) | Navarro 2011 | RDT | Migrants in Spain from Bolivia, Ecuador, Peru | Non-endemic area | Rapid immunochromato- graphy test (ICT) (Simple Chagas WB, Operon) | IFI, ELISA | May 2008 to December 2009 | Spain | 57 | 219 | 276 | 88% | 94%* |
| 21 (31) | Angheben 2017 | RDT | Migrants and travelers from endemic countries of Latin America | Non-endemic area | Rapid immunochromato- graphy test Chagas Quick Test (CQT), Cypress diagnostics of Belgium | ELISA whole ELISA for Chagas III®, BioChile, Chile (Lys ELISA) ELISA recombinant Bio-Elisa Chagas, Biokit, Spain (Ric-ELISA). |
April 2009 to June 2015 | Italy | 256 | 384 | 640 | 82.8% | 98.7% |
| 22 (32) | Egüez 2017_a | RDT | People who went to the reference laboratory Laboratorio de Referencia Departamental Chuquisaca in Sucre | Endemic area | Chagas Stat-Pak (CST; Chembio Inc., Medford, USA) | Elisa whole Wiener Lab (Rosario, Argentina), ELISA Wiener v2.0 ELISA recombinant ELISA Wiener v3.0 HAI IHA test, Chagas Polychaco kit from laboratorio Lemos (Buenos Aires, Argentina) |
March to May 2014 | Bolivia | 209 | 133 | 342 | 87% | 93.2% |
| Egüez 2017_b | Chagas Detect Plus (CDP; InBios Inc., Seattle, USA) | 93.4% | 95.2% | ||||||||||
| 25 (35) | Shah 2014_a | RDT | Participants with early and advanced heart disease | Endemic area | Chagas Detect Plus (CDP) (InBios International Inc, Seattle) Serum |
ELISA recombinant Wiener recombinant v3.0 ELISA IFI does not report any brand HAI IHA (Chagas Polychaco kit; Lemos Laboratories, Buenos Aires, Argentina |
April-May 2013 | Bolivia | 292 | 293 | 585 | 96.2% | 98.8% |
| Shah 2014_b | Chagas Detect Plus (CDP) (InBios International Inc, Seatle) Blood |
99.3% | 96.9% | ||||||||||
| 29 (39) | Flores 2012_a | RDT | Migrants and travelers to endemic countries of Latin America, natives and people born in Spain, with epidemiologic risk factors. Participants with visceral leishmaniasis and malaria. |
Non-endemic area | Operon Immunochromatogra-phy test (ICT-Operon; Simple Stick Chagas serum and plasma | ELISA whole, IFI, PCR Does not report any brand |
Not stated | Spain | 63 | 188 | 251 | 100% | 92.6% |
| Flores 2012_b | Simple ChagasWB Operon S.A., Spain) Peripheral blood |
91.8% | 93.7% | ||||||||||
| Flores 2012_c | Simple ChagasWB Operon S.A., Spain) Capillary blood |
86.1% | 94.8% | ||||||||||
| 32 (43) | Barfied 2011_a | RDT | No patient characteristics reported | Endemic area | Chagas STATPAK from Laboratorio Lemos, Argentina 15 minutes |
ELISA whole BioMerieux ChagaTek ELISA ELISA recombinant Laboratorio Lemos Biozima Chagas recombinant |
Not stated | Argentina | 190 | 185 | 375 | 95.3% | 99.5% |
| Barfied 2011_b | Chagas STATPAK from Laboratorio Lemos, Argentina 20 minutes |
95.8% | 99.5% | ||||||||||
| Barfied 2011_c | PATH Rapid Test from Lemos 15 minutes |
97.9% | 96.2% | ||||||||||
| Barfied 2011_d | PATH Rapid Test from Lemos 20 minutes |
99.5% | 96.8% | ||||||||||
| Barfied 2011_e | PATH Rapid Test from Lemos 25 minutes |
98.9% | 94% | ||||||||||
| 34 (45) | Chapouis 2010_a | RDT | Latin American migrants from several countries where the disease is endemic. | Non- endemic area | Stat-Pak in blood | ELISA whole and recombinant Stat-Pak assay: the bioMerieux Elisa cruzi Biokit bioelisa Chagas |
June to November 2008 | Switzerland | 125 | 874 | 999 | 95.2% | 99.9% |
| Chapouis 2010_b | Stat-Pak in serum | 96% | 99.8% | ||||||||||
| 36 (47) | Reithinger 2010_a | RDT | Patients from Argentina | Endemic area | Trypanosoma Detect MRA rapid test; Inbios, Seattle, WA in | ELISA whole, IFI, HAI Does not report any brand |
2000 to 2007 | United Kingdom | 40 | 61 | 101 | 82.5% | 96.7% |
| Reithinger 2010_b | Patients from Ecuador | Trypanosoma Detect MRA rapid test; Inbios, Seattle, WA in | Chagas III (BiosChile Ingeniería Genética S.A., Santiago, Chile) Chagatek ELISA (bioMérieux, Buenos Aires, Argentina) IFI, HAI does not report any brand |
51 | 49 | 100 | 84.3% | 95.9% | |||||
| Reithinger 2010_c | Patients from México | Trypanosoma Detect MRA rapid test; Inbios, Seattle, WA in | Kit Chagas III (BiosChile Ingenieria Genétca S.A., Santiago, Chile) IFI, HAI does not report any brand |
40 | 60 | 100 | 77.5% | 100% | |||||
| Reithinger 2010_d | Patients from Venezuela | Trypanosoma Detect MRA rapid test; Inbios, Seattle, WA in | ELISA home test IFI, HAI does not report any brand |
40 | 25 | 65 | 95% | 100% | |||||
| 42 (54) | Sánchez 2014_a | RDT | Existing samples from the serum banks in each national reference laboratory | Endemic area | Rapid test from different commercial brands: OnSite Chagas Ab Rapid test | ELISA whole. IFI, HAI Does not report any brand |
Not stated | Argentina, Brazil, Colombia, Costa Rica and Mexico | 237 | 237 | 474 | 90.1% | 91% |
| Sánchez 2014_b | WL Check Chagas | 88.7% | 97% | ||||||||||
| Sánchez 2014_c | Trypanosoma Detect Rapid Test | 92.9% | 94% | ||||||||||
| Sánchez 2014_d | Chagas Quick Test | 92.9% | 93.2% | ||||||||||
| Sánchez 2014_e | Chagas Stat-Pak assay | 87.2% | 93.2% | ||||||||||
| Sánchez 2014_f | SD Chagas Ab Rapid | 90.7% | 94% | ||||||||||
| Sánchez 2014_g | Serodia Chagas | 94.2% | 94.7% | ||||||||||
| Sánchez 2014_h | ImmunoComb II Chagas Ab | 97.2% | 94% | ||||||||||
| 43 (55) | López 2010 | RDT | Adult patients from Central and South America who went to the Primary Care Center Clot in Barcelona for a CD screening. | Non- endemic area | Simple CHAGASWB (Operon S.A, Spain) | ELISA whole (ELISAc) home test ELISA recombinant Bioelisa Chagas, BiokitS.A., Spain Western blot |
Not stated | Spain | 49 | 92 | 148 | 92.5% | 96.8% |
| 18 (27) | Antinori 2018_ a | ELISA and RDT | Migrants from Latin America (Brazil, Bolivia, Ecuador; Salvador and Peru) who participated in health promotion programs and screening | Non- endemic area | (ARCHITECT Chagas, Abbott, Chicago, IL, USA.) | Unknown reference standard | July 30, 2013 to July 30, 2014 | Italy | 48 | 453 | 501 | 100% | 99.7% |
| Antinori 2018_ b | (BioELISA Chagas III, BiosChile, Santiago, Chile) | 95.9% | 99.7% | ||||||||||
| Antinori 2018_ c | (Trypanosoma cruzi IgG Rapid Test, ImmunoSpark, SD, Rome, Italy) | 89.2% | 92.5% | ||||||||||
| 38 (49) | Whittman 2019_a | ELISA and RDT | Participants who are blood donors at the American Red Cross–migrants and native American | Non- endemic area | Ortho ELISA | ELISA whole ELISA Ortho ELISA ELISA recombinant Abbott PRISM (Abbott Laboratories, Abbott Park, IL) Radioimmunoprecipi-tation RIPA, Quest Diagnostics (Chantilly, VA) Immunochromatogra-phy Abbott enzyme strip assay (ESA) |
September 2006 to June 2018 | USA | 500 | 300 | 800 | 92.4% | 100% |
| Whittman 2019_b | Hemagen ELISA | 88% | 100% | ||||||||||
| Whittman 2019_c | Wiener ELISA | 94% | 99.3% | ||||||||||
| Whittman 2019_d | InBios rapid test | 97.4% | 92.3% |
* The authors of this paper calculated the sensitivity and specificity
Sensit: Sensitivity
Specif: Specificity