Chagas disease in Chagas disease in Spain: Spain: Experience from Experience from a reference laboratory a reference laboratory Teresa Gárate Teresa Gárate Servicio de Parasitología Servicio de Parasitología Centro Nacional de Centro Nacional de Microbiología Microbiología Second WHO consultation: Development Second WHO consultation: Development of a WHO reference panel for the of a WHO reference panel for the control of Chagas diagnostic tests control of Chagas diagnostic tests Geneva, 27 – 28 January 2009 Geneva, 27 – 28 January 2009
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Chagas disease in Spain: Experience from a reference laboratory Teresa Gárate Servicio de Parasitología Centro Nacional de Microbiología Second WHO consultation:
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Chagas disease in Spain:Chagas disease in Spain:Experience from Experience from
a reference laboratorya reference laboratory
Teresa GárateTeresa GárateServicio de ParasitologíaServicio de Parasitología
Centro Nacional de Centro Nacional de MicrobiologíaMicrobiología
Second WHO consultation: Development Second WHO consultation: Development of a WHO reference panel for the of a WHO reference panel for the control of Chagas diagnostic testscontrol of Chagas diagnostic tests
Geneva, 27 – 28 January 2009Geneva, 27 – 28 January 2009
General Role of the Parasitology Lab
Parasitology Lab and Chagas’ disease in Spain
Experience from a Experience from a Parasitology Reference Parasitology Reference
LaboratoryLaboratory
National National Microbiology Microbiology
Centre Centre
Parasitic diseasesParasitic diseasesAUTOCTHONOUS
Leishmaniasis
Toxoplasmosis
Cryptosporidiasis
Giardiasis
Amebiasis
Fasciolosis
Hydatidosis
Anisakiasis
Toxocariosis
Trichinellosis
IMPORTED
Malaria
Other Leishmaniasis
Chagas disease
Sleeping sickness
Cysticercosis
Schistosomiasis
Filariasis/Oncho
Intestinal parasites
The Parasitology Lab works with Spanish The Parasitology Lab works with Spanish hospitals and blood donor centers on Chagas hospitals and blood donor centers on Chagas
disease diagnosisdisease diagnosis
Other Activities related with Other Activities related with T. T. cruzicruzi diagnosisdiagnosis
Sensitivity 85 65 to 100 97 91 to 100 100 100 to 100
Specificity 100 100 to 100 98 96 to 100 100 100 to 100
PPV 100 100 to 100 94 85 to 100 100 100 to 100
NPV 88 73 to 100 99 97 to 100 100 100 to 100
Evaluation of serological Evaluation of serological tests:tests:
In house In house ELISAELISA and 3 and 3 serum panelsserum panels
Panel 1: Sera from Bolivian individuals with positive or negative xenodiagnosis
Panel 2: Sera from population with positive or negative T. cruzi IFAT. Healthy individuals from endemic and non-endemic areas
Panel 3: Sera of anti-T. cruzi Specific Panel and healthy individuals from endemic and non-endemic areas
Anti-T. cruzi Specific Sera Panel (QPanel, Sao Paulo-Brazil, http://www.panel.com.br) was kindly provided by Dra. Elena Franco
Characteristics of serum samples of Characteristics of serum samples of the 3 panels used in the evaluation the 3 panels used in the evaluation
of the In house of the In house ELISAELISA
CHAGAS HEALTHYVI SCERAL
LEI SHMANI ASI S
BLK Chagas test 25/25 (100%) 1/10 (10%) 5/9 (56%)
Biokit ELI SA 25/25 (100%) 1/10 (10%) 3/9 (33%)
I D-PaGI A 30/31 (97%) 1D/23 (4%) 4D/52 (8%)
BLK Chagas test
Biokit ELI SA I D-Pagia
Sensitivity 100 100 97
Specificity 90 90 96
PPV 96 96 97
NPV 100 100 96
Evaluation of Evaluation of serological tests:serological tests:Commercial Commercial ELISAsELISAs
38
Non Chagasic 2
28
Spain 22
Bolivia 19
Brazil 20
Argentina 14
Ecuador 20
30
30
Characteristics of SeraNº of sera
Panel 1 (QPanel, Brasil)
Chagasic
Chagasic patients diagnosed in Spain
Healthy individuals
Malaria
Panel 2 (Parasitology, CNM, ISCIII)
Panel 3 (Parasitology, CNM, ISCIII)
Visceral leishmaniasis
Characteristics of serum samples Characteristics of serum samples used in the evaluation of used in the evaluation of
commercial testscommercial tests
Evaluation of Commercial Evaluation of Commercial ELISAs: ELISAs: SensitivitySensitivity
(CI 95%)
IFAT-CNM 65 (66) 98.5 (95.5 - 100)
ELISA-CNM 66 (66) 100 (100 - 100)
Certest 66 (66) 100 (100 - 100)
Ortho 66 (66) 100 (100 - 100)
BLK 41 (42) 97.6 (93.0 - 100)
Biokit 66 (66) 100 (100 - 100)
ID-PaGIA2 61 (66) 92.4 (86 - 98.8)
ID-PaGIA3 65 (66) 98.5 (95.5 - 100)
ICT Operon 61 (66) 92.4 (86.0 - 98.8)
SensitivityChagasic
Nº of positive (total sera)
a The specificity was calculated into account results of healthy controlb The specificity was calculated into account results of healthy control and other pathologies.
Evaluation of Commercial Evaluation of Commercial ELISAs: ELISAs:
Distribution of cases Distribution of cases in Spainin Spain
2289
528
0
500
1000
1500
2000
2500
Seronegative Seropositive
MadridPrevalence
19 %
598
79
0
200
400
600
800
Seronegative Seropositive
AlicantePrevalence
12 %
173
150
50
100
150
200
Seronegative Seropositive
Almeria
Prevalence8 %
0%1%2%3%4%5%
ARG
ENTI
NA
BOLI
VIA
BRA
ZIL
CHIL
EPA
RAG
UAY
URU
GU
AYCO
LOM
BIA
ECU
AD
OR
PERU
VEN
EZU
ELA
GU
ATEM
ALA
HO
ND
URA
SN
ICA
RAG
UA
SALV
AD
OR
MEX
ICO
SPA
IN
60%
80%
100%
Origin of seropositive Origin of seropositive populationpopulation
ConclusionsConclusions Panel of Reference
- Positive samples by different serological tests, and
- Positive samples from chagasic individuals with parasitological, epidemiological and clinical evaluation.
Number of positive sera/panel- 3 serum samples for kit manufacturers- 100 serum samples for evaluation of tests- 3 serum samples for quality control.
Chagas in Spain- Imported and autochonous types.- Bolivian group, mainly from Santa Cruz region, shows the highest seropositivity rates and represents the highest risk for T. cruzi infection transmission.