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Development of a Lepto-IgM EIACR test to diagnose leptospirosis disease in Costa Rican patient samples.
Invest Clin. 2007 Sep; 48(3):295-304.IC

Abstract

Leptospirosis is an endemic disease throughout Costa Rica, which could be misdiagnosed because manifestations of this febrile disease may vary from mild flu-like symptoms to severe illness involving vital organs such as liver and lungs. Therefore an early specific diagnosis is important to ensure a favorable clinical outcome. The purpose of this study was to develop a Leptospira sp. anti-IgM EIA (Lepto-IgM EIACR) test and to compare it using Lepto-Dipstick IgM (Lepto-DS IgM) and PanBio-EIA IgM with the Microscopy Agglutination test (MAT) as a reference assay. Sera from 736 healthy blood donors were used as negative controls to calculate specificity (97.1%), Confidence Interval 95 (CI (96-98). Cross reactivity was evaluated in 268 patient samples with 6 different diseases. Dengue and measles had the highest cross reactivity (16%) while rubella showed the lowest (3%). To determine the sensitivity of the Lepto- IgM EIACR, 33 samples positive by MAT of 96 paired samples from patients with symptoms related to leptospirosis infection were tested. Lepto-IgM EIACR reached a sensitivity of 90.9% (CI 81-100), while Lepto-DS IgM was 48.5% (CI (31-66). The most frequent serovars detected by MAT in these paired samples were Hebdomadis 14.7%, Hardjo 11.8%, Pomona 8.8% and Icterohaemorrhagiae 5.9%. Furthermore 59 febrile patient samples were tested initially with PanBio-EIA IgM, 21 samples (35%) were positive. When these samples were re-tested by Lepto-IgM EIACR and Lepto-DS IgM, 80.9% and 33% were positive, respectively. The results of the evaluation indicate that Lepto-IgM EIACR test could be a good alternative to detect acute leptospirosis in Costa Rica.

Authors+Show Affiliations

Instituto Costarricense de Investigación y Enseñianza en Nutrición y Salud, INCIENSA, Tres Ríos, San José, Costa Rica. mvalverde@inciensa.sa.crNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

17853789

Citation

de los A Valverde, María, et al. "Development of a Lepto-IgM EIACR Test to Diagnose Leptospirosis Disease in Costa Rican Patient Samples." Investigacion Clinica, vol. 48, no. 3, 2007, pp. 295-304.
de los A Valverde M, León B, Taylor L, et al. Development of a Lepto-IgM EIACR test to diagnose leptospirosis disease in Costa Rican patient samples. Invest Clin. 2007;48(3):295-304.
de los A Valverde, M., León, B., Taylor, L., & Visona, K. (2007). Development of a Lepto-IgM EIACR test to diagnose leptospirosis disease in Costa Rican patient samples. Investigacion Clinica, 48(3), 295-304.
de los A Valverde M, et al. Development of a Lepto-IgM EIACR Test to Diagnose Leptospirosis Disease in Costa Rican Patient Samples. Invest Clin. 2007;48(3):295-304. PubMed PMID: 17853789.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of a Lepto-IgM EIACR test to diagnose leptospirosis disease in Costa Rican patient samples. AU - de los A Valverde,María,Jr AU - León,Bernal, AU - Taylor,Lizeth, AU - Visona,Kirsten, PY - 2007/9/15/pubmed PY - 2007/12/6/medline PY - 2007/9/15/entrez SP - 295 EP - 304 JF - Investigacion clinica JO - Invest Clin VL - 48 IS - 3 N2 - Leptospirosis is an endemic disease throughout Costa Rica, which could be misdiagnosed because manifestations of this febrile disease may vary from mild flu-like symptoms to severe illness involving vital organs such as liver and lungs. Therefore an early specific diagnosis is important to ensure a favorable clinical outcome. The purpose of this study was to develop a Leptospira sp. anti-IgM EIA (Lepto-IgM EIACR) test and to compare it using Lepto-Dipstick IgM (Lepto-DS IgM) and PanBio-EIA IgM with the Microscopy Agglutination test (MAT) as a reference assay. Sera from 736 healthy blood donors were used as negative controls to calculate specificity (97.1%), Confidence Interval 95 (CI (96-98). Cross reactivity was evaluated in 268 patient samples with 6 different diseases. Dengue and measles had the highest cross reactivity (16%) while rubella showed the lowest (3%). To determine the sensitivity of the Lepto- IgM EIACR, 33 samples positive by MAT of 96 paired samples from patients with symptoms related to leptospirosis infection were tested. Lepto-IgM EIACR reached a sensitivity of 90.9% (CI 81-100), while Lepto-DS IgM was 48.5% (CI (31-66). The most frequent serovars detected by MAT in these paired samples were Hebdomadis 14.7%, Hardjo 11.8%, Pomona 8.8% and Icterohaemorrhagiae 5.9%. Furthermore 59 febrile patient samples were tested initially with PanBio-EIA IgM, 21 samples (35%) were positive. When these samples were re-tested by Lepto-IgM EIACR and Lepto-DS IgM, 80.9% and 33% were positive, respectively. The results of the evaluation indicate that Lepto-IgM EIACR test could be a good alternative to detect acute leptospirosis in Costa Rica. SN - 0535-5133 UR - https://www.unboundmedicine.com/medline/citation/17853789/Development_of_a_Lepto_IgM_EIACR_test_to_diagnose_leptospirosis_disease_in_Costa_Rican_patient_samples_ L2 - http://www.diseaseinfosearch.org/result/4178 DB - PRIME DP - Unbound Medicine ER -