J Korean Med Sci.  2018 Apr;33(17):e131. 10.3346/jkms.2018.33.e131.

Evaluation of a Commercial Immuno-Chromatographic Assay Kit for Rapid Detection of IgM Antibodies against Leptospira Antigen in Human Serum

• Amran F
• Liow YL
• Halim NA

• KMID: 2409205
• DOI: http://doi.org/10.3346/jkms.2018.33.e131

Abstract

Leptospirosis is a febrile zoonotic disease. Routine diagnosis of leptospirosis is based on the detection of specific antibodies with serological tests. The aim of our study was to determine the usefulness of immunochromatographic assay (ICA), ImmuneMed Leptospira IgM Duo Rapid test kit from Korea, in rapid screening of acute leptospirosis in emergency cases with limited expertise. A total of 197 serum samples (93 positive, 104 negative) were selected randomly. The test has good diagnostic sensitivity 73% and specificity 90%. With positive predictive value of 87% and negative predictive value of 79%, this reassures patients have higher chance of correct diagnosis. This ICA is acceptable for screening of leptospirosis but confirmation with microscopic agglutination test should follow.

Keyword

Diagnostics; Leptospirosis; Immunochromatographic Test; Serological Tests; Serum IgM Antibodies

MeSH Terms

Agglutination Tests
Antibodies*
Diagnosis
Emergencies
Humans*
Immunochromatography
Immunoglobulin M*
Korea
Leptospira*
Leptospirosis
Mass Screening
Sensitivity and Specificity
Serologic Tests
Zoonoses
Antibodies
Immunoglobulin M