To fulfill the need for a simple and rapid diagnostic test for human brucellosis, we used the immunochromatographic lateral flow assay format to develop two assays, one for the detection of Brucella-specific immunoglobulin M (IgM) antibodies and one for the detection of Brucella-specific IgG antibodies. The diagnostic values of these tests were examined. The tests are shown to detect acute, persistent, and relapsing disease and can be used to monitor treatment. The sensitivity of Brucella IgM and IgG flow assays calculated for the combined assay results is 96%, and specificity amounts to 99%. The flow assay requires neither specialized training nor equipment, the assay is very easy to perform and to read, and the components are stable without a requirement for refrigeration and well standardized. Together these characteristics indicate that the Brucella IgM and IgG flow assays are ideal for use in clinical settings in rural and suburban areas in which brucellosis is endemic.

An assay device for the rapid detection of Leptospira-specific immunoglobulin M (IgM) antibodies in human sera is presented. The sensitivity (85.8%) and specificity (93.6%) of the assay compared well (91.9% agreement) with those of an IgM enzyme-linked immunosorbent assay routinely used in the serodiagnosis of leptospirosis. The sensitivity of the assay varied with the stage of the disease. The assay uses stabilized components and is simply performed by the addition of serum and sample fluid to the sample well of the assay device. The assay is read after 10 min, and a positive result is obtained when staining of the test line is observed.As the clinical symptoms and signs of leptospirosis often are nonspecific, the disease is easily mistaken for other major infectious diseases. Manifestations of leptospirosis may vary, and different types of disease may be observed, from relatively mild influenza-like symptoms to severe disease with renal failure, liver impairment, and haemorrhage (Weil's syndrome). Meningismus and (aseptic) meningitis can be observed as well. Because of the wide variety of symptoms, leptospirosis is easily confused with many other fibril illnesses including haemorrhagic fevers, e.g., dengue fever (7). Laboratory testing to confirm the clinical diagnosis thus is essential for optimal treatment and patient management. The laboratory diagnosis of leptospirosis mainly depends on serology (8). The microscopic agglutination test (MAT) (5, 31) is considered the reference test for leptospirosis, but the enzyme-linked immunosorbent assay (ELISA) (2, 15-17, 19, 32, 34, 36) and a number of other tests including the immunofluorescent-antibody test (IFAT) (3), the slide agglutination test (9), the macrocapsule agglutination test (4), and the hemagglutination test (13,28,29) can be used as well. Drawbacks of the standard diagnostic assays like MAT, ELISA, and IFAT are that they are not very easy to perform, require special and expensive equipment, depend on the availability of electricity and refrigeration, or can be applied only by trained personnel. Hence, these assays are available only in a few specialized laboratories. MAT, which is considered the reference test for leptospirosis, is rarely performed by routine diagnostic laboratories.Leptospirosis has been reported from countries all over the world (1). Sporadic cases of leptospirosis may occur in countries with moderate climates. The disease, however, can be endemic in countries with wet and warm climates. People living under poor socioeconomical and hygienic conditions are at particular risk of getting the disease. Outbreaks have been reported (6, 11, 12, 14, 20-23, 27, 30, 33). Most people at risk cannot depend on health care facilities supported by laboratories capable of performing the more complicated standard laboratory assays. We previously developed a dipstick assay for the detection of Leptospira-specific immunoglobulin M (IgM) antibodies in human sera (10,20,(24)(25)(26)35). This assay can be used outside the specialized laboratory and may e...