InBios International has developed an immunochromatographic rapid strip for the detection of visceral leishmaniasis that requires minimal equipment and only a small amount of blood to run a test. We compared the InBios rapid strip test with the CDC immunofluorescent antibody assay, and the agreement, sensitivity, and specificity were 98%, 90%, and 100%, respectively.
Visceral leishmaniasis (VL) is the result of infection by theLeishmania donovani species complex (including L. donovani, Leishmania chagasi, and Leishmania infantum) and Leishmania tropica (11,15). The recommended method for diagnosis has been microscopic determination of parasites from bone marrow, splenic, or lymphatic tissue biopsy specimens (7); however, these tests are invasive as well as difficult to perform in rural areas, where VL may be endemic and carry a high risk of complication (6,17). Recently, real-time PCR has been utilized to diagnose Leishmania infection and appears promising; nevertheless, the ability to perform the assay becomes prohibitive in many regions of endemicity with limited medical resources (10,12,16). It has therefore been a goal in VL testing to produce a rapid, noninvasive technique for diagnosis that can be used in the field (5, 7, 13). InBios International, Inc. (Seattle, WA), has developed such a test that has been approved by the Food and Drug Administration.The InBios Kalazar Detect rapid test utilizes the recombinant L. chagasi antigen rK39, which is a 39-amino-acid repeat section in the 230-kDa LcKin protein (1). It has previously been reported that L. chagasi, L. donovani, and L. infantum all contain the gene encoding the LcKin protein (1). A membrane strip which also contains a conjugate dye region is coated with this protein. Through capillary action, the patient serum will react with the dye and antigen to quickly indicate the presence of anti-rK39 immunoglobulin G (IgG) in a patient sample.In this study, we determined the efficacy of the InBios VL test by comparing results of the InBios test with results from the test used by the Centers for Disease Control and Prevention (CDC; Atlanta, GA).Human sera. This study was approved by the Institutional Review Board of the University of Utah (IRB 7275). Serum samples were divided into two categories: samples that were obtained from patients proven to have leishmaniasis by the CDC, and samples that were sent to ARUP Laboratories (Salt Lake City, UT) for leishmaniasis serological testing. Sixteen samples that had been collected from patients treated by the CDC for leishmaniasis and pathologically confirmed by PCR, culture, or direct detection at the CDC for leishmaniasis were de-identified and stored at 2 to 8°C. Seventy-eight serum samples that were originally collected between 2007 and 2008 and sent to ARUP Laboratories for leishmaniasis testing were deidentified and stored at 2 to 8°C.InBios Kalazar Detect rapid test. All 94 samples were tested for anti-rK39 IgG antibodies using the InBios Kalazar Detect rapid test (Seattle, WA) according to the manufacturer's ...