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The Chagas Detect™ Plus (CDP) Rapid Test is a rapid immunochromatographic strip assay for the qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood matrices (venous and capillary (finger prick) whole blood). CDP is a non-invasive diagnostic test for use in a primary care setting by personnel trained to obtain whole blood or serum samples. Reactive test results will be presumptive evidence of infection with T. cruzi. The CDP when used in conjunction with other serological and clinical information is useful for the diagnosis of individuals with Chagas disease. Definitive diagnosis of an acute phase infection (including acute congenital infection) must be made by alternative methods, e.g., hemoculture, blood smear. This test is not intended for use on cord blood or for screening blood or plasma donors.

The Chagas Detect™ Plus (CDP) Rapid Test is a rapid immunochromatographic strip assay for the qualitative detection of human IgG antibodies to Trypanosoma cruzi (T. cruzi) in human serum and whole blood matrices (venous and capillary (finger prick) whole blood).

The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four month old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL. The CL DetectTM Rapid To aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.

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The SMART Leish is a qualitative diagnostic real-time PCR test for the rapid detection of Leishmania species and the identification of L. major in skin lesion scrapings and punch biopsies from individuals suspected of having cutaneous leishmaniasis. The test utilizes real-time polymerase chain reaction assay on the Cepheid SmartCycler® II Dx to detect Leishmania species and L. major. The SMART Leish is indicated for use in patients with clinical presentations and travel history.

The SMART Leish consists of an assay reagent kit and assay definition files for the polymerase chain reaction (PCR) instrument platform. The kit contains sufficient reagents, in lyophilized bead form, to qualitatively assay 50 clinical samples for both Leishmania genus and L. major targets. Additional required accessories that are specified include the PCR instrument platform, a deoxyribonucleic acid (DNA) purification kit, and a positive extraction control. The device components and required accessories are listed as follows. For the Leishmania assays, a tissue specimen (skin scraping or punch biopsy) from an individual suspected of being infected with Leishmania species or L. major is collected in 70% or 100% ethanol, and the DNA is extracted from the specimen using the Qiagen QlAamp DNA Mini Kit. An aliquot of this DNA is tested using the Leishmania genus assay, which will amplify a portion of DNA encoding the Leishmania species 16S ribosomal ribonucleic acid (rRNA) gene if present. Amplified targets are detected using a TaqMan® hybridization probe with 6-carboxyfluorescein.(FAM) reporter dye (517 nm) and a Black Hole Quencher® (BHQ). This assay also contains a positive internal control consisting of a nonsensical, non-naturally occurring DNA sequence, with Texas Red reporter dye (615 nm) and BHQ, used to detect evidence of PCR inhibition and confirm the integrity of assay reagents in negative specimens. If the sample tests positive for Leishmania species, another aliquot of DNA may be tested using the L. major assay, which will amplify a portion of DNA encoding the GPI gene that is specific to L. major. Amplified targets are detected using a TaqMan hybridization probe with FAM reporter dye and a BHQ. The DNA amplification, detection of fluorescence, and interpretation of signals are done automatically by the SmartCycler instrument for each assay. The thermocycling protocols take approximately 45-55 minutes.

ORTHO T. cruzi ELISA Test System is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of antibodies (Immunoglobulin G) to Trypanosoma cruzi (T. cruzi) in human adult serum (glass, plastic, or serum separator tubes) and plasma (EDTA, lithium heparin or citrate) using whole-cell lysate antigens. Reactive assay results are presumptive evidence of past infection, and in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with Chagas' disease. Definitive diagnosis of an acute phase of infection (including acute congenital infection) must be made by alternate methods, e.g., hemoculture, blood smear. This test is not intended for use on samples of cord blood or screening blood or plasma donors.

The ORTHO T. cruzi ELISA Test System is an enzyme-linked immunosorbent assay (ELISA). ELISA technology utilizes the principle that antibodies bound to the solid phase can be detected by complementary antibodies or antigens labeled with an enzyme capable of acting on a chromogenic substrate. When substrate is applied, the presence of antigens or antibodies can be detected by development of a colored end product. The optical densities are read spectrophotometrically. This ELISA was developed to detect human antibodies to T. cruzi in serum and plasma. The assay utilizes microwells coated with a whole-cell lysate containing T. cruzi antigens as the solid phase. The assay procedure is a three-stage test carried out in a microwell coated with lysate (antigens) prepared from T. cruzi. In the first stage, test specimen, Negative Control, and Positive Calibrator are diluted directly in the test well containing Specimen Diluent, and incubated for a specified length of time. If antibodies to T. cruzi are present, antigen-antibody complexes will form on the microwell surface. If antibodies to T. cruzi are absent, complexes will not form. Unbound antibodies in the sample will be removed during the subsequent wash step. In the second stage, murine monoclonal antibody conjugated with Horseradish Peroxidase (Conjugate) is added to the test well. The Conjugate binds specifically to the antibody portion of the antigen-antibody complex. If complexes are not present, the unbound Conjugate is removed by the subsequent wash step. In the third stage, an enzyme detection system composed of o-phenylenediamine (OPD) and hydrogen peroxide is added to the test well. If bound Conjugate is present, the OPD with be oxidized, resulting in a colored end product. Sulfuric acid is then added to stop the reaction. The color intensity depends on the amount of bound Conjugate and, therefore, is a function of the concentration of antibodies to T. cruzi present in the specimen. The intensity of color in the substrate solution is then determined with a microwell reader (spectrophotometer) designed to measure light absorbance in a microwell.

The Wiener Laboratory enzyme-linked Immunosorbent assay (ELISA) recombinante V. 3.0 test system is a manual and automated instrument assay for the qualitative detection of total antibodies (IgG and IgM) to Trypanosoma cruzi in human serum and plasma (EDTA, heparin, or Citrate) using recombinant antigens of T. cruzi. Reactive results are presumptive evidence of present or past infection with Trypanosoma cruzi.

In this qualitative technique for the detection of antibodies anti-T. Cruzi, the sample is diluted in the wells in which recombinant antigens starting from specific proteins from the epimastigote and trypomastigote stages of the T. cruzi corresponding to highly conserved zones are immobilized. These antigens are proteins with aminoacid sequences repeated in tandem. SAPA (shed acute phase antigen) antigens detect antibodies in 93% of the patients' sera during the acute phase of the infection. It comes from the trypomastigote-bloodstream form of the parasite; #1, #2 and #30 antigens detect antibodies in chronic patients; #13 and #36 specially detect antibodies in sera both from acute and chronic patients. If the sample contains Chagas' antibodies, they bind to the antigens bound to the support. The unbound antigens and antibodies are removed by washing, after which anti-human immunoglobulin antibodies conjugated to peroxidase are added. If a reaction was produced in the first step of the process, the conjugate is bound. After a new washing step and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to T. cruzi produce a color reaction which can be read with a standard ELISA plate reader.

The Kalazar Detect™ Test is a rapid immuno-chromatographic strip assay for the qualitative detection of antibodies to members of L. donovani complex in human serum. This test is intended for laboratory or professional in vitro diagnostic use only.

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