Leptospira IgG/IgM Ab Rapid Test

CE APPROVED

A rapid and sensitive test for the qualitative detection and differentiation of IgG and IgM antibodies to the Leptospira organisms (L.interrogans) in human serum, plasma or whole blood.

 

Filariasis IgG/IgM Ab Rapid Test

CE APPROVED

 

Leishmania (Kalaazar) Rapid Test

CE APPROVED

Intended Use:

Tell Me Fast One Step Visceral Leishmaniasis (VL) Test is a rapid immunochromatographic assay for the qualitative detection of antibodies to members of L. donovani in human serum, plasma or whole blood. The test provides a visual, qualitative result, and all positive specimens must be confirmed with other qualified assays. The test is intended for healthcare professional use only.

Summary and Principle:

Leishmania is a genus of Trypanosomatid protozoa, and is the parasite responsible for the disease leishmaniasis. It is spread through sandflies of the genus Phlebotomus in the Old World, and of the genus Lutzomyia in the New World. Their primary hosts are vertebrates; Leishmania commonly infects hyraxescanidsrodents, and humans. Leishmania currently affects 12 million people in 88 countries. Visceral leishmaniasis infections are often recognised by fever, swelling of the liver and spleen, and anemia. They are known by many local names, of which the most common is probably Kala azar, which is Caused exclusively by species of the L. donovani complex (L. donovaniL. infantum syn. L. chagasi). Found in tropical and subtropical areas of all continents except Australia, visceral infections are most common in Bangladesh, Brazil, India, Nepal and Sudan. Visceral leishmaniasis also found in part of China, such as Sichuan Province, Gansu Province and Xinjiang Uygur Autonomous Region. Most forms of the disease are transmissible only from animals (zoonosis), but some can be spread between humans. Human infection is caused by about 21 of 30 species that infect mammals. These include the L. donovani complex with three species (L. donovani, L. infantum, and L. chagasi); the L. mexicana complex with four main species (L. mexicana, L. amazonensis, and L. venezuelensis); L. tropica; L. major; L. aethiopica; and the subgenus Viannia with four main species (L. (V.) braziliensis, L. (V.) guyanensis, L. (V.) panamensis, and L. (V.) peruviana). Cutaneous leishmaniasis is the most common form of leishmaniasis. Visceral leishmaniasis (Kala azar) is a severe form in which the parasites have migrated to the vital organs and can be fatal if untreated.   Visceral leishmaniasis - also known as kala azar - is characterized by irregular bouts of fever, substantial weight loss, swelling of the spleen and liver, and anaemia (occasionally serious). If left untreated, the fatality rate in developing countries can be as high as 100% within 2 years. As per WHO 90% of Visceral leishmaniasis cases occur in Bangladesh, India, Nepal, Sudan & Brazil. VL is a severe disease with high mortality. It is caused by members of the Leishmania donovani complex and canines have been identified as the major reservoir for transmission.  Serodiagnosis has been widely utilized to establish infection because antileishmanial antibody titers are high during acute disease.  The preferred method of diagnosis in a laboratory situation is by ELISA, although fluorescent antibody (IFAT) or direct agglutination tests (DAT), both utilizing whole parasites, are still widely used.  These tests are highly cross-reactive with trypanosomes and mycobacteria.  In addition, the whole parasite preparations used are unstable and variable in quality.  This rapid assay is for the qualitative determination of antibodies to a recombinant antigen specific for Visceral Leishmaniasis caused by parasite members of the L. donovani complex.   Biocan Tell Me Fast Test utilizes a recombinant antigen, rK39, which has been shown to be specific for antibodies in patients with VL caused by members of the L. donovani complex. rK39 is a fusion polyprotein comprising regions of L. donovani haspb1 (L. infantum k26 homologue), L. donovani kinesin (L. infantum k39 homologue) and L. donovani haspb2 (L. infantum k9 homologue). This antigen, which is conserved in the kinesin region, is highly sensitive and predictive of the onset of acute disease. The antigen is derived from L. chagasi, which in the United States is used for veterinary purposes, though it is not approved for human use. High antibody titers in immunocompetent patients with VL have been demonstrated. This antigen has been reported to be 100% sensitive and 100% specific in the diagnosis of VL and PKDL by ELISA. Another important facet of anti-rK39 antibody is that the titer correlates directly with the disease activity, indicating its potential for use in predicting response to chemotherapy. It was previously shown that anti-rK39 antibody titers were 59-fold higher than those of antibody against CSA at the time of diagnosis, and with successful therapy, it fell sharply at the end of treatment and fell further during follow-up monitoring. RK-39 can capture circulating antibodies against all three component proteins (Haspb1, LdK39, and Haspb2) leading to a more robust signal. Therefore, it is likely that tests using rK39 protein could potentially diagnose individuals that are missed by rK28. The development of an rK39-based point-of-care test has yielded promising results and will become a valuable tool in rapid diagnosis of VL in conjunction with complementary tools such as parasite circulating antigen detection tests and nucleic acid detection tests and permit addressing the under-reporting of this neglected disease.   Tell Me Fast One Step Visceral Leishmaniasis (VL) Test is a qualitative, membrane based immunoassay for the detection of antibodies to Visceral Leishmaniasis in human serum.  The test antigen is immobilized on a nitrocellulose membrane within the test zone. The liquid conjugate is applied to the device through the reagent port, priming the device to facilitate the migration of serum applied in the sample port. The specific antibodies present in the serum are captured by the immobilized antigens and subsequently visualized in the form of a magenta-colored test line by the conjugate. Regardless of the presence of antibody to VL antigen, as the mixture continues to migrate across the membrane to the immobilized control line region, a red line at the control line region will always appear.  The presence of this red line serves as verification for sufficient sample volume and proper flow and as a control for the reagents.  

 

Chagas Ab (Trypanosoma cruzi) Rapid Test

CE APPROVED

A rapid and sensitive test for the qualitative detection of anti-antibodies to Trypanosoma cruzi (T. cruzi) in human serum, plasma or whole blood. For professional in vitro diagnostic use only.

Intended Use:

Biocan TELL ME FAST Chagas Ab Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human serum, plasma or whole blood. It is intended to be used as a preliminary screening test and as an aid in the diagnosis of infection with T. cruzi.  Results with the Biocan Tell Me Fast Chagas Ab Rapid Test must be confirmed with alternative testing method (s) and clinical findings. This is a screening test and not a confirmatory test. For professional in vitro diagnostic use only.  

Summary and Principle:

Chagas disease is an insect-borne, zoonotic infection by the protozoan T. cruzi, which causes a systemic infection of humans with acute manifestations and long term sequelae. It is estimated that 16-18 million individuals are infected worldwide, and roughly 50,000 people die each year from chronic Chagas disease (World Health Organization). Buffy coat examination and xenodiagnosis used to be the most commonly methods, in the diagnosis of acute T. cruzi infection. However, both methods are either time consuming or lack of sensitivity.  Recently, serological test becomes the mainstay in the diagnosis of Chagas’s disease. In particularly, recombinant antigen based tests eliminate false-positive reactions which are commonly seen in the native antigen tests. Biocan Tell Me Fast Chagas Ab Rapid Test is an instant antibody test which detects IgG antibodies the T. cruzi within 15 minutes without any instrument requirements. By utilizing T. cruzi specific recombinant antigen, the test is highly sensitive and specific. Tell Me Fast Chagas Ab Rapid Test is a lateral flow chromatographic immunoassay based on the principle of indirect immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing Protein A conjugated with colloid gold (Protein A conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with recombinant T. cruzi antigens, and the C band is pre-coated with anti-Protein A antibodies. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette.  The IgG antibodies to T. cruzi if present in the specimen will bind to the Protein A conjugates. The immunocomplex is then captured on the membrane by the pre-coated T. cruzi antigens, forming a burgundy colored T band, indicating a Chagas Ab positive test result. Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of anti-protein A antibody-Protein A gold conjugates regardless of color development on the T band. Otherwise, the test result is invalid and the specimen must be retested with another device.

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