Testsealabs Leishmania IgG/IgM Rapid Test Kit(Whole Blood /Serum / Plasma)

Short Description:

The One Step Leishmania IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to the subspecies of the Leishmania donovani (L.donovani), the Visceral leishmaniasis causative protozoans, in Whole Blood /Serum / Plasma.


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Intended Use

It is intended to be used as a screening test and as an aid in the diagnosis of the disease of Visceral leishmaniasis.

Visceral leishmaniasis, or Kala-azar, is a disseminated infection caused by several subspecies of the L.donovani. The disease is estimated by the World Health Organization (WHO) to affect approximately 12 million people in 88 countries1. It is transmitted to humans by bites of the Phlebotomus sandflies, which acquire infection from feeding on infected animals. Though it is a disease found in poor countries, in Southern Europe, it has become the leading opportunistic infection in AIDS patients2-3.

Identification of L. donovani organism from the blood, bone marrow, liver, lymph nodes or the spleen provides a definite mean of diagnosis. Serological detection of anti-L. donovani IgM is found to be an excellent marker for the acute Visceral leishmaniasis. Tests used in clinic are included ELISA, fluorescent antibody or direct agglutination tests 4-5. Recently, utilization of L. donovani specific protein in the test has improved the sensitivity and specificity dramatically6-7. One step Leishmania IgG/IgM Test is a simple, visual qualitative test that detects L. donovani antibodies in human Whole Blood/serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes.

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The One step Leishmania IgG/IgM Test is a qualitative membrane strip based immunoassay for the detection of L. donovani antibodies (IgG and IgM) in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing L. donovani recombinant envelope antigens conjugated with Colloid gold (L. donovani conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of IgG anti- L. donovani, T2 band is coated with antibody for the detection of IgM anti- L. donovani, and the C band is pre-coated with goat anti rabbit IgG. 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. IgM anti- L. donovani, if present in the specimen, will bind to the L. donovani conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a Leishmania IgM positive test result and suggesting a fresh infection. IgG anti- L. donovani if present in the specimen will bind to the L. donovani conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a Leishmania IgG positive test result and suggesting a recent or repeat infection. Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

Leishmania IgG/IgM Test Procedure

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