INTENDED USE
PocTell® Leishmania IgG IgM Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies including IgG and IgM to the subspecies of the Leishmania donovani (L. donovani), the Visceral leishmaniasis causative protozoans in human serum or plasma. This test is intended to be used as a screening test and as an aid in the diagnosis of the disease of Visceral leishmaniasis. Any reactive specimen with the Leishmania IgG/IgM Rapid Test must be confirmed with alternative testing method(s).
Ordering Information
|
Test Item |
Format |
Specimen |
Reaction Time |
Shelf life |
Kit Size |
|
Leishmania |
Cassette |
S / P / WB* |
15 mins |
24 months |
25 T/Kit |
TEST PRINCIPLE
PocTell® Leishmania IgG IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant L. donovani specific antigen conjugated with colloid gold (Leishmania conjugates) and rabbit IgG-gold 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 un-conjugated L. donovani antigen, and the C band is pre-coated with goat anti-rabbit IgG antibody.
When an adequate volume of test specimen is dispensed onto the sample pad of the test strip, the specimen migrates by capillary action across the strip. Anti- L. donovani Ab if present in the specimen will bind to the Leishmania conjugates. The immunocomplex is then captured on the membrane by the pre-coated antigen, forming a burgundy colored T band, indicating a L. donovani 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 goat anti-rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on the T band. Otherwise, the test result is invalid and the specimen must be retested with another strip.
DIRECTIONS FOR USE
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2.Place the test strip on a clean and level surface.
Hold the dropper vertically and transfer 2 drops of sample (or approximately 50 μl) to the sample pad of the test strip, then add 1 drop of buffer (or approximately 40 μl) and start the timer.
3.Wait for the red line(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 30 minutes.
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