INTENDED USE
PocTell® Filariasis IgG IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-lymphatic filarial parasites (W. bancrofti, B. Malayi and B. Timori) in human serum, plasma or whole blood. This test is intended to be used as a screening test and as an aid in the diagnosis of infection with lymphatic filarial parasites. Any reactive specimen with the Filariasis IgG/IgM Rapid Test must be confirmed with alternative testing method(s).
Ordering Information
|
Test Item |
Format |
Specimen |
Reaction Time |
Shelf life |
Kit Size |
|
Filariasis |
Cassette |
S / P / WB |
15 mins |
24 months |
25 T/Kit |
TEST PRINCIPLE
The PocTell® Filariasis IgG IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant W. bancrofti, B. Malayi and B. Timori common antigens conjugated with colloid gold (Filariasis 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 monoclonal anti-human IgM for the detection of IgM anti- W. bancrofti, B. Malayi and B. Timori, T2 band is pre-coated with reagents for the detection of IgG anti-W. bancrofti, B. Malayi and B. Timori, 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 cassette, the specimen migrates by capillary action across the cassette. W. bancrofti, B. Malayi or B. Timori IgM antibodies if present in the specimen will bind to the Filariasis conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored T2 band, indicating a W. W. bancrofti, B. Malayi or B. Timori IgM positive test result.
W. bancrofti, B. Malayi or B. Timori IgG antibodies if present in the specimen will bind to the Filariasis conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a burgundy colored T1 band, indicating a W. bancrofti, B. Malayi or B. Timori IgG positive test result.
Absence of any test 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 test bands. Otherwise, the test result is invalid and the specimen must be retested with another device.
DIRECTIONS FOR USE
Allow test device, specimen, buffer and/or controls to reach room temperature (15 30°C) prior to testing.
1.Bring the specimen and test components to room temperature if refrigerated or frozen. Place the test device on a clean, flat surface.
2.For add specimen
3.Apply 2 drops of specimen (about 50 µL) into the sample well. Then add 1 drop of buffer(about 40 µL) into the sample well immediately.
4.Set up timer. Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute. Don't read result after 20 minutes. .
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