INTENDED USE
PocTell® Tuberculosis TB Rapid Test Device (Whole Blood/Serum/Plasma) is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) anti-Mycobacterium Tuberculosis (M.TB) in human serum , plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with M. TB. Any reactive specimen with the TB IgG/ IgM Rapid Test device must be confirmed with alternative testing method(s) and clinical findings..
Ordering Information
|
Test Item |
Format |
Specimen |
Reaction Time |
Shelf life |
Kit Size |
|
Tuberculosis TB |
Cassette |
S / P / WB |
1 mins |
24 months |
25 T/Kit |
TEST PRINCIPLE
PocTell® Tuberculosis TB Rapid Test Device (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay based on the principle of the sandwich technique. The test cassette consists of: 1) a burgundy colored conjugate pad containing M.TB antigens conjugated with colloid gold (M.TB conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane device containing two test bands (IgG and IgM bands) and a control band (C band). The IgM band is pre-coated with monoclonal anti-human IgM for the detection of IgM anti- M.TB, IgG band is pre-coated with reagents for the detection of IgG anti- M.TB , 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. Anti-M.TB IgM if present in the patient specimen will bind to the M.TB conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored IgM band, indicating a M.TB IgM positive test result. Anti-M.TB IgG if present in the patient specimen will bind to the M.TB conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a burgundy colored IgG band, indicating a M.TB IgG 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 the presence of any antibodies to M.TB. Otherwise, the test result is invalid and the specimen must be retested with another device..
DIRECTIONS FOR USE
Bring the specimen and test components to room temperature Mix the specimen well prior to assay once thawed. Place the test device on a clean, flat surface.
1.Bring the specimen and test components to room temperature. Place the test device on a clean, flat surface.
2.Be sure to label the device with specimen's ID number.
3.Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 2 drops (about 50 µL) of specimen into the sample well making sure that there are no air bubbles. Then add 1 drop (about 40 µL)of buffer into the sample well. Set up timer.
Results can be read in 10 minutes. Positive results can be visible in as short as 1 minute. Don't read result after 10 minutes. To avoid confusion, discard the test device after interpreting the result. .
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