INTENDED USE
PocTell® Chikungunya IgG IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM anti-chikungunya virus (CHIK) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with CHIK. Any reactive specimen with the Chikungunya IgG/IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.
Ordering Information
|
Test Item |
Format |
Specimen |
Reaction Time |
Shelf life |
Kit Size |
|
Chikungunya |
Cassette |
S / P / WB |
15 mins |
24 months |
25 T/Kit |
TEST PRINCIPLE
PocTell® Chikungunya IgG IgM Rapid Test is a lateral flow chromatographic immunoassay based on the principle of the IgG/IgM capture assay. The test cassette consists of: 1) a burgundy colored conjugate pad containing CHIK antigens conjugated with colloid gold (CHIK conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane device containing a test band (T1 or T2 band) and a control band (C band). The T1 band is pre-coated with anti-human IgM antibody, the T2 band is pre-coated with anti-human IgG antibody 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. The IgM antibody to CHIK, if present in the specimen will bind to the CHIK conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored T1 band, indicating a CHIK IgM positive test result. The IgG antibody to CHIK, if present in the specimen will bind to the CHIK conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgG antibody, forming a burgundy colored T2 band, indicating a CHIK 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 of the color development on the T band. 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 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 device on a clean and level surface. Hold the dropper vertically and transfer 2 drops of Sample (approximately 50 µL) to the specimen well (S) of the test device, then add 1 drops of buffer (approximately 40 µL) and start the timer.
3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret results after 20 minutes.
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