INTENDED USE
PocTell® HAV IgG IgM Combo Rapid Test Device (Whole blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM to Hepatitis A Virus (HAV) in whole blood, serum or plasma..
Ordering Information
|
Test Item |
Format |
Specimen |
Reaction Time |
Shelf life |
Kit Size |
|
HAV |
Cassette |
S / P / WB |
15 mins |
24 months |
25 T/Kit |
TEST PRINCIPLE
PocTell® HAV IgG IgM Combo Rapid Test Device (Whole blood/Serum/Plasma) is a qualitative membrane strip based immunoassay for the detection of Hepatitis A Virus IgG and IgM in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing HAV recombinant envelope antigens conjugated with Colloid gold (HAV conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing test band (IgG and IgM band) and a control band (C band). The IgG and IgM bands is pre-coated with the antibody for the detection of IgG and IgM anti-HAV 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. IgG or IgM anti-HAV if present in the specimen will bind to the HAV conjugates. The immunocomplex is then captured by the reagent coated on the IgG or IgM band, forming a burgundy colored IgG or IgM band, indicating a HAV IgG/IgM positive test result and suggesting a fresh infection. Absence of any IgG or IgM 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 IgG or IgM band. Otherwise, the test result is invalid and the specimen must be retested with another device..
DIRECTIONS FOR USE
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1.Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2.Place the test device on a clean and level surface.
3.Transfer 1 drops (approximately 5mL) of Whole blood/ serum/plasma and 2-3drop buffer (approximately 80-120mL) to the sample pad of the strip with a disposable pipette in the kit, and then start the timer.
4.As the test begins to work, you will see color move across the membrane. The result should be read at 15 minutes. Do not interpret the result after 20 minutes..
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