Sickle Cell Rapid Test

PocTell® Sickle Cell rapid test is lateral flow immuno-chromatographic qualitative assay to aid in rapid diagnosis of sickle cell disorder of hemoglobin A, S and C using whole blood sample for human. This In-vitro diagnostic test is for professional use only..

INTENDED USE

PocTell^® Sickle Cell rapid test is lateral flow immuno-chromatographic qualitative assay to aid in rapid diagnosis of sickle cell disorder of hemoglobin A, S and C using whole blood sample for human. This In-vitro diagnostic test is for professional use only..

Ordering Information

Test Item	Format	Specimen	Reaction Time	Shelf life	Kit Size
Sickle Cell	Cassette	S / P / WB	5 mins	24 months	25 T/Kit

TEST PRINCIPLE

The PocTell^® Sickle Cell Rapid test is a double antibody lateral flow chromato-graphic immunoassay. The test cassette consists of 1) a nitrocellulose membrane strip containing a test line (HA, HS and HC)

pre-coated with monoclonal antibodies and a control line (C line) pre-coated with Goat anti Mouse IgG. 2) Conjugate pad containing monoclonal antibodies to sickle cell conjugated with colloidal gold. When an adequate volume of test specimen applied to the sample well of the test cassette,the specimen migrates by capillary action across the cassette. Hemoglobin variant A, S and C, if present in the specimen, will bind to the antibody and will form the complex with coated and conjugated antibodies. The immune-complex migrates on the membrane, when it reaches the test line; it will be captured by pre-coated antibodies and forms a visible Pink / Purple band.

The control line is a procedural control should appear always.

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DIRECTIONS FOR USE

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

1. Remove the test device from the sealed foil pouch and use it as soon as possible. Place the test

device on a clean and level surface. Best results will be obtained if the assay is performed immediately after opening the foil pouch.

2. Remove the aluminum film. Take 5μl of whole blood sample into the extraction tube, insert the tip then mix sample by Shaking for 10 times.

3. Dispense 2 to 3 drops (approximately 80~120μl) of mixed sample buffer to sample well of the test device.

4. Wait for the colored line(s) to appear. Read the results at 10 minutes. Do not interpret the result after 15 minutes..

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