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Total IgE Rapid Test

Total IgE Rapid Test

A rapid test for the qualitative detection of human IgE antibodies in whole blood, serum or plasma specimen. For professional in vitro diagnostic use only.

Product Introduction

INTENDED USE

 

A rapid test for the qualitative detection of human IgE antibodies in whole blood, serum or plasma specimen. For professional in vitro diagnostic use only.

PocTell® Total IgE Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of human IgE antibody in whole blood, serum or plasma to aid in the diagnosis of allergy..

Total IgE Rapid Test Cassette
Total IgE Rapid Test001

 

Ordering Information

 

Test Item

Format

Specimen

Reaction Time

Shelf life

Kit Size

IgE

Cassette

S / P / WB

5 mins

24 months

25 T/Kit

 

TEST PRINCIPLE

 

PocTell® Total IgE Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, lateral flow immunoassay for the detection of human IgE antibody in whole blood, serum or plasma specimens. In this test, mouse anti-human IgE is coated in the test line region of the test.

During testing, IgE present in whole blood, serum or plasma specimen reacts with mouse anti-human IgE coated particles in the test strip. The mixture then migrates forward on the membrane by capillary action and reacts with the mouse anti-IgE on the membrane in the test line region. The presence of a colored line in the test line region indicates a positive result for IgE, while its absence indicates a negative result for that infection.

To serve as a procedural control, a colored line will always appear in the control line region of the strip indicating that proper volume of specimen has been added and membrane wicking has occurred..

 

36020250617135728

 

DIRECTIONS FOR USE

 

Allow the test, 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 cassette from the sealed pouch and use it within 1 hour.

2. Place the cassette on a clean and level surface.

For Serum or Plasma specimen:

Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50μL) to the specimen well, and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75μL) to the specimen well, then add 1 drop of buffer (approximately 40μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

Fill the capillary tube and transfer approximately 75μL of fingerstick whole bloodspecimen to the specimen well of test cassette, then add 1 drop of buffer (approximately 40μL) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes..

 

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