Dust Mite IgE Rapid Test Cassette, Detection of Human IgE Antibody to Dust Mite

Application

For professional in vitro diagnostic use only.

The Dust Mite IgE Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of human IgE antibody to dust mite in venipuncture whole blood, serum or plasma to aid in the diagnosis of allergy.

DIRECTIONS FOR USE

Allow the test, specimen, and buffer to reach room temperature (15-30 ℃ ) 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 1 drop of serum or plasma (approximately 25 μL) to the specimen well (S), then add 2 drops of buffer (approximately 80 μL),and start the timer. See illustration below.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 μL) to the specimen well (S), then add 2 drops of buffer (approximately 80 μL), and start the timer. See illustration below.

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

Note: It’s not suggested to use the buffer beyond 6 months after opening the vial.

INTERPRETATION OF RESULTS

POSITIVE:* Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region may vary depending on the concentration of human IgE antibodies to Dust Mite present in the specimen.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

SUMMARY

Allergens from dust mites and other indoor allergens are ubiquitous allergens to which people are exposed and become sensitised.

As a result of dusting, vacuuming, bed-making, or any other activity that causes settled dust to become airborne, the faecal pellets and smaller allergen-bearing particles become temporarily suspended in the air (the faecal pellets are too large to stay there for very long) and may become inhaled. Those people who are atopic (i.e. are genetically predisposed to develop allergic reactions to common allergens like those derived from pollens, dust mite and animal skin scales) respond to this exposure either by making IgE antibodies, which then bind with immunologically active cells to cause the release of mediators such as histamine, and the development of localized inflammation. The allergic reactions are manifest as symptomatic asthma, eczema, rhinitis and conjunctivitis.

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

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