Product Details
Dust Mite IgE Rapid Test Cassette, Detection of Human IgE Antibody
to Dust Mite
Product: | Dust Mite IgE Rapid Test Cassette,Detection Of Human IgE Antibody
To Dust Mite |
Specimen: | WB/S/P |
Principle: | Chromatographic Immunoassay |
Storage Temperature: | 2-30°C |
Sensitivity: | 98.20% |
Accuracy: | 97.60% |
Cat. No.: | ODME-402 |
Pack: | 10 T |
Format: | Cassette |
Shelf Life: | 2 Years |
Specificity: | 96.80% |
Cut-Off: | 0.35 IU/MI |
Application
A rapid test for the qualitative detection of human IgE antibody to
Dust Mite in human venipuncture whole blood, serum or plasma
specimen.
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.
Company Profile
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.
Our products are used in the clinical market to help people live
more healthy lives. When you select CITEST products, you can be
assured of high performance and accuracy along with a dedicated
customer support team.