Mycoplasma Pneumoniae IgG IgM Whole Blood Serum Plasma Infectious Disease Test Kit

Mycoplasma Pneumoniae IgG/IgM Rapid Test, whole blood, serum, or plasma,Infectious Disease Test Kit

A rapid test for the qualitative detection of IgG and IgM antibodies to Mycoplasma Pneumonia (M. pneumonia) in whole blood, serum or plasma CE certified

Applications:

The Mycoplasma Pneumonia IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Mycoplasma Pneumonia in whole blood, serum, or plasma to aid in the diagnosis of Mycoplasma Pneumonia infection.

Description:

Mycoplasma pneumonia is the causative agent of respiratory tract nfectious diseases and complication of other systems. There will be a symptom with headache, fever, dry cough, and muscle pain. People of all age groups can be infected while youth, middle-aged and children under 4 years old have a higher infection rate. 30% of the infected population may have a whole lung infection.

In normal infection, MP-IgG can be detected as early as 1 week after infected, continue to rise very rapidly, peaking in about 2-4 weeks, decreasing gradually in 6 weeks, disappear in 2-3 months. Detection of MP-IgM/IgG antibody can diagnose MP infection in early stage.

How to use?

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

Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

Place the cassette on a clean and level surface. Hold the dropper vertically, draw the specimen (whole blood/serum/plasma) up to the Fill Line as shown in illustration below (approximately 10μl). Transfer the specimen to the specimen position (S) each, then add 2 drops of buffer (approximately 80 μl) to the buffer position (B) each, and start the timer. See the illustration below.

Wait for the colored line(s) to appear. The result should be read at 10 minutes. Do not interpret results after 20 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

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

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Mycoplasma Penumonia antibody present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.

NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test 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 cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

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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