Микоплазма пневмонии МП IGM Кассета для быстрого

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Certificate
GMP
SFDA
ISO13485
ISO9001:2008

Intended Use

 

This kit is used to qualitatively detect the existence of MP -IgMantibodies in serum or plasma sample, as an auxiliary diagnostic reagent of MP infection in clinic. Mycoplasma pneumoniae(MP) is the common pathogenic microorganisms that caused the primary atypical pneumonia and other respiratory infections diseases. In addition to the respiratory tract that MP can cause other serious complication. MP infection is widespread and it can cause pharyngitis, tonsillitis, bronchitis, lung abscess, pulmonary bullae and pleurisy and multi system damage. It is not easy to identify the pneumonia is caused by MP, viruses, bacteria and other pathogens infection. And the treatment of MP infection is different to other bacterial or viral infections. MP –IgM is a specific antibody appeared first after MP infection. It can be detected in 7 days while onset.

 

Principles of the Tests

 

This kit is applying the technology of colloidal gold immunochromatography to qualitative test the MP-IgM antibody of serum or plasma samples. The MP-IgM antibodies in positive sample can combine with colloidal gold labeled mouse anti human IgM immobilized on conjugate pad to form immune complex, and move along the membrane strip by chromatography. Some of the complex is caught by recombinant MP Ag pre-coated on T line to form "gold labeled mouse anti human IgM- MP IgM Ab- MP Ag" and develop color. The remaining free complex will be caught by the goat anti-mouse IgG antibody coated on the C line to develop color. As for negative samples, in which have no MP- IgM antibodies, cannot form immune complexes and develop color on the T line, and colorate on C line only.

 

Main Constituent

 

Test Card (Coating the recombinant MP antigen on T-line (P1-P30), the goat anti-mouse IgG antibody on C-line): 25 test cards/ box

  1. The sample diluent: 1 bottle (5 ml )
  2. Product instruction: 

Sample Request

  1. 1.        Serum and plasma samples were collected from the venous blood by conventional method. Plasma sample: add 100ul heparin solution (1%) to 5 ~ 10ml blood; or sodium citrate solution (3.8%) to plasma according to the proportion of 1:9; or EDTA solution (15%) 0.04ml to 5ml plasma.
  2. 2.        Serum and plasma samples can be stored at 4 °Cif tests will be done within 5 days, otherwise stored at -20 °C. No more than 3 times of freeze-thaw.
  3. 3.        The test result is invalid for hemolysis sample.

 

Test Procedure

  1. 1.        Test preparation: 10μL, 100μL micropipettes and matched tips
  2. 2.        Test process: The temperature of the kit and the test sample should be the same with room temperature before test. Place the test card on a dry horizontal work surface. Add 10μL serum or plasma sample into the sample well, then add 100 μL of sample dilution immediately. Observe the result in 15-20 minutes after the serum or plasma samples added. The observation is invalid after 20 minutes.

 

 

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