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Chlamydia pneumoniae(Cpn)-IgM antibody Cassette

Chlamydia pneumoniae(Cpn)-IgM antibody Cassette
Chlamydia pneumoniae(Cpn)-IgM antibody Cassette
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Product Code : 07
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Product Description

INTENDED USE

This kit of Chlamydia Pneumonia is used to qualitatively detect the existence of Cpn -IgM antibodies present in the serum or plasma sample, as an auxiliary clinical diagnostic reagent of Cpn infection in early stages. Chlamydia Pneumoniae is a species of Chlamydophila, which is an obligate intracellular bacterium that infects the humans and also is a major cause of pneumonia. It is infected through the the respiratory transmission and can breed in human epithelial cells, alveolar macrophages, endothelial cells, smooth muscle cells and neutrophils. It is the main cause of the human atypical pneumonia, pharyngitis, bronchitis, sinusitis, otitis media, myocarditis, iritis, and other diseases. 5 to 10 percent of the community acquired pneumonia, sinusitis and bronchitis was caused by Cpn. In addition, aetiology and epidemiology research shows that the Cpn infection is associated with cardiovascular disease.

PRINCIPLES OF THE TESTS

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

MAIN CONSTITUENT

  • Test kit (Coating the recombinant Cpn 40Ku-73 Ku antigen on T-line, the goat-anti-mouse IgG antibody on C-line): 40 test cards/ box

  • The sample diluents: 1 bottle (5 ml)

  • Product instruction: 1

STORAGE CONDITIONS AND THE PERIOD OF VALIDITY

  • Can be stored for 24 months in a dry place at 4° to 30℃

  • Use test card within 1 hour once opened to atmosphere where the humidity is below 60%, or use it immediately if the humidity is higher

SAMPLE REQUEST

  • Serum and plasma samples are collected from the venous blood by the conventional method. Plasma sample: add 100ul heparin solution (1%) to 5 to 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.

  • Serum and plasma samples can be stored at 4℃ if test is done within 5 days or else store at -20 ℃ and not more than 3 times of freeze-thaw.

  • Whole blood samples should be stored at 2 to 8℃ and should be tested within 3 days, it cannot be frozen.

  • The test result is invalid for hemolytic sample.

TEST PROCEDURE

  • Test preparation: 10μL, 100μL micropipettes, and matched tips

  • Test process: Make sure that before the test the temperature of the kit and the sample should be the same with the room temperature. Place the test card on a horizontal dry work surface. Add 10μL serum or plasma sample into the sample well and then add 100 μL of sample dilution immediately. Observe the result in 15 to 20 minutes after the serum or plasma samples are added. The observation is invalid after 20 minutes.

TEST RESULTS EXPLAIN

The color developed on C line only: negative; color developed on both C line and T line: positive; color developed on T line only: invalid; color not developed on both C line and T line: invalid.

Note: Re-detection if the detected result is invalid. The invalid test cards should be dealt with as infectious pollutants and the temperature of the kit and sample should be the same with room temperature before pre-detection.

LIMITATION

  1. It was vulnerable to the visual error or the subjective judgment factors duplicate the detection when the stripe color is not obvious.

  2. The detection card is one of the assistant diagnostic methods; its test results are only for the reference and should not be the sole base for clinical diagnosis and its treatment. The positive results should be further verified by other methods also. Due to the limit of its detection sensitivity, the negative results should also be observed because the concentration of the antibodies is lower than the analysis sensitivity. It should combine with the clinical diagnosis, medical history, and other detection methods.

  3. During the early stage of infection, IgM may not be generated or may be in low titer. It may give negative results. Suggest the patients review the test in 7 to 14 days and do the parallel detection to the old samples at the same time, so as to confirm whether the serological positive or titer increased significantly.

  4. The results will be unreliable for patients with impaired immune function or immunosuppressive treatment.

  5. Positive results will not only occur in the primary infection but also in the secondary infection.

  6. This test kit is a qualitative test and cannot be used for determining the antibody levels.

  7. It is used for the test of serum or plasma samples only, not for saliva, urine or any other body fluids testing.

PRODUCT PERFORMANCE INDICATORS

Positive coincidence rate: to the internal reference (+/+) =10/10; Negative coincidence rate (-/-) =10/10; precision (n=10): positive for all tests, and develop color equably; Minimum detection limit: positive end point is not less than 1:8 dilution of positive reference. The samples which is positive with toxoplasma IgM antibody (S/C value: ≤ 13.65), rubella virus IgM antibody (S/C value: ≤ 11.42), cytomegalovirus IgM antibody (S/C value: ≤ 13.41), herpes simplex virus II IgM antibody (S/C value: ≤ 12.53), Toxoplasma IgG antibody (S/C value: ≤ 13.45), rubella virus IgG antibody (S/C value: ≤ 10.39), cytomegalovirus IgG antibody (S/C value: ≤ 13.15), herpes simplex virus II IgG antibody (S/C value: ≤ 14.28), hepatitis B virus surface antigen (S/C value: ≤ 13.57), hepatitis C virus surface antigen positive (S/C value: ≤ 14.75), Treponema pallidum antibody (S/C value: ≤ 12.35), HIV (S/C values: ≤ 11.37), HEV-IgM (S/C values: ≤ 12.15), MP-IgM (S/C values: ≤ 9.23), MP-IgG (S/C values: ≤ 9.66), RSV-IgM (S/C values: ≤ 5.56) rheumatoid factor (≤ 54IU/ml), antinuclear antibody (≤ 1:640), staphylococcus aureus etc cannot affect results. There is an impact in the test when the lipid content of the sample is higher than 6mmol / L and the bilirubin level is higher than 40μmol / L.

PRECAUTIONS

  • When the kit test result is positive use other methods also for confirmation

  • Avoid the test card being exposed in the air for a long time since it can absorb moisture that can affect the test results. Use the test card within 1 hour once opened to the atmosphere and humidity is below 60%, or use it immediately if the humidity is higher.

  • The degree of coloration on the test line does not connect to the antibody titers in the test sample.

  • The color of C line is likely to abate when the content of the Cpn-IgM is extremely high in the sample. It is a normal phenomenon.

  • Be attentive to the potential biological risks. Wear necessary protective equipment, and deal with the waste as infectious material.

 


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