CRP Quantitative Test

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NewScen Coast Bio-Pharmaceutical Co., Ltd

Business Type:Manufacturer

Country/Region:China

Ddu Verified

HOT Rank

8/10

Product Information

  • Certification:ISO13485
  • Brand Name:NewScen
  • Trademark:NewScen
  • Place of Origin:China
  • Warranty:2 years

Description

INTENDED USE
This CRP Quantitative Test Cassette is intended for use in the detection of C-reactive Protein in human serum/plasma or whole blood, at a cutoff concentration of 1mg/L. It is for health care professional use only.

PRINCIPLE OF THE PROCEDURE
The CRP Quantitative Test is a chromatographic immunoassay (CIA) for the detection of antigens to CRP in human serum/plasma or whole blood. CRP specific antibody are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with CRP specific antibodies. Antigen to CRP, if present, a red colored band will develop on the membrane in proportion to the amount of CRP antigens presented in the specimen. Absence of this red colored band in the test region suggests a negative result.To serve as a procedural control, red colored band in the control.

ASSAY PROCEDURE
1. Collect whole blood/serum/plasma specimen with a clean dry container.
2. Take the sample dilution, and blood/serum/plasma sample.Carefully apply 1ml sample dilution and apply 5μl serum/plasma or 10μl blood into a centrifuge tube, oscillate and mix them to diluted sample.
3. Remove the test cassette from pouch by tearing.
4. Carefully apply 100μl of diluted sample into the S well.
5. Read the result in to 15 -20 minutes following the reader.

INTERPRETATION OF RESULTS


 
Result: When the result shows CRP ≥ 10 mg/L, that means infected, usually CRP concentrate rise low or moderate levels, that means mild and moderate bacterial infection; when the result shows CRP ≥ 50 mg/L, that means universality infection.As vascular risk factor assessment, when the test result shows CRP>3 mg/L, it may have risk of coronary heart disease, it should be according to clinical manifestation and former measured value to determine. When the result shows “>200mg/L”, that means the concentrate of CRP in the sample is higher than the test range limit.
Invalid: If no band appears in the control region(C), regardless of the presence or absence of band in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.


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