One Step Test for Hs-CRP (Colloidal Gold)
One step test for hs-CRP (Colloidal Gold)
Intended Use
One Step Test for hs-CRP(Colloidal Gold) applies colloidal gold
immunochromatography to detect
high-sensitivity C-reactive protein(hs-CRP)in serum,plasma and whole blood samples
semi-quantitatively or quantitatively.This test supports the detection of mild or early
forms of
cardiovascular disease.
Principle of the Procedure:
Two kinds of high specific and sensitive anti-human hs-CRP monoclonal antibodies
are used for the test strips. One is gold-labelled and coated on the polyester film,and
the other is fixed on the test line of the product.The antibodies form sandwich
complexes with any hs-CRP in the blood sample. The sample passes through the
detection zone, in which the hs-CRP sandwich complexes gather along a line,appearing
as a purplish red streak(the test or signal line).Excess gold-l abelled
antibodies gather along the control line, signaling visually that the test is valid. The
intensity of the test line increases in proportion to the hs-CRP concentration.
Warnings and Precautions:
1. Use for in vitro diagnostics.
2. Use by healthcare professionals.
3. The best testing temperature is 15~30 ℃, and the best humidity is 40~60%.
4. Do not use the strip beyond the expiration date printed on the outside of the box.
5. The strip must be used within 1 hour once its foil pouch has been opened.
6. The transfer pipette should be used for one specimen only. Discard it after used.
7. Patient specimens, used strip and transfer pipettes may be potentially infectious.
Proper handling and disposal methods should be established by the laboratory direction
in accordance with local regulations.
8. Proper laboratory safety techniques should be followed at all times when working
with potentially infectious blood specimens.
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