Intended use
CRP is a fluorescence Immunoassay (FIA) for the quantitative determination of CRP in human whole blood/serum/ plasma. It is useful as an aid in management and monitoring of autoimmune diseases and infectious processes, such as rheumatoid arthritis.
For in vitro diagnostic use only.
Summary
The C-Reactive Protein (CRP) is synthesized by the liver in response to interleukin-6 and well known as one of the
classical acute-phase reactants and as a marker of inflammation. CRP is the first acute-phase protein to be described
and is an exquisitely sensitive systemic marker of inflammation and tissue damage. The acute-phase response
comprises the nonspecific physiological and biochemical responses of endothermic animals to most forms of tissue
damage, infection, inflammation, and malignant neoplasia. The serum CRP level may rise from a normal level of <5 mg/L
to 500 mg/L during the body's general, non-specific response to infectious and other acute inflammatory events. For some
time, the measurement of CRP concentration has been used as a clinical tool for monitoring autoimmune diseases and
infectious processes, such as rheumatoid arthritis.
PRODUCT PARAMETER
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TEST INFORMATION |
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Method |
Microfluidic Fluorescent Immunoassay |
Test |
LYOFIA® CRP |
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Format |
Cassette |
Reaction Time |
5min |
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Linearity |
0.4～200mg/L |
Reference Interval |
hs-CRP≤1mg/L |
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Sample |
WB / S / P / FB |
Certificate |
CE/NMPA |
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ORDERING |
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Cat. No. |
LMIFCR25 |
Applicable analyzer |
LYOFIA-I, LYOFIA 8, |
Kit Size |
25T |
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Cat. No. |
LAIFCR25 |
Applicable analyzer |
LYOFIA 100 (Full-Automatic) |
Kit Size |
25T |
FAQ
Q: Limit of detection and Linearity?
A: Limit of detection: Not higher than 0.4 mg/L. Linearity: Linear interval is [0.4, 100] mg/L.
Q: What about the Precision?
A: Repeatability imprecision: The coefficient of variation (CV) is not more than 10%.
Within-laboratory imprecision: The coefficient of variation (CV) is not more than 10%.
Inter-lot imprecision: The coefficient of variation (CV) is not more than 15%.
Q: If peripheral blood is applicable to this test?
A: Yes, peripheral blood (finger blood) is applicable to this test, as well as whole blood, serum, plasma.
Q: What about the kit size?
A: Normally 25tests/kit, customized kit size will be acceptable.
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