Intended use
Microfluidic FIA PCT POCT kit is a fluorescence Immunoassay (FIA) for the quantitative determination of Procalcitonin (PCT) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of bacterial infection and sepsis.
For in vitro diagnostic use only.
Summary
Identifying sepsis is a daily challenge in intensive care unit of every hospital. Early assessment of sepsis is vital for determination of the appropriate treatment since various therapeutic strategies are known to improve survival of patients with sepsis.
In healthy people, the concentration of plasma PCT is below 0.1ng/mL. The level of PCT rises rapidly after a bacterial infection with
systemic consequences. It can also be elevated by other situation such as major surgery, severe burns, or in neonates. However, it
returns to baseline rapidly. Viral infections, bacterial colonization, localized infections, allergic disorders, autoimmune diseases, and
transplant rejection do not usually induce a significant PCT response (values <0.5 ng/mL). Therefore, by evaluating PCT concentrations, the physicians are able to engage in the risk assessment for progression to severe sepsis and septic shock.
详情图片
PRODUCT PARAMETER
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TEST INFORMATION |
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Method |
Microfluidic Fluorescent Immunoassay |
Test |
LYOFIA® PCT |
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Format |
Cassette |
Reaction Time |
10min |
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Linearity |
0.02～100ng/mL |
Reference Interval |
＜0.05ng/mL |
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Sample |
WB / S / P |
Certificate |
CE/NMPA |
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ORDERING |
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Cat. No. |
LMIFPC25 |
Applicable analyzer |
LYOFIA-I, LYOFIA 8, |
Kit Size |
25T |
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Cat. No. |
LAIFPC25 |
Applicable analyzer |
LYOFIA 100 (Full-Automatic) |
Kit Size |
25T |
FAQ
Q: How about the Applicable analyzer?
A: LYOFIA-I, LYOFIA8, LYOFIA100
Q: Certificates?
A: Chinese NMPA, CE IVDD, ISO13485.
Q: How about QC?
A: Both Analyzer QC and Reagent QC are available.
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