CRP FIA Test

The C-Reactive Protein (CRP) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of CRP in human serum, plasma or whole blood, with a cut-off level of 10 mg/L, using the RaFIA system. This test is intended for in vitro diagnostic use only.
The levels of CRP in the blood provide information to healthcare practitioners as to whether inflammation is present, without identifying the source of the inflammation. This information can be used in conjunction with other factors such as signs and symptoms, physical exam and other tests to determine if the patient has an acute inflammatory condition or is experiencing a chronic inflammatory disease flare-up.
The CRP FIA Test was developed to detect circulating CRP in serum, plasma and whole blood within 3 minutes, without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.

  •  Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests

LIMINTS AND RANGES

  • Working range: 2.5–200 mg/L
  • Limit of Detection (LoD): 2.5 mg/L

PRECISION

  • Intra-lot Precision
    Intra-lot precision was determined by testing of CRP reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision
    Inter-lot precision was determined by testing of CRP reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.

ACCURACY

  • CRP control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.

LINEARITY

  • A serial concentration of CRP reference materials at 2.5–200 mg/L was tested, and the correlation coefficient (R) is ≥0.9900.

REAGENTS AND MATERIALS PROVIDED:

  1. Individually sealed foil pouches containing:
    a. One test device
    b. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use

MATERIALS REQUIRED BUT NOT PROVIDED:

  1.  Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator

Instructions for Use

Catalog #

Product

Quantity

Specimen

F0410CRP FIA Test25/kitSerum, Plasma, Whole blood

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Materials required but not provided:

Catalog #

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Catalog #

Product

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To learn about distribution opportunities or for additional product information, please contact info@ctkbiotech.com

FOR EXPORT ONLY