PCT FIA Test

The RaFIA Procalcitonin (PCT) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of PCT in human serum, plasma or whole blood. This test is intended for in vitro diagnostic use only.
PCT is a pro-hormone that belongs to the calcitonin protein superfamily. In healthy people, PCT levels in the blood are low (~0.05 ng/mL), but increase rapidly in response to a systemic bacterial infection. The concentration of PCT in the blood correlates with both bacterial load and severity of infection. The half-life of circulating PCT is short, only 25-30 hours. Therefore, PCT is a good biomarker for the specific detection of a systemic bacterial infection.
The PCT FIA Test was developed to detect circulating procalcitonin antigen in serum, plasma and whole blood within 15 minutes, without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.

PRODUCT FEATURES

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

RANGES

  • Working range: 0.1–100.0 ng/mL

PRECISION

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

ACCURACY

  • PCT 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 PCT reference materials at 0.1–100.0 ng/mL 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

Instruction for Use

Catalog #

Product

Quantity

Specimen

F0400PCT FIA Test25/kitSerum, Plasma, Whole blood

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Materials required but not provided:

Catalog #

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FIA-100Immunofluorescence Analyzer

Catalog #

Product

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

FOR EXPORT ONLY