PRL FIA Test

The Prolactin (PRL) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of PRL in human serum using the RaFIA system. This test is intended for in vitro diagnostic use only.

PRL is a single chain protein secreted by anterior pituitary basophils consisting of 199 amino acids and with a molecular weight of 23 kDa. PRL has the function of promoting proliferation of mammary glands and lactation. The level of PRL rises during pregnancy, reaches its peak at delivery and then declines after lactation. The concentration of PRL in blood can rise due to certain pituitary tumors, such as prolactin-producing tumors, hypothalamus tumors, and other conditions, including acromegalia and primary hypothyroidism.

The PRL FIA Test was developed to detect the concentration of prolactin in serum within 20 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

RANGES

  • Working range: 5.0-4000.0 μIU/mL

PRECISION

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

ACCURACY

  • PRL 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 PRL reference materials at 5.0-4000.0 μIU/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

Catalog #

Product

Quantity

Specimen

F1080PRL FIA Test25/kitSerum, Plasma

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Materials required but not provided:

Catalog #

Product

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