FSH FIA Test

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

Follicle-stimulating hormone is a glycoprotein hormone secreted by anterior pituitary basophil cells, and consists of an α peptide chain and a β peptide chain linked through covalent bond. FSH, controlled by hypothalamic gonadotropin, promotes the function of maturation of follicles in females, while it promotes the formation and maturation of the seminiferous ducts in males. The increase of the concentration of FSH can forecast ovulation according to the peak of the FSH and LH emerging at the same time at the mid-menstrual period. It can promote the maturation of follicles, cell proliferation in the granular layer, activate the aromatizing enzyme and increase the secretion of estriol. Furthermore, the formation of the follicles is due to the coordinating role of estriol and a few Luteinizing hormones. Therefore, FSH is considered as a biomarker for the detection of infertility.

The FSH FIA Test was developed to detect the concentration of FSH 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: 0.30-200.00 mIU/mL

PRECISION

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

ACCURACY

  • FSH 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 FSH reference materials at 1.00-200.00 mIU/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

F1100FSH FIA Test25/kitSerum, Plasma

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Materials required but not provided:

Catalog #

Product

FIA-100Immunofluorescence Analyzer

Catalog #

Product

FIA-101Immunofluorescence Incubator

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

FOR EXPORT ONLY