FSH CLIA Test CE

The Follicle-Stimulating Hormone (FSH) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of FSH in human serum or plasma (sodium heparin, K2EDTA, or K3EDTA) using the ALTA CLIAlyzer.

Follicle-stimulating hormone (FSH) is a glycoprotein polypeptide hormone that plays a vital role in regulating normal growth, sexual development, and reproductive function.

In females, FSH stimulates the growth, development, and maturation of ovarian follicles. As the follicle matures, estrogen levels increase, which results in suppression of FSH production. In males, FSH stimulates production of testosterone and spermatogenesis by activation of Sertoli cells in the testes.

Abnormal FSH levels have been found during aging, pregnancy, precocious puberty, menopause, castration, throughout hormone therapy, and in a variety of cases, including primary ovarian insufficiency, primary testicular failure, polycystic ovarian syndrome (PCOS), Klinefelter syndrome, Turner syndrome, multiple endocrine neoplasia, congenital adrenal hyperplasia, pituitary or adrenal tumors, thyroid disease, hypopituitarism, hypogonadism, eating disorders and organ failure.

Understanding optimal levels and accurate measurement of FSH and related hormones are very important for females and males. Immunoassay measurement of FSH in human serum is a first-line approach in assessing FSH levels, providing important information for diagnostic and monitoring purposes. The CTK FSH CLIA Test is intended for testing in patients with any signs and symptoms of suboptimal FSH levels, including issues with fertility, menstruation, and puberty.

  • Individual ready-to-use cartridges
  • Combines the sandwich immunoassay technique with enzyme-catalyzed chemiluminescence detection
  • Calibration kit follows national standard for follicle stimulating hormone immunoassay
  • Sample volume: 70 μL

Range

Working range: 0.2-200 mIU/mL

Detection Limits

Limit of Detection (LOD): 0.2 mIU/mL

Precision

Intra-lot Precision

CV less than 8%

Inter-lot Precision

CV less than 15%

Accuracy

Accuracy of ± 10% in comparison to the control

Linearity

Linearity between 0.2 and 200 mIU/mL

Specificity

No significant cross-reactivity was observed when TSH (100 μIU/mL), LH (200 mIU/mL), or HCG (20,000 mIU/mL) were added to the FSH Calibrator CAL 1, respectively. The results of FSH in these samples were less than 1 mIU/mL.

Interference 

No significant interference was detected up to the concentrations mentioned below:

SubstanceConcentration
Hemoglobin500 mg/dL
Bilirubin20 mg/dL
Triglyceride1500 mg/dL
Total Protein10 g/dL
Rheumatoid Factor1000 IU/mL

HAMA interference

Patient specimens containing human anti-mouse antibodies (HAMA) may give falsely elevated or decreased values. Although HAMA-neutralizing agents are added, extremely high HAMA serum concentrations may occasionally affect the results.

Hook effect

There is no high-dose hook effect at FSH concentration up to 1000 mIU/mL.

Reagents and Materials provided:

  1. 19-well FSH reagent cartridge
    1. Sample well (1st well)
    2. Reading well for chemiluminescent signal (19th well)
    3. Foil-sealed wells (2nd to 18th wells) comprised of a barcode indicating reagent assay information, the reagent lot number and the expiration date
  2. 3 Calibrators containing recombinant FSH antigen at:
    1. 0 mIU/Ml
    2. 5 mIU/mL
    3. 100 mIU/mL
  3. Two-level quality controls* containing Recombinant FSH antigen at:
    1. 15 mIU/Ml
    2. 40 mIU/mL
  4. Registration card
  5. Calibrator card
  6. Quality Control Sheet
  7. Instructions for Use

*Quality control values are lot specific and refer to the quality control sheet.

Materials required but not provided:

  1. Pipette with disposable tip to dispense up to 100 μL
  2. For other specific materials and disposables, refer to CLIAlyzer user manual
  3. CLIAlyzer instrument
  4. Powderless gloves
CATALOG #PRODUCTQUANTITYSPECIMEN
L1100FSH CLIA Test36/kitS/P
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MATERIALS REQUIRED BUT NOT PROVIDED:
CLIA-1CLIAlyzer

FOR EXPORT ONLY