LH CLIA Test CE

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

Luteinizing hormone (LH), also known as interstitial cell-stimulating hormone (ICSH), is a glycoprotein polypeptide hormone plays an important role in the regulation of normal growth, sexual development, and reproductive function.

LH stimulates secretion of sex steroid hormones from the gonads. In females, ovulation of mature ovarian follicles is induced by a spike in LH levels that is sometimes referred to as the “LH surge.” LH is also required for development and maintenance of the corpus luteum, which secretes estrogen and progesterone steroid hormones. In males, LH stimulates synthesis and secretion of testosterone by binding to its receptors on Leydig cells.

Abnormal LH 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), 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 LH concentration and related hormones, therefore, is very important for both females and males. The LH CLIA Test is intended for testing in patients with any signs and symptoms of suboptimal LH 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 WHO International Standard for luteinizing hormone
  • Sample volume: 70 μL

Range

Working range: 0.1-200 mIU/mL

Detection Limits

Limit of Detection (LOD): 0.1 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 0.1 and 200 mIU/mL

Specificity

No significant cross-reactivity was observed when TSH (100 μIU/mL), FSH (200 mIU/mL), or hCG (20,000 mIU/mL) were added to the LH Calibrator CAL 1, respectively. The results of LH in these samples were less than 0.1 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 LH concentration up to 1000 mIU/mL.

Reagents and Materials provided:

  1. 19-well LH 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 LH antigen at:
    1. 0 mIU/mL
    2. 5 mIU/mL
    3. 50 mIU/mL
  3. 2-level quality controls* containing recombinant LH antigen at:
    1. 10 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
L1090LH CLIA Test 36/kitS/P
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MATERIALS REQUIRED BUT NOT PROVIDED:
CLIA-1CLIAlyzer  

FOR EXPORT ONLY