AMH CLIA Test CE

The Anti-Müllerian Hormone (AMH) Chemiluminescence ImmunoAssay (CLIA) Test is a chemiluminescence-based immunoassay for the quantitative detection of AMH in human serum or plasma (lithium heparin) using the ALTA CLIAlyzer.

Anti-Müllerian hormone (AMH) or Müllerian inhibiting substance (MIS) is a glycoprotein consisting of two 70-kDa subunits and a member of the transforming growth factor-β super family. In females, AMH is at a detectable range throughout the reproductive period, slowly diminishes during the reproductive senescence and becomes undetectable during post-menopause.

Measurement of AMH has been observed as a reliable assessment of the ovarian reserve. Unlike FSH, the variability of the AMH measurement within the mensural cycle is small, hence it has clinical significance in determining ovarian reserve especially in sub-fertile women prior to ovulation induction, estimation of time of menopause, and diagnosis and follow-up of polycystic ovary syndrome (PCOS). Women with PCOS show 2- or 3-fold higher serum AMH levels than normally ovulating women.

Recently, AMH levels have become a primary marker for female fertility and an important indicator in the treatment and management in female infertility. A fertile woman has AMH levels ranging from 1.0-4.0 ng/mL, while a woman with an AMH level <1.0 ng/mL is considered to have a low ovarian reserve.

  • Individual ready-to-use cartridges
  • Combines the sandwich immunoassay technique with enzyme-catalyzed chemiluminescence detection
  • Sample volume: 75 μL

Range

Working range: 0.007 to 23 ng/mL

Detection Limits

Limit of Detection (LOD): 0.007 ng/mL

Precision

Intra-lot Precision

CV less than 8%

Inter-lot Precision

CV less than 10%

Linearity

Linearity between 0.007-23.00 ng/mL. The absolute linear correlation coefficient® should be bigger than 0.9900.

Interference

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

SubstanceConcentration
Hemoglobin≤ 1000 mg/dL
Bilirubin≤ 66 mg/dL
Triglyceride≤ 1000 mg/dL
Total Protein≤ 2.5 g/dL
Rheumatoid Factor≤ 1000 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 hook effect at AMH concentration of 1400 ng/mL.

Reagents and Materials provided:

  1. 19-well AMH 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 purified AMH antigen at:
    1. 0 ng/mL
    2. recombinant AMH antigen*
    3. recombinant AMH antigen*

*The exact calibrator concentration values are detailed in the kit calibration card

  1. Registration card
  2. Calibrator card
  3. Instructions for Use

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

Materials maybe required but not provided:

  1. Commercial controls

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
L1240AMH CLIA Test36/kitS/P
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