[CTK Biotech] AMH ELISA CE

[CTK Biotech] AMH ELISA CE

 

• AMH Antibody Coated Microwells
• AMH Calibrators*:
  • C1 (0 ng/mL)
  • C2 (0.2 ng/mL)
  • C3 (0.5 ng/mL)
  • C4 (1.0 ng/mL)
  • C5 (5.0 ng/mL)
  • C6 (15.0 ng/mL)
• AMH Assay Control A**
• AMH Assay Control B**
• AMH Enzyme Reagent
• Wash Buffer Concentrate (50X)
• TMB Substrate
• Stop Solution
• Instructions for Use

*AMH calibrators and controls are lyophilized and need to be reconstituted for further use.

**The Assay Control values are lot-specific. Please see vial labels for exact concentration ranges.

 

• Analytical Sensitivity:0.024 ng/mL LOB, 0.044 ng/mL LoD and LoQ
• Specificity: no cross-reactivity with other fertility hormones
• Accuracy: correlation coefficient is 0.98 with a reference method
• Precision: within-assay precision was determined with 3 different levels of pooled controls in forty test runs in duplicates over a period of 20 days.

 

Sample	Mean (ng/mL)	Within-run precision		Total precision (n =80)
		SD	CV%	SD	CV%
Low	0.80	0.02	2.9	0.04	5.3
Medium	4.54	0.12	2.6	0.24	5.2
High	14.16	0.30	2.1	0.77	5.5

 

• Open vial stability: 8 weeks at 2-8°C, the reconstituted calibrators and controls are stable for 10 days at 2-8°C.
• Shelf Life: 24 months

 

The CTK AMH ELISA is a solid-phase enzyme-linked immunosorbent assay.  The three main kit components are:

 

1) Solid microwells pre-coated with AMH antibody.

2) Lyophilized AMH calibrators and controls.

3) AMH enzyme reagent comprised of horseradish peroxidase conjugated to AMH antibody (Ab-HRP).

 

This test is intended for the quantitative determination of AMH concentration in human serum or plasma. It is intended to be used by trained professionals as an aid in assessing woman’s ovarian reserve.

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-b super family. In females, AMH is at detectable range throughout the reproductive period and slowly diminishes during the reproductive senescence, and during post-menopause it becomes undetectable. Measurement of AMH has been observed as a reliable assessment of the ovarian reserve. Unlike FSH, the variability of the AMH measurement within the menstrual 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, diagnosis and follow-up of polycystic ovary syndrome (PCOS). Women with PCOS show 2- or 3-fold higher serum AMH level than normally ovulating women. The AMH levels has also been used to evaluate infants with ambiguous genitalia.

Recently, AMH levels has 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.