AHM ELISA TEST KIT

1. Principle

The AMH ELISA is a quantitative immunoassay that measures Anti-Müllerian Hormone (AMH) in human serum or plasma. It uses a sandwich ELISA (Enzyme-Linked Immunosorbent Assay) format with antibodies specific to AMH, enabling precise detection of ovarian reserve biomarkers.

2. Intended Use

• Ovarian reserve assessment (fertility potential in women).

• Polycystic Ovary Syndrome (PCOS) diagnosis.

• Assisted Reproductive Technology (ART) monitoring (e.g., IVF).

• Pediatric and menopause-related hormone studies.

3. Key Features

• High Sensitivity: Detects low AMH levels (typical range: 0.01–24 ng/mL).

• High Specificity: Minimal cross-reactivity with related hormones (e.g., inhibin B).

• Format: 96-well microplate (competitive or sandwich ELISA, depending on kit).

• Sample Types: Serum (gold standard) or plasma (EDTA/heparin).

• Sample Volume: 20–50 µL per test.

4. Assay Procedure

1. Sample Prep: Centrifuge blood samples (10 min at 1000–3000 × *g*).

2. Incubation:

   • Add samples/standards to antibody-coated wells.

   • Incubate (1–2 hrs, RT or 37°C).

3. Washing: Remove unbound material.

4. Detection: Add enzyme-conjugated antibody (e.g., HRP) → substrate (TMB).

5. Stop Solution: Acidic solution halts reaction (color change).

6. Readout: Measure absorbance at 450 nm (reference: 620–650 nm).

5. Performance Metrics

• Accuracy: Recovery rate 90–110% (vs. WHO/NIBSC standards).

• Precision: Intra-assay CV <10%, inter-assay CV <12%.

• Linearity: Dilution recovery 85–115%.

• Limit of Detection (LOD): 0.01–0.1 ng/mL (kit-dependent).

6. Interpretation

• Normal Range:

  • Premenopausal women: 1.0–4.0 ng/mL.

  • Low ovarian reserve: <1.0 ng/mL.

  • PCOS: Often >4.0 ng/mL.

• Sex/age-specific cutoffs must be validated per lab.

7. Advantages

• Stability: AMH is robust (sample stable for 48–72 hrs at 2–8°C; long-term at –20°C).

• Automation-Compatible: Adaptable to platforms like DS2 (Dynex) or ELx808 (BioTek).

8. Limitations

• Not standardized across kits: Results may vary between manufacturers.

• Interferences: Hemolysis, lipemia, or repeated freeze-thaw cycles.

9. Example Commercial Kits

• "AMH Gen II ELISA" (Ansh Labs/Abbott).

• "picoAMH ELISA" (Ansh Labs, ultra-sensitive).

• "Human AMH ELISA Kit" (R&D Systems, Cat. No. DSL-10-14400).