Quantitative Fluorescent Immunoassay for Anti-Müllerian Hormone — Ovarian Reserve & Fertility Assessment
The AMH FIA Test is a high-performance fluorescent immunoassay for quantitative measurement of Anti-Müllerian Hormone (AMH) — the most reliable direct biomarker of ovarian reserve. AMH is secreted by granulosa cells of pre-antral and small antral follicles and reflects the remaining primordial follicle pool, making it the cornerstone marker for female fertility assessment, IVF planning, and PCOS diagnosis.
Built on a validated anti-AMH monoclonal antibody pair optimized for fluorescence lateral flow FIA, this assay covers 0.1–20 ng/mL with a limit of detection of 0.1 ng/mL. Benchmarked against the Roche Elecsys AMH platform across 60 clinical samples, it delivers results suitable for clinical decision-making in reproductive medicine.
Six analytical and clinical advantages that make this antibody pair the right choice for AMH quantification platforms.
LoD of 0.1 ng/mL and blank limit (LoB) of 0.049 ng/mL. Accurately measures the very low AMH levels seen in diminished ovarian reserve (DOR) and premature ovarian insufficiency (POI), where quantification at <1 ng/mL is clinically critical.
Linear range of 0.1–20 ng/mL spans the full clinical spectrum: DOR (<1 ng/mL), normal reserve (1–4 ng/mL), high reserve, and the elevated AMH levels characteristic of PCOS (>5 ng/mL) — all in a single assay without dilution.
Within-run CV of 6.6% at the low control (1.64 ng/mL) and 6.0% at the high control (10.92 ng/mL), each across 10 replicates — well within the IVD acceptance criterion of ≤10%.
Method comparison across 60 clinical serum samples spanning 0.11–18.2 ng/mL shows strong concordance with the Roche Elecsys AMH automated platform, the current reference standard in clinical laboratories.
10-calibrator standard curve with 4-parameter logistic (4PL) equation fitting provides optimal accuracy across the full 0.1–20 ng/mL range, minimising interpolation error at both extremes.
Antibody pair available as raw material for licensed IVD manufacturers. Compatible with FIA strip and cassette formats; optimized for fluorescence reader-based point-of-care systems.
All data generated using Sekbio's anti-AMH monoclonal antibody pair in an FIA sandwich format.
Ten calibrators spanning 0–18.99 ng/mL demonstrate a robust sigmoidal dose-response. The blank produces T/C of 0.017, consistent with low non-specific background. 4-parameter logistic curve fitting provides accurate interpolation across the full analytical range.
| Calibrator | Concentration (ng/mL) | T/C Ratio |
|---|---|---|
| S0 — Blank | 0 | 0.017 |
| S1 | 0.23 | 0.029 |
| S2 | 0.32 | 0.042 |
| S3 | 0.62 | 0.069 |
| S4 | 1.14 | 0.112 |
| S5 | 1.89 | 0.199 |
| S6 | 4.12 | 0.464 |
| S7 | 8.73 | 0.935 |
| S8 | 13.70 | 1.428 |
| S9 | 18.99 | 1.863 |
| T = Test line signal; C = Control line signal; T/C = signal ratio. Curve fit: 4-parameter logistic (4PL). | ||
Twenty blank replicates (0 ng/mL) and 20 low-concentration replicates (0.1 ng/mL) were measured. The blank limit (LoB = mean + 2 SD) is 0.019 T/C, corresponding to a concentration of 0.049 ng/mL. The 0.1 ng/mL level is clearly distinguishable from the blank distribution.
| Sample | Replicates (n) | Mean T/C | SD | Mean + 2 SD | LoB / LoD |
|---|---|---|---|---|---|
| Blank (0 ng/mL) | 20 | 0.010 | 0.005 | 0.019 | LoB = 0.049 ng/mL |
| 0.1 ng/mL | 20 | 0.029 | — | — | LoD = 0.1 ng/mL |
| LoB (Limit of Blank) calculated as blank mean + 2×SD. LoD confirmed at 0.1 ng/mL, where all 20 replicates exceed the LoB threshold. | |||||
Two quality control levels (R1 ≈1.64 ng/mL and R2 ≈10.92 ng/mL) were measured across 10 replicates each. Both levels achieve CV values well within the IVD acceptance criterion of ≤10%.
| Control Level | Replicates (n) | Mean Concentration (ng/mL) | SD (ng/mL) | CV (%) |
|---|---|---|---|---|
| R1 (low) | 10 | 1.64 | 0.108 | 6.6% |
| R2 (high) | 10 | 10.92 | 0.654 | 6.0% |
| Acceptance criterion: CV ≤ 10% (IVD industry standard). Both levels meet criteria. | ||||
Two spiked samples at clinically relevant concentrations (2.41 ng/mL and 10.80 ng/mL) were measured in triplicate. Back-calculated concentrations show bias within ±10%, meeting IVD accuracy requirements.
| Assigned Concentration (ng/mL) | Replicate 1 (ng/mL) | Replicate 2 (ng/mL) | Replicate 3 (ng/mL) | Mean Bias (%) |
|---|---|---|---|---|
| 2.41 | 2.37 (−1.7%) | 2.20 (−8.5%) | 2.25 (−6.5%) | −5.6% |
| 10.80 | 11.27 (+4.4%) | 10.15 (−6.0%) | 10.08 (−6.6%) | −2.7% |
| Acceptance criterion: Bias within ±10% of assigned concentration. Both levels meet criteria. | ||||
Sixty de-identified clinical serum samples spanning 0.11–18.2 ng/mL were measured in parallel on the Sekbio AMH FIA and the Roche Elecsys AMH automated platform. Results demonstrate strong proportional agreement across the full clinical AMH range.
The AMH antibody pair is validated across multiple clinical reproductive medicine contexts and OEM development formats.
Quantitative AMH measurement for evaluating the remaining primordial follicle pool in women of reproductive age. Essential for fertility counselling, predicting natural conception potential, and timing of fertility preservation.
AMH level guides ovarian stimulation protocol selection (antagonist vs. long protocol) and gonadotropin dosing before IVF. Predicts ovarian hyperstimulation risk (OHSS) and expected oocyte yield.
AMH is elevated 2–4× in polycystic ovary syndrome. Supports PCOS diagnosis alongside ultrasound antral follicle count, and monitors response to lifestyle and pharmacological interventions.
Capture and detection antibodies available in bulk for licensed IVD manufacturers. Sekbio supports OEM integration with consistent lot-to-lot performance and ISO 13485-compliant supply chain for FIA cassette production.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply and partnership arrangements with our team.