Follicle-Stimulating Hormone Monoclonal Antibody for Fertility Assessment & Ovarian Reserve CLIA / LFA Development
Follicle-Stimulating Hormone (FSH) is a 34 kDa glycoprotein gonadotropin produced by the anterior pituitary gland, sharing an identical alpha subunit with LH, TSH, and hCG, but with a unique beta subunit conferring receptor specificity. In females, FSH drives ovarian follicular development and estrogen synthesis; in males, FSH is essential for Sertoli cell function and spermatogenesis.
Clinically, serum FSH is the primary marker for ovarian reserve assessment in women undergoing fertility evaluation. Day-3 FSH >10–12 IU/L indicates diminished ovarian reserve and reduced IVF success probability. Elevated FSH in peri-menopausal women (>25 IU/L) with irregular cycles confirms early menopause transition. In post-menopausal women, FSH is typically >30–40 IU/L. In males, elevated FSH (>7.6 IU/L) in the context of azoospermia indicates non-obstructive azoospermia (primary testicular failure) — a key prognostic indicator in male infertility workup.
FSH immunoassay requires antibodies with specificity for the FSH beta subunit to avoid cross-reactivity with LH, TSH, and hCG. Sekbio's matched antibody pair (FSH-W331 + FSH-W332) is pre-screened for high-affinity binding with minimal cross-reactivity.
Matched capture and detection antibodies for FSH sandwich immunoassay development across CLIA and LFA platforms.
| Catalog No. | Product Name | Source | Concentration | Purity | Intended Use | Storage |
|---|---|---|---|---|---|---|
| FSH-W331 | Murine Anti-Human FSH mAb (Capture) | Mouse mAb | 6.95 mg/mL | ≥95% SDS-PAGE | Capture — LFA / CLIA | −20°C |
| FSH-W332 | Murine Anti-Human FSH mAb (Detection) | Mouse mAb | 7.04 mg/mL | ≥95% SDS-PAGE | Detection — LFA / CLIA | −20°C |
Both supplied in PBS pH 7.4. MOQ 1 mg; gram-scale OEM supply available. Also available as part of the Fertility Panel (FSH + LH + AMH + E2). Contact info@sekbio.com for panel pricing.
FSH-W331 and FSH-W332 are screened for specificity against the FSH beta subunit, minimising cross-reactivity with LH, TSH, and hCG — all sharing the same alpha subunit. This specificity is critical for accurate FSH measurement in serum containing concurrent LH and hCG (e.g., during the LH surge or early pregnancy).
FSH-W331 (6.95 mg/mL) and FSH-W332 (7.04 mg/mL) are purified with ≥95% purity by SDS-PAGE — above the standard IVD antibody purity threshold of ≥90%. High purity reduces non-specific binding and background signal in both LFA rapid test strips and automated CLIA analyzers.
Validated for both LFA (for POCT semi-quantitative FSH rapid tests for home-based ovulation and menopause monitoring) and CLIA (for quantitative clinical laboratory fertility panels). Single antibody pair supports diverse product lines from a single procurement source.
Manufactured under ISO 13485 QMS with batch-to-batch CV <10%. Consistent antibody binding activity across production lots ensures calibration stability and minimises lot-to-lot recalibration requirements in automated CLIA fertility analyzers.
Sekbio supplies FSH, LH, AMH, Estradiol (E2), and Progesterone antibody pairs — enabling complete female fertility panel procurement from a single ISO 13485-certified supplier. Multi-product agreements simplify supply chain management for OEM fertility kit manufacturers.
ISO 13485-compliant manufacturing in Shenzhen. MOQ 1 mg; gram-scale OEM supply for fertility kit manufacturers. CoA, lot traceability, and MSDS documentation provided. Supports CE IVD (IVDR), NMPA, and FDA regulatory submissions.
Day-3 serum FSH is the standard test for ovarian reserve in women undergoing fertility evaluation before IVF or ovarian stimulation. FSH >10 IU/L indicates diminished ovarian reserve; >15 IU/L is associated with poor response to ovarian stimulation. FSH used alongside AMH and antral follicle count (AFC) forms the standard ovarian reserve assessment panel per ASRM and ESHRE guidelines.
FSH >25 IU/L with irregular menstrual cycles in women >45 years suggests perimenopause; >30 IU/L on two separate measurements confirms menopause. FSH POCT rapid tests (LFA format) are increasingly used for home-based menopause symptom assessment. Sekbio's LFA-validated FSH antibody pair supports both POCT kit and clinical laboratory assay development targeting the menopause monitoring market.
In men with azoospermia, elevated FSH (>7.6 IU/L) indicates non-obstructive azoospermia (NOA) — primary testicular failure — versus obstructive azoospermia where FSH is typically normal. This distinction guides clinical management: NOA patients require microdissection TESE; obstructive patients undergo reconstruction or sperm retrieval. FSH measurement is a key component of the male infertility workup panel.
Home-based FSH rapid tests are a growing market segment, with women using POCT FSH tests for fertility self-assessment and menopause monitoring. Sekbio's LFA-validated FSH antibody pair (FSH-W331 + FSH-W332) enables OEM manufacturers to develop CE-marked POCT FSH cassettes and CLIA fertility analyzer reagents. Contact info@sekbio.com for technical integration support.
FSH (Follicle-Stimulating Hormone) is a pituitary gonadotropin that drives ovarian follicular development in females and spermatogenesis in males. Day-3 serum FSH >10–12 IU/L indicates diminished ovarian reserve in women undergoing IVF evaluation. In men, elevated FSH in azoospermia indicates primary testicular failure. FSH testing is recommended by ASRM and ESHRE guidelines as the standard ovarian reserve and male infertility assessment marker.
FSH-W331 (Murine anti-human FSH mAb, capture, 6.95 mg/mL, ≥95% SDS-PAGE, PBS pH 7.4) and FSH-W332 (Murine anti-human FSH mAb, detection, 7.04 mg/mL, ≥95% SDS-PAGE, PBS pH 7.4). Both validated for LFA and CLIA. MOQ 1 mg.
Validated for LFA (lateral flow assay POCT) and CLIA (quantitative chemiluminescence immunoassay). Supports both semi-quantitative POCT FSH rapid tests and high-throughput clinical laboratory fertility analyzer development.
FSH, LH, TSH, and hCG share an identical alpha subunit. FSH-W331 and FSH-W332 are screened for specificity against the FSH-specific beta subunit, minimising cross-reactivity with LH, TSH, and hCG. Cross-reactivity data is available in the product datasheet. Contact info@sekbio.com for specificity testing documentation.
Yes. Sekbio supplies matched antibody pairs for FSH, LH, AMH, Estradiol (E2), and Progesterone — enabling complete female fertility panel procurement from a single ISO 13485-certified source. Contact info@sekbio.com for multi-product panel pricing.
Store at −20°C for long-term (up to 2 years); at +2°C to +8°C for short-term use up to 30 days. Avoid multiple freeze/thaw cycles. Aliquot upon receipt to minimise freeze/thaw cycling. See also LH Antibody Pair and AMH Antibody Pair for the complete fertility testing range.
Request the full technical datasheet, fertility panel pricing, or discuss OEM supply with our team.