High-Affinity Monoclonal Antibody for Fertility CLIA & LFA Competitive Immunoassay Development
Progesterone is a C-21 steroid hormone and the principal progestogen in human physiology. It is produced by the corpus luteum after ovulation, the placenta during pregnancy, and the adrenal cortex in small amounts. Progesterone prepares the uterine endometrium for embryo implantation, maintains early pregnancy, and suppresses uterine contractility during gestation.
In IVD diagnostics, serum progesterone measurement is clinically essential across several fertility and pregnancy applications:
Progesterone is a small molecule (MW 314 Da) measured by competitive immunoassay. S01-Prog-1S is a high-affinity monoclonal antibody selected for the binding characteristics required for sensitive competitive CLIA and LFA progesterone quantification across the 0.5–500 nmol/L clinical range.
High-affinity monoclonal antibody for competitive progesterone immunoassay development in CLIA and LFA formats.
| Catalog No. | Product Name | Target | Assay Format | Purity | Platforms | Storage |
|---|---|---|---|---|---|---|
| S01-Prog-1S | Anti-Progesterone Monoclonal Antibody | Progesterone | Competitive | >90% SDS-PAGE | CLIA / LFA | +2°C to +8°C |
Supplied in PBS pH 7.2–7.4. MOQ 1 mg. OEM quantities (10 mg–gram scale) available. Contact info@sekbio.com for bulk pricing, lot availability, and progesterone hapten conjugate supply.
Engineered for the high affinity and cross-reactivity profile required in competitive progesterone CLIA and LFA immunoassay development.
S01-Prog-1S is selected for high binding affinity (Ka in the nanomolar range) essential for competitive immunoassay sensitivity. Higher antibody affinity enables lower detection limits, allowing accurate progesterone quantification below 1 nmol/L in follicular phase and post-menopausal samples.
Progesterone cross-reactivity profiles with related steroids (17α-hydroxyprogesterone, pregnenolone, allopregnanolone, cortisol) are characterised and documented in the CoA. Minimal cross-reactivity with testosterone, estradiol, and other sex hormones ensures assay specificity in complex serum matrices.
Manufactured under ISO 13485 QMS with inter-batch CV <10% for antibody affinity and specificity parameters. Each lot released with CoA including appearance, purity, concentration, and competitive binding IC50 values for progesterone.
S01-Prog-1S performs in both quantitative CLIA (analyzer-based competitive chemiluminescence for hospital and fertility clinic use) and competitive LFA (colloidal gold or fluorescence lateral flow for POCT cycle monitoring devices), enabling a complete fertility product range from one antibody source.
Sekbio offers a complete reproductive hormone antibody portfolio including LH, FSH, Estradiol (E2), Estriol (E3G), AMH, and HCG alongside Progesterone. IVD manufacturers can source a complete fertility panel from a single ISO 13485-certified supplier, simplifying supply chain and regulatory submissions.
MOQ 1 mg for R&D evaluation; gram-scale OEM production supply available from Shenzhen, China. Export experience to Europe, North America, South Korea, and Japan for fertility analyzer reagent manufacturers. Certificate of Analysis and lot documentation provided for each shipment.
Progesterone antibody validated for fertility testing, early pregnancy assessment, and OEM competitive immunoassay development.
Mid-luteal serum progesterone >16–30 nmol/L (5–10 ng/mL) on day 21 of a 28-day cycle is the standard biochemical confirmation of ovulation. This is the most widely ordered fertility test in primary care and reproductive medicine. CLIA and LFA tests using S01-Prog-1S provide quantitative progesterone measurement to guide fertility investigations and ovulation induction monitoring with clomifene or letrozole.
A single serum progesterone <6 nmol/L (2 ng/mL) in early pregnancy predicts miscarriage or ectopic pregnancy with >95% specificity. Combined with hCG measurement, progesterone <6 nmol/L + hCG plateau triggers early intervention (methotrexate for ectopic or expectant management for miscarriage). Sekbio's progesterone antibody supports both standalone and combined progesterone/hCG CLIA panel development.
During IVF, serum progesterone is measured daily during ovarian stimulation (premature luteinisation detection) and serially during luteal phase support (vaginal/IM progesterone efficacy monitoring). Target progesterone >100 nmol/L (30 ng/mL) during IVF luteal phase with exogenous progesterone supplementation. High-frequency CLIA monitoring using S01-Prog-1S supports fertility clinic analyzer reagent development.
IVD manufacturers developing quantitative progesterone CLIA reagents for hospital analyzers or consumer fertility monitors can integrate S01-Prog-1S with ISO 13485-compliant batch documentation. Sekbio's reproductive hormone antibody portfolio (LH, FSH, E2, E3G, AMH, HCG, Progesterone) enables single-source fertility panel supply. Visit our Products page or contact info@sekbio.com.
Technical and commercial questions from IVD R&D engineers and procurement teams.
Progesterone is a C-21 steroid hormone produced by the corpus luteum post-ovulation and placenta during pregnancy. Mid-luteal progesterone >16 nmol/L confirms ovulation; early pregnancy progesterone <6 nmol/L predicts miscarriage/ectopic. Accurate CLIA and LFA quantification across 0.5–500 nmol/L is essential for fertility investigations, IVF monitoring, and early pregnancy assessment.
Sekbio supplies S01-Prog-1S — a monoclonal antibody against progesterone for competitive immunoassay development in CLIA and LFA formats. Available from MOQ 1 mg with ISO 13485-compliant lot documentation.
Progesterone (MW 314 Da) is a small molecule with a single epitope, requiring a competitive immunoassay format. Serum progesterone competes with labelled progesterone tracer for antibody binding — higher sample progesterone produces lower signal. S01-Prog-1S is selected for the high affinity characteristics required for sensitive competitive CLIA and LFA.
Key thresholds: Follicular phase <3 nmol/L; Ovulation confirmation (day 21) >16–30 nmol/L; Early intrauterine pregnancy viability >25 nmol/L; Ectopic/miscarriage risk <6 nmol/L; IVF luteal support target >100 nmol/L. Each IVD product must establish platform-specific reference ranges through clinical validation.
S01-Prog-1S is affinity-purified with purity >90% by SDS-PAGE. Manufactured under ISO 13485 QMS with inter-batch CV <10%. Certificate of Analysis provided with each lot including appearance, purity, concentration, and IC50 for competitive binding against progesterone.
Yes. S01-Prog-1S is validated for competitive CLIA (analyzer-based quantitative measurement in fertility clinics and hospitals) and competitive LFA (colloidal gold or fluorescence lateral flow for POCT cycle-monitoring consumer devices). Contact info@sekbio.com or visit our Platforms page to discuss your specific assay format requirements.
Request the full technical datasheet, S01-Prog-1S specifications, or discuss OEM supply with our team.