Preeclampsia Risk Stratification — Matched Antibodies for CLIA & LFA Assay Development
Placental Growth Factor (PlGF) is a member of the VEGF family produced by the placenta that stimulates healthy angiogenesis and placentation. Soluble Fms-like tyrosine kinase-1 (sFlt-1) is an anti-angiogenic protein that circulates in maternal blood and binds free PlGF, reducing its bioavailability. In normal pregnancy, PlGF rises through the second trimester; in preeclampsia, sFlt-1 is markedly elevated and PlGF is suppressed weeks before clinical onset of hypertension and proteinuria.
The landmark PROGNOSIS trial (Verlohren et al., New England Journal of Medicine, 2016) demonstrated that the sFlt-1/PlGF ratio ≤38 rules out preeclampsia within 1 week (NPV 99.3%), while a ratio >85 predicts onset within 4 weeks. This evidence-based biomarker ratio is now integrated into European and Asian clinical guidelines for preeclampsia triage at 20–36+6 weeks gestation.
Sekbio supplies matched monoclonal antibody pairs for both PlGF and sFlt-1, enabling IVD manufacturers to develop quantitative CLIA analyzers and LFA-based POCT devices for complete sFlt-1/PlGF ratio testing from a single ISO 13485-certified antibody supplier.
Matched capture and detection antibodies for both PlGF and sFlt-1 — enabling complete sFlt-1/PlGF ratio assay development.
| Catalog No. | Product Name | Target | Role | Isotype | Purity | Platforms | Storage |
|---|---|---|---|---|---|---|---|
| S01-PLGF-1M | Mouse Anti-PlGF mAb (Capture) | PlGF | Capture | Mouse IgG | >90% SDS-PAGE | CLIA / LFA | +2°C to +8°C |
| S01-PLGF-2M | Mouse Anti-PlGF mAb (Detection) | PlGF | Detection | Mouse IgG | >90% SDS-PAGE | CLIA / LFA | +2°C to +8°C |
| S01-sFlt-1M | Mouse Anti-sFlt-1 mAb (Capture) | sFlt-1 | Capture | Mouse IgG | >90% SDS-PAGE | CLIA / LFA | +2°C to +8°C |
| S01-sFlt-5M | Mouse Anti-sFlt-1 mAb (Detection) | sFlt-1 | Detection | Mouse IgG | >90% SDS-PAGE | CLIA / LFA | +2°C to +8°C |
All products 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 and lot availability.
Engineered for the clinical sensitivity and specificity required in maternal serum ratio testing at 20–36+6 weeks gestation.
S01-PLGF-1M and S01-PLGF-2M are pre-screened to bind non-overlapping epitopes on PlGF, maximising sandwich efficiency. Similarly, S01-sFlt-1M and S01-sFlt-5M form a high-affinity sFlt-1 sandwich pair for quantitative CLIA and LFA development.
PlGF assays must reliably detect low concentrations (<12 pg/mL in high-risk patients) while sFlt-1 assays must cover the high-concentration range (>10,000 pg/mL). Sekbio's matched pairs are selected for affinity characteristics matching these clinical measurement requirements.
PlGF and sFlt-1 antibody pairs are both available from Sekbio, enabling a complete sFlt-1/PlGF ratio assay from a single ISO 13485-certified source. This simplifies regulatory dossier preparation and ongoing supply chain management for OEM manufacturers.
Validated for both CLIA (quantitative analyzer platforms) and LFA (lateral flow, colloidal gold or fluorescence) formats. Enables manufacturers to develop both high-throughput hospital analyzer reagents and bedside POCT devices for resource-limited settings from the same antibody source.
All Sekbio antibodies are manufactured under ISO 13485 QMS with full batch documentation, Certificate of Analysis, and inter-batch CV <10%. Suitable for IVD products requiring CE Marking, NMPA registration, or FDA 510(k) submissions.
MOQ 1 mg for R&D evaluation; gram-scale OEM production supply available. Shenzhen-based manufacturing with export experience to Europe, North America, South Korea, Japan, and India. Certificate of Analysis and lot release documentation provided for each shipment.
Antibody pairs validated for maternal serum preeclampsia assays and OEM immunoassay kit development.
The sFlt-1/PlGF ratio is used in obstetric triage to risk-stratify pregnant women with suspected preeclampsia. A ratio ≤38 (Elecsys reference) allows safe outpatient monitoring with NPV 99.3% for 1-week event-free survival. Sekbio's antibody pairs support development of new analyzer reagents or lateral flow devices implementing equivalent ratio cut-offs per ACOG, ISSHP, and NICE guidance.
Combined with uterine artery Doppler and mean arterial pressure, PlGF measured at 11–13 weeks gestation forms part of the FMF first-trimester screening algorithm for preterm preeclampsia (detection rate ~75% at 10% false-positive rate). LFA-based PlGF tests enable first-trimester screening in resource-limited settings without access to advanced Doppler equipment.
Serial sFlt-1/PlGF ratio measurement guides delivery timing decisions in women with confirmed preeclampsia. Rapidly rising ratios indicate deteriorating placental function requiring urgent delivery. Quantitative CLIA platforms using Sekbio antibody pairs can provide the high-frequency, high-precision measurements needed for intensive inpatient monitoring.
IVD manufacturers developing CE-marked or NMPA-registered preeclampsia assay kits can integrate Sekbio's PlGF and sFlt-1 antibody pairs with ISO 13485-compliant batch documentation. Sekbio's antibody development platform also supports custom clone generation for improved epitope specificity or alternate assay formats. Contact info@sekbio.com or visit our Platforms page for custom development options.
Technical and commercial questions from IVD R&D engineers and procurement teams.
PlGF (Placental Growth Factor) promotes healthy placental angiogenesis, while sFlt-1 is an anti-angiogenic protein that sequesters PlGF. In preeclampsia, sFlt-1 rises and PlGF falls weeks before clinical symptoms. The sFlt-1/PlGF ratio (PROGNOSIS trial, NEJM 2016) provides a ratio ≤38 to rule out preeclampsia within 1 week (NPV 99.3%) and ratio >85 to predict onset within 4 weeks.
Sekbio supplies: S01-PLGF-1M (Mouse IgG, PlGF capture), S01-PLGF-2M (Mouse IgG, PlGF detection), S01-sFlt-1M (Mouse IgG, sFlt-1 capture), and S01-sFlt-5M (Mouse IgG, sFlt-1 detection). All are available from MOQ 1 mg with ISO 13485-compliant batch documentation.
Sekbio PlGF and sFlt-1 antibodies are validated for CLIA (quantitative analyzer-based chemiluminescence) and LFA (lateral flow assay, colloidal gold or fluorescence immunoassay) formats, supporting both hospital analyzer reagents and POCT device development.
The PROGNOSIS study established ratio ≤38 = rule out preeclampsia within 1 week (NPV 99.3%), ratio 38–85 = intermediate risk (require monitoring), and ratio >85 = predict preeclampsia onset within 4 weeks. These cut-offs were established on the Elecsys platform; IVD manufacturers developing new assays must establish equivalent cut-offs through clinical validation studies.
All antibodies are 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, concentration, purity, and functional validation results.
Yes. Sekbio supplies matched pairs for both PlGF and sFlt-1 from a single ISO 13485-certified source, simplifying regulatory submissions and supply chain management. Custom clone development for improved sensitivity or alternate assay formats is also available through Sekbio's antibody development platform. Contact info@sekbio.com to discuss your requirements.
Request the full technical datasheet, PlGF & sFlt-1 antibody pair specifications, or discuss OEM supply with our team.