Free & Total Prostate-Specific Antigen Monoclonal Antibody for Prostate Cancer IVD Development
Prostate-Specific Antigen (PSA), also known as kallikrein-3 (KLK3), is a serine protease produced by prostatic epithelial cells. In serum, PSA exists as two major forms: free PSA (fPSA) — unbound, enzymatically inactive; and complexed PSA (cPSA) — bound mainly to alpha-1-antichymotrypsin. Total PSA (tPSA) = fPSA + cPSA. PSA is the most widely used biomarker for prostate cancer screening, staging, and post-treatment monitoring globally.
The clinical power of PSA lies not just in total PSA level, but in the free/total PSA ratio (fPSA%). In the diagnostic grey zone (tPSA 4–10 ng/mL), an fPSA% <15–25% significantly increases the likelihood of prostate cancer versus benign prostatic hyperplasia (BPH), improving biopsy decision accuracy. Measuring both fPSA and tPSA requires antibodies with distinct epitope specificities — both are available from Sekbio.
PSA-based screening is recommended by EAU, AUA, and WHO guidelines. The global PSA testing market exceeds USD 3 billion annually, driven by prostate cancer incidence in Europe, North America, and increasingly in Asia-Pacific.
Capture, detection, and HRP-conjugated antibodies for free PSA and total PSA immunoassay development.
| Catalog No. | Product Name | Isotype | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| S01-fpsa-1M | Mouse Anti-Human Free PSA mAb (Capture) | Mouse IgG1 | >90% SEC-HPLC | Capture — ELISA / CLIA / POCT | −20°C ±5°C |
| S01-fpsa-4M | Mouse Anti-Human Free PSA mAb (Detection) | Mouse IgG | >90% SEC-HPLC | Detection — ELISA / CLIA / POCT | −20°C ±5°C |
| HA114-2Hhrp | HRP-Conjugated Anti-Human Free PSA mAb | Mouse IgG (HRP) | >90% | Detection — ELISA (direct use) | +2°C to +8°C |
Total PSA (tPSA) antibodies also available. Contact info@sekbio.com for tPSA pair specifications, fPSA/tPSA cross-reactivity data, and matched pair recommendations.
High-purity, consistent PSA antibodies for clinical-grade fPSA and tPSA immunoassay development.
Sekbio supplies both fPSA and tPSA antibodies, enabling development of dual-analyte assays for fPSA% calculation. The fPSA/tPSA ratio improves prostate cancer specificity in the diagnostic grey zone (4–10 ng/mL tPSA) reducing unnecessary biopsies by up to 20%.
Affinity-purified from cell culture supernatants with SEC-HPLC purity >90%. Mouse IgG1 isotype provides consistent Fc-region characteristics for protein A/G purification and colloidal gold conjugation in lateral flow assay development.
HA114-2Hhrp HRP-conjugated anti-free PSA antibody (0.5 mg/mL) is available for direct ELISA applications, eliminating in-house conjugation. Stable at +2°C to +8°C, the conjugate is suitable for manual ELISA kit development and clinical laboratory use.
ISO 13485 QMS manufacturing ensures inter-batch CV <10%. Each lot is released only after rigorous QC testing, providing the manufacturing consistency required for CE IVD registration and NMPA approval of PSA diagnostic kits.
Validated for ELISA (sandwich), CLIA, CMIA, and Rapid Test (POCT) formats. Supports the full range of PSA testing platforms — from benchtop ELISA analysers to automated CLIA platforms and POCT cartridges for point-of-care prostate cancer screening.
ISO 13485-compliant manufacturing in Shenzhen, China. MOQ 1 mg for R&D; gram-scale production supply for OEM manufacturers. Certificate of Analysis and batch consistency data available for regulatory submissions.
PSA antibody pair for prostate cancer screening, staging, monitoring, and OEM assay development.
Total PSA >4.0 ng/mL is the primary threshold for prostate biopsy referral in men aged 50–70. Age-adjusted thresholds (2.5 ng/mL for men under 60) and PSA velocity (>0.75 ng/mL/year) further refine risk stratification. Sekbio's PSA antibody pair supports CLIA and ELISA assay development for both individual screening and high-throughput population screening programs.
In the grey zone (tPSA 4–10 ng/mL), an fPSA% <15% has positive predictive value of ~56% for prostate cancer vs. ~8% when fPSA% >25%, reducing unnecessary biopsies by approximately 20%. Dual-analyte immunoassays using matched fPSA and tPSA antibody pairs from Sekbio enable accurate ratio calculation on the same patient sample.
PSA should become undetectable (<0.1 ng/mL) after radical prostatectomy. PSA persistence >0.2 ng/mL or two consecutive rises define biochemical recurrence. After radiotherapy, PSA nadir + 2 ng/mL (Phoenix definition) defines treatment failure. Ultra-sensitive PSA assays (<0.01 ng/mL) using Sekbio antibodies support post-prostatectomy recurrence monitoring platforms.
PSA POCT tests are increasingly used at point-of-care urology clinics for immediate triage decisions. Sekbio PSA antibodies — Mouse IgG1, >90% purity — are optimised for colloidal gold conjugation in lateral flow assay cartridges and for integration into automated CLIA analyzer reagent kits. ISO 13485 batch data supports CE IVD registration across EU markets.
PSA (Prostate-Specific Antigen) is a serine protease produced by prostatic epithelial cells. Total PSA (tPSA) includes free PSA (fPSA, unbound) and PSA complexed to proteins. The fPSA/tPSA ratio improves specificity in the diagnostic grey zone (tPSA 4–10 ng/mL): fPSA% <15–25% significantly increases the likelihood of prostate cancer versus benign prostatic hyperplasia, reducing unnecessary biopsies.
Sekbio supplies: S01-fpsa-1M (Mouse IgG1 free PSA capture), S01-fpsa-4M (Mouse IgG free PSA detection), and HA114-2Hhrp (HRP-conjugated anti-free PSA, 0.5 mg/mL, for direct ELISA use). Total PSA antibodies are also available — contact info@sekbio.com for tPSA pair specifications.
Sekbio PSA antibodies are validated for ELISA (sandwich), CLIA, CMIA, and Rapid Test (POCT). The Mouse IgG1 isotype is compatible with major analytical platform requirements for protein A/G purification and colloidal gold conjugation.
Affinity-purified from cell culture supernatants with purity >90% by SEC-HPLC. Mouse IgG1 isotype. ISO 13485 QMS manufacturing with batch-to-batch CV <10%. Certificate of Analysis with every shipment.
MOQ 1 mg for R&D; gram-scale OEM supply available. Storage: −20°C ±5°C long-term; +2°C to +8°C for up to 1 month. Avoid repeated freeze/thaw cycles. HRP conjugate (HA114-2Hhrp): +2°C to +8°C only.
Yes. Sekbio's antibody development platform covers hybridoma screening, recombinant antibody engineering, and affinity maturation. Ultra-sensitive PSA assays for post-prostatectomy monitoring (<0.01 ng/mL) require antibodies with Kd in the sub-nanomolar range — achievable through Sekbio's custom antibody development service. Contact info@sekbio.com or visit Platforms.
Request the full technical datasheet, fPSA/tPSA pair specifications, or discuss OEM supply with our team.