HE4 Capture & HRP-Conjugated Detection Antibody Pair Plus Recombinant HE4 Antigen for Ovarian Cancer ELISA IVD Development
Human Epididymis Protein 4 (HE4), encoded by the WFDC2 gene, is a small secreted glycoprotein belonging to the WAP (whey acidic protein) four-disulfide core (WFDC) domain family. HE4 was first identified in the epithelium of the distal epididymis, where it was originally predicted to function as a protease inhibitor involved in sperm maturation. Comprehensive immunohistochemical profiling of normal and malignant human tissue shows that HE4 is overexpressed in 93% of serous epithelial ovarian carcinomas, 100% of endometrioid ovarian carcinomas, and 50% of clear cell (non-mucinous) ovarian carcinomas. Because HE4 is actively secreted into the circulation by these tumor cells, it produces a measurable, dose-dependent rise in serum concentration — the biochemical basis for its use as a blood-based tumor marker.
Epithelial ovarian cancer remains one of the most lethal gynecological malignancies, but outcomes are highly stage-dependent: the 5-year survival rate reaches approximately 95% when disease is confined to the ovary at diagnosis, but falls to approximately 17% once the cancer has spread to other abdominal organs. Roughly one in five women will develop a pelvic mass during her lifetime, and all require an accurate benign-versus-malignant risk assessment. The long-standing biomarker CA125 has notable limitations: approximately 50% of Stage I ovarian cancer patients do not show elevated CA125, and CA125 specificity is low (approximately 20%) because many benign gynecological conditions — particularly common in premenopausal women — also raise CA125 levels. Published comparative studies report HE4 sensitivity of approximately 82.7% for early-stage disease detection versus 45.9% for CA125, and HE4 specificity of approximately 99% versus approximately 20% for CA125, meaning the false-positive rate in healthy women is roughly 1% when HE4 is used. Combining HE4 with CA125 raises sensitivity to approximately 92% and reduces false-negative results by 30–50% relative to either marker alone (Molina R et al., Tumour Biol 2011; Moore RG et al., Gynecol Oncol 2008; Havrilesky LJ et al., Gynecol Oncol 2008; Huhtinen K et al., Br J Cancer 2009; Escudero JM et al., Clin Chem 2011; Galgano MT et al., Mod Pathol 2006). This dual-marker approach underpins multivariate risk-of-malignancy algorithms that combine HE4, CA125, and menopausal status to triage women with a pelvic mass.
For IVD developers, Sekbio's HE4 panel provides every raw material needed to build a complete ovarian cancer ELISA sandwich kit from a single source: the recombinant HE4 antigen (S01-HE4-1) for calibrator and standard curve preparation, the capture monoclonal antibody (S06-HE4-McAb1#) for microplate coating, and the HRP-conjugated detection monoclonal antibody (S06-HE4-HRP1#) for signal generation — together with the companion blocking reagent S01-blocker-02 used during plate blocking and enzyme-conjugate dilution. All three core products are manufactured under an ISO 13485 quality management system with documented batch traceability.
Three complementary HE4 raw materials — capture antibody, HRP-conjugated detection antibody, and recombinant antigen — for complete ovarian cancer ELISA double-antibody sandwich IVD development.
| Catalog No. | Product Name | Type | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| S01-HE4-1 | Recombinant Human HE4 Protein (Prokaryotic, Full-Length) | Recombinant Antigen (E.coli) | Per CoA | Calibrator / Standard / Coating Antigen | Per CoA |
| S06-HE4-McAb1# | Anti-HE4 Monoclonal Antibody (Capture) | mAb (Mouse IgG2a) | ≥90% | ELISA Sandwich — Capture / Coating | 4°C short-term / −20°C long-term |
| S06-HE4-HRP1# | Anti-HE4 Monoclonal Antibody, HRP-Conjugated (Detection) | mAb (Mouse IgG1), HRP-Labeled | Per CoA | ELISA Sandwich — Detection | −20°C |
S06-HE4-McAb1#: buffer 10mM PBS pH 7.4 + 1‰ ProClin 300. S06-HE4-HRP1#: buffer 10mM PB with 50% glycerol + 1‰ ProClin 300. Companion blocking reagent S01-blocker-02 (used at 5–15 µg/mL in enzyme diluent, −20°C storage) available on request. MOQ available for all products. Contact info@sekbio.com for datasheets, CoA, and bulk pricing.
A complete, protocol-validated HE4 raw material panel from a single ISO 13485-certified source, engineered for ELISA sandwich kit development.
S06-HE4-McAb1# (Mouse IgG2a, capture) and S06-HE4-HRP1# (Mouse IgG1, HRP-conjugated detection) bind non-overlapping HE4 epitopes, the prerequisite for a functional double-antibody sandwich ELISA. Supplying both clones pre-matched removes the epitope-mapping and pair-screening work that otherwise delays HE4 kit development.
S01-HE4-1 is a prokaryotic-expressed, full-length recombinant human HE4 protein suitable for calibrator and standard curve preparation, spike-recovery studies, and assay linearity validation — giving developers a single-source antigen that matches the antibody pair used in the same panel.
The capture antibody S06-HE4-McAb1# is supplied at ≥90% purity, manufactured under ISO 13485 QMS with inter-batch CV <10%. Consistent purity and potency across lots reduce plate-to-plate variability during kit manufacturing scale-up.
Sekbio provides a complete reference protocol — plate coating concentration, blocking conditions, enzyme-conjugate dilution ratio, and reaction/read timing — alongside the raw materials, shortening the time from raw material receipt to a working prototype ELISA.
Published data cited for HE4 report approximately 99% specificity and approximately 82.7% early-stage sensitivity individually, rising to approximately 92% sensitivity when combined with CA125 — a performance profile that supports strong analytical and clinical claims for kits built on this panel.
Sekbio supplies HE4 antibody and antigen raw materials to OEM IVD kit manufacturers worldwide, with full batch documentation and traceability supporting CE IVD and other regulatory submissions. Gram-scale OEM quantities available for commercial-scale kit production.
HE4 antibody and antigen panel for ELISA sandwich kit development, dual-marker ovarian cancer panels, and disease monitoring assay construction.
S06-HE4-McAb1# and S06-HE4-HRP1# are the core raw materials for a classic double-antibody sandwich ELISA: coat the capture antibody at 1–2 µg/mL, block with S01-blocker-02-treated enzyme diluent, incubate sample, then develop with the HRP-conjugated detection antibody and TMB substrate, reading OD450/630nm. Use S01-HE4-1 recombinant antigen to build the calibration curve. Contact info@sekbio.com for the full protocol and sample supply.
Because HE4 and CA125 have complementary strengths — HE4's high specificity offsets CA125's lower specificity in premenopausal women, while dual-marker sensitivity reaches approximately 92% — many IVD developers build combination panels or multivariate risk algorithms using both markers to triage women presenting with a pelvic mass. See our CA125 Antibody Pair for the matching CA125 raw materials.
Because HE4 is secreted proportionally to tumor burden, serial post-surgical or post-chemotherapy HE4 measurement supports monitoring for treatment response and early detection of disease recurrence, complementing existing CA125-based surveillance protocols used during long-term follow-up.
Sekbio's ISO 13485-certified manufacturing, full CoA documentation, and validated reference protocol support OEM ELISA kit manufacturers preparing CE IVD and other regulatory submissions for HE4 diagnostic products. Visit our Products page for the full oncology raw material portfolio, or contact us to discuss OEM supply.
Technical and commercial questions from IVD R&D engineers and procurement teams.
HE4 (Human Epididymis Protein 4, gene symbol WFDC2) is a small secreted glycoprotein first identified in the epithelium of the distal epididymis, where it was originally predicted to function as a protease inhibitor involved in sperm maturation. HE4 belongs to the WAP four-disulfide core (WFDC) protein family. Comprehensive tissue profiling shows HE4 is overexpressed in 93% of serous epithelial ovarian carcinomas, 100% of endometrioid ovarian carcinomas, and 50% of clear cell (non-mucinous) ovarian carcinomas, and is secreted into the circulation, producing measurable elevated serum levels. This high tissue specificity for the most common ovarian cancer histotypes makes HE4 one of the best-performing single biomarkers for early ovarian cancer detection and risk assessment.
Sekbio's HE4 panel includes three products: S01-HE4-1 (recombinant human HE4 protein, prokaryotic-expressed full-length antigen, for calibrator/standard curve and coating antigen use), S06-HE4-McAb1# (anti-HE4 capture monoclonal antibody, Mouse IgG2a, purity ≥90%, for ELISA plate coating), and S06-HE4-HRP1# (anti-HE4 HRP-conjugated detection monoclonal antibody, Mouse IgG1, for enzyme-labeled detection). This matched set is designed for ELISA double-antibody sandwich assay development. Contact info@sekbio.com for datasheets and MOQ pricing.
Published clinical data show HE4 alone achieves approximately 82.7% sensitivity for early-stage ovarian cancer detection versus 45.9% for CA125 alone, with HE4 specificity reaching approximately 99% compared to approximately 20% for CA125. Combining HE4 and CA125 in a dual-marker panel raises sensitivity to approximately 92% and reduces false-negative results by 30–50% compared with either marker used alone. Because CA125 is frequently elevated by benign gynecological conditions (especially in premenopausal women), HE4's higher specificity makes it a valuable complement that reduces unnecessary surgical referrals for benign pelvic masses.
S06-HE4-McAb1# and S06-HE4-HRP1# form a matched non-competing antibody pair for double-antibody sandwich ELISA: the capture antibody (McAb1#, Mouse IgG2a) is coated onto the microplate at 1–2 µg/mL to bind HE4 antigen from the sample, and the HRP-conjugated detection antibody (HRP1#, Mouse IgG1) then binds a separate, non-overlapping epitope on the captured HE4 molecule, generating a signal proportional to HE4 concentration after TMB substrate development and OD450/630nm reading. Sekbio supplies a complete reference protocol covering coating, blocking, enzyme-conjugate dilution, and reaction timing to accelerate kit development.
S06-HE4-McAb1# (capture antibody): store at +4°C for short-term use or −20°C for long-term storage, supplied in 10mM PBS pH 7.4 with 1‰ ProClin 300. S06-HE4-HRP1# (HRP-conjugated detection antibody): store at −20°C, supplied in 10mM PB with 50% glycerol and 1‰ ProClin 300. S01-HE4-1 (recombinant antigen): storage per Certificate of Analysis. Sekbio also supplies the companion blocking reagent S01-blocker-02 (−20°C storage) used at 5–15 µg/mL in the enzyme diluent. Avoid repeated freeze/thaw cycles for all products; contact info@sekbio.com for MOQ and bulk pricing.
Yes. Sekbio is an ISO 13485-certified manufacturer supplying the matched HE4 capture antibody, HRP-conjugated detection antibody, recombinant antigen, and blocking reagent needed to build a complete ovarian cancer ELISA sandwich kit. We provide full batch documentation, Certificate of Analysis, and a validated reference protocol to support CE IVD and other regulatory submissions. Contact info@sekbio.com to request datasheets, sample vials, or OEM pricing. Visit our Platforms page for antibody development and custom antigen expression services.
Request the full technical datasheet, product specifications, or discuss OEM supply for your HE4 IVD development programme.