Apolipoprotein B (ApoB) Antibody for Cardiovascular Risk CLIA & ELISA IVD Development
Apolipoprotein B (ApoB) is the principal structural protein of all atherogenic lipoprotein particles, including LDL (low-density lipoprotein), VLDL (very-low-density lipoprotein), IDL (intermediate-density lipoprotein), and Lp(a). The predominant form, ApoB-100, is a 4,536 amino acid protein with a molecular weight of approximately 512 kDa, synthesised in the liver and serving as the non-exchangeable backbone of LDL particles throughout their lifespan. A critical feature for IVD development is that each atherogenic lipoprotein particle contains precisely one ApoB-100 molecule — meaning serum ApoB concentration is a direct stoichiometric measure of the total circulating atherogenic particle count, irrespective of particle size or cholesterol content.
The clinical significance of ApoB as a cardiovascular risk biomarker is substantial. Large-scale clinical studies, including the INTERHEART study and multiple prospective cohort analyses, have consistently demonstrated that ApoB is among the strongest predictors of cardiovascular events, outperforming LDL-C in patients with metabolic syndrome, diabetes, and mixed dyslipidaemia. The AHA/ACC 2018 Cholesterol Guidelines include ApoB as a risk-enhancing factor, with a target below 80 mg/dL for patients at high cardiovascular risk. Normal reference ranges are 60–140 mg/dL for men and 55–125 mg/dL for women. The ApoB/ApoA-I ratio, recommended by European Society of Cardiology lipid guidelines, serves as an atherogenicity index for residual cardiovascular risk assessment, particularly relevant in patients achieving LDL-C targets but remaining at elevated particle-level risk.
For IVD development, ApoB is measured by immunoturbidimetry on clinical chemistry analyzers and by CLIA/ELISA sandwich immunoassay. The large molecular weight of ApoB-100 (512 kDa) presents multiple accessible epitopes, making polyclonal antibodies particularly effective for immunoturbidimetric and ELISA-based detection. Sekbio's ApoBA01 (goat polyclonal anti-ApoB) provides broad multi-epitope recognition suitable for immunoturbidimetric and ELISA development. ApoBP01 (calibrator-grade ApoB antigen) supports accurate standard curve construction and assay calibration, enabling traceability to reference materials. The target market for ApoB assay development spans Europe (driven by ESC lipid guideline adoption), North America, the Middle East, and Asia-Pacific regions where cardiovascular disease burden is high.
Anti-ApoB goat polyclonal antibody and calibrator-grade ApoB antigen for complete CLIA and ELISA sandwich immunoassay development.
| Catalog No. | Product Name | Type | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| ApoBA01 | Anti-ApoB Goat Antibody (Polyclonal) | Antibody | >90% SDS-PAGE | Capture / Detection — CLIA, ELISA | −20°C / +2–8°C <1 month |
| ApoBP01 | ApoB Antigen (Calibrator Grade) | Antigen / Calibrator | As per CoA | Standard curve / Calibration | As per CoA |
ApoBA01 supplied in PBS pH 7.4. MOQ 1 mg. OEM quantities available. Contact info@sekbio.com for bulk pricing and technical datasheet.
Designed for the precision and specificity required in clinical cardiovascular risk stratification and lipid management IVD development.
ApoBA01 is a goat-derived polyclonal antibody providing broad multi-epitope recognition across the ApoB-100 protein (512 kDa). Polyclonal antibodies are ideally suited for immunoturbidimetric assays and sandwich ELISA/CLIA where multi-site binding improves signal intensity. The goat host minimises cross-reactivity issues common with rodent-based antibodies in human serum matrices.
ApoBA01 is validated for both CLIA (chemiluminescence immunoassay) and ELISA formats, enabling a single raw material source for hospital laboratory quantitative ApoB measurement. The antibody's broad epitope coverage also supports immunoturbidimetric adaptation on clinical chemistry analyzers, which represent the dominant ApoB testing platform in European hospital laboratories.
ApoBP01 (calibrator-grade ApoB antigen) is supplied alongside the antibody to support accurate standard curve construction and assay calibration. Traceable calibration is essential for ApoB quantification, where target values (<80 mg/dL for high-risk patients per AHA/ACC guidelines) require accurate absolute measurement for clinical decision-making.
ApoBA01 purity exceeds 90% by SDS-PAGE with batch CV <10%, manufactured under ISO 13485 QMS. Each lot is released with a full Certificate of Analysis covering purity, protein concentration, and functional binding activity. Consistent batch-to-batch performance simplifies assay validation and regulatory submission during OEM kit manufacturing scale-up.
ApoB testing adoption is growing globally, driven by ESC 2019/2021 lipid guidelines recommending ApoB as a primary treatment goal in high-risk patients and as a superior alternative to LDL-C in metabolic syndrome. The ApoB/ApoA-I ratio is increasingly used for residual cardiovascular risk assessment. IVD manufacturers entering this growing market segment benefit from Sekbio's ready-to-use antibody and antigen pair.
ISO 13485-compliant manufacturing in Shenzhen, China supports CE, NMPA, and other regulatory submissions. MOQ 1 mg for R&D evaluation; larger quantities available for OEM kit production. Sekbio serves 200+ IVD brands across 30+ countries. Key ApoB markets: Europe (Germany, Italy), North America, the Middle East, South Korea, and Japan.
ApoB antibody and antigen validated for cardiovascular risk stratification, lipid management, and metabolic disease IVD kit development.
ApoB quantification provides a direct measure of atherogenic lipoprotein particle number — a cardiovascular risk metric that outperforms LDL-C in multiple prospective studies. Each ApoB-100 molecule represents one circulating atherogenic particle (LDL, VLDL, IDL, or Lp(a)). ApoB CLIA and ELISA assays enable IVD manufacturers to develop cardiovascular risk panels beyond traditional lipid profiles, targeting cardiologists, endocrinologists, and preventive medicine physicians who require particle-level risk assessment. ESC 2021 guidelines list ApoB <65 mg/dL as the treatment target for very high-risk patients.
The ApoB/ApoA-I ratio is a validated atherogenicity index recommended by European cardiovascular guidelines for residual risk assessment. ApoB measures atherogenic lipoprotein particles; ApoA-I measures cardioprotective HDL particles. IVD manufacturers developing comprehensive lipid panels can combine Sekbio's ApoB antibody (ApoBA01) with ApoA-I antibodies for dual-marker cardiovascular risk assessment. This is particularly valuable for patients who achieve LDL-C targets on statin therapy but retain elevated particle-level risk.
Statins reduce LDL-C but their effect on atherogenic particle number (as measured by ApoB) may not correlate linearly, particularly in patients with metabolic syndrome or type 2 diabetes who exhibit LDL discordance (normal LDL-C but elevated ApoB). Serial ApoB measurement during statin or PCSK9-inhibitor therapy provides a more accurate assessment of treatment efficacy at the particle level. IVD manufacturers developing lipid monitoring assays for cardiology and endocrinology clinics benefit from Sekbio's matched ApoB antibody-antigen pair for accurate, traceable quantification.
Patients with type 2 diabetes, obesity, and metabolic syndrome frequently exhibit LDL discordance — elevated ApoB with normal or low LDL-C — due to a predominance of small, dense LDL particles that carry less cholesterol per particle but are highly atherogenic. ApoB screening in these populations identifies individuals at elevated cardiovascular risk who would be missed by LDL-C measurement alone. The growing prevalence of type 2 diabetes globally (537 million adults in 2021, IDF data) is expanding demand for ApoB testing in endocrinology and primary care settings. Contact Sekbio to discuss ApoB assay development for metabolic disease panels.
Technical and commercial questions from IVD R&D engineers and procurement teams developing cardiovascular risk assays.
Apolipoprotein B (ApoB) is the primary structural protein of atherogenic lipoproteins — LDL, VLDL, IDL, and Lp(a). ApoB-100 (512 kDa, 4,536 amino acids) is synthesised in the liver and forms the structural backbone of LDL particles throughout their lifespan. Because each atherogenic particle contains exactly one ApoB-100 molecule, serum ApoB directly measures total atherogenic particle number. Clinical evidence from the INTERHEART study and multiple cohort analyses shows ApoB is among the strongest predictors of cardiovascular events, particularly superior to LDL-C in patients with metabolic syndrome and type 2 diabetes. AHA/ACC 2018 guidelines include ApoB as a risk-enhancing factor (target <80 mg/dL for high-risk patients).
LDL-C measures the total cholesterol content within LDL particles, not particle number. ApoB measures actual atherogenic lipoprotein particle count (LDL + VLDL + IDL + Lp(a)) since each particle carries exactly one ApoB-100 molecule. In patients with small, dense LDL (metabolic syndrome, type 2 diabetes), LDL-C can underestimate risk while ApoB accurately reflects atherogenic burden — a phenomenon known as LDL discordance. ESC 2021 lipid guidelines recommend ApoB as the primary treatment target for very high-risk patients (<65 mg/dL). The ApoB/ApoA-I ratio is also recommended by European guidelines as an atherogenicity index for residual risk.
Sekbio supplies: ApoBA01 (Anti-ApoB Goat Polyclonal Antibody — >90% purity by SDS-PAGE, in PBS pH 7.4, validated for CLIA and ELISA capture/detection) and ApoBP01 (ApoB Antigen, calibrator grade — for standard curve preparation and assay calibration). MOQ 1 mg for both products. Contact info@sekbio.com for datasheet, pricing, and availability.
ApoBA01 (goat polyclonal anti-ApoB) is validated for CLIA (chemiluminescence immunoassay) and ELISA sandwich formats. The multi-epitope polyclonal binding profile also makes ApoBA01 suitable for immunoturbidimetric assay development on clinical chemistry analyzers — the dominant ApoB testing platform in European hospital laboratories. Contact info@sekbio.com for immunoturbidimetry optimisation guidance.
MOQ is 1 mg for both ApoBA01 and ApoBP01. ApoBA01 storage: PBS pH 7.4; −20°C for long-term storage; +2°C to +8°C for periods less than 1 month. Avoid repeated freeze/thaw cycles. ApoBP01 storage as specified on the Certificate of Analysis. Full CoA provided with every shipment. Contact info@sekbio.com for bulk OEM pricing at 10 mg–gram scale.
Yes. Sekbio supplies ApoBA01 antibody and ApoBP01 calibrator antigen to IVD manufacturers worldwide for OEM kit production under ISO 13485 QMS. Regulatory documentation for CE, NMPA, and other submissions is available. ApoB testing is growing in Europe (ESC guideline adoption), North America, the Middle East, South Korea, and Japan. Contact info@sekbio.com or call +86-13590345917 to discuss your ApoB assay development project. Visit our Platforms page for antibody development services.
Request the full technical datasheet, antibody specifications, or discuss OEM supply with our cardiovascular IVD team.