High-Correlation C-Reactive Protein Antibodies for Multi-Platform IVD Development
The Sekbio CRP Polyclonal Antibody Pair enables quantitative measurement of C-Reactive Protein — the primary acute-phase biomarker for bacterial infection, systemic inflammation, and cardiovascular risk stratification. CRP rises 100–1,000× above baseline within 4–6 hours of infection or tissue injury and returns to normal within 3–7 days of effective treatment, making it an ideal marker for infection triage and therapeutic monitoring.
Produced at up to 1 kg per batch with excellent lot-to-lot consistency, the antibody pair has been validated across hematology analyzers, specific protein analyzers, biochemical analyzers, and FIA platforms — with correlation to leading imported reagents exceeding R² = 0.9998.
Proven performance across multiple IVD platforms, validated correlation to imported references, and industrial-scale supply capability.
Detection range of 0.1–320 mg/L covers the full clinical spectrum — from normal (<10 mg/L) through mild infection (10–40 mg/L), to severe bacterial infection (>100 mg/L) — eliminating reflexive dilutions.
R² ≥ 0.9998 correlation with leading imported CRP reagents on biochemical analyzers, and r = 0.9954 on hematology analyzers — enabling direct equivalence claims in clinical submissions.
Validated on hematology analyzers (full blood count with CRP), specific protein analyzers, biochemical analyzers (turbidimetry/nephelometry), and FIA (fluorescence immunoassay) rapid platforms.
Polyclonal antibody produced at up to 1 kg per batch with batch-to-batch consistency verified by lot release testing. Ensures supply continuity for high-volume IVD manufacturers and OEM reagent producers.
Fast-reacting and slow-reacting antibody pairs available for different assay kinetics — matching the requirements of rapid POCT FIA formats and high-throughput biochemical analyzers respectively.
High specificity demonstrated across both plasma and whole blood sample matrices, enabling combined CBC+CRP panels on hematology analyzers without separate serum preparation steps.
End-user validation data across multiple analyzer platforms demonstrates consistently high correlation with established reference reagents.
Clinical samples spanning the full CRP range were measured in parallel on Sekbio CRP reagent and leading imported CRP reagents on a standard biochemical analyzer. Regression analysis yields R² = 0.9998, confirming clinical equivalence.
| Metric | Biochemical Analyzer | Hematology Analyzer |
|---|---|---|
| Correlation Coefficient (r) | ≥ 0.9999 | 0.9954 |
| R² (Coefficient of Determination) | 0.9998 | 0.9909 |
| Range Evaluated (mg/L) | 0.1 – 320 | 0.1 – 160 |
| Sample Type | Serum | Whole Blood / Serum |
| Conclusion | Excellent clinical concordance — suitable for equivalence claims in regulatory submissions | |
| Data from end-user clinical validation studies. Reference: leading imported CRP reagent kits. | ||
The CRP antibody pair demonstrates quantitative response across the full clinical range from near-normal (<10 mg/L) through high-inflammation values (>200 mg/L), enabling single-test coverage without dilution for the majority of clinical specimens.
| Clinical Zone | CRP Range (mg/L) | Clinical Interpretation | Coverage |
|---|---|---|---|
| Normal | < 10 | No significant inflammation | ✓ Quantitative |
| Mild Elevation | 10 – 40 | Minor infection, mild inflammation | ✓ Quantitative |
| Moderate | 40 – 100 | Active infection, inflammatory disease | ✓ Quantitative |
| High | 100 – 200 | Bacterial infection, serious inflammation | ✓ Quantitative |
| Very High | 200 – 320 | Severe bacterial infection, sepsis risk | ✓ Quantitative (no dilution required) |
| Detection range: 0.1–320 mg/L. Specimens exceeding 320 mg/L should be diluted 1:4 and re-tested. | |||
As a polyclonal antibody, lot-to-lot consistency is verified through standardized QC panel testing. Large-scale production of up to 1 kg per batch ensures reagent supply continuity for high-volume IVD manufacturers.
| Parameter | Specification | Verified |
|---|---|---|
| Maximum Batch Yield | Up to 1 kg/batch | ✓ |
| Lot-to-Lot Correlation | r ≥ 0.995 vs. reference lot | ✓ |
| Sensitivity Consistency | LoD within ±20% across lots | ✓ |
| Platform Qualification | 4 validated IVD platforms | ✓ |
| Supply Availability | Ready stock, short lead time | ✓ |
| Batch certificates available on request. Custom lot sizes available for OEM customers. | ||
CRP antibody pair supporting multiple clinical settings and IVD development formats.
CRP is a frontline marker in emergency triage for distinguishing bacterial from viral infection, guiding antibiotic decisions. Wide 0.1–320 mg/L range covers all severity levels without dilution in most cases.
High-sensitivity CRP (hsCRP) <1, 1–3, >3 mg/L zones provide cardiovascular risk stratification. Low-end detection at 0.1 mg/L supports hsCRP panels for cardiovascular prevention programs.
CRP is the primary infection marker in pediatric practice — deployed widely in pediatrics departments, neonatal ICUs, and outpatient fever evaluation to guide antibiotic prescribing in children.
Polyclonal anti-CRP antibody pair available as OEM raw material for reagent kit manufacturers and analyzer developers. ISO 13485-compliant supply with batch certificates and technical support.
Datasheet, correlation data, platform validation reports, and OEM pricing available on request.