Semi-Quantitative Colloidal Gold Lateral Flow Antibody for Total Immunoglobulin E Detection
The IgE Antibody Pair is designed for colloidal gold lateral flow immunoassay (LFA) strips for the semi-quantitative detection of total Immunoglobulin E (IgE) in human serum or plasma. Total IgE is the primary biomarker for allergic sensitisation, atopic disease, and parasite infection, and elevated levels are associated with asthma, allergic rhinitis, atopic dermatitis, and food allergy.
The antibody pair generates a visually gradable band intensity scale (B0 through B7) that correlates consistently with chemiluminescence reference values across the clinical range of 96–1,158 IU/mL. Repeatability at a defined positive level (B5+, ≈785 IU/mL) is 100% across 10 consecutive readings.
Key analytical and clinical performance advantages of the Sekbio IgE antibody pair.
Eight-band grading system (B0 = negative through B7 = highest positive) provides clinically useful IgE stratification beyond simple positive/negative, enabling risk categorisation without a reader device.
Ten consecutive tests at the B5+ level (≈785 IU/mL) produced identical band grading with chemiluminescence values tightly clustered at 1,512,154–1,538,456 RLU — confirming lot-to-lot consistency.
40 clinical and random samples (20 random + 20 clinical) tested in parallel with a CLIA analyzer show consistent gradient correlation across the full 96–1,158 IU/mL range.
Sample diluent (n=10) produces B0 on colloidal gold with 0.00 IU/mL chemiluminescence value — confirming negligible non-specific background and high signal specificity.
Visual band intensity grading enables deployment in primary care clinics, pharmacies, and resource-limited settings without fluorescence or luminescence reader instrumentation.
Capture and detection antibody pair available as colloidal gold-conjugated reagents for licensed LFA strip manufacturers. Compatible with standard nitrocellulose membrane formats.
All data generated using Sekbio IgE antibody pair (Batch G03001B) in colloidal gold LFA format.
Twenty random serum samples (chemiluminescence IgE range: 96–624 IU/mL) were tested on the Sekbio IgE colloidal gold strip. Band intensity grades correlate consistently with the reference CLIA values, with higher IU/mL corresponding to higher band grades.
| Sample | Colloidal Gold Grade | CLIA Concentration (IU/mL) | CLIA RLU |
|---|---|---|---|
| 1–6, 8–13, 16–17, 19–20 | B0 (Negative) | 96 – 179 IU/mL | 108,423 – 241,612 |
| 10 | B2 | 281 IU/mL | 430,843 |
| 7, 15 | B3 | 418 – 435 IU/mL | 711,836 – 748,276 |
| 18 | B4− | 532 IU/mL | 928,815 |
| 14 | B4 | 624 IU/mL | 1,158,485 |
| n=20 random samples. Chemiluminescence values used as reference standard. Gradient concordance confirmed across all samples. | |||
Twenty clinical serum samples spanning a wider IgE range (100–1,158 IU/mL) were tested. The colloidal gold strip resolves the full clinical range with consistent band intensity progression from B0 to B7.
| Grade | Sample Count | CLIA Range (IU/mL) |
|---|---|---|
| B0 (Negative) | 3 | 101 – 162 IU/mL |
| B2 | 1 | 260 IU/mL |
| B3 / B3+ | 3 | 452 – 508 IU/mL |
| B4 / B4+ | 4 | 545 – 583 IU/mL |
| B5 / B5+ | 3 | 718 – 782 IU/mL |
| B6 / B6+ | 4 | 867 – 940 IU/mL |
| B7− / B7 | 2 | 1,007 – 1,158 IU/mL |
| n=20 clinical samples. All samples show consistent gradient concordance with CLIA reference values. | ||
Ten consecutive measurements of a positive control sample at approximately 785 IU/mL (B5+ grade) produced identical band grading across all replicates. CLIA RLU values were tightly grouped, confirming intra-lot consistency.
| Replicate | Colloidal Gold Grade | CLIA Concentration (IU/mL) | CLIA RLU |
|---|---|---|---|
| 1 – 10 (all) | B5+ (100% concordance) | 778 – 798 IU/mL | 1,494,654 – 1,538,456 |
| n=10. All replicates B5+. CV of CLIA RLU ≈ 1.1%, confirming excellent reproducibility. | |||
The IgE antibody pair supports allergy screening and atopic disease management across multiple clinical and OEM contexts.
Rapid total IgE measurement for initial allergy workup. Elevated total IgE (>200 IU/mL) indicates allergic sensitisation and guides referral for specific allergen panel testing in asthma, rhinitis, and atopic dermatitis.
Markedly elevated total IgE (>1,000 IU/mL) is a characteristic feature of helminth infections (Ascaris, Toxocara, Schistosoma). Rapid screening supports endemic-area population surveys and individual diagnosis.
Visual readout without a reader device enables deployment in GP clinics, community pharmacies, and remote settings. Same-consultation results support immediate clinical decision-making on antihistamine or referral pathways.
Capture and detection antibodies available as colloidal gold conjugates or unconjugated pairs for licensed IVD manufacturers. ISO 13485-compliant supply with consistent lot performance for strip production integration.
Request the full technical datasheet, antibody pair specifications, or discuss OEM supply and strip development with our team.