Cardiac Troponin I — Dual-Format CLIA and FIA for Acute MI Diagnosis
The Sekbio cTnI Antibody Pair enables quantitative measurement of cardiac Troponin I — the gold-standard biomarker for AMI diagnosis per ESC/ACC guidelines. cTnI is released from damaged cardiomyocytes within 2–6 hours of cardiac injury, peaks at 12–24 hours, and remains elevated for 5–10 days, enabling both early detection and retrospective AMI diagnosis.
Available in two validated formats: CLIA (AE platform) with 6-point calibration from 0.001–35.97 ng/mL and S/N of 12,736 at the upper calibrator; and FIA with 0.1–40 ng/mL range, LoD 0.1 ng/mL, validated against Abbott ARCHITECT across 60 clinical samples.
CLIA and FIA performance data verified in head-to-head comparison with Abbott ARCHITECT cTnI.
Blank limit 0.0032 ng/mL (avg+2SD, n=20). S/N of 5.71 at 0.023 ng/mL — well above the AMI decision cut-off zone, confirming reliable low-level cTnI quantification.
S/N of 12,736 at 35.97 ng/mL — capturing both early low-level release and massive MI concentrations in a single assay without dilution for most clinical presentations.
FIA format validated against Abbott ARCHITECT across 60 clinical serum samples — supporting regulatory equivalence documentation and market positioning.
FIA (0.1–40 ng/mL) for portable fluorescence readers in ED. CLIA for high-throughput central lab analyzers — one antibody pair, two platforms.
Within-run CV 8.7% (0.045 ng/mL) and 5.0% (1.85 ng/mL) for CLIA; ≤9.7% across all FIA QC levels — supporting reliable serial troponin trending.
Serial dilution from 35.97 ng/mL confirms quantitative linearity — back-calculated concentrations within acceptable recovery across all 6 calibrator levels.
One-step sandwich: 30 µL Ra + 30 µL sample, 5 min, wash; Rd AE label; read RLU after Pre-Trigger/Trigger.
Six calibrators spanning 0.001–35.97 ng/mL demonstrate robust dose-response with S/N exceeding 12,000 at the upper limit.
| Calibrator (ng/mL) | RLU Run 1 | RLU Run 2 | RLU Run 3 | Avg RLU | S/N |
|---|---|---|---|---|---|
| 0.001 (Blank) | 225 | 207 | 233 | 222 | — |
| 0.023 | 1,262 | 1,204 | 1,331 | 1,266 | 5.71 |
| 0.045 | 2,407 | 2,200 | 2,091 | 2,233 | 10.07 |
| 1.851 | 112,633 | 114,785 | 113,942 | 113,787 | 513 |
| 10.466 | 756,507 | 762,147 | 775,572 | 764,742 | 3,450 |
| 35.974 | 2,847,046 | 2,814,194 | 2,807,991 | 2,823,077 | 12,736 |
| S/N = Avg RLU / Blank RLU. Blank limit (avg+2SD, n=20 blanks): 0.0032 ng/mL. | |||||
| QC Level (ng/mL) | Avg Conc (ng/mL) | SD | CV |
|---|---|---|---|
| 0.045 (Low) | 0.042 | 0.004 | 8.7% |
| 1.851 (Mid) | 1.79 | 0.09 | 5.0% |
| Acceptance criterion: CV ≤10%. | |||
| Parameter | Value |
|---|---|
| Detection Range | 0.1 – 40 ng/mL |
| Limit of Blank (LoB) | 0.027 ng/mL |
| Limit of Detection (LoD) | 0.1 ng/mL |
| CV (Low / Mid / High QC) | 9.7% / 7.7% / 7.9% |
| Clinical Correlation (vs. Abbott, n=60) | Strong concordance validated |
| FIA: lateral flow strip with fluorescence reader. Sample: serum/plasma. | |
Gold-standard per ESC/ACC guidelines. Supports 0–1h and 0–3h rapid rule-out/rule-in protocols with serial measurements at presentation and follow-up.
FIA strip for portable fluorescence readers — 15–20 min bedside result for rapid ED triage without central lab transport delay.
CLIA AE bulk reagent for high-throughput automated analyzers. ≤5 min turnaround for ICU and cardiac ward serial monitoring.
Anti-cTnI pair as OEM raw material for CLIA and FIA manufacturers. Abbott comparison data package available for regulatory submissions.
Full technical specifications, performance data, and OEM pricing available on request.