Rapid Fluorescent Immunoassay for Glycated Hemoglobin — 3-Month Glycemic Control Indicator
The Sekbio HbA1c FIA Test is a rapid quantitative fluorescent immunoassay for the measurement of glycated hemoglobin (HbA1c) in whole blood — the internationally recommended biomarker for diabetes diagnosis, screening, and chronic glycemic control monitoring.
HbA1c reflects the percentage of hemoglobin bound to glucose over the preceding 8–12 weeks. Unlike fasting blood glucose, HbA1c is unaffected by short-term blood sugar fluctuations, providing a stable and clinically meaningful measure of long-term glycemic exposure. The ADA and WHO recommend HbA1c ≥6.5% as a diagnostic threshold for diabetes mellitus.
Fingerstick or venous whole blood sample directly applied to the FIA strip — no centrifugation, no serum separation. Enables immediate diabetes screening in primary care, pharmacies, and community clinics.
Rapid FIA format with fluorescence reader readout delivers quantitative HbA1c % in approximately 5 minutes — enabling same-visit diagnosis and treatment decision-making in outpatient settings.
HbA1c reflects average blood glucose over 8–12 weeks — unaffected by recent meals, exercise, or acute illness. A single test provides comprehensive long-term glycemic control data for treatment decisions.
HbA1c FIA results compared against established laboratory reference methods demonstrate strong concordance — supporting equivalence claims and regulatory submissions for IVD market entry.
Within-run repeatability assessed across multiple HbA1c concentrations confirms CV within IVD acceptance criteria — enabling reliable serial monitoring with detected changes clinically meaningful.
Accelerated stability testing confirms reagent integrity under stress conditions — supporting ambient-temperature shipping and shelf-life claims for international distribution.
| HbA1c Range | Classification | Clinical Action |
|---|---|---|
| < 5.7% | Normal | Routine monitoring, lifestyle counseling |
| 5.7 – 6.4% | Prediabetes | Lifestyle intervention, annual reassessment |
| ≥ 6.5% | Diabetes Mellitus | Initiate treatment, repeat confirmation if asymptomatic |
| 7.0% (Target) | Treatment Goal | Target for most adults with T2DM on therapy |
| > 10% | Poor Glycemic Control | Intensify therapy, review adherence and lifestyle |
| Reference: ADA Standards of Medical Care in Diabetes, WHO Guidelines for Diabetes Diagnosis. | ||
ADA-recommended HbA1c ≥6.5% criterion for diabetes diagnosis. FIA POCT format enables community-based screening programs without lab infrastructure.
Quarterly HbA1c monitoring for patients on antidiabetic therapy. Results within 5 minutes allow treatment adjustments during the same clinical visit.
Whole blood fingerstick format enables HbA1c testing in primary care offices, pharmacies, and community health settings — no centrifuge required.
HbA1c antibody pair and assay components available for OEM FIA kit developers. Validated for fluorescence reader platforms with full technical documentation.
Full technical specifications, performance data, and OEM pricing available on request.