Hemoglobin A1c (HbA1c)
PDB ID: 1A3N. Source: RCSB Protein Data Bank. For illustration purposes only.
VeriLumenTM 糖化血红蛋白
The VeriLumenTM HbA1c Rapid Test is a fluorescence immunochromatographic assay for the quantitative measurement of glycated hemoglobin (HbA1c) in human whole blood samples. HbA1c reflects the average blood glucose levels over the preceding weeks and is widely used in the clinical evaluation and long-term monitoring of glycemic control in patients with diabetes mellitus. The assay provides rapid quantitative results to support timely clinical assessment in laboratory and point-of-care settings.
This test is mainly used in the clinical assessment of diabetes and prediabetes, as well as in the monitoring of long-term blood glucose control. Quantitative HbA1c measurement supports clinical decision-making when interpreted together with clinical findings and other laboratory data, helping to evaluate treatment effectiveness and disease progression over time.
| Ref. Code | 808172 |
| Analyte | Hemoglobin A1c (HbA1c) |
| Format | Fluorescence lateral flow immunoassay (cassette format) |
| Diagnostic Readout | Quantitative |
| Time to Result | 5 minutes |
| Measuring Range | 2–14% |
| Reference Value | 4–6% | R2 | ≥ 0.95 |
| Storage Conditions | 2–30°C |
| Shelf Life | 18 months |
| Certificate | CE, NMPA |
| Sample Types | Human whole blood |
| Sample Volume | 10μL |
| Collection Method | Venous blood |
| Sample Stability | Stable for testing within 1 hour at room temperature (as validated) |
| Acceptable Anticoagulants | EDTA / Heparin / Citrate (as applicable) |
| Notes on Handling | Specimens should be collected and handled using standard laboratory procedures. Use fresh samples when possible and avoid hemolyzed, lipemic, or contaminated specimens. |
| Detection Method | Quantitative fluorescence immunochromatography |
| Antibody Format | Monoclonal / sandwich |
| Signal Generation | Fluorescence signal (fluorescent-labeled immunochromatography) |
| Reading Method | Instrument-based |
| Mechanism | The assay is based on a fluorescence immunochromatographic sandwich principle, in which glycated hemoglobin (HbA1c) present in hemolyzed whole blood binds to specific fluorescently labeled anti-HbA1c antibodies during capillary migration along the membrane. The resulting antigen–antibody complexes are captured by immobilized antibodies at the test region, and the fluorescence signal is measured and correlated with the HbA1c concentration in the specimen. |
| Tests per Kit | 10/25/50 Tests |
| Dimension of Kit Box | 21 × 13.5 × 8 cm |
| Kits per Carton | 48 Kits |
| Tests per Carton (Bulk) | 1200 Tests |
| G.W. per Carton (Boxed) | 23.2 kg |
| G.W. per Carton (Bulk) | 26.2 kg |
| Carton Dimension | 67 × 57.5 × 39 cm |
| Carton Volume | 0.15 CBM |
| Packaging Format | Individual sealed test kits / bulk configuration (as applicable) | Items Included | - Test cassette - Desiccant- Sample diluent- ID chip- Instructions for Use |
| Storage & Shipping Conditions | Standard ambient transport; store according to product label requirements |
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Shenzhen Kang Sheng Bao
Biotechnology Co., Ltd.
Second Floor, Block 3, Anda
Electronic Industrial Park,
Fuhai, Bao’an District,
518103 Shenzhen,
Guangdong Province, PRC
+86 0755 27417763
info@ksbbiotech.com