Insulin Rapid Quantitative Test（Fluorescence Immunoassay）

1. Auxiliary Differential Diagnosis of Diabetes Mellitus

• Type 1 diabetes mellitus: Characterized by severe destruction of pancreatic β-cells, resulting in significantly reduced insulin secretion with a flat low-response curve.
• Early-stage type 2 diabetes mellitus: Insulin levels may be normal or even elevated, indicating the presence of insulin resistance; in advanced stages, secretory function declines and insulin levels decrease.
• Latent autoimmune diabetes in adults (LADA): Pancreatic function deteriorates rapidly over several years, with insulin secretion patterns falling between those of type 1 and type 2 diabetes.

2. Assessment of Pancreatic β-cell Function

By measuring fasting and postprandial (or post-glucose-load) insulin secretion levels, the test enables quantitative evaluation of islet function and provides critical evidence for assessing the degree of β-cell impairment.

3. Guidance for Clinical Treatment Decisions

• Helps differentiate whether a patient requires exogenous insulin supplementation or insulin-sensitizing therapy
• Provides a basis for selecting appropriate hypoglycemic agents
• Assists in dynamically monitoring treatment efficacy and adjusting therapeutic regimens

4. Early Screening and Risk Assessment

Abnormal insulin secretion patterns (e.g., hyperinsulinemia or early-phase secretion defects) may serve as early warning signals for metabolic disorders and glucose dysregulation, facilitating timely intervention.

Target Populations

The insulin test is recommended for the following patient groups:

1. Individuals with abnormal fasting blood glucose or impaired glucose tolerance

2. Patients with suspected or confirmed diabetes mellitus requiring classification

3. Diabetic patients requiring assessment of islet function or adjustment of treatment plans

4. Obese individuals or those with metabolic syndrome

5. Women with a history of gestational diabetes mellitus

6. Individuals with a family history of diabetes undergoing risk screening

7. Patients with unexplained hypoglycemia

Testing Considerations

To ensure the accuracy and reliability of test results, the following points should be noted:

1. Fasting requirement: A fasting blood sample (≥8 hours) is typically required; for postprandial or glucose-load testing, samples should be collected at specified time points as directed by the physician.

2. Medication interference: Certain drugs (e.g., exogenous insulin, oral hypoglycemic agents, corticosteroids) may affect test results; patients should inform their physician of all medications they are taking.

3. Hemolysis prevention: Hemolyzed specimens may interfere with assay accuracy; proper specimen handling procedures should be .

4. Interpretation considerations: Results should be interpreted in conjunction with blood glucose levels, C-peptide values, and the patient's clinical presentation. A single abnormal value should not be used as the sole basis for diagnosis.

5. Reference range: Reference intervals may vary across laboratories and detection methods; results should be interpreted based on the reference range provided by the testing laboratory.