Diagnostic Kit for the Quantitative Detection of Alpha-fetoprotein(Time-resolved immunofluorometric assay)

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【INTENDED USE】

   The Diagnostic Kit for the Quantitative Detection of Alpha-fetoprotein(Time-resolved immunofluorometric assay) is an solid phase, two-site fluoroimmunometric assay for the quantitative detection of Alpha fetoprotein in human serum.

 

【SPECIFIC PERFORMANCE CHARACTERISTICS】

1. Sensitivity

   1087 samples (401 abnormal, 686 normal) were collected and tested. The result shows that the minimum detectable concentration of AFP TRFIA by this assay is less than 0.5 U/ml. 

2. Dosage-reaction curve linea(r) should be more than 0.9900.

3. Precision

   The inner analysis precision: CV%10.0; the inter analysis precision: CV%15.0

4. Specificity

   The test result of CEA(1000ng/ml), CA125(600U/ml), CA15-3(500U/ml) and CA19-9(1000ng/ml) detected by the kit is lower than 0.5U/ml.

5. Anti-interference

   The assay is not interfered by Triglyceride(21.54 mmol/L), bilirubin(818µ mmol/L) and hemoglobin(18 g/L).