Diagnostic Kit for the Quantitative Detection of Carcinoembryonic Antigen(Time-resolved immunofluorometric assay)

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【INTENDED USE】

The Diagnostic Kit for the Quantitative Detection of Carcinoembryonic Antigen (Time-resolved immunofluorometric assay) is a solid phase, two-site fluoroimmunometric assay for the quantitative detection of carcinoembryonic antigen in human serum.

 

【SPECIFIC PERFORMANCE CHARACTERISTICS】

1.  Sensitivity

    1107 samples (457 abnormal, 650 normal) were collected and tested. The result shows that the minimum detectable concentration of CEA by this assay is less than 0.5 ng/ml.

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

3.  Repeatability

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

4.  Specificity

   The test result of AFP(1000 U/ml), CA125(600 U/ml), CA19-9(500 U/ml) and albumin(1000 ng/ml) detected by the kit is lower than 0.15 ng/ml, 0.15 ng/ml, 0.15 ng/ml and 0.20 ng/ml.

5. Anti-interference

   The assay is not interfered by Triglyceride(21.54 mmol/L), bilirubin(818µ mmol/L) and hemoglobin(18 g/L) Measuring range The measuring range of the kit is from 0.02 ng/ml to 830 ng/ml.