CEA FIA Test
Quantitative, non-subjective results.
Increased sensitivity and broader detection range compared to rapid tests.
Range
?Working range: 0.5-500.0 ng/mL.
Precision
?Intra-lot Precision.
?Intra-lot precision was determined by testing of CEA reference materials using 10 test devices from the same lot. ?CV _ 15%.
Inter-lot Precision
?Inter-lot precision was determined by testing of CEA reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV _ 20%.
Accuracy
CEA control materials with three different concentrations were tested by every lot of test device, and the deviations were within ?15%.
Linearity
A serial concentration of CEA reference materials at 1-500.0 ng/mL was tested, and the correlation coefficient (R) is _ 0.9900.
Hook Effect
?There is no Hook effect when the level is 100000.0 ng/mL.


