Performance Characteristic Comparison of two kind HBsAg ELISA kits

Document Sample
Performance Characteristic Comparison of two kind HBsAg ELISA kits Powered By Docstoc
					Performance Characteristic Comparison of two kind HBsAg ELISA kits with Different
Incubation Time

Shen MN, Song BB, Guo W, Pan BS
Shanghai Jiaotong University School of Medicine, Department of Laboratory Medicine,
Zhongshan Hospital, Fudan University, Shanghai 200032, China.

Objective: To compare the performance characteristic of two HBsAg ELISA kits with
different incubation times (30min and 60min). Method: Two HBsAg ELISA kits from the
same manufacturer, with 30 min and 60 min incubation time were used to assay the same
batch of patient sera. The results were compared and the performance characteristic including
precision, ability of interference resistance and results agreement between the two kits were
compared. Results: The bias of precision between the two kits had no significant deviation.
Intra-assay imprecision (CV) were within 10% and Inter-assay imprecision (CV) were within
15%; hemoglobin (<4.0g/L), triglyeride (<2.2mmol/L), bilirubin (<260µmol/L) could not
interfere the test results; 229 samples were parallel tested by the two kits, there were 33
discrepant results of which samples tested with ECLIA were all weakly reactive. Conclusion:
Precision and ability of interference resistance of the two kits had no significant different but
the kit of 60 minutes incubation time had a higher sensitivity.