Objective To compare the differences in the detection of performance among the automatic enzyme-free analysis system and the imported enzyme-free analysis system and the manual method.
Methods A total of 196 hepatitis B/C negative serum samples, 20 hepatitis B positive serum samples, 20 hepatitis C positive serum samples randomly collected in Hangzhou First People's Hospital in 2016. To compare the sensitivity, precision, accuracy and specificity of the three methods, we use 1 set of Zhuhai Lizhu company hepatitis B detection kit and a set of Beijing Kang Chester anti-HBV national standard material, a set of Beijing million Thai hepatitis C kit and a set of Beijing Kang Chester anti-HCV national standard substances, respectively. Data were analyzed by SPSS 17.0 software.
Results Abbott i2000SR system sensitivity was significantly higher than Addcare ELISA 600 system and manual method, Addcare ELISA 600 system sensitivity higher than manual method, the difference was statistically significant (
P<0.05). The test CVs of the standard materials of the hepatitis B and the hepatitis C antibody were 14.5%> 12.3%>2.1%, 17.0%>12.5%>3.5%, 10.8%>8.4%>3.0%, 24.4%>19.6%>4.4%, 20.0%>19.4%>2.0%, 12.7%>11.1%>3.2%, respectively. The CV of the manual method is greater than that of the domestic automatic enzyme-free analysis system. The CV of the system is greater than that of the Abbott. The CV of the i2000SR system was statistically significant (
P<0.05). The coincidence rate of the three methods was 100.0% for HBV and anti-HCV kit positive and negative reference. The specificity of the three methods was 100.0% for 176 negative specimens.
Conclusion The automatic enzyme-free analysis system and the Abbott i2000SR system are more reproducible than manual operation, and the coincidence rate and specificity of the three are consistent. The domestic automatic enzyme-free analysis system can replace the manual operation Clinical routine specimen testing.
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