The Performance of the Abbott i2000 for Measuring Serum Markers of Infectious Diseases.
BACKGROUND
To date, there is a trend that the chemiluminescent microparticle immunoassays (CMIA) and electrochemiluminescence immunoassays (ECIA) technology gradually replacing the enzyme-linked immunosorbent assay (ELISA). But the performance such as the limit of quantitation (LOQ), precision, linear range of CMIA, or ECIA for serum markers of infectious diseases has rarely been reported.


METHODS
Using proficiency testing samples and standard materials, we confirmed the LOQ of the ELISA and the precision, linear range, LOQ, and instrument biases of the Abbott i2000 for eight serum markers. We used the Abbott i2000 and ELISAs to assess five HIV samples; the researchers were blinded to the true status of the samples.


RESULTS
For the Abbott i2000, the coefficients of variation (CV) for the low, medium, and high concentration samples ranged from 1.06 to 12.74%, which were less than the allowable error; the linear ranges of HBsAg and HBsAb were 0.66-304.11 IU/ml and 8.16-1205.9 mIU/ml, respectively. For the Abbott i2000, the LOQs of HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, anti-HCV, anti-TP, and anti-HIV were 0.026 IU/ml, 4 mIU/ml, 0.14 NCU/ml, 0.56 NCU/ml, 0.99 NCU/ml, 0.5 NCU/ml, 8.8 mIU/ml, and 1.92 NCU/ml, respectively, and these values were 0.16 IU/ml, 6.97 mIU/ml, 1.16 NCU/ml, 1.63 NCU/ml, 1.79 NCU/ml, 1.03 NCU/ml, 8.33 mIU/ml, and 1.3 NCU/ml, respectively, for the ELISA. When five HIV samples were blindly assessed, two cases were missed by the Abbott i2000 and the ELISA results were consistent with the expected results.


CONCLUSIONS
The Abbott i2000 performed significantly better than the ELISA on HBV and HCV screening; however, for anti-TP and anti-HIV, the ELISA remained the preferred method.
Clinical Laboratory of the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province, China.
Linchuan
L
Wang
Clinical Laboratory of the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province, China.
Wei
W
Chen
Clinical Laboratory of Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi Province, China.
Yan
Y
Yu
D015415:Biomarkers / Q000097:blood*; D003141:Communicable Diseases / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation* / Q000379:methods*; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006801:Humans; D057230:Limit of Detection
D015415:Biomarkers; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens
Abbott i2000; enzyme-linked immunosorbent assay; serum markers