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 ELISA s 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 HB sAg and HB sAb were 0.66–304.11 IU /ml and 8.16–1205.9 mIU /ml, respectively. For the Abbott i2000, the LOQ s of HB sAg, HB sAb, HB eAg, HB eAb, HB cAb, 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.