Clinical diagnostic performance of light‐initiated chemiluminescent assay compared with the Architect chemiluminescence immunoassay for detection of HCV antibody

Abstract

BackgroundHepatitis C virus antibody (anti‐HCV) test had been approved as a preliminary screening test for HCV infection. Light‐initiated chemiluminescent assay (LiCA) was a homogenous method. We aimed to assess the clinical diagnostic performance of LiCA and compare it with that of chemiluminescence immunoassay (CLIA) which was widely used in clinical laboratories.MethodsA total of 10 772 patients from the Peking University Third Hospital were enrolled. The serum samples were detected on the ChIVD LiCA500 and Abbott Architect i2000SR platforms. Recombinant immunoblot assay (RIBA) and HCV RNA assay were used for confirmation.ResultsThe negative agreement rate between ChIVD LiCA anti‐HCV assay and Abbott Architect anti‐HCV assay was 99.91%, the positive agreement rate was 37.31%, the total agreement rate was 98.74%, and the kappa coefficient (κ) was 0.519. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ChIVD LiCA anti‐HCV assay were 96.39%, 99.95%, 89.58%, and 99.97%, respectively, which were superior to those of Abbott Architect anti‐HCV assay (93.98%, 99.25%, 51.90%, and 99.95%, respectively).ConclusionChIVD LiCA anti‐HCV assay was a highly sensitive, specific homogenous method with good diagnostic performance, and was applicable for the routine screening of HCV infection in clinical laboratories.

A hook-effect-free homogeneous light-initiated chemiluminescence assay: is it reliable for screening and the quantification of the hepatitis B surface antigen?

“…This may partly explain why the quantitative HBsAg results in our studies are genotype independent. Previous data have shown that LICA-like technology is suitable for detecting small molecules such as hormones and some new drugs, and for detecting antibodies against pathogens (25,(41)(42)(43)(44). Our study shows that the LICA technology could also be extended to the measurement of much larger analytes, such as HBsAg, which is composed of various forms of particles with diameters ranging from 17 to 45 nm (8,45).…”

Analytical and clinical evaluation of the light‐initiated chemiluminescent assays for measurement of human thyroid hormones

“…[6][7][8] Various assays based on this technology have been developed recently. [14][15][16] In this study, we have validated the analytical and diagnostic performance of the LiCA thyroid assays.…”

Performance characteristics of the light-initiated chemiluminescent assay for quantitative determination of progesterone

“…Though with high sensitivity and accuracy, it also has certain disadvantages. For example, the above immunoassay requires several washing steps as well as solid-phase immobilization of antibodies, which is time-consuming and laborious (13). Similarly, liquid chromatography-tandem mass spectrometry (LC-MS/ MS) is also an emerging technology for the detection of small molecular hormones (14,15), but its high cost and low degree of automation limit its popularity and application in clinical laboratories.…”