Detection of Carbohydrate Antigen 50 Based on a Novel Miniaturized Chemiluminescence Analyzer Enables Large-Scale Cancer Early Screening in Grassroots Community

Abstract

Early screening of cancer can effectively prolong survival time and reduce cancer mortality. However, the existing health-monitoring devices can only be carried out in professional laboratories, so large-scale early cancer screening in resource-limited settings is hardly achieved. To embrace the challenge, we developed a novel chemiluminescence immunoassay (CLIA) analyzer that does not require a professional operation. Then, it was applied to detect carbohydrate antigen 50 (CA50), a non–organ-specific tumor marker for screening various cancers. As a result, the analyzer exhibited excellent performance that the total assay time was only 15 min, and the detection limit reached 0.057 U ml−1. A coefficient of variance (CV) less than 15% was well-controlled for both intra- and inter-assay precision, and the linear range was 0–500 U ml−1. More importantly, this analyzer can continuously detect 60 samples per hour without any professional paramedic. Finally, this analyzer has been applied to evaluate clinical samples and the detected results showed a good correlation with the clinical test results (correlation coefficient, 0.9958). These characteristics exactly meet large-scale and high-throughput early screening of cancer. Thus, this miniaturized analyzer for CA50 detection is promising to achieve early large-scale screening of cancer in the resource-limited grassroots community.