Unleashing the power of CLIA from Snibe Diagnostics

Illuminating breakthroughs in small molecule detection technology. “Small molecules” refer to compounds with a molecular weight typically less than 1000 Daltons and a simple structure, such as physiologic hormones, drug residues. Small molecule detection plays a crucial role in clinical diagnosis, environmental monitoring, and food safety control. In particular, in the field of medical diagnosis, as research on small molecules advances, their clinical applications are becoming increasingly widespread.

However, due to the structural characteristics of small molecules, their molecular volume and spatial hindrance are restricted. In addition, small molecule substances usually only have one antigenic epitope and only possess reactivity, lacking immunogenicity. Therefore, it is difficult to generate an immune response. Only by combining with large molecular proteins or carrier proteins to form a “complete antigen” can they possess immunogenicity and produce antibodies that specifically recognize small molecule antigens.

Currently, small molecule compounds are mainly detected in medical testing using LC-MS and CLIA. LC-MS detection has always been the gold standard for small molecule detection. This method quantifies small molecule substances through their mass-to-charge ratio and has high accuracy and specificity. However, in the entire process, the pre-processing step is the most critical and time-consuming step in the entire analysis process, including solution preparation, sample preparation, sample extraction, protein precipitation, centrifugation, concentration, and reconstitution. For complex specimens such as blood, the pre-processing is more cumbersome, and different analytes require different processing methods. Therefore, the quality of pre-processing largely determines the accuracy of subsequent mass spectrometry detection results. Currently, due to the limitations of expensive equipment, the need for professional operators, and the often special treatment required for samples, LC-MS methods are difficult to popularize in medical testing.

At present, the improvement of small molecule detection technology is mainly focused on CLIA, which transforms small molecule detection from competitive method to sandwich method, known as “small molecule sandwich detection technology”. It overcomes the natural defects in competitive method detection and significantly improves the sensitivity, accuracy, and anti-interference ability of chemiluminescent immunoassay method detection.

Snibe has been focusing on non-competitive method small molecule technology since 2017 and has conducted detailed research and exploration for more than 4 years around this technology. In 2021, Snibe successfully established a complete small molecule sandwich detection technology platform, including a raw material development platform and a reagent process development platform.

The iteration and innovation of technology are driven by demand. The development of innovative technology and products ultimately needs to be applied in clinical and laboratory settings, providing high-quality services to clinical and laboratory practices. The breakthrough of the sandwich immunoassay technology using small molecule compounds has brought about multidimensional improvements in product performance, essentially avoiding the inherent limitations brought about by competitive method. A large body of evidence shows that the small molecule sandwich method is highly consistent with the LC-MS method, with a qualitative leap in sensitivity and specificity. This can further expand and deepen clinical application research, while also providing more scientific evidence for the standardization of small molecule detection technology.

As a leading manufacturer in CLIA, Snibe has already harnessed the power of small molecule detection technology for 25-OH vitamin D testing, Estradiol testing, and ALD testing. The results are consistent with the LC-MS. Studies have demonstrated that this breakthrough sandwich method surpasses the competitive method by offering superior accuracy in measuring small molecules like 25-OH vitamin D, E2, and ALD. As technology continues to advance, transformative technologies such as the MAGLUMI solutions for Drug Monitoring and Thyroid will soon have widespread applications.