In Vitro Diagnostic Industry in China - POCT I

Introduction

Point-of-care testing (POCT) is a subfield of in vitro diagnostics (IVD), where portable analytical instruments and supporting reagents are used to obtain test results quickly at the sampling site. POCT is a dynamically developing category of testing methods. Its core goal is to meet the diagnostic requirements to realize clinical treatment or home monitoring, with rapid and reliable diagnostic results. POCT is defined by the National Academy of Clinical Biochemistry (NACB) as “Clinical laboratory testing performed in close proximity to a patient’s treatment by clinical personnel or patients (self-monitoring, testing) not trained in clinical laboratory science.” In other words, POCT refers to all tests performed outside the traditional, core laboratory.

POCT dates back to 1500 BC, when doctors observed that ants were attracted to the urine of a patient with a “wasting disease.” Physicians inferred that the urine contained sugar; thus, they were able to diagnose diabetes. The second scientific and technological revolution, which took place between the 1870s to the early twentieth century, was mainly marked by the invention and application of atomic energy, electronic computers, space technology, and biological engineering. These factors accelerated the rapid development of POCT detection technology.

As POCT technology has developed, it has achieved complete quantification, automation, as well as improved precision. While POCT detection technology itself has developed, more information technology, intelligence, big data, and other “Internet+” elements have been integrated. POCT has become an essential link in the clinical diagnosis and treatment of critical diseases and in other fields, making it a key support for most primary institutions seeking to establish detection, diagnosis, and treatment capabilities. As POCT technology has improved, it is expected that the detection index range and performance will be further improved. POCT has also been gradually extended from an exclusively in vitro detection technology to include multidimensional detection technologies, such as mobile ultrasound and electrocardiography. POCT enables more convenient information collection platforms, such as implementing convenient rapid monitoring for a target population. It can be combined with traditional hospital information collection and third-party lab omics information, both in hospitals and in large data centers for disease control. By connecting this rapidly acquired information with artificial intelligence (AI)-based auxiliary analysis, it can provide comprehensive and accurate assessments of health. It can also provide early warning and management reference for public health emergencies, chronic disease management, and early tumor screening. POCT can become an important starting point for improving global public health management.