Point-of-Care Diagnostics

Point-of-care (POC) diagnostic technology is a broad term that could be applied to many medical devices that enable physicians to obtain relevant information about patients’ clinical status during an examination or in the course of therapy delivery. For the purposes of this report, the term POC diagnostic technology has been narrowed to include simple, portable, instrument-based or self-contained diagnostic devices that may be used in various near-patient settings throughout hospitals, alternate care facilities, and patient homes. 

The industry and market analysis offered in this report is focused on the mainstream applications of the POC diagnostic technology in the management of the four major groups of acute and chronic disorders that afflict the most populous patient caseloads: infectious diseases, diabetes mellitus, cardiovascular diseases (CVDs), and respiratory diseases.

Point-of-care diagnosis of patients with infectious diseases, diabetes mellitus, CVDs, and respiratory disorders rely on devices employing established methods and in vitro diagnostic (IVD) technology. In compliance with the Clinical Laboratory Improvement
Act (CLIA) of 1988, such IVD devices are labeled either as moderate-complexity or CLIA-waived testing systems. Near-patient IVD testing systems covered by this report include:

• rapid test kits for detection of chlamydia, group A streptococcus (GAS), group B streptococcus (GBS), Helicobacter pylori, human immunodeficiency virus (HIV), influenza types A and B, mononucleosis, respiratory syncytial virus (RSV), and rotavirus;
• blood glucose testing products, lancing devices, and ancillary blood and urine testing products used in diabetes management;
• cholesterol testing products, cardiac markers, and coagulation monitoring systems used in CVD management; and,
• blood gas analysis systems, pulse oximetry products, and spirometry products used in respiratory care delivery.