The healthcare industry has realized the value of POCT as an option in emergencies
Point-of-care testing (POCT) refers to the performance of analytical tests on patient specimens outside of the laboratory by inexperienced staff. Among the existing point-of-care tests, there are two different types: simple lateral flow tests (pregnancy, HIV, glucose or even drugs-of-abuse (DOA) testing), where no complex fluid management is required and complex microfluidics-based tests. POCT testing based on microfluidic technology is expected to grow from $2.7 billion in 2015 to $7.4 billion in 2019-with a compound annual growth rate of 23% between 2015-2020.
Major diagnostics companies have realized the potential of rapid molecular diagnostic testing. Indeed, several successful products based on microfluidic technology have been launched in the past few years. Most common applications mentioned in the literature and by technology developers include emergency testing, home care, tests to be performed by practitioners, forensics, homeland security, industrial testing, water quality and agro-food applications. Depending on the application, the nature of sample (swab, whole blood, urine, spores, water, solids samples, etc.) can vary widely and, subsequently, so can the required sample preparation process (filtration, dilution, concentration, mixing, etc.).
Typical POCT tests include five principal steps: the sample collection, the sample injection, the sample preparation, the amplification and, finally, the detection. There are three main types of tests, depending on the detection method, including molecular diagnostics, cytometry testing and immunoassays and chemical analysis. Nowadays, immunoassays and chemical analysis are the most widespread in POCT.
Applications in the Emergency Department
POCT applications in the emergency department are tests that have to be performed in life-threatening situations to provide the most appropriate care. Some cardiac markers (troponin, creatine kinase, LDH, AST, myoglobin, etc.) confirm or rule out a heart attack diagnosis. Other rapid tests get a very quick overview of blood gas concentrations (pH, PCO2, PO2, TO2, HCO3, base excess, SO2, lactate, etc.) or identify a pathogen responsible for sepsis (staphylococcus, streptococcus, MRSA, etc.).
All are typical situations in which fast on-site testing can enable physicians to make the right decision and save lives. These true POCT options have a higher market adoption than others available for physician office screening or decentralized tests due to the significant added value provided in comparison with reference methods-such as the ability to process one sample at a time with very fast turnaround times (TATs).
Microfluidics enable miniaturization and integration of laboratory protocols into portable devices. The technology is useful for POCT because it enables low consumption of reagents, miniaturization and integration for the device, automation of complex protocols and high sensitivity and reduces the time to result. Numerous technologies have been introduced so far, and despite a slow start, the outlook for the industry in the next 10 years is very positive.
The market of first-level package microfluidic disposable chips for POCT applications is expected to grow by 18% in the coming years and exceed $847 million in 2020.1
POCT based on microfluidics are complex systems, as they need to provide very fast and actionable results from a relatively small sample size. False results are not acceptable and multiplexing is often mandatory. In 2015, 50% of the microfluidic POCTs were dedicated to emergency testing applications.1
The need to quickly decentralize diagnostics has never been greater. A transition from simple immunoassays and lateral flow tests for POCT toward complex microfluidics tests is clearly in progress. Strong research involvement has led to start-ups and growing interest from semiconductor players, and the number of new players in the field is growing fast.
- Microfluidic Applications in the Pharmaceutical, Life Sciences, In-Vitro Diagnostic, Yole Développement, June 2015