Point-of-care testing – A game changer for India

The concept of point-of-care testing (POCT) is not new. While it exists in the form of self-care devices, such as glucometers, ECG, and fitness trackers, as well as other testing devices in hospital settings, the Covid-19 pandemic clearly accelerated the use of devices. These compact instruments can be placed at or near the point of patient care, physician’s office, offering significant advantages over traditional central lab in-vitro diagnostics (IVD) systems.

While POC devices have been playing a pivotal role in the monitoring/diagnosis of non-communicable diseases, the Indian government’s commitment to combat diseases, such as HIV and tuberculosis are also contributing to the growth of the POC analyzers market. Further, the portability of POCT devices addresses the problem of accessibility.

As per GlobalData, India’s POC analyzers market is expected to be the fastest-growing analyzers market in the Asia-Pacific region, followed by South Korea and China, and is estimated to be worth USD 70 million by 2030. The growth will be driven by the increasing adoption of molecular diagnostics, an ageing population, and a growing disease burden. Markets and Markets report states that the global POC and rapid diagnostics market is expected to reach USD 75.5 billion by 2027 from an estimated USD 45.4 billion in the current year, at a CAGR of 10.7 percent from 2022 to 2027.

Advantages offered by POCT
At present, POCT ranges from basic blood-glucose measurement to complex viscoelastic coagulation assays, blood gas and electrolyte testing. This includes operating rooms (ORs), intensive care units (ICUs), cardiac catheterization labs (CCL), emergency departments (ED), and many primary care clinical settings.

The benefits include:

• Shorter time between sample acquisition and analysis
• Quicker decision making
• Lesser TAT (turn-around time)

Most current POCT devices can be interfaced to both laboratory information systems (LIS) and electronic medical record systems (EMR). For today’s current high test volumes, and the need to minimize transcription errors, connection to information systems is essential. Well-functioning information systems can automatically transfer (download) results from the analyzer and display them to the physician. This ensures both accuracy and rapid delivery of results to multiple caregivers. Additionally, new devices can be fully portable and rechargeable as well as connect with the phone via an app or IoT (Internet of Things), which positions them as ideal for ambulances, where the initial result can be given even prior to arriving at the ER.

Healthcare trends
There is a clear trend toward prescribing a complete test panel rather than running multiple single tests in series or parallel. A recent study has shown that clinicians prefer to order a comprehensive syndromic panel even when the cost is higher (O’Reilly, 2016). Some studies show that the trend in the POCT market is to consolidate multiple tests into a single instrument rather than spreading them over multiple systems.

Miniaturization of microfluidics, chip technology, and electrochemical detection has enabled the construction of miniaturized systems, with which even DNA may be directly analyzed in a few microliters of sample. Immunoassays and other methods of protein determination may also be carried out by micro-total analysis systems (μTAS). The fluid volumes in the nL and pL range reduce not only the amount of reagents required but also the time needed for basic analytical processes.

Managing POCT compliance
As POCT is not usually performed by trained laboratory personnel, maintaining regulatory compliance and quality assurance with POCT are challenges that require continual surveillance. Therefore, internal quality protocols are being defined and incorporated in the daily routine of testing. Some of the measures taken include classification of devices into a higher-risk category, which poses additional regulatory compliance requirement.

Indian healthcare represents budget constraints, caters to diverse population and demands multifaceted healthcare needs. POC devices can serve as an effective solution as they are affordable, accessible, and efficient, thereby helping the Indian primary healthcare system in a significant way.