Drivers for the strong growth of Point-of-Care Testing (POCT),

aside diabetes self-monitoring, are applications like the testing for cardiac markers, coagulation and infectious diseases (mainly viruses and bacteria). Near patient testing allows fast availability of diagnostic results. For applications like cardiac marker, sepsis diagnostics and some others, that is crucial for better patient outcomes.

Instrument size varies from bench-top to handheld devices. Typically, one to a few samples at a time are processed. Clinical environments and some pharmacies have adopted POCT, where fast availability is crucial for the quality of care.

An increasing number of sample-to-answer NAT solutions and immunochemistry based test instruments are in use, and companies develop and launch new platforms offering wider test menus.

Various kinds of consumables, from lateral flow stripes for qualitative and semi-quantitative measurements to integrated, instrument platform specific cartridges with microfluidic features and sample preparation reagents for NAT, are in use.

Point-of-Care IVD Applications

Molecular Diagnostics at the POC

Molecular diagnostics POC applications demand reliable measurement solutions, which combine high sensitivity and fast readout with a small physical envelope size at favorable economics. The used qPCR or isothermal amplification based testing measures fluorescence light.

To cover broad disease panels, many IVD companies strive for higher degrees of multiplexing ans thus enhance versatility and market adoption of their platforms.
This can be achieved through tailored multi-channel LED light engines (typically 4-6 channels) with solution specific LED and filter selections, combined with optics for illumination and detection, and detectors. Sensitivities of <1nmol can be achieved.

Volpi is an expert for measurement solutions in molecular diagnostics at the POC, and beyond.

6-Color qPCR Measurement Module for POC Molecular Diagnostics

6-Color qPCR Measurement Module for POC Molecular Diagnostics

Industry: In Vitro Diagnostics

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Immunochemistry at the POC

Qualitative and semi-quantitative POC immunochemistry tests using lateral flow strips and fluorescence or color reactions as signals to detect are common.

Some newer technology developments allow quantitative, high sensitivity measurements and strive for close to core lab precision at the POC, e.g. for cardiac markers. These technologies require LEDs and single photon counting devices for readout.

Clinical Chemistry at the POC

Chemistry panels help evaluate the body’s electrolyte balance and/or the status of several major body organs. They are routinely ordered to determine a person’s general health status. Aside from POC test systems for the determination of individual clinical chemistry parameters, there are complete systems covering a wide analytical spectrum. However, these are not widely used, as the purchasing and running costs are high when compared to core lab clinical chemistry testing.

Microbiology at the POC

Microbiology testing at the POC is primarily lateral flow based. Amplification based assays are gaining importance.

For anti-microbial resistance (AMR) testing, several phenotypic tests involving cell growth imaging in the presence of antibiotics on a cellular level are entering the POC market for microbiology.