point of care testing

At POCT from early experiments to its current mainstream status
Point of Care Testing (POCT) is medical diagnostic testing performed outside the clinical laboratory where the patient is receiving care. POCT is typically performed by non-laboratory personnel. The advantage is little waiting time until the tests results are known and the patient care can then quickly be adjusted.
There are a number of interesting developments which make POCT a quickly growing sector. One of the drivers is cost effective and functional microfluidics in a cartridge. This has enabled high-performance assays, even molecular, at commercially feasible prices.
Point of Care Testing (POCT) is medical diagnostic testing performed outside the clinical laboratory where the patient is receiving care.

Why POCT is so important

From CLIA-waiver to China market expansion
  • CLIA-waived devices are seeing strong market demand as enablers to increasing accessible market.
  • Microfluidics in cartridges is a reality now. Complex processes, including molecular, can now be automated in a cartridge. As a result “dry” instrument and “wet” cartridge pairings are popular with many hitting the market. Performance is up and cost per test is down making this commercially feasible.
  • POCT in China is seeing rapidly escalating market penetration.
  • Isothermal amplification makes molecular POCT compact, low power and low in instrument cost.
  • Consumer electronics are used for communications and user interface, although data security/privacy requirements and selected workflow factors remain issues to be mindful of.
  • Modular designs with a user interface module and several processing modules enable scalable POCT devices, extending the devices to small clinics and main lab specialty testing.

Point of Care Testing with its many advantages is a key growth driver of the diagnostics market.

BIT’s track record

Compact and modular instrument platform
BIT is ideally suited to support health care innovators with in the point of care testing segment. We offer compact, scalable and modular electronics architecture with a software suite to match and have experience in designing for CLIA-waiver and for overall ease of use.
We have worked on multiple projects in isothermal amplification as well as microfluidics cartridge pairing.

BIT is ideally suited to support health care innovators within the point of care testing segment.

key features

What makes our devices special

CLIA-Waiver Focus

  1. Develop unambiguous, simple interaction between user and instrument
  2. Offer a simple graphical user interface guiding the user through the instrument workflow or simplified one-touch buttons
  3. Provide fully automated processing of the sample to result steps
  4. Use instrument technology that includes self-calibration of the sensors with minimal user interaction
  5. Provide error-free loading and unloading
  6. Develop automatic positioning, automatic homing, automatic inventory verification, automatic sample ID read
Targeting the CLIA-waiver market will expand your market share through regulatory channel but it also provides inherent benefits from built-in ease-of-use that is in demand globally regardless of the local regulatory environment.
Are you working on a new point of care testing device? Let’s discuss how to help you develop it faster, accelerate the regulatory process and increase your margin.
Dr. Philippe Grandjean
Vice President
Business Development Global
Frankfurt, Germany
Dr. Josée Naegelen
Vice President
Global Business Development
Montpellier, France
Mona Elkebir
Mona Elkebir
Vice President
VP Commercial Operations