Radiometer: High Precision Sampling Subsystem
for Point of Care Analyzer

Client

Radiometer ApS
(Copenhagen, Denmark)

Product

High precision sampling subsystem for new Point-of-Care immunoassay analyzer

The development was for a subsystem that would pierce closed sample tubes, extract the sample and dispense this into a processing vessel, with very high precision and accuracy, and used the same piercing probe.

Our Ingenuity

Leveraging our vast expertise in precision fluidics and robotics, we worked with Radiometer to clearly define the subsystem requirements and boundaries. Following this, our work included:

• Concept generation and selection of the best subsystem concepts,
• The development of several test systems and experimental analyses, including the application of Robust Engineering principles,
• Subsystem design and development, concurrently with the evolving instrument design,
• The subsystem prototype and build,
• The execution of a rigorous performance and reliability test program, and
• The design transfer to Radiometer for instrument manufacture.

Working collaboratively with Radiometer, and following our FDA QSR compliant development processes, we embedded the subsystem into the evolving design of this compact instrument. This was done via Pro-Engineer and Intralink in our client's own engineering database.

Our integrated team of scientists and engineers focused on meeting the following key subsystem requirements:

• Closed tube (Vacutainer) sample extraction,
• Low-volume, high-precision sample dispense via piercing probe,
• Dispensed volume 5¬µl to 25¬µl,
• 2% dispense volume CV,
• 2% dispense volume inaccuracy,
• Broad range of sample viscosities,
• Minimised carryover and system fluid use,
• Samples: Whole blood, serum, plasma,

QC solution

Effective communications, disciplined management of the interface between instrument and subsystem (via Interface Control Specification) and a rigorous experimental test program were critical to success.

Your Advantage

A critical subsystem for a breakthrough in acute care testing, supporting the overall system sensitivity and specificity through its high accuracy and precision.