Lab on a Chip Testing Standards Needed for Commercialization

A microfluidic lab on a chip device sitting on a polystyrene dish. Stainless steel needles inserted into the device serve as access points for fluids into small channels within the device, which are about the size of a human hair.Microfluidic and nanofluidic lab on chip (LOC) devices are microchip sized systems that can arrange and analyze tiny fluid samples with volumes ranging from a few microliters (a millionth of a liter) to sub-nanoliters (less than a billionth of a liter). They are envisaged to one day revolutionize how laboratory tasks such as diagnosing diseases and investigating forensic evidence are performed. But before LOC technology can be fully commercialized, a new paper from the National Institute of Standards and Technology (NIST) states, testing standards will need to be developed and put into place.

“A testing standard,” says Samuel Stavis, NIST physical scientist and paper author, “defines the procedures used to determine if a lab on a chip device, and the materials from which it is made, conform to specifications.”

Standardized testing and measurement methods, Stavis explains in the paper, will enable MEMS (microelectromechanical systems) LOC manufacturers at all stages of production, from processing of raw materials to final rollout of products, to accurately establish key physical characteristics of LOC devices such as dimensions, electrical surface properties, and fluid flow rates and temperatures.

Autofluorescence

To make his case for testing standards, Stavis spotlights the phenomenon of autofluorescence. Autofluorescence is the background fluorescent glow of a Lab On a Chip device that can interfere with the analysis of a sample.

Stavis argues that multiple factors must be considered in the development of a testing standard for autofluorescence, including: the materials used in the device, the measurement methods used to test the device and how the measurements are interpreted. “All of these factors must be rigorously controlled for, or appropriately excluded from, a meaningful measurement of autofluorescence,” Stavis writes.

Quality control during LOC device manufacturing, Stavis says, may necessitate diverse tests of autofluorescence throughout the process. “There may be one measure of autofluorescence from the block of plastic that is the base material for a chip, another once the block has been fashioned into the substrate in which the functional components are embedded, and yet another as the final device is completed,” Stavis says. “To manufacture lab on a chip devices with reliably low autofluorescence, accurate measurements may be needed at each stage.”

Stavis also stresses that it is important not to confound testing standards with product standards, and to recognize how the former facilitates the latter. “A product standard specifies the technical requirements for a lab on a chip device to be rated as top quality,” he says. “A testing standard is needed to measure those specifications, as well as to make fair comparisons between competing products.”

Reference:

Stavis, S.M. A glowing future for lab on a chip testing standards. Lab on a Chip (2012), DOI: 10.1039/c2lc40511c