Liquid Delivery Quality Assurance Technologies Meet New Challenges Faced by Molecular Laboratories

The risk of liquid delivery error in molecular laboratories is growing as the average size of tested liquid volumes continues to diminish. Tasked with performing a large number of tests in a short amount of time, laboratories must balance productivity demands with the need for enhanced quality assurance.

To meet these challenges, ARTEL offers its PCS® (Pipette Calibration System) and MVS® (Multichannel Verification System), tools that rapidly verify the accuracy and precision of liquid delivery devices. Able to measure small volumes at the bench-top level, ARTEL’s technologies provide stronger assurance of data integrity, helping laboratories avoid failed assays, inefficiency and non-compliance.

“Tremendous advances in technology, chemistry and instrumentation used in molecular testing are allowing laboratories to conduct tests with smaller liquid quantities. But with this advancement comes a significant challenge: volume accuracy and precision have become even more critical to the success or failure of the assay,” noted Dr. Gregory Tsongalis, Director of Molecular Pathology at Dartmouth Medical School and Dartmouth Hitchcock Medical Center, and president-elect of the Association for Molecular Pathology (AMP).

In a presentation at AMP 2006, November 16 in Orlando, FL, Dr. Tsongalis discussed these trends and offered solutions to help laboratories improve quality assurance and productivity.

“ARTEL’s systems provide an easy-to-use, cost-effective way to eliminate significant sources of test variability by verifying that pipettes and automated liquid handlers are performing correctly,” Dr. Tsongalis said.

As tested liquid volumes decrease in size, minor fluctuations have a greater impact on assay results because the chemistries of the measured reactions are more sensitive. In today’s molecular laboratories, where technicians typically work with volumes in the 10-20 microliter range and employ liquid handling instrumentation throughout the testing process, the potential for error is significant.

For example, a common molecular test consists of the addition of one microliter of nucleic acid to 10 microliters of solution containing specified quantities of reaction buffer, enzyme, nucleotides and sterile water. Here, accurate test results are especially dependent on the concentration of nucleic acid, the analyte, which, at just one microliter, comprises ten percent of the tested solution.

“If volumes are inaccurate by just one microliter when adding any of the liquid components to an assay, the risk of generating incorrect results significantly increases,” said Dr. Tsongalis. “This can cause assay failure, resulting in expensive reruns, wasted time and resources, and improper patient management.”

To offset this risk, molecular laboratories can implement the ARTEL PCS to verify single-channel devices and MVS to verify multichannel and automated devices. These systems are based on ARTEL’s Ratiometric Photometry, which measures light absorption by two specially formulated reagents to combat problems associated with small-volume measurement. Completing calibration in minutes, the MVS and PCS also provide automated calculation and documentation of NIST-traceable results. This facilitates efficient and regular calibration processes, leading to compliance and greater trust in test results.

“As one of the fastest growing segments of the in-vitro diagnostics market, molecular diagnostics is poised for further expansion, especially given increasing interest in pharmacogenomics and genetic testing,” said Kirby Pilcher, president, ARTEL. “ARTEL will continue to innovate solutions to help molecular laboratories adapt to liquid delivery advancements and corresponding quality demands.”

To request a copy of Dr. Tsongalis’ presentation on quality assurance in molecular laboratories given at AMP 2006, November 16 in Orlando, FL, please visit www.artel-usa.com/AMPpresentation.