The molecular diagnostics industry is a relatively new territory that offers much promise for early disease detection and personalized patient care. When analyzing samples at the molecular level, there are serious consequences of error and tests must be highly accurate and precise.
While quality molecular test results are essential, standardized quality controls for molecular diagnostic tests were rare until recently, when Maine Molecular Quality Control, Inc. (MMQCI) was founded to fill this market need. The company manufactures and sells the first FDA-approved quality control for genetic testing – INTROL™ – and is on a mission to help companies using or manufacturing molecular diagnostics enhance data integrity.
From R&D to product manufacture, testing and package filling, liquid handling quality control processes are in place throughout MMQCI’s facilities. Pipetting accuracy and precision are most essential in the manufacture of the company’s INTROL controls. Pipettes are used for the most critical manufacturing task – the addition of small volumes of DNA. Quantities must be exact for reproducibility.
“Pipettes are the single most used tool in our laboratories,” said Joan Gordon, President, MMQCI. “We manufacture our products using highly controlled processes so that each lot contains the identical concentration. There is no room for error.”
Reproducible quality controls such as MMQCI’s products provide the ability to identify variation in a laboratory test system. For example, trending over time in the signal strength can indicate a failing probe or system malfunction that could lead to failure to detect a genetic mutation. It is critical that MMQCI’s product lots be consistent batch-to-batch so that any variation is due to the system, and not due to variation in the control.
In addition, the small volumes typically handled in MMQCI’s facilities make liquid handling quality assurance even more important. The smaller the volume being pipetted, the larger the risk for error, because small volume pipettes are more prone to error. Inaccuracy of even one microliter can make a difference.
While pipette calibration is a given at MMQCI, like most regulated laboratories, there are several available options. One option is to outsource pipette calibration to an external service provider, which was the method employed by MMQCI when the company was in its infancy. However, as the company grew and operations expanded, the company sought stronger control over its quality control processes.
To ensure that its pipetting is accurate to the sub-microliter level, MMQCI now uses the Artel PCS® Pipette Calibration System. Portable and robust, the PCS can be used in the laboratory to rapidly verify the accuracy and precision of pipetted volumes. The PCS also provides NIST-traceable measurements for standardized assessment of dispensed volumes.
The PCS’ Pipette Tracker software automatically alerts laboratory managers when pipettes are due for calibration and stores performance data for each pipette, facilitating regulatory compliance.
“The PCS is fast, easy-to-use, and provides traceable results,” said Gordon.
In addition to helping MMQCI prevent liquid handling errors caused by pipette failure, the PCS is used to improve operator pipetting technique. When handling the minute volumes typical of molecular diagnostics, accuracy and precision are critical and operator technique can contribute to errors. MMQCI now requires all scientists to pass annual pipetting proficiency tests and review proper technique as part of the company quality plan.
After switching to the PCS, MMQCI now has control over its liquid handling operations and can rest assured that its pipetting is accurate and precise, ensuring that its products always meet the demanding quality requirements of its customers. The result has been greater control over operations, enhanced efficiency, and confidence in laboratory operations.
MMQCI designs and manufactures unique quality controls for molecular tests worldwide. These innovative extractable products fulfill regulations by monitoring the entire assay and provide confidence in laboratory results. Rare genotypes are now available and multiple mutations are contained in single samples, which makes the best practice of monitoring all test analytes affordable. Easy-to-use INTROL™ products are non-infectious, stable and provide consistent results to aid identification of potential system problems. MMQCI controls assist laboratories in providing high caliber patient care. MMQCI supplies manufacturers with custom controls for development of new molecular diagnostic assays and quality control of existing products.
For more information, contact Maine Molecular Quality Controls, Inc, at 10 Southgate Road, Suite 170, Scarborough, Maine 04074; TEL: 207-885-1072, FAX: 207-885-1079; Website: www.mmqci.com