Validation and Integration of an Automated Nucleic Acid Extraction System for Mycoplasma Testing
The demand for automated methods in science is rapidly increasing to streamline workflows, reduce turnaround times, and alleviate analyst fatigue. The DNA isolation portion of PCR-based workflows can be laborious and highly subject to human error. To increase testing capacity and repeatability, Bionique Testing Laboratories LLC validated the AutoMate ExpressTM Nucleic Acid Extraction System for integration into their hybrid Real Time PCR-based workflow (Cat. #:M-1500/M-1500Q).
The validation of this automated DNA extraction system demonstrated that the instrument can successfully recover mycoplasma from a representative Jurkat cell matrix while simultaneously establishing comparability to the manual extraction method. Identical samples were subjected to each isolation method prior to PCR analysis to demonstrate that the isolation methods produced results that were statistically the same.
The study addressed the key validation parameters including repeatability, ruggedness, and detection sensitivity. With data to support comparability between the manual and automated isolation methods, Bionique was able to successfully integrate the automated DNA extraction system into their hybrid PCR-based workflow resulting in a time savings of about 1 hour (16%) per isolation, a 45% increase in sample throughput capability, and a significant reduction in repetitive motions associated with micropipetting.