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Abstract

Aim The United States FDA (Food and Drug Administration) has issued draft guidance stating that extraction systems for molecular diagnostic use must be designed and manufactured under cGMP, and labeled as Clinical Sample Concentrators (CSC). Promega Corporation is introducing a new Maxwell ® system and reagent kit for the extraction of genomic DNA from human whole blood, that is designed and manufactured in compliance with this directive. Many laboratories may wish to transition from the legacy Maxwell ® 16 to the Maxwell ® CSC due to the FDA draft guidance. To aid customers in making this transition, Promega has done an extensive comparison of DNA yield, purity, and customer workflow between the Maxwell ® CSC with the Maxwell ® CSC Blood kit and the Maxwell ® 16 and Maxwell ® 16 LEV Blood kit. Methods Human blood samples were evaluated for: DNA concentration, total yield, and purity with a spectrophotometer. Results Samples processed on the Maxwell ® 16 and the Maxwell ® CSC yielded comparable total yields, concentrations, and purity as measured by A 260 /A 280. The Maxwell ® CSC showed equal or better purity values as measured by A 260 /A 230 when compared to the Maxwell ® 16. Maxwell® CSC boasts an improved workflow primarily driven by shorter instrument run time and simplified user interface. Conclusions Laboratories that wish to transition to the Maxwell ® CSC will find the same great performance they have seen on the Maxwell ® 16 with human blood collected in EDTA, heparin, and citrate tubes but with an improvement in workflow and ease of use, and reporting functionality. Maxwell ® CSC is manufactured in compliance with the FDA directives regarding Clinical Sample Concentrators and thus gives laboratories a compliant choice for genomic DNA purification from human whole blood samples. Cowan: Promega Corporation: Employee. Franz: Promega Corporation: Employee. Newton: Promega Corporation: Employee. Cameron: Promega Corporation: Employee. McCombs: Promega Corporation: Employee.