DETERMINATION OF THE SHELF LIFE OF A COMMERCIAL DNA ISOLATION KIT (MINI COLUMN) FOR MEDICAL BIOTECHNOLOGICAL APPLICATIONS

Sudhir Bhatia

Medical Science and Discovery - 2025;12(11):316-322

Genekam Biotechnology AG

 

Objective: Polymerase chain reaction (PCR) is a core technology in medical diagnostics and bioscience research. DNA isolation is a critical pre-analytical step; however, despite regulatory requirements, there is a lack of published evidence regarding the long-term stability and shelf life of commercial DNA isolation kits. Material and Methods: Stability experiments were conducted over an eight-year period using the Genekam mini-column DNA isolation kit. DNA was extracted from multiple biological matrices and analysed by conventional PCR and real-time PCR targeting the human beta-globin gene and Epstein-Barr virus (EBV). Results: High-quality DNA suitable for PCR was consistently obtained for at least five years after the manufacturing date. Conventional PCR yielded specific amplicons, and real-time PCR showed stable Ct values for both human internal controls and pathogen targets. Conclusion: This study provides the first published evidence that a commercial mini-column DNA isolation kit maintains functional performance for over five years, supporting an extension of its shelf life beyond the current two-year specification.