Custom Certified Stock Solutions for Use in Manufacture of IVD Reagents or Controls
Authors: Mitzi Rettinger, Uma Sreenivasan, Isil Dilek, Sherri Pogue
Presented at American Association for Clinical Chemistry (Clinical Lab Expo) (AACC), Anaheim, CA, July 2010
Abstract
Accuracy and quality of reagents are critical to medical device performance and patient care. IVD manufacturers often produce stock solutions for use in preparation of reagents. Many times concentration of the target analytes is very low, materials are difficult to handle, and may be unstable or toxic and require special handling. Concentration accuracy is dependent on extensive neat material characterization and precise weighing and dilution operations.
IVD manufacturers are looking to streamline operations but risks of outsourcing reagent preparation are high. One alternative approach is to outsource the preparation of stock solution. Accurate shelf-stable certified stock solutions allow IVD manufacturers the ability to eliminate tedious operations and provide efficiency of resources while ensuring consistency, accuracy, and traceability of materials. Custom stocks solutions can be quantitatively prepared and certified elminating material waste and non-conforming batches resulting from weighing errors or inaccurate material characterization allowing IVD manufacturers to focus on their core.