Article for Today’s Clinical Lab written by ADAM ZABELL, PHD & Business Analyst at Indigo BioAutomation
Laboratories wishing to take advantage of the unique capabilities of LC-MS/MS can opt to purchase an in vitro diagnostic (IVD) medical device from a commercial manufacturer, or utilize their own laboratory developed test (LDT). When no IVD is available to cover even the common analytes, disease states, or drug classes, laboratories wishing to provide clinical testing will tend to utilize LDTs. While IVDs include a set of quality measures and metrics as part of their manufacture, the laboratory operating an LDT must develop and maintain its own holistic quality architecture. The testing procedures must also include intentional, effective, and efficient quality procedures that align with laboratory best practices and regulatory requirements.