Multiplex assays generate multiple, simultaneous results from a single sample. As such, they must always be verified (if unmodified FDA approved) or validated (if non-FDA approved) to achieve optimization.
One of the most challenging aspects of implementing a multiplex PCR, whether a laboratory-developed test (LDT) or a commercially available test (FDA approved), is obtaining adequate control material for the verification and validation process. These may be purchased through several commercial vendors, obtained from:
- Standardized material from regulatory organizations
- Proficiency testing material
- Reference laboratories
- Known values from patient samples
- Shared specimens from other routine laboratories performing assays
