Regulation of Laboratory Developed Tests

Scope of Reviews
Molecular Microbiology-nucleic acid amplification assays
Method Validation
Specificity
Must determine that assay does not detect related organisms,
organisms producing similar illness, or organisms that may be present in
specimen types to be tested.
S. aureus Enterotoxin Type B
Tested 69 different organisms including:
• Organisms causing similar enteric illness
• Genetic near neighbors
• Other toxin producing S. aureus and Clostridium sp.
• Select Agents
* If cross-specificity is found, must be included on the patient report