CLIA regulations require that PT samples be tested in an identical manner to patient samples. Sample preparation for PT samples may be required. There may be slight alterations in the evaluation process due to suspension medium or the origin of sample contents. Failure to comply with kit instructions may lead to incorrect test results that may result in event failure.
Prior to any testing, perform the following steps:
- Thoroughly read the kit instructions.
- Reconstitute samples as specified in the kit instructions.
- Follow all handing instructions, including warming, mixing, and test mode for performance.
- Follow patient testing protocol per your institution's policies and procedures.