PURPOSE OF TEST
The NexScreenTM Cup is a waived in vitro diagnostic test for rapid detection of drugs in human urine. The NexScreenTM Cup provides only a preliminary screening result. It will be necessary to confirm a positive NexScreenTM Cup result in a Clinical Laboratory / Reference Laboratory to conclude the test result is truly positive.
IDA Pages (Clinical Indications, Documentation Plan, Clinical Actions)
INITIAL ORIENTATION, TRAINING & COMPETENCY
Initial Orientation & Training – This must be completed (once) with all new staff trained to use this test.
Competency Test Part 1 (Written) – This must be completed by all testing personnel 1) twice in the first year; and 2) annually thereafter.
Competency Test Part 2 (QC) – This must be completed by all testing personnel 1) twice in the first year; and 2) annually thereafter.
MATERIAL SAFETY DATA SHEETS (MSDS)