Cue COVID-19 (Specialty Clinic Use)

PURPOSE OF TEST

The Cue COVID-19 Test is a molecular in vitro diagnostic test that aids in the detection and diagnosis of SARS-CoV-2 and is based on widely used nucleic acid isothermal amplification technology. The Cue COVID-19 Test contains primers and probes and internal controls used in molecular tests for the in vitro qualitative detection of SARS-CoV-2 RNA. The Cue COVID-19 Test detects SARS-CoV-2 nucleic acid in nasal specimens.

POLICY

Cue COVID-19 (NOTE: Please refer to signed policy on unit. Version provided within the link is for reference only.)

MANUFACTURER’S INFORMATION

EUA Cue COVID-19 Instructions for Use

INITIAL ORIENTATION, TRAINING & COMPETENCY

Initial Orientation & Training – This must be completed (once) with all new staff trained to use this test.

Competency Test – This must be completed by all testing personnel 1) After initial training and before technical duties are performed; 2) 6 months after initial training (California Law); and 3) annually thereafter.

QUALITY CONTROL

QC Log

SAFETY DATA SHEETS (SDS)

PENDING