PURPOSE OF TEST
The FlowFlex SARS-CoV-2 COVID-19 Low Level Nasal Non-Invasive Swab Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. The FlowFlex SARS-CoV-2 COVID-19 Low Level Nasal Non-Invasive Swab Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV2.
POLICY
FlowFlex COVID-19 Rapid Test Kit
SUPPLIES
FlowFlex COVID-19 Rapid Test Kit Supplies (PENDING)
MANUFACTURER’S INFORMATION
Package Insert (for healthcare providers)
IDA Pages (Clinical Indications, Documentation Plan, Clinical Actions)
Emergency Dept / Labor & Delivery H22-H25 / Medicine & Cardiology MedSurg H62-H64 & General MedSurg H66-H68
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 Information (PENDING)
SAFETY DATA SHEETS (SDS)
FlowFlex COVID-19 Rapid Test Kit (PENDING)
FlowFlex COVID-19 Rapid Test Kit Reagent (PENDING)