2019 Novel Coronavirus (COVID-19) With Influenza A and Influenza B
Use
Results are for the identification and differentiation of RNA from SARS-CoV-2, Influenza A and Influenza B.
Special Instructions
Not provided.
Limitations
The test is intended for use under the FDA's Emergency Use Authorization and has not been FDA cleared or approved. False negatives may occur depending on the timing of sample collection or variability in viral shedding. In such cases, test results should be interpreted in the context of clinical signs and symptoms as well as patient exposure history. Additionally, substances such as heparin, hemoglobin, ethanol, and EDTA at concentrations above 0.01M should not be present in specimens as these can inhibit PCR and potentially cause test failure.
Methodology
PCR-based (RT-PCR)
Biomarkers
Influenza A
MicroorganismInfluenza B
MicroorganismSARS-CoV-2
Microorganism
LOINC Codes
- 95380-2 - FluAB+SARS-CoV-2+SARSr-CoV Resp NAA+prb
- 94759-8 - SARS-CoV-2 RNA Nph Ql NAA+probe
- 76078-5 - FLUAV RNA Nph Ql NAA+probe
- 76080-1 - FLUBV RNA Nph Ql NAA+probe
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Nasopharyngeal Swab
Volume
1 - 3 mL
Minimum Volume
1 mL
Container
nasopharyngeal (NP) swab in VTM/UTM or 0.9% saline
Collection Instructions
Collect using standard techniques. Place the swab into VTM/UTM and cap tightly.
Storage Instructions
Frozen at -20° C (preferred). Refrigerated specimens and room temperature specimens (if received for testing within 72 hours of collection) are also acceptable.
Causes for Rejection
Specimens that are beyond the established stability, improperly labeled, grossly contaminated, broken, with significant leakage in transit, improperly collected or shipped, or containing substances inhibitory to PCR.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 72 hours |
| Frozen | > 72 hours |
Other tests from different labs that may be relevant