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HelpTest Code CVFLU Rapid PCR SARS-CoV-2 and Flu A + B
Additional Codes
| Software | Test Code |
|---|---|
| Label Text | CVFLU |
| EPIC | LAB20504 |
Performing Laboratory
NorDx Laboratories
Useful For
Detecting and diffentiating among SARS-CoV-2, Influenza A, and Influenza B respiratory infection.
Test performance is not impacted by mutations in the SARS-CoV-2 Delta or Omicron Variants.
Per manufacturer, patients presenting with H5N1 (Avian Bird Flu), will test as Influenza A positive.
Method Name
Multiplex Real-Time Polymerase Chain Reaction (RT-PCR)
Reference Values
Not Detected
Days and Times Test Performed
Monday through Sunday
Report Available
1 Day
Available STAT
Specimen Type
Mid-Turbinate Nasal Swab in Media
Preferred Container
| Specimen Collection Kit | Manufacturer Part Number |
|---|---|
|
Nasopharyngeal Swab Collection Kits: Flexible minitip FLOQSwab with Universal Transport Media (UTM) from Copan Diagnostics or BD Universal Viral Transport (UVT) 3-mL collection kit with flocked minitip swab |
305 C
220531 |
|
Nasal (Mid-Turbinate) Swab Collection Kits: Regular FLOQSwab with Universal Transport Media (UTM) from Copan Diagnostics or BD Universal Viral Transport (UVT) 3-mL collection kit with regular flocked swab or Copan Universal Transport Medium (UTM-RT) without beads |
306C
220528
3C047N |
|
ThermoFisher Scientific Remel M4RT
ThermoFisher Scientific Remel M4
ThermoFisher Scientific Remel M5
ThermoFisher Scientific Remel M6
ThermoFisher Scientific Remel M4RT without beads
|
R12565, R12566, R12567
R12550
R12555
R12563, R12568, R12569
R12622, R12591 |
|
Pre-aliquotted 3 mL 0.9% Physiological Saline Thomas Scientific MANTACC 0.9% Saline Solution, 3 mL in 10 mL tube, 50 tubes per pack |
20A00K984 |
Preferred Volume
3 mL fill-volume container is the only acceptable initial volume.
Minimum Volume
250 uL sample is needed per run. Original sample volume must be 3 mL.
Specimen Collection and Handling
Use only sterile synthetic flocked swabs with plastic or wire shafts. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and may inhibit molecular tests.
NASOPHARYNGEAL:
1. Insert minitip flocked swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated with fluid from the first collection. If a deviated septum or blockage create difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.
2. Depending on the swab, break at the score in the shaft without touching the swab tip.
3. Place specimen in viral media.
4. Maintain sterility, forward promptly and send refrigerated.
MID-TURBINATE NASAL SWAB:
1. Use a flocked swab. Tilt patient’s head back 70 degrees. While gently rotating the swab, insert swab less than one inch (about 2 cm) into nostril (until resistance is met at turbinates). Rotate the swab several times against nasal wall and repeat in other nostril using the same swab. Unless there is a contraindication, both sides should be sampled with a single swab.
2. Depending on the swab, break at the score in the shaft without touching the swab tip.
3. Place specimen in viral media.
4. Maintain sterility, forward promptly and send refrigerated
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Transport Media | Refrigerated | 72 hours |
| Ambient | 4 hours | |
| Frozen (-70oC) | Indefinitely |
| Specimen Type | Temperature | Time |
|---|---|---|
| 0.9% Physiological Saline | Refrigerated | 72 hours |
| Ambient | 4 hours | |
| Frozen | Not acceptable |
Add On Capable
Yes. Molecular Pathology keeps samples for 48 hours. Site-specific storage may vary.
Advance Beneficiary Notice Requirements
No ABN Required
CPT Code Information
| CPT Code | CPT Description | CPT Disclaimer |
|---|---|---|
| 87636 | Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique |
Keywords
COVID-19, Novel Coronavirus, Influenza A, Influenza B, Liat, Combination, Multiplex
Rejection Information
Any fill volume other than 3 mL.
Any transport medium other than those on the approved list.
Any collection site other than nasal mid-turbinate or nasopharyngeal.
Wooden shafted or non-flock-tipped swabs.
Please note: The above samples will be rejected for rapid analysis but may be acceptable for routine analysis by Molecular Pathology.
Acceptable Alternative Collection Site
Nasopharyngeal (NP)
LOINC Code Information
95422-2
94500-6
92142-9
92141-1
31208-2
95417-2
95418-0
95419-8
11368-8
95421-4
82810-3
77974-4
95420-6
Additional Notes and Limitations
This SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System is an automated multiplex real-time RT-PCR assay intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B virus RNA.
Influenza B at concentrations above 8.10E+05 copies/mL can cause inhibition of SARSCoV-2 detection, and SARS-CoV-2 concentrations above 3.60E+04 copies/mL can cause inhibition of both influenza A and influenza B detection, when present at low concentrations (~3x LoD) in a sample.
Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Negative results must be combined with clinical observations, patient history, and/or epidemiological information.
The D614G and N501Y mutations will not affect the cobas® SARS-CoV-2 & Influenza A/B Test for use on the cobas® Liat® System because they are in different regions from the target.