FDA Fact Sheet - Health Care Providers
The BioFire® Respiratory Panel 2.1 (RP2.1) Panel with SARS-CoV-2 is FDA approved for use on the BioFire Systems. In addition to the detection of SARS-CoV-2, the BioFire RP2.1 detects 21 additional respiratory pathogens to help clinicians quickly rule in and rule out other common causes of respiratory illness in about 45 minutes.
Test Summary
Test Name:
BioFire Respiratory Panel 2.1
Alias:
BioFire Resp Panel 2.1; BioFire RP2.1
Classification:
FDA Approved for use by authorized laboratories.
Methodology:
RT-PCR
Reference Range:
Not Detected
Result Interpretation:
- Positive (Detected) - results are indicative of an active infection with the detected virus/bacteria in the panel but does not rule out other bacterial infections or co-infection with other viruses.
- Negative (Not Detected) - results indicate that the virus/bacteria was not detected in the specimen. However, a low level below the level of detection could be possible. In addition, this result does not rule out the possibility of other bacterial infection or infection with other viruses.
Specimen (Preferred):
Anterior Nasal Swab collected in Viral Transport Medium (VTM)
Transport Temperature:
Frozen
Storage Condition:
Room Temperature - up to 4 hours
Refrigerated - up to 3 days
-20 degrees Celsius - up to 30 days
Turn Around Time:
Standard - less than 6 hours of sample(s) being received in the lab
STAT/RUSH - less than 1.5 hours of sample(s) being received in the lab
THE BIOFIRE RESPIRATORY 2.1 (RP2.1) PANEL MENU with SARS-CoV-2
Overall 97.1% Sensitivity and 99.3% Specificity1
VIRUSES:
● Adenovirus
● Coronavirus HKU1
● Coronavirus NL63
● Coronavirus 229E
● Coronavirus OC43
● Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
● Human Metapneumovirus
● Human Rhinovirus/Enterovirus
● Influenza A
● Influenza A/H1
● Influenza A/H3
● Influenza A/H1-2009
● Influenza B
● Parainfluenza Virus 1
● Parainfluenza Virus 2
● Parainfluenza Virus 3
● Parainfluenza Virus 4
● Respiratory Syncytial Virus
BACTERIA:
● Bordetella parapertussis
● Bordetella pertussis
● Chlamydia pneumoniae
● Mycoplasma pneumoniae
About Emergency Use Authorization:
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms
Note: $50.00 fee applied to returned payments.