Multiplex diagnostic test used for detection of COVID-19, influenza A & B, and respiratory syncytial virus in individuals suspected of upper respiratory illness by their healthcare provider.
This test provides increased sensitivity and specificity over rapid antigen tests and should especially be ordered when community prevalence is low.
Nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens in 3 mL of viral transport medium
Collection procedure:
NP: Insert the sterile swab into either nostril, keeping the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab by firmly brushing against the nasopharynx several times.
NS: Insert a dry swab into a nostril. Rotate the swab against the inside of the nostril for 3 seconds while applying pressure with a finger to the outside of the nostril. Repeat on the other nostril with the same swab.
Place swab in UTM immediately and break the swab at the indicated break line and cap the tube.
Storage/Transport Temperature
Specimens should be transported at 2–8°C.
Unacceptable Conditions
Swabs not submitted in approved liquid (dry swabs)
Swabs in saline
Stability (from collection to initiation)
Room temperature (15–30°C) for up to 48 hours
Refrigerated (2–8°C) up to 7 days
Frozen (-80°C) and undergo 1 freeze thaw/cycle
Reference Interval
Normal
SARS-CoV-2: Not Detected
Influenza A: Negative
Influenza B: Negative
RSV: Negative
Abnormal
SARS-CoV-2: Detected
Influenza A: Positive
Influenza B: Positive
RSV: Positive
Interpretive Data
The SAR-CoV-2, Influenza, and RSV nucleic acid amplification test is an automated in vitro diagnostic real time RT-PCR test for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, Flu A, Flu B, and RSV. The primers and probes in the test are designed to amplify and detect unique sequences in the following: nucleocapsid (N) and envelope (E) and RNA-dependent RNA polymerase (RdRP) genes of the SARS-CoV-2 virus genome, influenza A matrix (M), influenza A basic polymerase (PB2), influenza A acidic protein (PA), influenza B matrix (M), influenza B nonstructural protein (NS), and the RSV A and RSV B nucleocapsid.
Negative results do not preclude SARS-CoV-2, influenza or RSV infection and should not be used as the sole basis for treatment or other patient management decisions.
This test has not been evaluated for monitoring treatment of infection.
Notes
This assay has EUA from the FDA for nasopharyngeal, nasal swab, or nasal wash/aspirate specimens from individuals suspected of COVID-19 by their healthcare provider. The Xpert Xpress SARS-CoV-2/Flu/RSV Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients can be found at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
CPT Codes
87637
LOINC
95941-1
Overview
Ordering Recommendations
Multiplex diagnostic test used for detection of COVID-19, influenza A & B, and respiratory syncytial virus in individuals suspected of upper respiratory illness by their healthcare provider.
This test provides increased sensitivity and specificity over rapid antigen tests and should especially be ordered when community prevalence is low.
Nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens in 3 mL of viral transport medium
Collection procedure:
NP: Insert the sterile swab into either nostril, keeping the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab by firmly brushing against the nasopharynx several times.
NS: Insert a dry swab into a nostril. Rotate the swab against the inside of the nostril for 3 seconds while applying pressure with a finger to the outside of the nostril. Repeat on the other nostril with the same swab.
Place swab in UTM immediately and break the swab at the indicated break line and cap the tube.
Storage/Transport Temperature
Specimens should be transported at 2–8°C.
Unacceptable Conditions
Swabs not submitted in approved liquid (dry swabs)
Swabs in saline
Stability (from collection to initiation)
Room temperature (15–30°C) for up to 48 hours
Refrigerated (2–8°C) up to 7 days
Frozen (-80°C) and undergo 1 freeze thaw/cycle
Interpretive
Reference Interval
Normal
SARS-CoV-2: Not Detected
Influenza A: Negative
Influenza B: Negative
RSV: Negative
Abnormal
SARS-CoV-2: Detected
Influenza A: Positive
Influenza B: Positive
RSV: Positive
Interpretive Data
The SAR-CoV-2, Influenza, and RSV nucleic acid amplification test is an automated in vitro diagnostic real time RT-PCR test for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, Flu A, Flu B, and RSV. The primers and probes in the test are designed to amplify and detect unique sequences in the following: nucleocapsid (N) and envelope (E) and RNA-dependent RNA polymerase (RdRP) genes of the SARS-CoV-2 virus genome, influenza A matrix (M), influenza A basic polymerase (PB2), influenza A acidic protein (PA), influenza B matrix (M), influenza B nonstructural protein (NS), and the RSV A and RSV B nucleocapsid.
Negative results do not preclude SARS-CoV-2, influenza or RSV infection and should not be used as the sole basis for treatment or other patient management decisions.
This test has not been evaluated for monitoring treatment of infection.
Notes
This assay has EUA from the FDA for nasopharyngeal, nasal swab, or nasal wash/aspirate specimens from individuals suspected of COVID-19 by their healthcare provider. The Xpert Xpress SARS-CoV-2/Flu/RSV Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients can be found at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
