Flu A-B + SARS-CoV-2 PCR

Alternate Name: FluAB-Covid19

  | FluVid; Covid and Flu

SAL Code:

2016

CPT:

87636

Turn Around Time:

1 Day

Setup:

Daily

Department:

Molecular Diagnostics

Methodology:

Polymerase Chain Reaction (RT-PCR)

Specimen Requirements:

Primary Tube:

VTM

Primary Substance:

BioMat

Alternate Sample Info:

Nasal and nasopharyngeal specimens

Temperature

Period

Stable Ambient:

1 Day

Stable Fridge:

5 Days

Stable Frozen:

30 Days

Rejection Criteria:

Expired or non-approved collection devices or improperly collected samples. Noticeably leaking samples or samples with obvious PCR inhibitors will be rejected or canceled.

Clinical Info:

Influenza A, Influenza B and SARS-CoV-2 are the top three causative agents of severe respiratory illnesses. Influenza viruses are seen to increase during the flu season, late summer into winter. SARS-CoV-2 is a viral agent causing the year-round pandemic occurring around the world beginning in late 2019. Real-time RT-PCR testing is used to detect the nucleic acids from SARS-CoV-2, Influenza A (multiple stains) and Influenza B in nasopharyngeal and nasal swab samples collected in Universal Viral Transport Media System, cobas® PCR Media, or saline from patients who meet COVID-19 clinical and/or epidemiological criteria during infection.
The Cobas® SARS-CoV-2 & Influenza A/B test is an automated qualitative molecular diagnostic test that utilizes multi-plex real time RT-PCR for the simultaneous detection of SARS-CoV-2, Influenza A virus and/or Influenza B virus nucleic acids. Nasopharyngeal or nasal swab specimens are used to detect the presence of viral RNA. Positive results are indicative of the presence of SARS-CoV-2, Influenza A and/or Influenza B RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. A negative result does not rule out a SARS-CoV-2 infection. This test is intended to detect SARS-CoV-2, Influenza A and/or Influenza B only in patients with proper collection and epidemiological criteria.

Additional Information:

Amplification of target nucleic acids are performed using forward and reverse primers specifically designed for the ORF1 a/b, a region unique to SARS-CoV-2. A conserved region in the structural protein envelope E-gene was selected for the detection for pan-Sarbecovirus which will detect SARS-CoV-2.
For Influenza A and Influenza B viruses, selective amplification is performed using target specific forward and reverse primers. Targets include matrix proteins 1 and 2 (M1/M2) for Influenza A and nuclear export protein (NEP)/nonstructural protein 1 (NS1) genes for Influenza B.
Selective amplification of the RNA internal control is performed using specific primers with no homology with the coronavirus or influenza genomes.

Cobas® SARS-CoV-2 & Influenza A/B master mix contains detection probes specific for SARS-CoV-2, members of the Sarbecovirus subgenus, Influenza A virus, Influenza B virus and the RNA internal Control nucleic acids. Probes with fluorescent dyes are cleaved separating the dyes from the quenchers when hybridization occurs during amplification. The signal released is measured enabling detection of amplified coronavirus target and RNA IC.

Testing was performed using the Roche Cobas(R) SARS-CoV-2 and Influenza A/B RT-PCR test. This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient's recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. An individual without symptoms of COVID-19/Influenza and who is not shedding SARS-CoV-2/Influenza virus would expect to have a negative (Not Detected) result in this assay. For more information please see below:

Fact Sheet for Healthcare Providers: https://www.fda.gov/media/141885/download

Fact Sheet for Patients: https://www.fda.gov/media/141886/download

Sample Collection:

Use only synthetic fiber swabs with thin plastic or wire shafts that have been designed for sampling the nasopharyngeal mucosa. 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.
Tilt patient’s head back 70 degrees.
Gently and slowly insert a minitip 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.
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.
Place swab, tip first, into the transport tube provided.
For a visual guide see https://www.cdc.gov/coronavirus/2019-ncov/downloads/lab/NP_Specimen_Collection_Infographic_FINAL_508.pdf

Test Limitations:

1. Reliable results depend on proper sample collection, storage, and handling procedure.
2. This test is intended to be used for detection of SARS-CoV-2, Influenza A and Influenza B RNA in nasal and nasopharyngeal swab samples from UTM-RT, UVT, cobas ® PCR Media, and 0.9% physiological saline. Testing of other sample type may result in inaccurate results.
3. Detection of SARS-CoV-2 RNA may be affected by sample collection methods, patient factors and/or stage of infection.
4. False negative or invalid results may occur due to interference. The internal control is included to help identify the specimens' containing substances that may interfere with nucleic acid isolation and PCR amplification.

Test Handle Instructions:

Maintain at ambient temperature; or refrigerated if more than 12 hours. Avoid exposure to heat or freezing temperatures.

Test Information:

Components:

Component Name CPT Loinc
Influenza A 85477-8
Influenza B 85478-6
SARS-CoV-2, NAA (PCR) 94500-6