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Clear
 
Test Code:
090-91-0012

Order Name:
POCT - Flu A/B and RSV

 
Useful For:
The cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System (cobas® Influenza A/B & RSV) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus, Influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.

The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude Influenza virus or RSV infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not ruleout bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. 
 
Methodology:
The real-time PCR assays, The cobas® Liat® System
 
Test List In Profile:
POCT FluA/B & RSV:
Influenza A
Influenza B
Respiratory Syncytial Virus
 
AliasesName:
Flu A
Flu B
RSV
Flu A/B
PCR Flu A/B
PCR RSV
 
 
 
Test Code:
090-91-0012

Order Name:
POCT - Flu A/B and RSV

 
Patient Preparation:
For Nasopharyngeal Swab Collection step:
  1. Instruct the patient to blow their nose 
  2. Place the patient in a seated position with head against a fixed object (e.g. a wall) to prevent the patient from pulling away during this procedure
 
Collection Specimen Or Container:
  1. Sterile flexible minitip flocked swab with a synthetic tip (e.g. Dacron, nylon, or rayon) 
  2. Tube containing 3 mL of UTM
 
Specimen Testing Type:
Nasopharyngeal swab in 3 mL of UTM tube
 
Rejection Criteria:
Wrong specimen container will be reject.
 
Specimen Stabillity:
Specimen Type Temperature Time
Nasopharyngeal swab in 3 mL of UTM tube Room temperature, 18oC to 25oC Immediately testing
Nasopharyngeal swab in 3 mL of UTM tube Refrigerated, 2oC to 8oC 72 hours
 
 
 
Test Code:
090-91-0012

Order Name:
POCT - Flu A/B and RSV

 
Method detail:
The cobas® Liat® Influenza A/B & RSV assay is an automated in vitro diagnostic test for the qualitative detection of Influenza A, Influenza B, and RSV RNA in nasopharyngeal (NP) swab specimens. The sample-to-result time is ~20 minutes. The test is performed on the Analyzer which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using real-time PCR assays.
The assay targets a well-conserved region of the matrix gene of Influenza A (Inf A target), the non-structure protein gene of Influenza B (Inf B target), and the matrix gene of RSV (RSV target). An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target virus through all steps of the assay process and to monitor the presence of inhibitors in the RT-PCR processes. 
 
Schedule:
Test Daily (Only provided at ER Department, Instant clinic and Evening clinic)
 
Turnaround Time:
Collected specimen to report within 25 minutes (Bedside testing)
 
Performing Location:
POCT, ER Department, Instant clinic and Evening clinic
 
 
 
Test Code:
090-91-0012

Order Name:
POCT - Flu A/B and RSV

 
 
Clinical Information:
Influenza and RSV are the leading causes of respiratory infections. Influenza viruses consist of three types: Influenza A, Influenza B and Influenza C.

Influenza A viruses are further classified by two membrane proteins, hemagglutinin (H) and neuraminidase (N). In the U.S., Influenza A/H1N1, A/H3N2 and Influenza B are the predominant seasonal viruses. Symptoms of Influenza include fever, chills, headache, malaise, cough, coryza, nausea, vomiting, and diarrhea.

RSV is a common virus that leads to mild, cold-like symptoms in adults, but can cause severe illness in infants, young children, the elderly, and adults with chronic heart or lung disease. Symptoms of RSV infections include nasal congestion, sore throat, cough, sputum production, difficulty breathing, and fever.

Signs and symptoms of Influenza and RSV infections overlap extensively with other infectious causes. Automated and rapid assays that identify patients infected with Influenza and RSV can aid in effective control, proper choice of treatment, and prevention of outbreaks.
 
Reference Value:
Test Reference Value
Influenza A Negative
Influenza B Negative
Respiratory Syncytial Virus Negative
 
Clinical Reference:
  1. cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System package insert; Roche Molecular Systems, Inc., USA : 2018
  2. cobas® Liat® system Operator’s Manual Version 7.2; Roche Diagnostics, USA : 2017