Sentosa® SA Influenza A/B & RSV RT-PCR Test

Integrated workflow for Influenza A, Influenza B, and RSV diagnosis

RELEVANCE

Influenza (or the flu) is an infectious disease caused by RNA viruses of the family Orthomyxoviridae. It mainly affects the nose, throat and bronchi, with characteristics of sudden onset of high fever, aching muscles, headache and severe malaise, non-productive cough, sore throat and rhinitis.1

Influenza epidemics occur seasonally each year, e.g., during autumn and winter in temperate regions by different virus subtypes. There are three types of seasonal influenza – A, B and C, of which A and B are most clinically relevant. 

Respiratory Syncytial Virus (RSV) is a RNA virus causing respiratory tract infections in children, elderly adults and immunocompromised patients. Two subtypes, A and B, have been identified.2 RSV affects both the upper and lower respiratory tracts, but has been shown to be more prevalent in the lower respiratory tract. It is one of the main causes of bronchiolitis and pneumonia in susceptible patient groups. The spreading of RSV is seasonal and typically begins in autumn and continues through the winter period. As RSV spreads very easily, it is important to identify infected patients early and avoid antibiotic treatment.

References:

1) Taubenberger JK, Kash JC. Influenza virus evolution, host adaptation, and pandemic formation. Cell Host Microbe. 2010:7: 445–451.

2) Collins PL, Melero, JA Progress in understanding and controlling respiratory syncytial virus: still crazy after all these years. Virus Res. 2011;162:80–99.

INTENDED USE

The Sentosa  SA Influenza A/B & RSV RT-PCR Test is a fourplex, real-time polymerase chain reaction (PCR)-based in vitro diagnostic test. This test is intended for the qualitative detection of influenza A, influenza B and / or respiratory syncytial virus (RSV) nucleic acids obtained from clinical specimens (nasal swabs or nasopharyngeal swabs) from patients with signs and symptoms of respiratory tract infections. The targets in the PCR are the matrix protein genes from the influenza virus or the M gene from RSV.

This in vitro diagnostic test is configured for use on the Sentosa SX101 instrument, with the Sentosa SX Virus Total Nucleic Acid Kit v2.0, in conjunction with the Rotor-Gene Q MDX 5plex HRM instrument.

Negative results do not preclude influenza or RSV infection and should not be used as a sole basis for treatment or other patient management decisions. Mutations that arise within the highly conserved regions of the viral genome covered by the kit’s primers and / or probes may result in failure to detect the presence of the virus.

The product is to be used by personnel trained in in vitro diagnostic procedures. Detection of viral RNA depends on the number of viruses present in the sample, and can be affected by sample collection methods, patient-related factors (e.g., age, symptoms), or infection stage and sample size.

FEATURES AND BENEFITS

Supporting Clinical Decision Making

  • Sensitive and robust
  • Differentially detect Influenza A, Influenza B & RSV

Providing Laboratory Efficiency

  • Only 20 minutes of hands-on work
  • Automatic result call-out within 2 minutes
  • Test up to 192 reactions per day

Increasing Cost Effectiveness

  • Three targets in one test to save reagents and consumables
  • Less than 9% hands-on work per workflow to reduce time and cost
  • Comprehensive and fast result call-out to reduce patient management cost

WORKFLOW

SPECIFICATIONS

AttributeValue
Analytical Sensitivity (95% CI)

Influenza A/Aichi2/68 (H3N2): 1.2 copies/μL,
Influenza B/Lee/40: 4.2 copies/μL,

Human respiratory syncytial virus, strain A2: 1.4 copies/μL
Analytical Reactivity Able to detect 13 Influenza A, 8 Influenza B and 5 RSV strains tested
Analytical Specificity No cross-reactivity with 32 pathogens tested
Clinical Sensitivity

Influenza A/Aichi2/68 (H3N2): 100%,
Influenza B/Lee/40: 100%,

Human respiratory syncytial virus, strain A2: 100%
Clinical Specificity

Influenza A/Aichi2/68 (H3N2): 99.76%,
Influenza B/Lee/40: 99.76%,

RSV: 100%
Reproducibility 100%
Sample Type(s) Nasal or nasopharyngeal swabs

PRODUCT FLYERS

ORDERING INFORMATION

ProductPack SizeItem Number
Sentosa SA Influenza A/B & RSV RT-PCR Test (4x24) CE-IVD 4x24 300145
Sentosa SA Influenza A/B & RSV RT-PCR Test (4x24) RUO 4x24 300146
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) CE-IVD 4x24 300042
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) RUO 4x24 300044

For availability in your country, please contact your Vela Diagnostics sales representative.