cobas® ADV/hMPV/EV-RV UC Test

DGN-AMER
High-throughput respiratory solution on the cobas® 6800/8800 Systems for detecting and differentiating AdV, hMPV and EV/RhV

Acute respiratory infections are one of the leading causes of morbidity and mortality worldwide. Accurate and timely diagnosis of viral infections can ensure appropriate treatment plans, reduce the cost of care and assist with controlling the spread of disease.

Adenovirus (AdV), human metapneumovirus (hMPV) and enterovirus/rhinovirus (EV/RhV) are common respiratory pathogens responsible for cold-like illnesses amongst all age groups. However particularly in the young, eldely and immunocompromised, these viruses can progress to severe clinical manifestations, such as pneumonia, bronchitis, bronchiolitis and chronic obstructive pulmonary disease (COPD).123

Differential diagnosis of respiratory viral infections is therefore important for subsequent evaluation of antiviral drugs, prevention of secondary bacterial infections, or containment of potential outbreaks. 

The cobas® ADV/hMPV/EV-RV UC Test  assay for use with the cobas omni Utility Channel on the cobas® 6800/8800 Systems is a high-throughput multiplex assay for the qualitative detection and differentiation of respiratory viruses AdV, hMPV and EV/RhV. 

Benefits of the cobas® ADV/hMPV/EV-RV UC Test

Lab icon
Simplified and turnkey solution

 

Run fully compliant, CE-IVD workflow without further optimization. Positive and negative controls included.

Consolidated testing icon
Consolidated menu on high-throughput systems

 

Benefit from fully automated cobas® 6800/8800 Systems and an industry-leading menu to tackle seasonal high demand.

Effient workflow icon
Efficient, simultaneous workflow


Create time and cost savings by testing up to three respiratory assays from a single sample without batching nor pre-sorting.

Flexible testing icon
Flexible syndromic testing
 

Test what is medically relevant and necessary by customizing a targeted menu to address patient needs according to test setting, seasonality and geography.

cobas® ADV/hMPV/EV-RV UC Test is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human Adenovirus (ADV), Metapneumovirus (MPV) and Enterovirus/Rhinovirus (EV/RV). This test is intended to be used with the cobas® ADV/hMPV/EV-RV UC Test USAP on the open channel functionality (cobas omni Utility Channel) of the cobas® 6800/8800 Systems and the Remote User Interface (RUI).

This test is intended for use as an aid in the diagnosis of ADV, MPV and EV/RV infections in human nasopharyngeal swab (NPS) specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection.

The results from the cobas® ADV/hMPV/EV-RV UC Test must be interpreted within the context of all relevant clinical and laboratory findings.

CE-IVD

Comparison of cobas® ADV/hMPV/EV-RV UC with three real-time PCR CE-IVD kits for detection of ADV, MPV and EV/RV4

Se hela tabellen

Comparison of cobas® ADV/hMPV/EV-RV UC with three real-time PCR CE-IVD kits for detection of ADV, MPV and EV/RV4

PPA = Positive Percent Agreement; NPA = Negative Percent Agreement; CI = confidence interval; LCL = Lower confidence Limit; UCL = Upper confidence Limit

PPA = Positive Percent Agreement; NPA = Negative Percent Agreement; CI = confidence interval; LCL = Lower confidence Limit; UCL = Upper confidence Limit

 

Target  Number of Samples (N) Concordant Positive (N) Discordant Positive (N) Concordant Negative (N) Discordant Negative (N) Agreement Parameter  Percent Agreement (%) 95% CI (LCL,UCL) 
ADV 186 22 4* 159 1 PPA 95.7% (79.0%, 99.2%)
NPA 97.5% (93.9%, 99.0%)
MPV 188 22 2* 164 0 PPA 100% (85.1%, 100.0%)
NPA 98.6% (95.7%, 99.7%)
EV/RV 188 40 7* 139 2** PPA 95.2% (84.2%, 98.7%)
NPA 95.2% (90.4%, 97.7%)
*From 13 discordant positive samples (4 for ADV, 2 for MPV, 7 for EV/RV), 8 (1 for ADV, 1 for MPV, 6 for EV/RV) of these could be confirmed positive. **Two discordant negative results had been confirmed ER/RV positive

Key Parameters

  • Parameter

    Performance

  • Targets

    Adenovirus, human metapneumovirus, enterovirus/rhinovirus

  • Sample and media types

    Nasopharyngeal swab samples collected in the Copan UTM-RT® System, the BDTM UVT System or equivalent

  • Minimum amount of sample required

    0.6 mL

  • Sample processing volume

    0.4 mL

  • Test duration

    Results are available within less than 3.5 hours after loading the sample on the system

  • System software

    cobas® 6800/8800 System Software 1.4 or higher

References

1. Centers for Disease Control and Prevention. About Adenoviruses. https://www.cdc.gov/adenovirus/about/index.html. Accessed 15 Jun 2021.

2. Hamelin ME, A bed Y, Boivin G. Human metapneumovirus: a new player among respiratory viruses. Clin Infect Dis. 2004;38(7):983-990. doi:10.1086/382536

3. Royston L, Tapparel C. Rhinoviruses and Respiratory Enteroviruses: Not as Simple as ABC. Viruses. 2016;8(1):16. Published 2016 Jan 11. doi:10.3390/v8010016