Qualitative ADV, MPV, EV/RV 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 UC-DGN-AMERTM 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 Qualitative ADV, MPV, EV/RV Test

Lab
Simplified and turnkey solution

 

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

Consolidated testing
Consolidated menu on high-throughput systems

 

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

Intended Use

Intended Use

UC-DGN-AMER 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 UC-DGN-AMER 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 UC-DGN-AMER™ must be interpreted within the context of all relevant clinical and laboratory findings.

 

Registration Status

CE-IVD

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



Clinical performance of UC-DGN-AMERTM  as compared to CE-IVD comparative kit

 * Two samples were excluded from the analysis as confirmed belonging to ADV species D and F.

** The sample has been sequenced but the results were not interpretable. 

*** None of the four discordant positive samples gave interpretable sequencing results. One of them had been confirmed ADV positive by the supplier.

 * The two discordant positive samples have been sequenced and did not gave interpretable results. One of them had been confirmed MPV positive by the supplier.

 * Among the seven discordant positive samples sent to sequencing, three have been confirmed as RV positive. The sequencing results were not interpretable for four samples but three of them had been confirmed as EV/ RV positive by the supplier. In conclusion, six out of the seven discordant positive samples were confirmed EV/ RV positive.

** The two discordant negative results had been confirmed ER/RV positive by the supplier. 

Key Parameters

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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