Qualitative Parainfluenza 1-4 Test

Parainfluenza

High-throughput, flexible respiratory solution on the cobas® 6800/8800 Systems

 

Human parainfluenza viruses are the second main cause of hospitalisation of young children suffering from respiratory illness. Appropriate diagnosis can help personalize patient care and improve health outcomes. Human parainfluenza viruses (HPIVs) are enveloped RNA viruses responsible for upper and lower respiratory illnesses in all age groups. Although anyone can become infected, young children, older adults, and the immunocompromised are especially vulnerable.1 HPIVs often produce mild cold-like symptoms but can progress to severe clinical manifestations such as otitis media, pharyngitis, conjunctivitis, croup, tracheobronchitis, and pneumonia, which can result in life-threatening consequences.2

Reliable and timely diagnosis of respiratory pathogens can help differentiate among viruses, improve clinical decision making, and prevent viral outbreaks. 

The UC-DGN-PARA Test 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 parainfluenza 1, parainfluenza 2, parainfluenza 3, and parainfluenza 4.

 

Benefits of the UC-DGN-PARA Test

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Flexible syndromic testing

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

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Efficient, simultaneous workflow

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

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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.

References

1. Centers for Disease Control and Prevention. About Human Parainfluenza Viruses (HPIVs).  https://www.cdc.gov/parainfluenza/about/index.html. Accessed 7 Jun 2021.

2. Branche, A. R., & Falsey, A. R. (2016). Parainfluenza Virus Infection. Seminars in respiratory and critical care medicine, 37(4), 538–554. https://doi.org/10.1055/s-0036-1584798

 

Key Parameters

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Key Parameters

PARAMETER PERFORMANCE
Targets Parainfluenza 1 to 4
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

Comparison of UC-DGN-PARA™ with real-time PCR CE-IVD kit for detection of Parainfluenza 1-4 (HP1V1-4)

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)
HP1V1 222 55 1* 163 3* PPA 94.8% (85.9%, 98.2%)
NPA 99.4% (96.6%, 99.9%)
HP1V2 222 58 2* 162 0 PPA 100% (93.8%, 100.0%)
NPA 98.8% (95.7%, 99.7%)
HP1V3 221 30 0 190 1** PPA 96.8% (83.8%, 99.4%)
NPA 100% (98.8%, 100.0%)
HP1V4 222 67 1* 153 1** PPA 98.5% (92.1%, 99.7%)
NPA 99.4% (96.4%, 99.9%)

 

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

*From 4 discordant positive samples (1 for HPIV1, 2 for HPIV2, 1 for HPIV4), 3 (1 for HPIV1, 1 for HPIV2, 1 for HPIV4) of these could be resolved as in agreement with the retrospective clinical status. 
**With the exception of 1 HPIV1 discordant negative, all could be resolved as in agreement with the retrospective clinical status