cobas® Paraflu 1-4 UC 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 cobas® Paraflu 1-4 UC 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 cobas® Paraflu 1-4 UC Test

tube

Flexible syndromic testing
 

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

clock

Efficient, simultaneous workflow
 

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

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.

cobas® Paraflu 1-4 UC is an in vitro nucleic acid amplification test for the qualitative detection and discrimination of human Parainfluenza virus serotypes 1, 2, 3, and 4 (HPIV1-4). This test is intended to be used with the cobas® Paraflu 1-4 UC 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 HPIV1-4 in nasopharyngeal swab specimens from patients with signs and symptoms of a respiratory infection in conjunction with clinical and epidemiological risk factors.

The results from the cobas® Paraflu 1-4 UC must be interpreted within the context of all relevant clinical and laboratory findings.

CE-IVD

Comparison of cobas® Paraflu 1-4 UC with real-time PCR CE-IVD kit for detection of Parainfluenza 1-4 (HP1V1-4)

View Full Table

Comparison of cobas® Paraflu 1-4 UC with real-time PCR CE-IVD kit for detection of Parainfluenza 1-4 (HP1V1-4)

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)
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%)
*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

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

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