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Prodesse ProParaflu+ Assay

The Prodesse Plus series of respiratory assays can be used alone or in combination with each other, offering flexibility and control over your molecular respiratory test menu and the ability to personalize patient testing.

The Prodesse ProParaflu+ assay detects and differentiates:

  • Parainfluenza 1
  • Parainfluenza 2
  • Parainfluenza 3

 

 

About

The Prodesse ProParaflu+ assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the qualitative detection and discrimination of Parainfluenza 1 virus, Parainfluenza 2 virus and Parainfluenza 3 virus nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections.

The parainfluenza viruses are second only to respiratory syncytial virus (RSV) in causing lower respiratory disease in children. Parainfluenza 1 is the leading cause of croup. ProParaflu+ offers laboratories, clinicians and their patients an important tool for the diagnosis and differentiation of viral respiratory disease, delivering:

Results in as little as 4 hours

Like all of the Prodesse product line assays, the ProParaflu+ assay uses proven real-time PCR technology, ensuring that accurate test results are delivered quickly and easily. The test's compatibility with automated nucleic-acid extraction technology minimizes hands-on time and expedites results. 

 Easy to implement in the lab

Designed to run on standard molecular diagnostic equipment, the ProParaflu+ assay has a simple workflow that makes it easy to implement and validate. A universal internal control allows a single nucleic-acid extract to be used in any combination of Prodesse respiratory virus assays .

Performance Data

ProParaflu+

Parainfluenza 1 Comparison Results

 

 

Culture/DFA

 

 

 

 

Positive

Negative

Total

 

Positive

16

1a

17

Sensitivity 88.9% (67.2% - 96.9%) 95% CI

Negative

2b

838

840

Specificity 99.9% (99.3% - 100.0%) 95% CI

Total

18

839

857

 

aOne (1) sample positive for HPIV-1 by bi-directional sequence analysis.
bTwo (2) samples negative for HPIV-1 by bi-directional sequence analysis.  One sample positive for HPIV-3 by ProParaflu+ Assay and bi-directional sequence analysis.

Discrepant analysis (genetic sequencing):
1 PCR positive, culture negative specimen:

  • 1 sample positive by sequence analysis.

2 PCR negative, culture positive specimens:

  • 2 samples negative by sequence analysis.
  • 1 positive for parainfluenza 3 by ProParaflu+ and by sequence analysis.

 

Parainfluenza 2 Comparison Results

 

 

Culture/DFA

 

 

 

 

Positive

Negative

Total

 

Positive

26

2a

28

Sensitivity 96.3% (81.7% - 99.3%) 95% CI

Negative

1b

828

829

Specificity 99.8% (99.1% - 99.9%) 95% CI

Total

27

830

857

 

aTwo (2) samples positive for HPIV-2 by bi-directional sequence analysis.
bOne (1) sample negative for HPIV-2 by bi-directional sequence analysis.

Discrepant analysis (genetic sequencing):

2 PCR positive, culture negative specimens:

  • 2 samples positive by sequence analysis.

1 PCR negative, culture positive specimen:

  • 1 sample negative by sequence analysis.

 

Parainfluenza 3 Comparison Results

 

 

Culture/DFA

 

 

 

 

Positive

Negative

Total

 

Positive

36

8a

44

Sensitivity 97.3% (86.2% - 99.5%) 95% CI

Negative

1b

812

813

Specificity 99.2% (98.1% - 99.5%) 95% CI

Total

37

820

857

 

 aSeven (7) samples positive for HPIV-3 and one (1) sample negative for HPIV-3 by bi-directional sequence analysis.
 bOne (1) sample negative for HPIV-3 by bi-directional sequence analysis.

Discrepant analysis (genetic sequencing):

8 PCR positive, culture negative specimens:

  • 7 samples positive by sequence analysis.
  • 1 sample negative by sequence analysis.

1 PCR negative, culture positive specimen:

  • 1 sample negative by sequence analysis.

Please see package insert for detailed information.

 

Regulatory

The Prodesse ProParaflu+ assay was cleared for in vitro diagnostic use by the FDA in 2009.

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.