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Prodesse ProFlu+ Assay

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

The Prodesse ProFlu+ assay is for the detection and differentiation of:

  • Influenza A
  • Influenza B
  • Respiratory syncytial virus (RSV)
About

The Prodesse ProFlu+ assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and discrimination of Influenza A virus, Influenza B virus, and respiratory syncytial virus (RSV) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from symptomatic patients.  The Prodesse ProFlu+ assay delivers: 

The sensitivity and specificity you need

  The Prodesse ProFlu+ assay's sensitivity, specificity and reliability make it the respiratory virus test of choice.  .

Results in as little as 4 hours

The ProFlu+ 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 ProFlu+ 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

ProFlu+ Influenza A Comparison Results

 

Culture/DFA

 

 

 

Positive

Negative

Total

Comments

Positive

127

52a

179

Sensitivity 100%
(97.1% - 100%)
95% CI

Negative

0

647

647

Specificity 92.6%
(90.4% - 94.3%)
95% CI

Total

127

699

826

 

aForty-three (43) samples positive for Influenza A by sequence analysis, 8 samples negative for Influenza A by sequence analysis, and 1 sample unavailable for sequence analysis.

Discrepant analysis (genetic sequencing):

52 PCR positive, culture negative specimens:

  • 43 samples positive.
  • 8 samples negative.
  • 1 sample unavailable for analysis.

 

ProFlu+ Influenza B Comparison Results

 

Culture/DFA

 

 

 

Positive

Negative

Total

Comments

Positive

45

11a

56

Sensitivity 97.8%
(88.7% - 99.6%)
95% CI

Negative

1b

769

770

Specificity 98.6%
(97.5% - 99.2%)
95% CI

Total

46

780

826

 

aEleven (11) samples positive for Influenza B by sequence analysis.
bOne (1) sample negative for Influenza B by sequence analysis.

Discrepant analysis (genetic sequencing):
11 PCR positive, culture negative specimens:

  • 11 samples positive.

1 PCR negative, culture positive specimen:

  • 1 sample negative.

 

ProFlu+ RSV Comparison Results

 

Culture/DFA

 

 

 

Positive

Negative

Total

Comments

Positive

34

40a

74

Sensitivity 89.5%
(75.9% - 95.8%)
95% CI

Negative

4b

748

752

Specificity 94.9%
(93.2% - 96.2%)
95% CI

Total

38

788

826

 

aThirty-four (34) samples positive for RSV by sequence analysis, 3 samples negative for RSV by sequence analysis, and 3 samples unavailable for sequence analysis.
bOne (1) sample positive for RSV by sequence analysis and 3 samples negative for RSV by sequence analysis.

Discrepant analysis (genetic sequencing):
40 PCR positive, culture negative specimens:

  • 34 samples positive.
  • 3 samples negative.
  • 3 samples unavailable for analysis.

4 PCR negative, culture positive specimens:

  • 1 sample positive.
  • 3 samples negative.

Please see package insert for detailed information.
 

Clinical comparison results

The ProFlu+ Assay’s supermix was reformulated (available starting September 2013), and performance characteristics were established by comparing the reformulated assay to the original ProFlu+ assay. All samples positive for Influenza A, Influenza B or RSV using either the current ProFlu+ assay and/or the reformulated “New” ProFlu+ assay were confirmed using bidirectional sequencing. The sequencing assays targeted either a different gene than the ProFlu+ assay or targeted a different region of the same gene as the ProFlu+ assay. Prospectively collected archived samples from respiratory season years 2008 and 2009, which were collected at two clinical study sites (Columbus, OH and Albuquerque, NM), were used for this study.

“True” Influenza A, Influenza B or RSV positives were considered as any sample that tested positive for the respective analyte by the original ProFlu+ assay. “True” Influenza A, Influenza B or RSV negatives were considered as any sample that tested negative by the original ProFlu+ assay.

Influenza A comparison results

 

 

Current ProFlu+ Assay

 

 

 

Positive

Negative

Total

Comments

New
ProFlu+
Assay

Positive

60

1*

61

Percent Positive Agreement 100% (93.98%-100%)
95% CI

Negative

0

172

172

Percent Negative Agreement 99.4% (96.80%-99.90%)
95% CI

 

Total

60

173

233

 

*Sample was positive for Influenza A using bi-directional sequencing.

Influenza B comparison results

 

 

Current ProFlu+ Assay

 

 

 

Positive

Negative

Total

Comments

New
ProFlu+
Assay

Positive

14

0

14

Percent Positive
Agreement 100%
(78.47% - 100%)
95% CI

Negative

0

219

219

Percent Negative
Agreement 100%
(98.28% - 100%)
95% CI

 

Total

14

219

233

 

RSV comparison results

 

 

Current ProFlu+ Assay

 

 

 

Positive

Negative

Total

Comments

New
ProFlu+
Assay

Positive

35

2*

37

Percent Positive
Agreement 100%
(90.11% - 100%)
95% CI

Negative

0

196

196

Percent Negative
Agreement 99.0%
(96.39%-99.72%)
95% CI

 

Total

35

198

233

 

*Two samples positive for RSV using bi-directional sequencing.

Please see package insert for detailed information. 

Regulatory

The Prodesse ProFlu+ assay was cleared for in vitro diagnostic use by the FDA in 2008.

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