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Prodesse ProFAST+ 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 ProFAST+ assay is for Flu A Sub-Typing and discriminates:

  • Seasonal Influenza A/H1
  • Seasonal Influenza A/H3
  • 2009 H1N1 Influenza

 

About

The Prodesse ProFAST+ assay is a multiplex real-time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of seasonal influenza A/H1, seasonal influenza A/H3 and 2009 H1N1 influenza viral nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.

The Prodesse ProFAST+ assay delivers: 

Results in as little as 2 hours

The Prodesse ProFAST+ 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.  Designed as a companion assay to ProFlu+, results can be obtained from nucleic acid extracts in about 2 hours.

Easy to implement in the lab

Designed to run on standard molecular diagnostic equipment, ProFAST+ 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

Prospective data from clinical trials
 

Pro FAST+

Seasonal Influenza A/H1 Comparison Results

 

 

ProFlu+/Sequencing

 

 

 

 

Positive

Negative

Total

 

Positive

53

8a

61

Positive Percent Agreement=100.0%
(93.2% - 100.0%) 95% CI

Negative

0

781

781

Negative Percent Agreement=99.0%
(98.0% - 99.5%) 95% CI

Total

53

789

842

 

aTwo (2) samples were negative for Influenza A by the ProFlu+ assay, but positive for seasonal A/H1 by bi-directional sequence analysis. One (1) sample was negative for Influenza A by the ProFlu+ assay, and negative for seasonal A/H1 by bi-directional sequence analysis, but positive for Influenza A, un-subtyptable, by the FDA cleared CDC rRT-PCR Influenza Panel. Five (5) samples were positive for Influenza A by the ProFlu+ assay, negative for A/H1, A/H3 and 2009 H1N1 by bi-directional sequence analysis, but positive for A/H1 by the FDA cleared CDC rRT-PCR Influenza Panel.

 

Seasonal Influenza A/H3 Comparison Results

 

 

ProFlu+/Sequencing

 

 

 

 

Positive

Negative

Total

 

Positive

25

3a

28

Positive Percent Agreement=100.0%
(86.7% - 100.0%) 95% CI

Negative

0

814

814

Negative Percent Agreement=99.6%
(98.9% - 99.9%) 95% CI

Total

25

817

842

 

aOne (1) sample was negative for Influenza A by the ProFlu+ Assay, also negative for seasonal A/H1 and A/H3, and 2009 H1N1 by bi-directional sequence analysis. One (1) sample was positive for Influenza A by the ProFlu+ assay, negative for A/H1, A/H3 and 2009 H1N1 by bi-directional sequence analysis, but positive for A/H3 by the FDA cleared CDC rRT-PCR Influenza Panel. One (1) sample was positive for Influenza A by the ProFlu+ assay, positive for A/H1 and negative for A/H3 and 2009 H1N1 by bi-directional sequence analysis.

 

2009 H1N1 Influenza Comparison Results

 

 

ProFlu+/Sequencing

 

 

 

 

Positive

Negative

Total

 

Positive

62

0

62

Positive Percent Agreement=95.4%
(87.3% - 98.4%) 95% CI

Negative

3

777

780

Negative Percent Agreement=100.0%
(99.5% - 100.0%) 95% CI

Total

65

777

842

 

               

 

Clinical Performance - Seasonal A/H1 Influenza

      ProFlu+/Sequencing    

 

 

Positive

Negative

Total

Percent Agreement

ProFAST+

Positive

17

1a

18

Positive 100%
(74.3 – 99.0%) 95% CI

Negative

1

141

142

Negative 99%
(96.1 – 99.9%) 95% CI

Total

18

142

160

 

             

aOne (1) sample was negative or Influenza A by one the ProFlu+ assay, but positive for seasonal A/H1 by bi-directional sequence analysis.

 

Clinical Performance - Seasonal A/H3 Influenza

      ProFlu+/Sequencing    

 

 

Positive

Negative

Total

Percent Agreement

ProFAST+

Positive

72

0

72

Positive 100%
(94.9 – 100%) 95% CI

Negative

0

88

88

Negative 99%
(95.8 – 100%) 95% CI

Total

72

88

160

 

             

 

Clinical Performance - 2009 H1N1 Influenza

      ProFlu+/Sequencing    

 

 

Positive

Negative

Total

Percent Agreement

ProFAST+

Positive

25

0

25

Positive 100%
(86.7 – 100%) 95% CI

Negative

0

135

135

Negative 99%
(97.2 – 100%) 95% CI

Total

25

135

160

 

             

 

Please see package insert for detailed information.

 

Regulatory

The Prodesse ProFAST+ assay was cleared for in vitro diagnostic use by the FDA in 2010.

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