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Prodesse ProPneumo-1 Assay

An easy-to-use real-time multiplex PCR kit for detection and differentiation of:

  • Chlamydophila pneumoniae
  • Mycoplasma pneumonia

This product is not approved by the FDA and is not available for sale in the US.

For additional availability in other countries please contact your local sales reap or distributor.

About

Results in roughly 3 hours

Results from ProPneumo-1 can be obtained in about 3 hours, including nucleic acid extraction and real-time amplification/detection.

Performance Data

Clinical sensitivity of the ProPneumo-1 Real Time Assay was evaluated by analyzing 30 C. pneumoniae positive, 30 M. pneumoniae positive, and 12 negative clinical specimens with three unique lots of reagents, resulting in 216 tests. Samples were evenly split between sputum, bronchoalveolar lavage, and nasopharyngeal swab specimens. C. pneumoniae and M. pneumoniae positive specimens were spiked with whole organism at three concentrations. All positive and negative samples were spiked with Internal Control. Samples were extracted with the Roche High Pure Viral Nucleic Acid Kit and processed as outlined in Instructions for Use on the Rotor-Gene 3000 and Cepheid SmartCycler II. Sensitivity was calculated by dividing the number of true positive samples detected by the sum of the true positives and false negatives for each organism. Specificity was calculated by dividing the number of true negative samples by the sum of true negatives and false positives for each organism.

ProPneumo-1

Sensitivity

Rotor-Gene 3000

SmartCycler

C. pnuemoniae

95.6%

90.0%

M. pnuemoniae

93.3%

98.9%

 

ProPneumo-1

Specificity

Rotor-Gene 3000

SmartCycler

C. pnuemoniae

100.0%

100%

M. pnuemoniae

95.2%

100%

 

 

Roche is a trademark of Hoffman-LaRoche Inc.

Cepheid and SmartCycler are trademarks of Cepheid Corporation.

Rotor-Gene is a trademark of Corbett Research Pty Ltd.

Please see package insert for detailed information.

Regulatory

The ProPneumo-1 assay is CE marked for in vitro diagnostic yse.

For additional availability in other countries please contact your local sales rep or distributor.