Validation of the Cepheid Xpert Flu A Real Time RT-PCR detection panel for Emergency Use Authorization

Anthony R. Sambol, Peter C. Iwen, Maura Pieretti, Samik Basu, Michael H. Levi, Kimberly D. Gilonske, Kimberly D. Moses, Jamie L. Marola, Preveen Ramamoorthy

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Background: In April 2009, the United States Secretary of the Department of Health and Human Services declared a public health emergency concerning the 2009 influenza H1N1 outbreak. This declaration allowed the FDA to issue Emergency Use Authorization (EUA) of approved in vitro diagnostics to detect the 2009 influenza H1N1 in clinical specimens. Objectives: This report outlines the validation testing of the Cepheid Xpert Flu A Panel for the qualitative detection of 2009 H1N1 viral RNA. Study design: This study was a multi-site, dual-method clinical evaluation comparing the results of testing between the Xpert Panel assay to the FDA-cleared Luminex Molecular Diagnostics xTAG™ Respiratory Viral Panel (Luminex RVP) assay and the EUA-granted Focus Diagnostics Influenza A/H1N1 (2009) Real Time RT-PCR (Focus H1N1) assay. Results: When compared to Luminex RVP (n= 300) for influenza A detection, the Xpert Panel had a sensitivity of 91.2% (95% CI: 85.1-95.4), specificity of 99.4% (95% CI: 96.7-100), positive predictive value (PPV) of 99.2% (95% CI: 95.6-100), and a negative predictive value (NPV) of 93.1% (95% CI: 88.3-96.4). When compared to the Focus H1N1 (n= 258) for detection of H1N1, the Xpert Panel had a sensitivity of 92.1% (95% CI: 82.4-97.4), specificity of 100% (95% CI: 98.5-100), PPV of 100% (95% CI: 95.0-100), and a NPV of 97.5% (95% CI: 94.3-99.2). Conclusions: The results show the Cepheid Xpert Flu A Panel to be comparable to both the Luminex RVP and the Focus H1N1 assays. The Cepheid Xpert Panel was granted an EUA on 24 Dec 2009.

Original languageEnglish (US)
Pages (from-to)234-238
Number of pages5
JournalJournal of Clinical Virology
Volume48
Issue number4
DOIs
StatePublished - Aug 2010

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Human Influenza
Molecular Pathology
Real-Time Polymerase Chain Reaction
Emergencies
United States Dept. of Health and Human Services
Viral RNA
Disease Outbreaks
Public Health

Keywords

  • 2009 Influenza A/H1N1
  • Cepheid Xpert
  • Clinical Laboratory Improvement Amendment
  • Emergency Use Authorization
  • RT-PCR

ASJC Scopus subject areas

  • Virology
  • Infectious Diseases
  • Medicine(all)

Cite this

Validation of the Cepheid Xpert Flu A Real Time RT-PCR detection panel for Emergency Use Authorization. / Sambol, Anthony R.; Iwen, Peter C.; Pieretti, Maura; Basu, Samik; Levi, Michael H.; Gilonske, Kimberly D.; Moses, Kimberly D.; Marola, Jamie L.; Ramamoorthy, Preveen.

In: Journal of Clinical Virology, Vol. 48, No. 4, 08.2010, p. 234-238.

Research output: Contribution to journalArticle

Sambol, AR, Iwen, PC, Pieretti, M, Basu, S, Levi, MH, Gilonske, KD, Moses, KD, Marola, JL & Ramamoorthy, P 2010, 'Validation of the Cepheid Xpert Flu A Real Time RT-PCR detection panel for Emergency Use Authorization', Journal of Clinical Virology, vol. 48, no. 4, pp. 234-238. https://doi.org/10.1016/j.jcv.2010.06.001
Sambol, Anthony R. ; Iwen, Peter C. ; Pieretti, Maura ; Basu, Samik ; Levi, Michael H. ; Gilonske, Kimberly D. ; Moses, Kimberly D. ; Marola, Jamie L. ; Ramamoorthy, Preveen. / Validation of the Cepheid Xpert Flu A Real Time RT-PCR detection panel for Emergency Use Authorization. In: Journal of Clinical Virology. 2010 ; Vol. 48, No. 4. pp. 234-238.
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AU - Basu, Samik

AU - Levi, Michael H.

AU - Gilonske, Kimberly D.

AU - Moses, Kimberly D.

AU - Marola, Jamie L.

AU - Ramamoorthy, Preveen

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N2 - Background: In April 2009, the United States Secretary of the Department of Health and Human Services declared a public health emergency concerning the 2009 influenza H1N1 outbreak. This declaration allowed the FDA to issue Emergency Use Authorization (EUA) of approved in vitro diagnostics to detect the 2009 influenza H1N1 in clinical specimens. Objectives: This report outlines the validation testing of the Cepheid Xpert Flu A Panel for the qualitative detection of 2009 H1N1 viral RNA. Study design: This study was a multi-site, dual-method clinical evaluation comparing the results of testing between the Xpert Panel assay to the FDA-cleared Luminex Molecular Diagnostics xTAG™ Respiratory Viral Panel (Luminex RVP) assay and the EUA-granted Focus Diagnostics Influenza A/H1N1 (2009) Real Time RT-PCR (Focus H1N1) assay. Results: When compared to Luminex RVP (n= 300) for influenza A detection, the Xpert Panel had a sensitivity of 91.2% (95% CI: 85.1-95.4), specificity of 99.4% (95% CI: 96.7-100), positive predictive value (PPV) of 99.2% (95% CI: 95.6-100), and a negative predictive value (NPV) of 93.1% (95% CI: 88.3-96.4). When compared to the Focus H1N1 (n= 258) for detection of H1N1, the Xpert Panel had a sensitivity of 92.1% (95% CI: 82.4-97.4), specificity of 100% (95% CI: 98.5-100), PPV of 100% (95% CI: 95.0-100), and a NPV of 97.5% (95% CI: 94.3-99.2). Conclusions: The results show the Cepheid Xpert Flu A Panel to be comparable to both the Luminex RVP and the Focus H1N1 assays. The Cepheid Xpert Panel was granted an EUA on 24 Dec 2009.

AB - Background: In April 2009, the United States Secretary of the Department of Health and Human Services declared a public health emergency concerning the 2009 influenza H1N1 outbreak. This declaration allowed the FDA to issue Emergency Use Authorization (EUA) of approved in vitro diagnostics to detect the 2009 influenza H1N1 in clinical specimens. Objectives: This report outlines the validation testing of the Cepheid Xpert Flu A Panel for the qualitative detection of 2009 H1N1 viral RNA. Study design: This study was a multi-site, dual-method clinical evaluation comparing the results of testing between the Xpert Panel assay to the FDA-cleared Luminex Molecular Diagnostics xTAG™ Respiratory Viral Panel (Luminex RVP) assay and the EUA-granted Focus Diagnostics Influenza A/H1N1 (2009) Real Time RT-PCR (Focus H1N1) assay. Results: When compared to Luminex RVP (n= 300) for influenza A detection, the Xpert Panel had a sensitivity of 91.2% (95% CI: 85.1-95.4), specificity of 99.4% (95% CI: 96.7-100), positive predictive value (PPV) of 99.2% (95% CI: 95.6-100), and a negative predictive value (NPV) of 93.1% (95% CI: 88.3-96.4). When compared to the Focus H1N1 (n= 258) for detection of H1N1, the Xpert Panel had a sensitivity of 92.1% (95% CI: 82.4-97.4), specificity of 100% (95% CI: 98.5-100), PPV of 100% (95% CI: 95.0-100), and a NPV of 97.5% (95% CI: 94.3-99.2). Conclusions: The results show the Cepheid Xpert Flu A Panel to be comparable to both the Luminex RVP and the Focus H1N1 assays. The Cepheid Xpert Panel was granted an EUA on 24 Dec 2009.

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