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Validation of the Cepheid Xpert Flu A real time RT-PCR detection panel for emergency use authorization
Anthony R Sambol1, Peter C Iwen, Maura Pieretti
1Department of Pathology & Microbiology, University of Nebraska Medical Center, 42nd and Emile Str., Omaha, NE 68198-5900, USA. asambol@unmc.edu
Insights
The Cepheid Xpert Flu A Panel accurately detects 2009 H1N1 viral RNA, showing high sensitivity and specificity. This diagnostic tool received Emergency Use Authorization (EUA) in December 2009.
Area of Science:
- Virology
- Infectious Diseases
- Diagnostic Assays
Background:
- The 2009 influenza H1N1 outbreak prompted a public health emergency declaration in the US.
- This allowed the FDA to issue Emergency Use Authorization (EUA) for in vitro diagnostics to detect 2009 H1N1.
- The Cepheid Xpert Flu A Panel was developed for qualitative detection of 2009 H1N1 viral RNA.
Purpose of the Study:
- To validate the performance of the Cepheid Xpert Flu A Panel.
- To assess its accuracy in detecting 2009 H1N1 viral RNA in clinical specimens.
Main Methods:
- A multi-site, dual-method clinical evaluation was conducted.
- The Xpert Panel assay was compared against two established assays: Luminex Molecular Diagnostics xTAG Respiratory Viral Panel (Luminex RVP) and Focus Diagnostics Influenza A/H1N1 (2009) Real Time RT-PCR (Focus H1N1).
Main Results:
- Compared to Luminex RVP (n=300), the Xpert Panel demonstrated 91.2% sensitivity and 99.4% specificity for influenza A detection.
- Compared to Focus H1N1 (n=258), the Xpert Panel showed 92.1% sensitivity and 100% specificity for H1N1 detection.
- High positive and negative predictive values were observed for both comparisons.
Conclusions:
- The Cepheid Xpert Flu A Panel demonstrated comparable performance to both the Luminex RVP and Focus H1N1 assays.
- The Xpert Panel received EUA on December 24, 2009, indicating its utility during the H1N1 outbreak.
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.
