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Xpert® Respiratory Panel (10-test kit)
GXRESP-10
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Data sheet
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Package Insert
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MSDS/SDS
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Verification Guide
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Quick Reference Guide
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XPRS4PLEX-10
On-demand 4-in-1 PCR test delivering actionable results with less than 1 minute of hands-on time. FDA cleared: moderate complexity and CLIA waived
GXGI-10|GXGI-SPAK
Detection and identification of DNA and RNA from multiple bacteria, parasites and/or virus in approximately 74 minutes
XPRSTREPA-10
Delivers accurate and timely results that optimizes fast treatment decisions
1. What does the Xpert Respiratory panel test for?
1. What does the Xpert Respiratory panel test for?
The Xpert Respiratory Panel test, performed on the GeneXpert Instrument Systems, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of DNA and RNA from multiple bacteria and/or viruses in nasopharyngeal swab (NPS) specimens obtained from individuals with clinical signs and symptoms of respiratory tract infection. Detecting and identifying specific viral and bacterial nucleic acids from individuals presenting with signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction with other clinical, epidemiological and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
2. What specimen types and collection materials can be used with Xpert Respiratory Panel?
2. What specimen types and collection materials can be used with Xpert Respiratory Panel?
Sample Types:
• Nasopharyngeal swabs from individuals suspected of having respiratory tract infection (RTI).
Collection Devices:
• Nasopharyngeal Sample Collection Kit for viruses:
Examples include:
• Copan, Flexible Minitip Flocked Swab with UTM® Medium w/o Beads, P/N: 3C057N or equivalent
• BD Becton Dickinson, Flexible Minitip Flocked Swab with UVT Medium, Universal Viral Transport Kit P/N 220531
• Copan, Flexible Minitip Flocked Swab with eNAT® Medium P/N: 6U074S01
Swabs and Collection Media:
• Nylon flocked swab (Copan P/N 503CS01)
• 3mL of viral transport media (UTM/VTM)
• 2mL of eNAT
3. Can you use the same Nasopharyngeal Sample Collection Kit, as used with Xpert Xpress CoV-2/Flu/RSV plus and Xpert Xpress CoV-2 plus?
3. Can you use the same Nasopharyngeal Sample Collection Kit, as used with Xpert Xpress CoV-2/Flu/RSV plus and Xpert Xpress CoV-2 plus?
Yes. The Nasopharyngeal Sample Collection Kits currently used for Xpert Xpress CoV-2/Flu/RSV plus and Xpert Xpress CoV-2 plus can be also used with the Xpert Respiratory Panel.
4. How does the test work?
4. How does the test work?
The test utilizes automated, qualitative polymerase chain reaction (PCR) for DNA targets and reverse transcription polymerase chain reaction (RT-PCR) for RNA targets using both amplification and melt detection methods.
5. What is the test complexity (CLIA categorization) for the Xpert Respiratory Panel?
5. What is the test complexity (CLIA categorization) for the Xpert Respiratory Panel?
The Xpert Respiratory Panel is FDA-cleared and is categorized as a moderate complexity test.
6. What Instruments and software are required for use of the Xpert Respiratory Panel?
6. What Instruments and software are required for use of the Xpert Respiratory Panel?
The Xpert Respiratory Panel is compatible with the following systems using 10-color modules:
• GeneXpert Dx system: GeneXpert Dx software version 6.6 or higher (use Xpert Respiratory Panel IFU PN 303-3322)
• GeneXpert Infinity-80 and Infinity-48s systems: Xpertise software version 7.2 or higher (use Xpert Respiratory Panel IFU PN 303-3322)
• GeneXpert system with touchscreen: Cepheid OS software version 2.3 or higher (use Xpert Respiratory Panel IFU PN 303-5121)
7. What external quality control (QC) material options are available for Xpert Respiratory Panel (US-IVD)?
7. What external quality control (QC) material options are available for Xpert Respiratory Panel (US-IVD)?
The external controls listed for optional use with the Xpert Respiratory Panel listed in the IFU are from Zeptometrix:
• External Positive Control – NATtrol Respiratory Positive Control NATRSSPPOS-8C-IVD
• External Negative Control – NATtrol Respiratory Negative Control NATRSPNEG-8C-IVD
8 . Do you have any guidelines for verification studies of the Xpert Respiratory Panel test?
8 . Do you have any guidelines for verification studies of the Xpert Respiratory Panel test?
Before going live with a new test, a verification study may be necessary. Please refer to your relevant laboratory accreditation regulations for verification requirements. A verification guide that describes the preparation of contrived positive specimens (prepared by spiking commercial reference material into negative specimens) is available for download on the Cepheid website: Verification Guide. However, the decision to perform verification studies and the level of verification required is at the discretion of the laboratory director and should be conducted according to applicable regulations.
9. What are my options for obtaining the ADF or the Package Insert for my Xpert Respiratory Panel test?
9. What are my options for obtaining the ADF or the Package Insert for my Xpert Respiratory Panel test?
The Instructions for Use (IFU) and Assay Definition Files (ADF) for Xpert Respiratory Panel, as well as the SDS and ADF import instructions are being made available in electronic version and are available for download here. A CD containing the ADF is also being provided to new customers on their first order of GXRESP-10. For customers who would like to order additional copies and/or misplaced the CD, please fill out the CD ADF request using the following link:
10. What proficiency panels can Cepheid recommend for the Xpert Respiratory Panel (US-IVD)?
10. What proficiency panels can Cepheid recommend for the Xpert Respiratory Panel (US-IVD)?
Customers should consult their proficiency testing provider regarding programs designed for molecular respiratory panels.
View our additional portals to find documents and resources not listed here.
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