Molecular Reagent Xpert® Mpox For GeneXpert Dx / GeneXpert Infinity / GeneXpert Xpress Instruments 10 Tests

Features

• The Xpert® Mpox Test is for use under an Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-mpox-emergency-use-authorizations-medical-devices
• The Xpert® Mpox is a real-time PCR test intended for the qualitative detection of DNA from monkeypox virus clade II and non-variola Orthopoxvirus DNA in human lesion swab specimens (i.e., swabs of acute pustular or vesicular rash) from individuals suspected of mpox by their healthcare provider
• Testing on the GeneXpert Dx and GeneXpert Infinity instruments is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high or moderate complexity tests
• Testing on the GeneXpert Xpress (Hub Configuration) instrument is limited to laboratories certified under CLIA that meet requirements to perform high, moderate, or waived complexity test
• Testing on the GeneXpert Xpress (Hub Configuration) instrument is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
• Positive results are indicative of the presence of monkeypox virus (clade II) and/or non-variola Orthopoxvirus DNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
• Positive results do not rule out bacterial infection or co-infection with other viruses
• Negative results obtained with this device do not preclude monkeypox virus (clade II) and/or non-variola Orthopoxvirus infection and should not be used as the sole basis for treatment or other patient management decisions
• Negative results must be combined with clinical observations, patient history, and epidemiological information
• Laboratories within the United States and its territories are required to report test results to the appropriate public health authorities
• The Xpert Mpox is intended for use by trained operators who are proficient in performing a test using either GeneXpert Dx, GeneXpert Infinity and/or Gene Xpert Xpress systems
• Kit includes: (10) Xpert Mpox Cartridges with Integrated Reaction Tubes, Bead 1, Bead 2, Bead 3, and Bead 4 (freeze-dried) (1 of each per cartridge), 1 mL Lysis Reagent (Guanidinium Thiocyanate) per Cartridge, 1 mL Binding Reagent per Cartridge, 3 mL Elution reagent per Cartridge, 0.4 mL Wash Reagent per Cartridge, Disposable 300 µL Transfer Pipettes ( 2 bags of 12 per kit) Flyer and Quick Ref Instructions
• Materials available but not provided: External Positive Control: Catalog # NATMPXVPOS-6C, External Negative Control: Catalog # NATMPXVNEG-6C

More Information

• Xpert Mpox FDA EUA Letter
• Xpert Mpox IFU POC
• Xpert Mpox IFU Labs
• Xpert Mpox Healthcare Providers Fact Sheet
• Xpert Mpox Patients Fact Sheet
• Xpert Mpox Data Sheet
• SDS