Sexual Health Test Kit Cue® Mpox 10 Tests

Features

• The Cue Health Mpox Molecular Test is For use under an Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-mpox-emergency-use-authorizations-medical-devices
• The Cue Mpox (Monkeypox) Molecular Test is an isothermal nucleic acid amplification assay for the qualitative detection of DNA from the monkeypox virus (clade I/II), in human lesion swab specimens (i.e., swabs of acute pustular or vesicular rash) from individuals suspected of mpox by their healthcare provider
• The test is run using the Cue Health Monitoring System (Cue Reader), the Cue Mpox (Monkeypox) Molecular Test Cartridge, the Cue Sample Wand, and the Cue Health App on a compatible mobile smart device named on the Cue Health website at www.cuehealth.com
• Testing 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, moderate, or waived complexity tests
• Testing 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
• Results are for the identification of monkeypox virus (clade I/II) DNA which is generally detectable in human pustular or vesicular lesion specimens during the acute phase of infection
• Positive results are indicative of the presence of monkeypox virus (clade I/II) 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 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
• Use with the Emergency Use Authorization Only Cue Health Monitoring System and Cue Health App
• Material Required but not Provided: Cue Health Monitoring System (see 1219993), Mobile Smart Device, Cue Health Application installed on the mobile smart device (download from Apple App Store or Google Play Sotre, External Controls

More Information

• Cue Mpox Molecular Test FDA EUA Letter
• Cue Mpox Molecular Test IFU
• Cue Mpox Molecular Test Quick Ref Guide
• Cue Mpox Molecular Test Healthcare Providers Fact Sheet
• Cue Mpox Molecular Test Patients Fact Sheet