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Xpert® Mpox
On-demand Mpox testing provides accurate point-of-care results in approximately 36 minutes, with EAT results as soon as 25 minutes. For use under an Emergency Use Authorization in the United States
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10 Tests
GXMPX-10
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The Need
Human mpox disease was first observed in 1970 in the Democratic Republic of the Congo and two clades have been described; clade I (formerly Congo Basin) and clade II (formerly West African).1,2 Cases were mostly limited to Central and West Africa until the outbreak in 2022 caused by mpox clade II. Within 6 months >80,000 cases were reported in more than 100 countries; approximately 30% of cases were identified in the US.3
Laboratory quality PCR-based test results are needed on the same day of visit to support clinical management and public health reporting.
Challenges
Laboratory quality PCR-based test results are needed on the same day of visit to support clinical management and public health reporting.
Challenges
- Obtaining same-day results to support clinical management and public health intervensions
- Ability to differente monkeypox virus from other agents that cause cutaneous lesions
- Testing options that offer accurate and objective test results to drive timely and appropriate treatment for improved patient management
- Lack of flexibity to run tests on demand with scalable throughput
1Monkeypox: experts give virus variants new names. Accessed Jan 6, 2023.Monkeypox: experts give virus variants new names (who.int)
2 McCollum AM, Damon IK. Human Monkeypox. Clin Infect Dis. 2014 Jan;58(2):260-7. doi: 10.1093/cid/cit703.
32022 Mpox Outbreak Global Map | Mpox | Poxvirus | CDChttps://www.cdc.gov/poxvirus/monkeypox/response/2022/world-map.htmlaccessed 6 jan 2023
2 McCollum AM, Damon IK. Human Monkeypox. Clin Infect Dis. 2014 Jan;58(2):260-7. doi: 10.1093/cid/cit703.
32022 Mpox Outbreak Global Map | Mpox | Poxvirus | CDChttps://www.cdc.gov/poxvirus/monkeypox/response/2022/world-map.htmlaccessed 6 jan 2023
The Solution
The Xpert Mpox* test, authorized for use under FDA Emergency Use Authorization (EUA), provides a clade II-specific call out where positive specimens are excluded from select agent program requirements.
The Xpert Mpox* test delivers the convenience of on-demand testing with fast and accurate results. Some of the key benefits include:
The Xpert Mpox* test delivers the convenience of on-demand testing with fast and accurate results. Some of the key benefits include:
- High quality, actionable results in approximately 36 minutes
- Can be performed in point of care (POC) settings as well as in moderate and high complexity laboratories
- Suitable for low to high test volumes due to the flexibility of on-demand testing
- Less than 1 minute of hands-on time, and no specimen prep
*This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratories; This product has been authorized only for the detection of nucleic acid from monkeypox virus or other non-variola orthopoxviruses, not for any other viruses or pathogens; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
The Impact
The Xpert Mpox* test provides on-demand testing with point-of-care results in approximately 36 minutes. This allows healthcare providers to address the care needs and treatment for their patients on the same day.
In addition providers can:
In addition providers can:
- Offer vaccination and prevention strategies that may result in minimized isolation time and peace of mind
- Diagnose and treat patients faster
- Alleviate patient uncertainty and risk of community transmission
- Increase efficiency in workflow with quick turn around time
- Reduce staff time commitments and training