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Monkeypox (mpox) is an Orthopoxvirus. The variola virus, which causes smallpox and has been eradicated globally, is another type of Orthopoxvirus. Monkeypox (mpox) is a non-variola Orthopoxvirus and is generally not fatal. It typically resolves on its own without treatment. The current outbreak in the U.S. usually presents as a rash on the body, face, or genital area. Although there is a very low risk of death, there have been reported complications including severe pain, at times requiring hospital admission.
On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox [mpox] virus.
On the basis of this determination, on September 7, 2022, the Secretary of HHS subsequently declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of infection with the monkeypox [mpox] virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
Monkeypox (mpox) diagnostic tests are in vitro diagnostic (IVD) devices used to determine if a person is infected with the virus that causes monkeypox (mpox), which is a type of Orthopoxvirus. They may detect the virus that causes monkeypox (mpox) specifically or more generally detect non-variola orthopoxviruses, which includes monkeypox (mpox).
Information for Monkeypox (mpox) Test Developers
On September 7, 2022, the FDA issued a guidance, Policy for Monkeypox [mpox] Tests to Address the Public Health Emergency, that describes:
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Review priorities of emergency use authorization (EUA) requests for monkeypox (mpox) diagnostic tests,
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Enforcement policies for certain diagnostic tests that are developed by and performed in a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) that meets the requirements to perform tests of high complexity,
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Enforcement policies for FDA-cleared or authorized monkeypox (mpox) diagnostic tests that are modified,
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Enforcement policies for certain serology tests, and
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Recommendations for diagnostic test validation.
Answers to FAQs on Testing for Monkeypox (mpox) are also available to assist developers by providing additional clarity on the policies in the guidance.
FDA Cleared and EUA-Authorized Monkeypox (mpox) Tests
Information on Emergency Use Authorizations (EUAs) for in vitro diagnostics that the FDA has issued related to monkeypox (mpox) to address the public health emergency is available on the Monkeypox (mpox) EUAs web page.
Additionally, the Centers for Disease Control and Prevention (CDC) has an FDA-cleared real-time polymerase chain reaction (PCR) test that detects non-variola Orthopoxvirus DNA, including the virus that causes monkeypox (mpox). The CDC Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (CDC test) is available in designated CDC Laboratory Response Network (LRN) and other CDC-designated laboratories.
HHS has taken several actions to quickly increase monkeypox (mpox) testing capacity and access. In June 2022, HHS, through the CDC, began shipping the CDC test to five commercial laboratory companies. The FDA cleared the use of additional reagents and automation, which helped to increase testing capacity of laboratories using the CDC test.
The CDC test was cleared in 2018 (K181205) for in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA extracted from human pustular or vesicular rash specimens and viral cell culture lysates submitted to an LRN reference laboratory. In 2022, the FDA cleared additional 510(k)s from CDC, which expanded testing capacity through use:
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of additional reagents and automation (K221658; cleared on June 10, 2022),
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in CDC-designated laboratories outside the LRN (K221834; cleared on June 24, 2022), and
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of new extraction platform options, among other changes (K222558; cleared on August 30, 2022).
Laboratory Developed Tests
In addition to FDA-cleared or EUA-authorized monkeypox (mpox) tests, there are also certain laboratory developed tests (LDTs), that FDA has not reviewed or authorized, that are being used to test for non-variola Orthopoxvirus or specifically for monkeypox (mpox). An LDT is a type of in vitro diagnostic test that is designed, manufactured, and used within a single site CLIA-certified laboratory that meets the requirements for high complexity testing.
The FDA has generally exercised enforcement discretion with respect to LDTs, including those developed by hospitals or academic laboratories, meaning that, except in certain circumstances, the FDA generally does not exercise its authority to enforce the regulatory requirements for these devices, although it maintains that authority.
The FDA has not applied this general enforcement discretion approach to tests used for declared emergencies under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In the case of a contagious disease, for example, inaccurate tests can lead to greater spread of the disease and impede the public health response. The FDA, therefore, has generally expected EUAs for LDTs during all prior declared public health emergencies, starting with H1N1 in 2009 and continuing through the COVID-19 emergency. However, in developing policies for specific emergencies, the FDA has considered the national testing needs, availability of cleared or authorized tests, and consequences of a false result, among other factors, and has tailored its specific enforcement discretion policies accordingly.
In line with these considerations, to address current public health needs, the Policy for Monkeypox [mpox] Tests to Address the Public Health Emergency (discussed above), includes enforcement discretion policies for certain monkeypox (mpox) tests developed by laboratories. These policies do not apply to at-home tests, tests with home specimen collection, and tests performed outside of a high-complexity CLIA-certified laboratory. For purposes of the guidance, "high-complexity CLIA-certified laboratories" are referring to single site laboratories that are certified under CLIA that meet the requirements to perform tests of high complexity. The FDA will continue monitoring the developing situation and will evaluate whether we should adjust our policies for LDTs and other tests for monkeypox (mpox) based on the public health needs and taking into account lessons learned from COVID-19.
In the enforcement discretion policies described in the following sections of the guidance, FDA generally expects laboratories to notify the FDA regarding its offering an appropriately validated test:
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Section IV.A.2 for monkeypox (mpox) diagnostic tests developed and performed by laboratories,
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Section IV.A.3 for modifications by laboratories to FDA-cleared or EUA-authorized diagnostic tests,
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Section IV.A.4 for notification content for laboratories notifying as described in sections IV.A.2 or IV.A.3, and
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Section IV.C for serology tests that are developed and performed by certain laboratories.
Considering the availability and accessibility of monkeypox (mpox) tests, FDA has not been accepting notifications submitted as described in section IV.A.2 of the guidance and received after October 13, 2022, for monkeypox (mpox) diagnostic tests developed and performed in a CLIA-certified laboratory.
To provide transparency, the FDA is posting notification lists that include certain laboratories that have notified the FDA of their laboratory developed monkeypox (mpox) diagnostic test, modification to an FDA-cleared or EUA-authorized monkeypox (mpox) diagnostic test, or laboratory developed monkeypox (mpox) serology test, as described in Sections IV.A.2, IV.A.3, and IV.C, respectively, of the Policy for Monkeypox [mpox] Tests to Address the Public Health Emergency. The lists of notifications include laboratories that have either agreed to be identified on the FDA's website or are currently offering their test. For the list of notifications submitted as described in section IV.A.2 of the guidance, this includes notifications submitted prior to October 14, 2022. The FDA has not reviewed the laboratory's validation of tests offered as described in these policies and has not issued EUAs for these tests.
Note that various laboratories around the country, including public health, commercial, and healthcare system/academic laboratories, are providing testing for monkeypox (mpox) using an FDA-cleared or EUA-authorized monkeypox (mpox) test.
Lists of Laboratories Offering Notified Laboratory-Developed Monkeypox (mpox) Tests
Notifications as described in Section IV.A.2 of the guidance - Monkeypox [mpox] Diagnostic Tests Developed and Performed by Single-Site High Complexity CLIA-Certified Laboratories
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