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 Monkeypox Testing (PCR)

Detect monkeypox virus DNA, delivering faster answers for you and your patients.

Last updated September 22, 2022

About our test

Our lab-developed molecular diagnostic test aids in the diagnosis of infection with Monkeypox virus. This novel dual target test employs polymerase chain reaction (PCR) to aid in the qualitative detection of non-variola orthopoxviruses and monkeypox virus (West African clade/Clade II) DNA, using swab specimens from patients presenting with an acute pustular or vesicular rash. The Quest test can differentiate Monkeypox viral DNA from other non-variola orthopoxviruses in a specimen, helping to enable faster final diagnosis. Test results are intended to be used in conjunction with clinical observations and epidemiological risk factors, and should not be used as the sole basis of treatment or other patient management decisions.

Ordering, collection & results
Test name Monkeypox Virus DNA, Qualitative, Real-Time PCR
Test code 12084
Specimen Requirements Lesion swab collected in 3 mL of viral transport media (VTM) or equivalent
Collection Swab Specimens for Monkeypox virus Real Time PCR should be collected in appropriate health care settings, such as hospitals and physician offices. Quest Patient Service Centers (PSCs) do not collect these samples.
Expected Turnaround 2-3 days
Intended Use The Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR assay is a real-time PCR test intended for the qualitative detection of DNA from monkeypox virus (West African clade; clade II) and non-variola Orthopoxvirus in lesion swab specimens (i.e., swabs of acute pustular or vesicular rash) in universal viral transport media (UTM) from individuals suspected of monkeypox virus infection by their healthcare provider.
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Please note this form is intended for healthcare professionals and administrators. For medical concerns, contact your healthcare provider.

Disclaimers:

• 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. 

Are you a patient experiencing monkeypox symptoms? Contact your healthcare provider for testing and treatment.

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