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Quest Diagnostics

 Mpox Testing (PCR)

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

Last updated March 15, 2023

About our test

Our lab-developed molecular diagnostic test aids in the diagnosis of infection with mpox virus. This novel dual target test employs polymerase chain reaction (PCR) to aid in the qualitative detection of non-variola orthopoxviruses and mpox 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 Mpox 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 Mpox 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 Mpox 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 Mpox Virus Qualitative Real-Time PCR assay is a real-time PCR test intended for the qualitative detection of DNA from mpox 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 mpox 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.

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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 mpox 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 mpox 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 mpox symptoms? Contact your healthcare provider for testing and treatment.

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Quest® is the brand name used for services offered by Quest Diagnostics Incorporated and its affiliated companies. Quest Diagnostics Incorporated and certain affiliates are CLIA certified laboratories that provide HIPAA covered services.  Other affiliates operated under the Quest® brand, such as Quest Consumer Inc., do not provide HIPAA covered services. 

 

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