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Non-variola Orthopoxvirus (monkeypox, Mpox Clade II)

Clinical Specimen Submission Guidance

Submit all specimens to 50 Orms St, Providence RI 02904. Open Monday to Friday 8:30 AM to 4:30 PM

Lab

Molecular Diagnostics Laboratory 401-222-5538

Analyte Name

Monkeypox, MPOX 

Disease

Monkeypox Virus (Mpox)

Test Description

Real time PCR testing is conducted at the RI State Health Laboratories on specimens from patients meeting the definition of low to moderate risk of having monkeypox.

Cepheid Xpert Mpox Assay

The Cepheid Xpert Mpox Assay is a real-time PCR test intended for the qualitative detection of DNA from monkeypox virus clade II and non-variola Orthopoxvirus DNA in human lesion swab specimens. The Xpert Mpox Assay is only for use under FDA Emergency Use Authorization; assay performance characteristics were verified by the RISHL. Results should be used in conjunction with the patient's clinical symptoms, medical history, and other clinical/laboratory findings to determine an overall clinical diagnosis.

Special Instructions

PREAUTHORIZATION by the RIDOH Center for Acute Infectious Disease Epidemiology (401) 222-2577 is required prior to transporting specimens.

Specimen

For detailed Mpox specimen collection instructions, click here.

CDC detailed specimen collection instructions for Healthcare Professionals can be found at  Tips for Adequate Collection of a Lesion Specimen from a Suspect Monkeypox Virus Case.   

Information for Patients: https://fda.gov/media/165320/download

Information for Providers: https://fda.gov/media/165319/download

CLIA regulations require two patient identifiers on the specimen container and the test requisition

Form Required

Rhode Island State Health Laboratories (RISHL) test requisition form https://health.ri.gov/forms/LabRequisitionForm.pdf

Test Request

Monkeypox

Transport

Specimens must be packaged & transported in accordance with current federal shipping regulations.

Integrity

Strict adherence to the specimen collection and transport instructions.

Normal Value

PCR negative for Non-variola Orthopox

Reporting Requirement

Providers must report patient information on Monkeypox Virus immediately using the RIDOH reportable disease form.

Turnaround Time

PCR result within 24 hours

Kit

Monkeypox Collection & Transport Kits are available by calling the RISHL at (401) 222-5538. Detailed specimen collection and transport instructions are included in the kit.