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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.

Store specimens refrigerated at 2-8°C and transport within 24 hours.

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

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

 

Specimen Identification

CLIA regulations require specimens be labeled with at least two patient identifiers. Examples of identifiers are first and last name, date of birth, chart/medical record number. The specimen container must be labeled to match the test requisition or the electronic order.

Form Required

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

Test Request

Mpox

Transport

Transport as soon as possible.

Refrigerated: Transport and deliver to the laboratory within 24 hours of collection at 2-8°C in a cooler able to maintain specimen temperature. A plug-in electric cooler is recommended, however, a cooler packed with excess frozen gel packs is acceptable as long as the transport temperature is maintained at 2-8°C. 

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 Mpox Virus immediately using the RIDOH reportable disease form.

Turnaround Time

PCR result within 24 hours

Kit

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