Orthopoxvirus/Monkeypox Infection Testing

Monkeypox virus is an orthopoxvirus. ARUP’s test will detect orthopoxvirus DNA, which includes monkeypox virus.

Testing that detects orthopoxvirus DNA is sufficient to meet the case definition of probable monkeypox infection in the United States, per the CDC, given the absence of any other orthopoxviruses in circulation.¹

Yes. ARUP’s test, Orthopoxvirus (includes monkeypox virus) by PCR, is performed in-house.

ARUP’s laboratory-developed test (LDT) is validated for an automated specimen extraction method and can be performed on higher-throughput instruments to optimize workflow efficiency, decrease turnaround times, and enable rapid scaling of testing capacity if needed.

ARUP’s test is also a real-time polymerase chain reaction (PCR) test, based on the same assay principles as the CDC's U.S. Food and Drug Administration FDA-cleared test. As ARUP's test is optimized for modern instrumentation and automated processes, it is classified as a laboratory-developed test (LDT). This allows for rapid scaling of testing capacity, if needed, and reduced turnaround times.

Our test is a laboratory-developed test (LDT). The FDA has declared enforcement discretion and will not require LDTs for monkeypox to be submitted to the FDA.

ARUP’s test, Orthopoxvirus (includes monkeypox virus) by PCR, is New York approved.

ARUP’s test is not affected.

On Friday, September 2, 2022, the CDC released a laboratory alert regarding rare false-negative results for monkeypox virus that were obtained when using assays with the CDC's published primers and probes.

ARUP’s test, Orthopoxvirus (includes monkeypox virus) by PCR, is designed to detect an essential viral gene and will detect members of the Orthopoxvirus genus, including monkeypox virus and vaccinia virus. Due to the initial assay design and the targets selected, ARUP’s assay is not affected by this CDC alert.

For pricing, please contact ARUP Client Services.

The CPT code is 87593.

Effective July 26, 2022, the Current Procedural Terminology (CPT) Editorial Panel approved this new CPT code to use specifically for orthopoxvirus (monkeypox) detection to improve reporting in cases of suspected or confirmed monkeypox.

No, per guidance from the CDC for laboratory-developed tests (LDTs), our test will not require confirmation testing.

Yes, ARUP clients can build this test into their interface. Please refer to the following document for test-build specifications: TD Test Mix Excel Sheet.

Refer to the following information for specimen requirements or see the LTD entry:

Refer to the Orthopoxvirus (Includes monkeypox virus) by PCR Specimen Collection and Shipping Instructions as a reference.

Please collect specimens using a swab placed in viral transport media (VTM), which is ARUP Supply #12884. You can order these swabs online through ARUP eSupply.

Yes, the following media types are acceptable for ARUP’s Orthopoxvirus (includes monkeypox virus) by PCR test: M4, M4-RT, M5, M5-RT, M6, UTM, BD Universal Transport Media (UVT), BD Liquid Amies Elution Swab (eSwab), Cellmatics Viral Transport Pack, ChlamTrans Transport Media, Bartels ViraTrans Transport Media, Bartels FlexTrans Transport Media, Hardy Diagnostic Media CVM and VCM, Meridian Viral Transport Media, Starplex Multitrans System and Saline.

Yes, the specimen source and media type are required for all monkeypox testing to ensure that tests are performed on validated specimen and media and for the purpose of public health reporting. Please provide the specimen source and media type for each order.

Yes, per CDC guidance, specimens can be shipped as UN 3373 Biological Substance, Category B. Please see details below.

When orthopoxvirus DNA is detected in a patient specimen, an ARUP representative will call our client labs to report the result as an “alert value.” Results will also be available on ARUP Connect or in our client’s interface.

Yes, example reports can be found here (detected) and here (not detected).

This assay does not differentiate members of the orthopoxviruses. In the United States, a detected result is most likely due to monkeypox virus or vaccinia virus. Other orthopoxviruses may be considered if appropriate.

According to the CDC, “Once results are received from the laboratory, a positive Orthopoxvirus test is considered to meet the case definition for probable Monkeypox virus infection since there are no other circulating Orthopoxviruses within the United States that cause systemic disease. Clinical care and prevention precautions should begin based on the Orthopoxvirus test result and should not wait for any additional viral characterization testing that may be performed.”¹ Refer to the CDC if additional confirmatory testing is needed.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). This test was performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory and is intended for clinical purposes.

The performing lab will provide public health reporting. ARUP will report as required by state laws and regulations; this meets our reporting requirements as the performing laboratory. This does not cover reporting that may or may not be required by other healthcare providers. ARUP does not maintain a list of reporting requirements for providers, so we are not able to provide guidance on provider/client reporting.

Yes. To meet public health reporting regulations, ensure an appropriate response to this evolving public health emergency, and limit spread within your community, please submit the Patient Demographics Form for Public Health Reporting with all Orthopoxvirus (includes monkeypox virus) by PCR test specimens.

If you do not submit the Patient Demographics Form for Public Health Reporting, please transmit complete demographic information with each order, including the patient’s name, another unique identifier such as Medical Record Number (MRN), address, date of birth, sex, race, and ethnicity.

ARUP continues to perform other testing to support the care of patients with suspected or confirmed monkeypox infection, including tests for sexually transmitted diseases and other infections, to help provide a differential diagnosis in individuals with suspected or confirmed monkeypox.

Other infections can present with lesions similar to monkeypox. Consider 2010095 Herpes Simplex Virus (HSV-1/HSV-2) Subtype by PCR, 0060042 Varicella-Zoster Virus by PCR, 0050920 Treponema pallidum Antibody, IgG by ELISA as alternative tests.

ARUP will NOT perform viral culture testing for patients suspected or confirmed to have monkeypox infection. Orthopoxviruses, including monkeypox viruses, cannot be identified clinically by using this test method.

Please see the list of tests above for viral culture testing ARUP will not perform if a patient has a known or suspected monkeypox virus infection. These orders will be placed on except for cancellation.

Yes, per CDC guidance, specimens can be shipped as UN 3373 Biological Substance, Category B.

When submitting a specimen with a suspected or confirmed monkeypox infection, clients should write “suspected monkeypox” on the ARUP packing list, specimen bag, and in the LIS order comments. This will help ensure that specimens are handled and tested using the proper precautions.

Please see our Specimen Transport Guide for more details on Category B shipping: https://www.aruplab.com/testing/resources/specimen.