The monkeypox virus is an orthopoxvirus that is related to variola virus, which causes smallpox. Monkeypox virus causes relatively rare infections in humans. Earlier this year, countries that don’t normally see monkeypox cases, including the United States, began to experience outbreaks. On August 4, 2022, the U.S. Department of Health and Human Services (DHHS) declared a public health emergency as a result of the ongoing outbreak of monkeypox.

Since the initial outbreak of monkeypox in 2022, ARUP has actively participated in the formulation of an appropriate national response in partnership with the Centers for Disease Control and Prevention (CDC) and other laboratories.

ARUP has validated an in-house test, Orthopoxvirus (includes monkeypox virus) by PCR (3005716) that is now available to order.

Orthopoxvirus (includes monkeypox virus) by PCR is a real-time polymerase chain reaction (PCR) test to detect the DNA of orthopoxviruses, including monkeypox. ARUP’s test is based on the CDC assay but has been optimized for state-of-the-art instrumentation and an automated specimen extraction process. These optimizations will allow for reduced turnaround times and increased capability to upscale testing capacity.

Please see the FAQs below for more details. This page will be updated regularly as new details become available.

important

Please do not submit viral cultures of any kind from patients with suspected or confirmed monkeypox infections. Orthopoxviruses, including monkeypox viruses, cannot be identified clinically using this test.

Do not order the following tests for cases in which monkeypox may be suspected.
0065005 Herpes Simplex Virus Culture
0065065 Herpes Simplex Virus Culture with Reflex to HSV Typing
2006498 Herpes Simplex Virus DFA with Reflex to Herpes Simplex Virus Culture
0060283 Varicella-Zoster Virus and Herpes Simplex Virus DFA with Reflex to Varicella-Zoster Virus Culture and Herpes Simplex Virus Culture
2006496 Viral Culture, Non-Respiratory and Cytomegalovirus Rapid Culture
0060282 Varicella-Zoster Virus DFA with Reflex to Varicella-Zoster Virus Culture

For clinician-focused information, see the ARUP Monkeypox Consult Topic.

FAQs

Updated: September 7, 2022

ARUP’s In-House Test for Monkeypox Infection

Which test should be ordered for suspected monkeypox infection?

Order Orthopoxvirus (includes monkeypox virus) by PCR (ARUP test code 3005716).

What does ARUP’s test detect?

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

Is ARUP’s test performed in-house?

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

What is ARUP’s capacity for monkeypox testing?

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.

Does ARUP’s test use the same methodology as the CDC’s test?

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.

Does ARUP’s test have FDA approval?

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.

Does ARUP’s test have New York approval?

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

Is ARUP’s test affected by the laboratory alert about false-negative results that was sent by the CDC on September 2, 2022?

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.

What is the cost of ARUP’s test?

For pricing, please contact ARUP Client Services.

What is the CPT code for ARUP’s test?

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.

Does ARUP’s test require confirmation testing?

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

Can ARUP clients interface ARUP’s Orthopoxvirus (includes monkeypox virus) by PCR test?

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.

What are the specimen requirements for the ARUP Orthopoxvirus (includes monkeypox virus) by PCR test?

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

Specimen Collection

Swab the lesion vigorously to collect adequate DNA. It is not necessary to deroof the lesion before swabbing.

Place lesion swab in Viral Transport Media (ARUP supply #12884), available online through eSupply, or contact ARUP Client Services at 800-522-2787.

Specimen Preparation

Swab in viral transport media (VTM): Transfer swab to viral transport media.

Transport Requirements Frozen
Unacceptable Conditions Calcium alginate swab, wooden swab. Specimens without swabs.
Specimen Stability Ambient: 24 hours; refrigerated: 7 days; frozen: 1 month

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

What supplies should be used for the ARUP Orthopoxvirus (includes monkeypox virus) by PCR test?

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.

Can alternate media be used for collection and transport?

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.

Is the specimen’s source required for ARUP’s Orthopoxvirus (includes monkeypox virus) by PCR test?

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.

Are there special shipping and handling instructions for samples from patients with suspected or confirmed monkeypox?

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

How will positive results be communicated?

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.

Can I receive an example report for ARUP’s orthopoxvirus test?

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

What is the interpretive data for ARUP’s orthopoxvirus test?

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.

How is public health reporting handled?

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.

Is demographic information required when ordering testing for monkeypox?

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.

Ancillary Testing

Is ARUP providing testing for a differential diagnosis?

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.

Are there special shipping and handling instructions for samples from patients with suspected or confirmed monkeypox?

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.

Reference

1. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Update for clinicians on testing and treatment for monkeypox. [Updated; Jul 28, 2022; Accessed: Aug 1, 2022]

To learn about signs and symptoms, how monkeypox is spread, prevention, treatment, and vaccines, please see the CDC’s site for monkeypox.


When calling Client Services with inquiries about monkeypox testing, please use keyword: Monkeypox.