Test Catalog

Test Id : MPXDX

Orthopoxvirus Molecular Detection PCR, Swab

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection of non-variola Orthopoxvirus in individuals presenting with signs and symptoms suggestive of monkeypox

Highlights

This real-time polymerase chain reaction test provides qualitative detection of non-variola Orthopoxvirus (ie, monkeypox) DNA in swab specimens of skin or genital lesions present in individuals with suspected monkeypox. See additional case definitions and epidemiologic criteria of monkeypox at www.cdc.gov/poxvirus/monkeypox/clinicians/case-definition.html

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Orthopoxvirus DNA, PCR, Swab

Aliases
Lists additional common names for a test, as an aid in searching

Monkeypox

Monkeypox virus

Orthopoxvirus

Non-variola

Specimen Type
Describes the specimen type validated for testing

Swab

Ordering Guidance

If ordering multiple tests, this test must have its own specimen. Other tests ordered on the same specimen/order with this test will be canceled.

 

This test should be requested for individuals with a pustular or vesicular rash that could be consistent with monkeypox, especially:

1) Those with a travel history to a geographic area reporting monkeypox cases in the month prior to illness onset

2) Men who report sexual contact with other men and who present with lesions in the genital or perianal area

3) Those who report contact with a suspected or confirmed case of monkeypox. See up-to-date information on monkeypox for healthcare professionals at www.cdc.gov/poxvirus/monkeypox/response/2022/hcp/index.html

Shipping Instructions

-Transport refrigerated specimens within 7 days of collection or frozen specimens within 60 days of collection.

-Specimens that arrive at greater than 8 degrees C (ambient) will be rejected.

Necessary Information

Specimen source with anatomical location is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
MPXDS MPXDX Specimen Source
OETHN Patient Ethnicity Hispanic or Latino
Not Hispanic or Latino
Not Obtainable
Refused
Asked but Unknown
Unknown
ORACE Patient Race American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian/Other Pacific Islander
White
Other Race
Refused to Answer
Unknown

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Separate specimens must be submitted for monkeypox testing. Other tests ordered on the same specimen/order with this test will be canceled.

 

Submit only 1 of the following specimens:

 

Preferred Specimen

Specimen Type: Swab of skin or genital lesion in viral transport media (VTM)

Supplies:

-Swab, Sterile Polyester, 10 per package (T507)

-BD Dual Shafted Media-Free Swab (T922)

-M4-RT (T605)

-Bartels FlexTrans VTM-3 mL (T892)

-Jiangsu VTM-3 mL (T891)

Collection Container/Tube:

Preferred: Sterile polyester-tipped swabs

Acceptable: Nylon-, Dacron-, or rayon-tipped swab with a plastic, or thin aluminum shaft

Submission Container/Tube: Sterile, screw-capped, round-bottom tube containing VTM (ie, M4-RT or equivalent)

Specimen Volume: 2 Swabs placed in a single VTM tube containing 1.5 to 3 mL of media. Universal media (UTM) is not acceptable.

Collection Instructions:

1. Swab or brush the lesion vigorously (not obtaining adequate DNA can result in inconclusive results) with 2 sterile swabs.

2. Place both swabs in same 1 tube containing VTM.

3. Do not send swabs in glass tubes, vacutainer tubes, tubes with push caps, or paper swab sleeves.

4. Refrigerate or freeze (-20 degrees C or lower) specimens within 1 hour after collection.

Additional Information: Source information should include anatomical site of collection. Each lesion should be ordered separately. To avoid cross contamination, do not combine multiple sites into one order.

See additional specimen collection details at www.cdc.gov/poxvirus/monkeypox/clinicians/prep-collection-specimens.html

 

Alternative Specimen

Specimen Type: Dry swab of skin lesion

Collection Container/Tube: BD CultureSwab sterile, media- and charcoal-free, rayon-tipped double swabs

Submission Container/Tube: Sterile round-bottom tube

Specimen Volume: 2 Dry swabs in a single sterile tube

Collection Instructions:

1. Swab or brush lesion vigorously (not obtaining adequate DNA can result in inconclusive results) with 2 sterile swabs.

2. Place both swabs in a single sterile, empty container (no gel, liquid, foam, or cotton).

3. Do not place or send swabs in glass tubes, vacutainer tubes, tubes with push caps, or paper swab sleeves.

4. Refrigerate or freeze (-20 degrees C or lower) specimens within 1 hour after collection.

See additional specimen collection details at www.cdc.gov/poxvirus/monkeypox/clinicians/prep-collection-specimens.html

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Swab submission tubes containing foam, gel, charcoal, or any liquid besides viral transport media
Glass transport tubes
Swabs submitted in paper swab packaging sleeve
Swabs submitted in UTM (universal transport media)
Wood swabs
Foam tipped swabs
Cotton swabs
Bloody specimens
Reject
Thawed Cold OK; Warm reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Swab Refrigerated (preferred) 7 days
Frozen 60 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detection of non-variola Orthopoxvirus in individuals presenting with signs and symptoms suggestive of monkeypox

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Monkeypox virus is a double-stranded DNA virus, a member of the Orthopoxvirus genus within the Poxviridae family. Poxviruses cause disease in humans and many other animals, and infection typically results in the formation of lesions, skin nodules, or a disseminated rash. Other Orthopoxvirus species include variola virus (causing smallpox, which has been eradicated), vaccinia virus (used in smallpox vaccine), and cowpox virus.

 

Monkeypox was first detected in laboratory monkeys in 1958. The virus is, however, assumed to transmit from wild animals such as rodents (eg, African giant pouched rats) to people or from human to human. In an average year, a few thousand cases occur in Western and Central Africa. However, cases outside Africa have been associated with travel to Africa or importation of infected animals. The natural reservoir of monkeypox remains unknown, but African rodents and nonhuman primates (eg, monkeys) may harbor the virus and infect people.

 

Since early May 2022, multiple cases of monkeypox have been reported in several developed countries (including the United States; www.cdc.gov/poxvirus/monkeypox/outbreak/us-outbreaks.html) that do not normally have monkeypox. Health authorities are urging healthcare providers to be alert for patients presenting with rash illnesses suggestive of monkeypox and to obtain skin swab specimens from such patients for diagnosis of monkeypox by rapid, molecular detection of viral DNA in the specimens.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Undetected

Interpretation
Provides information to assist in interpretation of the test results

A "Detected" result indicates that non-variola Orthopoxvirus DNA is present and suggests the diagnosis of monkeypox. Test result should always be considered in the context of patient's clinical history, physical examination, and epidemiologic exposures when making the final diagnosis. The assay detects the DNA of common non-variola Orthopoxvirus human pathogens, including vaccinia, cowpox, and monkeypox viruses.

 

An "Undetected" result indicates the absence of non-variola Orthopoxvirus DNA in the patient's skin swab specimen. However, this result may be influenced by the stage of the infection and quality of the swab specimens collected for testing. Result should be correlated with patient's history and clinical presentation.

 

An "Equivocal" result indicates an inadequate specimen due to possible cross contamination during specimen testing. If patient diagnosis has not been determined, submit additional specimens for testing.

 

An "Inconclusive" result indicates either polymerase chain reaction inhibition due to presence of interfering substances in the specimen submitted for testing or low DNA yield from inadequate collection or extraction. If the patient's diagnosis has not been determined, submit additional specimens for analysis.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The sensitivity of the assay is dependent on the timing of the specimen collection in relation to appearance of the skin rash and the quality of the swab specimens submitted for testing.

 

An "Undetected" result does not rule out monkeypox in patients and should not be used as the sole basis for treatment or other patient management decisions. Result should be correlated with the patient's history and clinical presentation.

 

The test is specific for non-variola Orthopoxviruses (ie, monkeypox, vaccinia virus, cowpox). The test does not detect variola virus, which is the causative agent of smallpox. Due to the current circulation of monkeypox, a positive result by this assay can be interpreted as presence of monkeypox virus.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases, Division of High-Consequence Pathogens and Pathology: Monkeypox: Information for healthcare professionals. CDC; Updated June 23, 2022. Accessed August 11, 2022. Available at www.cdc.gov/poxvirus/monkeypox/response/2022/hcp/index.html

2. World Health Organization: Multi-country monkeypox outbreak in non-endemic countries. WHO; Updated May 21, 2022. Accessed August 11, 2022. Available at www.who.int/emergencies/disease-outbreak-news/item/2022-DON385

3. World Health Organization: Laboratory testing for the monkeypox virus: interim guidance. WHO; Updated May 23, 2022. Accessed August 11, 2022. Available at www.who.int/publications/i/item/WHO-MPX-laboratory-2022.1

4. Bunge EM, Hoet B, Chen L, et al: The changing epidemiology of human monkeypox - a potential threat? A systematic review. PLos Negl Trop Dis. 2022 Feb 11; 16(2):e0010141

5. Li Y, Zhao H, Wilkins K, Hughes C, Damon IK:Real-time PCR assays for the specific detection of monkeypox virus West African and Congo Basin strain DNA. J Virol Methods. 2010 Oct;169(1):223-227.

Method Description
Describes how the test is performed and provides a method-specific reference

This FDA-cleared, real-time polymerase chain reaction (PCR) assay uses TaqMan probe chemistry to detect Orthopoxvirus DNA in specimens from patients under investigation for a non-variola Orthopoxvirus infection (eg, monkeypox). Samples first undergo nucleic acid extraction, followed by amplification and detection with a PCR primer/probe set specific for a conserved sequence of the poxvirus DNA polymerase gene (E9L) using the ABI 7500 Fast DX real-time PCR instrument. The assay does not detect variola virus because of a 3-base pair mismatch between the target detection probe sequence and the variola virus genomic sequence. A second PCR primer/probe set targets the human RNase P gene, which serves as an internal control of the assay to detect possible PCR inhibition. Human DNA should be present in DNA extracted from clinical specimens containing human cellular material.(Package insert: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set; CDC; v1.0, 06/2022)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 5 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

30 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87593

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
MPXDX Orthopoxvirus DNA, PCR, Swab 100434-0
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
MPXDS MPXDX Specimen Source 31208-2
ORACE Patient Race 72826-1
OETHN Patient Ethnicity 69490-1
618596 Orthopoxvirus DNA, PCR 100434-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports