Detecting non-variola Orthopoxvirus in individuals presenting with signs and symptoms suggestive of monkeypox
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
Real-Time Polymerase Chain Reaction (PCR)
Monkeypox
Monkeypox virus
Orthopoxvirus
Non-variola
Swab
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
-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.
Specimen source with anatomical location is required.
| 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 |
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)
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
See Specimen Required
| 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 Type | Temperature | Time | Special Container |
|---|---|---|---|
| Swab | Refrigerated (preferred) | 7 days | |
| Frozen | 60 days |
Detecting non-variola Orthopoxvirus in individuals presenting with signs and symptoms suggestive of monkeypox
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.
Undetected
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.
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.
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 November 4, 2022. Accessed February 21, 2023. 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.
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)
Monday, Wednesday, Friday
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.
87593
| 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 |