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Monkeypox (Orthopoxvirus) DNA by PCR

Orthopoxvirus, Non-variola, Vaccinia virus, NAA

Test Codes

EPIC: LAB8570

Department

Molecular Pathology

Specimen Collection Criteria

Collect: Vigorously swab or brush lesion(s) and collect one of the following specimens:

1. (Preferred): One swab from each lesion in viral transport media (VTM).
2. (Alternate): Two dry swabs from each lesion in a sterile container, preferably from different locations on the body or from lesions which differ in appearance. Dry swabs from different locations should be placed in separate sterile collection containers.

Specimens for monkeypox testing should be submitted in a sealed bag and clearly labeled as “Suspect Monkeypox.” Swabs from different sites should be placed in separate collection containers. Please limit monkeypox orders to two different sites per patient.

Physician Office/Draw Specimen Preparation

Maintain all specimen types refrigerated (2-8°C or 36-46°F) prior to transport.

Preparation for Courier Transport

Place specimens in a sealed bag clearly labeled as “Suspect Monkeypox.”
Keep all specimen types refrigerated (2-8°C or 36-46°F).

Preparation for Intra-Hospital Transport:

Specimens sent through the pneumatic tube system should be double bagged, completely sealed, and labeled as “Suspect Monkeypox.”

Rejection Criteria

• Specimens in non-sterile or leaking containers.
• Cotton/calcium alginate swabs or swabs with wooden shafts
• Contaminated media (e.g. yellow in color or contain black particles)

Storage

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 2 days
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): 30 days

Specimen Storage in Department Prior to Disposal:

Refrigerated Temperature (20-26°C or 68-78.8°F): 7 days

Laboratory

Royal Oak Clinical Molecular Pathology Laboratory

Performed

Monday, Wednesday, Friday.
Results available within 2-4 days

Reference Range

Not Detected: No monkeypox DNA detected.

Test Methodology

Polymerase Chain Reaction (PCR)/Nucleic Acid Amplification (NAA). This test was developed, and its performance characteristics determined by Beaumont Laboratory. It has not been cleared or approved by the US Food and Drug Administration (FDA). This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Clinical Utility

Aid in the diagnosis of monkeypox in patients with a rash that is considered consistent with monkeypox infection, especially those with a recent travel history to central or west African countries, parts of Europe where monkeypox has been reported, or other areas reporting monkeypox cases.

Clinical Disease

The rash associated with monkeypox involves vesicles or pustules that are deep-seated, firm, or hard, and well-circumscribed; the lesions may umbilicate or become confluent and progress over time to scabs.

Presenting symptoms typically include fever, chills, the distinctive rash, or new lymphadenopathy; however, onset of perianal or genital lesions in the absence of subjective fever has been reported.

The rash associated with monkeypox can be confused with other diseases that are encountered in clinical practice (e.g., secondary syphilis, herpes, chancroid, and varicella zoster). However, a high index of suspicion for monkeypox is warranted when evaluating people with a characteristic rash, particularly for men who report sexual contact with other men and who present with lesions in the genital/perianal area or for individuals reporting a significant travel history in the month before illness onset or contact with a suspected or confirmed case of monkeypox.

Disease Reporting

This is a reportable disease and positive results will be reported to the local county health department.

Epidemiology

Monkeypox virus is an enveloped double-stranded DNA virus that belongs to the Orthopoxvirus genus of the Poxviridae family. There are two distinct genetic clades of the monkeypox virus: the central African (Congo Basin) clade and the west African clade. The Congo Basin clade has historically caused more severe disease and was thought to be more transmissible. However, the current monkeypox outbreak (2022) is caused by the less severe West African clade and is behaving in new ways to spread more widely.

Incubation Period

The incubation period (interval from infection to onset of symptoms) of monkeypox is usually from 6 to 13 days but can range from 5 to 21 days.

Transmission

Monkeypox virus can spread from animals to humans (zoonotic transmission) through direct contact with the blood, bodily fluids, or cutaneous or mucosal lesions of infected animals. In the United States 2003 outbreak, monkeypox was reported among several people who had contact with sick pet prairie dogs that had contact with imported African rodents.

Human-to-human transmission can result from close contact with respiratory secretions or skin lesions from those infected. The spread of monkeypox virus via respiratory secretions is uncommon since respiratory droplets cannot travel more than several feet and prolonged face-to-face contact is needed. Monkeypox primarily spreads through direct contact with body fluids or sores on the body of someone who has monkeypox, or with direct contact with materials that have touched body fluids or sores, such as clothing or linens.

CPT Codes

87593

Contacts

Last Updated

9/9/2022