What are the other Names for this Test? (Equivalent Terms)

• Monkeypox Virus DNA, PCR Test
• Orthopoxvirus DNA, PCR Test
• PCR-based Orthopoxvirus DNA Assay

What is Monkeypox (Orthopoxvirus) DNA, PCR Test? (Background Information)

• Monkeypox is a viral infection which affects humans and other animals. The Monkeypox virus, belongs in the Orthopox virus genus
• The disease results in fever, body pain, fatigue, and widespread skin rashes that form into pustules and rupture
• Discharge from the lesions/vesicles of infected individuals are collected and tested for the presence of non-variola Orthopoxvirus
• The test is usually qualitative polymerase chain reaction (PCR). Quantitative PCR testing is not performed, since it has no significant clinical relevance
• The Monkeypox (Orthopoxvirus) DNA, PCR Test is an FDA-approved test used in the diagnosis of monkeypox infection

What are the Clinical Indications for performing the Monkeypox (Orthopoxvirus) DNA, PCR Test?

Following are the clinical indicators for performing the Monkeypox (Orthopoxvirus) DNA, PCR Test:

• Exposure to monkeypox virus from international travel or contact with infected individual
• Infected animal bites, cuts, contact with animal fluids to the eyes and mouth and respiratory system
• Presence of signs and symptoms such as:
  • Fever and chills
  • Headache
  • Cough, sore throat, and nasal congestion
  • Body aches, including back pain
  • Fatigue
  • Skin rashes - anywhere on the body, including the genitals
  • Enlarged lymph nodes

How is the Specimen Collected for Monkeypox (Orthopoxvirus) DNA, PCR Test?

Following is the specimen collection process for Monkeypox (Orthopoxvirus) DNA, PCR Test:

Sample required: Lesion swab (optimal - 3 mL in viral culture media tube; min. 0.5 mL volume required)

Process of obtaining the sample:

• Take the swab; avoid touching the tip of the swab
• Hold the swab in one hand and the viral transport media (VTM) collection tube in the other
• With the swab, vigorously brush the pustule/lesion, (to collect the discharge material)
• Place the swab into the VTM and tightly close the tube (screw the top/lid back on)
• If there are multiple lesions that appear different from each other, separate sample swabs per lesion may be taken (from the same individual)

Preparation required: No special preparation is needed prior to the test.

Sample rejection: Following may be the reasons why labs may reject the specimen

• Specimens that do not meet the lab sample submission specifications (such as leaking samples)
• Samples submitted in unapproved specimen containers (such as saline or liquid Amies swabs)
• Use of aerobic or anaerobic transport devices

Notes:

• The types of sterile swabs that may be used include:
  • Dry polyester swabs
  • Rayon swabs
  • Dacron swabs
• Calcium alginate and wooden swabs should be avoided
• Room temperature swabs are unacceptable
• The collected specimen should be placed/sealed in a biohazard bag. If there are multiple samples, each specimen should be submitted in separately sealed bags
• Shipping and transportation: Refrigerated or frozen specimens (at -20 deg C) are acceptable for up to 7 and 30 days respectively

What is the Significance of the Monkeypox (Orthopoxvirus) DNA, PCR Test Result?

Monkeypox (Orthopoxvirus) DNA, PCR Test result may be reported as “detected”, “undetected”, “baseline minimum viral level”, and “inconclusive”. 

• Detection of non-variola Orthopoxvirus: Probably positive for monkeypox
• No detection of non-variola Orthopoxvirus: Negative for monkeypox
• Baseline minimal level of the virus is detected: The result is termed equivocal, and new patient sample may be necessary for further evaluation and confirmation
• No conclusive result: Due to poor sample collection, lack of observing assay control criteria, and no detection of the virus, the results are inconclusive. In such cases, a new patient sample may be necessary for further evaluation and confirmation

The laboratory test results are NOT to be interpreted as results of a "stand-alone" test. The test results have to be interpreted after correlating with suitable clinical findings and additional supplemental tests/information. Your healthcare providers will explain the meaning of your tests results, based on the overall clinical scenario.

Additional and Relevant Useful Information:

Certain medications that you may be currently taking may influence the outcome of the test. Hence, it is important to inform your healthcare provider, the complete list of medications (including any herbal supplements) you are currently taking. This will help the healthcare provider interpret your test results more accurately and avoid unnecessary chances of a misdiagnosis.

Please visit our Laboratory Procedures Center for more physician-approved health information:

http://www.dovemed.com/common-procedures/procedures-laboratory/