Test Code LAB10035 Orthopoxvirus (Mpox) Virus DNA Qual PCR
Performing Laboratory
Quest Diagnostics thru SLCH Core Lab
Specimen Requirements
Patient Preparation: None
Acceptable Specimens: Lesion swab collected in 1.0-3.0 mL universal transport media (UTM)
NOTE: No additional confirmatory testing is required at the CDC, therefore a duplicate swab from the same lesion is not needed. If clinically indicated, consider submitting additional swabs if multiple lesions with different stages are present. Multiple specimens collected on a single patient should be submitted separately and be accompanied by its own separate requisition and transported in its own sealed bag.
Collection procedure:
- Obtain a vial of universal transport media (UTM) with collection swab
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Swab or brush skin lesion vigorously (not obtaining adequate DNA can result in inconclusive results) with 1 sterile swab.
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Place swab in tube containing UTM
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Do not send swab in glass tubes, vacutainer tubes, tubes with push caps, or paper swab sleeves.
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Multiple specimens collected on a single patient should be submitted separately and be accompanied by its own separate requisition and transported in its own sealed bag
- Maintain sterility and transport promptly to laboratory.
Note: Specimen source is required. If transport is delayed, refrigerate specimen.
Sample Rejection
Mislabeled or unlabeled specimens received
Calcium Alginate swabs • Cotton swabs • Wooden shaft swabs • Dry swabs (e.g., not submitted in UTM or equivalent)
Logistics
Day(s) Test Set Up: Monday-Sunday
Cut-off time: specimens are picked up daily at 1800 by Quest, If specimen is not ready for transport prior to 1800 pickup it will be held until next day
Turnaround Time: 3-4 days
Reference Values
Reference Range:
Orthopoxvirus DNA, Qual PCR: | Negative |
Monkeypox Virus DNA, Qual PCR: | Negative |
Critical Values: None established
Methodology
Real-Time Polymerase Chain Reaction
Limitations
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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.
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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
Additional Information
For SLCH Laboratory use only
Lab Processing instructions: No processing. Give specimen directly to Send-out bench. Refrigeratate or freeze (at -20o C or below) specimen(s) within 1 hour after collection
Processed Volume: 1 Swab in single sterile UTM
Transport Temperature: Frozen
Analyte Stability:
Specimen Type | Temperature | Time |
---|---|---|
Swab in UTM | Ambient | unacceptable |
Refrigerated | 7 days | |
Frozen | 30 days |
Test Classification and CPT Coding
87593x2
This test has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.
LOINC
Orthopoxvirus, non-variola DNA: 100434-0
West African Monkeypox Virus DNA: 100888-7
Last Reviewed
07/2025