Monkeypox Virus DNA, Qualitative Real-Time PCR
Test Summary
The Mpox Virus DNA, Qualitative Real-time PCR test is intended for the qualitative detection of non-variola Orthopoxviruses and Mpox virus (clade II) DNA using swabs from human pustular or vesicular rash specimens.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Lesion swab collected in 3 mL viral culture media (VCM) or equivalent
Minimum Volume
0.5 mL
Instructions
Swab a pustule/lesion vigorously and place the swab into a viral culture media (or equivalent) tube.
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.
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.
Patient Preparation
N/A
Storage
VCM, VTM, UTM or equivalent
Transport Temperature
Frozen
Specimen Stability
- Room temperature: Unacceptable
- Refrigerated: 7 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Calcium Alginate swabs • Cotton swabs • Wooden shaft swabs • Dry swabs (e.g., not submitted in VCM or equivalent)
Order Code
MNKYPX
EPIC (Premier) Code
LAB6810
Includes
Orthopoxvirus and Mpox Virus
CPT Code
- 87593 (x2)
Billing Code
- 671106
CPT Statement
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
FDA Status
This test has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
| Orthopoxvirus DNA, QL PCR | Not detected |
| Mpox Virus DNA, QL PCR | Not detected |
Setup Schedule / Expected Turnaround Time
Daily; Report available: 2 - 3 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
Lesion swab collected in 3 mL viral culture media (VCM) or equivalent
Minimum Volume
0.5 mL
Instructions
Swab a pustule/lesion vigorously and place the swab into a viral culture media (or equivalent) tube.
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.
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.
Patient Preparation
N/A
Storage
VCM, VTM, UTM or equivalent
Transport Temperature
Frozen
Specimen Stability
- Room temperature: Unacceptable
- Refrigerated: 7 days
- Frozen: 30 days
Limitations
N/A
Other Acceptable Specimens
N/A
Unacceptable Specimens
Calcium Alginate swabs • Cotton swabs • Wooden shaft swabs • Dry swabs (e.g., not submitted in VCM or equivalent)
Result Information
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
Testing Laboratory
N/A
Reference Range
| Orthopoxvirus DNA, QL PCR | Not detected |
| Mpox Virus DNA, QL PCR | Not detected |
Setup Schedule / Expected Turnaround Time
Daily; Report available: 2 - 3 days