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Monkeypox Virus DNA, Qualitative Real-Time PCR
Test CodeMNKPX
CPT Codes
<p>87593 (x2)</p>
Includes
Orthopoxvirus and Mpox Virus
Preferred Specimen
Specimen Type: Swab
Collection Container/Type
Preferred: Sterile polyester-tipped swabs in VCM
Acceptable: VCM, VTM, UTM or equivalent
Submission Container/Tube: Viral media culture (VCM) or equivalent
Specimen Volume: 3 mL
Collection Instructions:
- Swab a pustule/lesion vigorously and place the swab into a viral culture media (or equivalent) tube.
Additional Information:
- 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.
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.
Transport Container
VCM, VTM, UTM or equivalent
Transport Temperature
Frozen
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 30 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Calcium Alginate swabs • Cotton swabs • Wooden shaft swabs • Dry swabs (e.g., not submitted in VCM or equivalent)
Methodology
Real-Time Polymerase Chain Reaction
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
FDA Status
This test has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.
Setup Schedule
Set up: Daily; Report available: 2-3 days
Report Available
2-3 days
Reference Range
| Orthopoxvirus DNA, QL PCR | Not detected |
| Mpox Virus DNA, QL PCR | Not detected |
Clinical Significance
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.
Performing Laboratory
Quest Diagnostics Nichols Institute 14225 Newbrook Drive Chantilly, VA 20153
Last Updated: February 17, 2023