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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:

  1. Obtain a vial of universal transport media (UTM) with collection swab
  2. Swab or brush skin lesion vigorously (not obtaining adequate DNA can result in inconclusive results) with 1 sterile swab.

  3. Place swab in tube containing UTM 

  4. Do not send swab in glass tubes, vacutainer tubes, tubes with push caps, or paper swab sleeves.

  5. 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

  6. 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

  • 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.

  •  

    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 -20C 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