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Test Order
Test Order
Poxvirus Molecular Detection
CDC-10515
Synonym(s)
Monkeypox virus, Variola virus, Vaccinia virus, smallpox, sore mouth
CDC Pre-Approval Needed
Supplemental Information Required
Consultation is required prior to specimen submission. A brief written clinical summary with pertinent medical information (e.g. rash onset date, rash type, symptoms, smallpox vaccination date if relevant) and exposure history should be included. Information must be documented in written form, discussion during initial phone consultation is not a suitable alternative to a written record.
Supplemental Form
None
Performed on Specimens from
Human and Animal
Acceptable Sample/ Specimen Type for Testing
Swabbed lesion material is required for persons with an active lesion or rash. Acceptable samples are: dry swabs, swabs in viral transport media (except for Clade I/Congo Basin Monkeypox virus), and crusts from lesions without transport media. Swabs should be nylon, dacron, polyester or rayon.
Do not use cotton swabs. Do not use transport media labeled "Universal transport media" or "M4 transport media".
Viral culture can also be accepted only if a poxvirus other than monkeypox is suspected. Do not attempt to culture or ship monkeypox virus.
Do not use cotton swabs. Do not use transport media labeled "Universal transport media" or "M4 transport media".
Viral culture can also be accepted only if a poxvirus other than monkeypox is suspected. Do not attempt to culture or ship monkeypox virus.
Minimum Volume Required
Viral Cultures: 0.5 mL. Note that monkeypox virus should not be cultured and sent for testing.
Transport media: 0.3 mL
Transport media: 0.3 mL
Collection, Storage, and Preservation of Specimen Prior to Shipping
For dry swabs:
Freeze (-20°C or lower) or refrigerate (2-8°C) specimens promptly after collection. Store frozen samples for up to 60 days. Freezing is strongly recommended. However, if there is no freezer available, refrigerate samples (2-8°C) and store for up to 7 days. It is strongly recommended to send samples within 7 days of collection.
For crusts and swabs in viral transport media:
Freeze (-20°C or lower) or refrigerate (2-8°C) specimens promptly after collection. Store frozen samples for up to 30 days. Freezing is strongly recommended. However, if there is no freezer available, refrigerate samples (2-8°C) and store for up to 7 days.
Freeze (-20°C or lower) or refrigerate (2-8°C) specimens promptly after collection. Store frozen samples for up to 60 days. Freezing is strongly recommended. However, if there is no freezer available, refrigerate samples (2-8°C) and store for up to 7 days. It is strongly recommended to send samples within 7 days of collection.
For crusts and swabs in viral transport media:
Freeze (-20°C or lower) or refrigerate (2-8°C) specimens promptly after collection. Store frozen samples for up to 30 days. Freezing is strongly recommended. However, if there is no freezer available, refrigerate samples (2-8°C) and store for up to 7 days.
Transport Medium
Transport medium can be added to swabs, but it must be viral transport media. Other media such as universal transport medium, M4 viral transport medium, etc. cannot be accepted. Do not add any transport media to crusts. Contact the CDC POC for appropriate guidance/relevant information
Specimen Labeling
This test order can accommodate diagnostic and non-diagnostic specimens. Testing subject to CLIA regulations requires two primary patient identifiers (e.g., patient first and last name, date of birth, unique patient identifier from time of collection, such as medical record number) on the specimen container and on the test requisition form.
Research or surveillance specimens may be labeled according to protocol. Labels should not include personally identifiable information. The results reported should NOT be used for diagnosis, treatment, assessment of health or management of the individual patient.
Research or surveillance specimens may be labeled according to protocol. Labels should not include personally identifiable information. The results reported should NOT be used for diagnosis, treatment, assessment of health or management of the individual patient.
Shipping Instructions which Include Specimen Handling Requirements
CDC does not accept routine shipments on weekends or holidays. Please make sure packages arrive Monday – Friday. Please email the tracking number of the package to the CDC Point of Contact and poxviruslab@cdc.gov. It is preferred to ship samples frozen on dry ice. If dry ice is not available, specimens may be shipped refrigerated with frozen cold packs. Please include several ice packs to ensure samples arrive at the correct temperature.
Upon shipment, submitter should send an email to the CDC POC and poxviruslab@cdc.gov providing the shipping company, the date shipped and the package tracking number.
Ship To:
[Insert CDC Point of Contact]
Centers for Disease Control and Prevention
RDSB/STATT Unit 47
1600 Clifton Road, NE
Atlanta, GA 30329
[Insert CDC Point of Contact’s Telephone Number]
All samples must be shipped in accordance with all applicable local, state and federal regulations.
Upon shipment, submitter should send an email to the CDC POC and poxviruslab@cdc.gov providing the shipping company, the date shipped and the package tracking number.
Ship To:
[Insert CDC Point of Contact]
Centers for Disease Control and Prevention
RDSB/STATT Unit 47
1600 Clifton Road, NE
Atlanta, GA 30329
[Insert CDC Point of Contact’s Telephone Number]
All samples must be shipped in accordance with all applicable local, state and federal regulations.
Methodology
Real-time polymerase chain reaction
Turnaround Time
14 Days
Interferences & Limitations
Cotton swabs and swabs in media designed for bacterial preservation and/or transport may cause PCR inhibition and should not be used. Specimens with insufficient human DNA will be resulted as inconclusive.
Additional Information
Submitters should contact the Poxvirus Inquiry Line by telephone prior to using email and/or contacting the second POC.
Diagnostic real-time polymerase chain reaction can detect the following poxviruses: variola, monkeypox, vaccinia, orf, pseudocowpox, and bovine papular stomatitis virus.
Research real-time polymerase chain reaction can detect the viruses listed above plus cowpox, sealpox, molluscum contagiosum, and tanapox virus.
Diagnostic real-time polymerase chain reaction can detect the following poxviruses: variola, monkeypox, vaccinia, orf, pseudocowpox, and bovine papular stomatitis virus.
Research real-time polymerase chain reaction can detect the viruses listed above plus cowpox, sealpox, molluscum contagiosum, and tanapox virus.
CDC Points of Contact
Version
1.7
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