How to Report Results from Orthopoxvirus, Non-Variola Orthopoxvirus, and Monkeypox Virus Diagnostic Testing

Introduction

Timely and comprehensive laboratory testing and result reporting is a critical piece of the public health response to monkeypox. These data help public health officials understand more about the spread of the Monkeypox virus. Testing and result data can help predict increases in testing demand and plan for potential supply chain issues for reagents and other testing materials.

Who should report

  • Any laboratory that performs diagnostic testing for monkeypox should report test results to state, tribal, local, or territorial (STLT) health departments. This includes real-time polymerase chain reaction or PCR testing for Orthopoxvirus, non-variola Orthopoxvirus, or Monkeypox virus.
  • Report all results (positive, negative, equivocal) unless otherwise specified by the applicable health department.
    • Report positive results within 24 hours of testing, or immediately by telephone to the appropriate STLT health department per the regulations in the appropriate jurisdiction.
  • Report test results to the health department in the patient’s state or territory of residence.

What to report

Laboratories should make every reasonable effort to provide the following data elements when reporting results to state and jurisdictional health departments.

  1. Test order—use appropriate Logical Observation Identifiers, Names and Codes (LOINC) terms (see table below)
  2. Test order date (date format)
  3. Test result
    • Performed Test—use appropriate LOINC terms (see table below)
    • Test result value –
      • For quantitative results include units of measure, if applicable—coded in Unified Codes for Units of Measure (UCUM)
      • For qualitative results use appropriate Systematized Nomenclature of Medicine- Clinical Terms (SNOMED-CT) code (see table below)
  4. Test result date (date format)
  5. Patient ID** (unique identifier assigned to an individual)
  6. Patient name (Last name, First name, Middle Initial)
  7. Patient street address
  8. Patient phone number with area code
  9. Patient date of birth
  10. Patient age
  11. Patient race
  12. Patient ethnicity
  13. Patient sex/gender
  14. Patient residence zip code
  15. Ordering provider name
  16. Ordering provider zip code
  17. Ordering provider address
  18. Ordering provider phone number
  19. Performing facility name and Clinical Laboratory Improvement Amendments, or CLIA number
  20. Performing facility zip code
  21. Accession # / Specimen ID** (unique identifier assigned to a specimen)
  22. Specimen Source
    • Specimen Type—use appropriate SNOMED-CT codes from the specimen hierarchy (see table below for some examples), or HL70487 codes
    • Source site—when the specimen type is a crust or a swab, it may be necessary to indicate where on the body this was taken from—use appropriate SNOMED-CT codes from the anatomic body site hierarchy (see table below for examples); in addition, more detailed topography like laterality may be needed. Include this in the code for the source site, or send in as an additional element—properly coded using SNOMED-CT codes from the qualifier hierarchy
  23. Specimen collection date (date format)

**Patient ID and Accession #/Specimen ID are necessary to identify multiple specimens from an individual once the data is deidentified.

To protect patient privacy, any data CDC receives from state and jurisdictional health departments will be deidentified and will not include patient-level information.

Note: Laboratories are strongly encouraged to obtain complete information, including:

  1. Information about the patient to facilitate a rapid public health response; this includes complete patient contact information (name, date of birth, street address, phone number) so that public health may quickly contact the patient, provide treatment if necessary, and limit transmission
  2. Demographic data (gender, race, and ethnicity) data to support critical health equity priorities
  3. Information about the specimen, including the type, the source site (with topography, for example, right, left, distal) and collection method to support clear differentiation of the multiple submitted specimens, as well as better understanding of the clinical relevance
    • Clinical history, if known, including symptoms, onset dates, travel history, epidemiological links to other cases, and treatment with any medical countermeasures (Medical Countermeasures Available for the Treatment of Monkeypox); also co-morbidities (International Classification of Diseases, or ICD diagnoses) that accompany the lab order

This may require updates to the laboratory test order process, including:

  • Updating electronic laboratory order interfaces to ensure necessary information (from the electronic health record, or the ordering physician, or both) is fully populated
  • Educating physicians (and those who place test orders on their behalf) about data needs at the time of test order

Laboratories should not reject specimens if data elements are missing and there is enough information to perform testing.

How to report

Laboratories should follow these best practices when reporting test results:

  • Submit laboratory diagnostic test results directly to STLT health departments according to state or local law, or policy
  • Send reports using existing electronic laboratory reporting (ELR) channels to ensure rapid initiation of case investigations
    • Share results concurrently with the ordering provider
  • Send compliant HL7 messages, if possible, and prioritize the data elements described in the “How to Use Standard Terminology” section (see below)
  • Engage with your STLT health department to ensure compliance with STLT-specific implementation guides, if available in your jurisdiction
  • Coordinate with your STLT health department to review data feeds before you submit results

How to use standard terminology

Laboratories should use standardized LOINC and SNOMED-CT codes. This improves the accuracy of reporting results for Orthopoxvirus, non-variola Orthopoxvirus, and Monkeypox virus and helps ensure that test types are represented uniformly across the United States.

LOINC codes represent the “question” a test asks of a specimen (for example, does this specimen have monkeypox?), and SNOMED-CT codes represent the diagnostic “answer” (for example, what was detected?). Find more background on these terminology standards here:

Whenever possible, laboratories should use standard codes that already exist.

Test

Test

Test

Test Performed LOINC Long Name

Test Performed LOINC Long Name

Test Performed LOINC Long Name

LOINC Code

LOINC Code

LOINC Code

Orthopoxvirus

Test

Orthopoxvirus

Orthopoxvirus Deoxyribonucleic acid, or DNA [Presence] in Specimen by Nucleic Acid Amplification, or NAA with probe detection

Test Performed LOINC Long Name

Orthopoxvirus Deoxyribonucleic acid, or DNA [Presence] in Specimen by Nucleic Acid Amplification, or NAA with probe detection

41853-3

LOINC Code

41853-3

Non-variola Orthopoxvirus

Test

Non-variola Orthopoxvirus

Orthopoxvirus non-variola DNA [Presence] in Specimen by NAA with probe detection

Test Performed LOINC Long Name

Orthopoxvirus non-variola DNA [Presence] in Specimen by NAA with probe detection

100434-0

LOINC Code

100434-0

Monkeypox Virus

Test

Monkeypox Virus

Monkeypox virus DNA [Presence] in Specimen by NAA with probe detection

Test Performed LOINC Long Name

Monkeypox virus DNA [Presence] in Specimen by NAA with probe detection

100383-9

LOINC Code

100383-9

West African Monkeypox Virus

Test

West African Monkeypox Virus

West African monkeypox virus DNA [Presence] in Specimen by NAA with probe detection

Test Performed LOINC Long Name

West African monkeypox virus DNA [Presence] in Specimen by NAA with probe detection

100888-7

LOINC Code

100888-7

Congo Basin Monkeypox Virus

Test

Congo Basin Monkeypox Virus

Congo Basin monkeypox virus DNA [Presence] in Specimen by NAA with probe detection

Test Performed LOINC Long Name

Congo Basin monkeypox virus DNA [Presence] in Specimen by NAA with probe detection

100889-5

LOINC Code

100889-5

Parapoxvirus

Test

Parapoxvirus

Parapoxvirus DNA [Presence] in Specimen by NAA with probe detection

Test Performed LOINC Long Name

Parapoxvirus DNA [Presence] in Specimen by NAA with probe detection

100885-3

LOINC Code

100885-3

Orf Virus

Test

Orf Virus

Orf virus DNA [Presence] in Specimen by NAA with probe detection

Test Performed LOINC Long Name

Orf virus DNA [Presence] in Specimen by NAA with probe detection

100886-1

LOINC Code

100886-1

Pseudocowpox Virus

Test

Pseudocowpox Virus

Pseudocowpox virus DNA [Presence] in Specimen by NAA with probe detection

Test Performed LOINC Long Name

Pseudocowpox virus DNA [Presence] in Specimen by NAA with probe detection

100887-9

LOINC Code

100887-9

Orthopoxvirus IgG

Test

Orthopoxvirus IgG

Orthopoxvirus IgG Ab [Presence] in Serum or Plasma by Immunoassay

Test Performed LOINC Long Name

Orthopoxvirus IgG Ab [Presence] in Serum or Plasma by Immunoassay

100891-1

LOINC Code

100891-1

Orthopoxvirus IgM

Test

Orthopoxvirus IgM

Orthopoxvirus IgM Ab [Presence] in Serum or Plasma by Immunoassay

Test Performed LOINC Long Name

Orthopoxvirus IgM Ab [Presence] in Serum or Plasma by Immunoassay

100892-9

LOINC Code

100892-9

Result Value

Result Value

Result Value

SNOMED-CT Codes

SNOMED-CT Codes

SNOMED-CT Codes

Detected*

Result Value

Detected*

260373001

SNOMED-CT Codes

260373001

Inconclusive

Result Value

Inconclusive

419984006

SNOMED-CT Codes

419984006

Equivocal

Result Value

Equivocal

42425007

SNOMED-CT Codes

42425007

Not detected*

Result Value

Not detected*

260415000

SNOMED-CT Codes

260415000

Test not done

Result Value

Test not done

373121007

SNOMED-CT Codes

373121007

* These are the preferred terms to use, when reporting results from PCR testing; other presence/absence terms like positive/negative are possible and should be mapped to these terms.

Specimen Type

Specimen Type

Specimen Type

SNOMED-CT Codes

SNOMED-CT Codes

SNOMED-CT Codes

Scab specimen (crust)

Specimen Type

Scab specimen (crust)

435541000124108

SNOMED-CT Codes

435541000124108

Swab from lesion of skin

Specimen Type

Swab from lesion of skin

472862007

SNOMED-CT Codes

472862007

Swab from lesion

Specimen Type

Swab from lesion

16210971000119108

SNOMED-CT Codes

16210971000119108

Oral swab

Specimen Type

Oral swab

418932006

SNOMED-CT Codes

418932006

Rectal swab

Specimen Type

Rectal swab

258528007

SNOMED-CT Codes

258528007

Example Source Site

Example Source Site

Example Source Site

SNOMED-CT Codes

SNOMED-CT Codes

SNOMED-CT Codes

Oral cavity

Example Source Site

Oral cavity

74262004

SNOMED-CT Codes

74262004

Rectum

Example Source Site

Rectum

34402009

SNOMED-CT Codes

34402009

Genital structure

Example Source Site

Genital structure

71934003

SNOMED-CT Codes

71934003

Upper Arm (between shoulder and elbow)

Example Source Site

Upper Arm (between shoulder and elbow)

40983000

SNOMED-CT Codes

40983000

Shoulder

Example Source Site

Shoulder

16982005

SNOMED-CT Codes

16982005

Elbow

Example Source Site

Elbow

127949000

SNOMED-CT Codes

127949000

Hand

Example Source Site

Hand

85562004

SNOMED-CT Codes

85562004

Thigh

Example Source Site

Thigh

68367000

SNOMED-CT Codes

68367000

Left hand

Example Source Site

Left hand

85151006

SNOMED-CT Codes

85151006

Right thigh

Example Source Site

Right thigh

11207009

SNOMED-CT Codes

11207009

Example Topography***

Example Topography***

Example Topography***

SNOMED-CT Codes

SNOMED-CT Codes

SNOMED-CT Codes

Right

Example Topography***

Right

24028007

SNOMED-CT Codes

24028007

Left

Example Topography***

Left

7771000

SNOMED-CT Codes

7771000

Proximal

Example Topography***

Proximal

40415009

SNOMED-CT Codes

40415009

Distal

Example Topography***

Distal

46053002

SNOMED-CT Codes

46053002

*** These could also be included in the Source Site values above; for example: Left hand (85151006) or Right thigh (11207009).

How to get assistance with electronic reporting

CDC can provide technical assistance to laboratories that are not currently reporting electronically to their STLT health department and would like to establish electronic reporting. Contact the CDC Electronic Data Exchange inbox at edx@cdc.gov and use “Monkeypox Technical Assistance Request” as the subject line.