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Monkeypox Virus DNA, Qualitative, Real-Time PCR 

Test Code: 12084

The Monkeypox Virus DNA, Qualitative, Real-Time PCR test is a laboratory-developed assay from Quest. This multiplex polymerase chain reaction (PCR) assay detects DNA of non-Variola orthopoxviruses (NVOs) (ie, Vaccinia virus and Monkeypox virus) and the West African clade of the Monkeypox virus. This assay does not detect Variola virus, the causative agent of smallpox.

The Quest Monkeypox Virus DNA, Qualitative, Real-Time PCR is a CLIA laboratory developed test that is also based on the CDC targets for the NVOs as well as West African clade.1, 2 It has been designed for high throughput specific testing. The CDC NVO Real-Time PCR Primer and Probe set has been granted 510K clearance by the FDA. 

The key differences between the Quest Monkeypox Virus DNA, Qualitative, Real-Time PCR and the CDC NVO DNA test are

1) The Quest developed Monkeypox virus DNA test is a dual-target assay. It can detect NVO DNA and detect the West African clade of the monkeypox virus DNA. Therefore, confirmatory testing is not needed with the dual target Monkeypox Virus DNA, Qualitative, Real-Time PCR test.3 The CDC NVO assay targets NVOs (see Table below).

2) The Quest Monkeypox Virus DNA, Qualitative, Real-Time PCR test is performed from specimens collected in viral transport media, and the liquid media, not the swab, is used for testing. The CDC NVO PCR protocol requires that either a dry swab or a swab in media be processed for testing. Because the CDC protocol includes processing of the swab and not testing of the media, 2 swabs per lesion need to be collected so that 1 swab can be sent to the CDC for additional confirmatory testing if the NVO PCR is positive. 

The table below shows the molecular targets of the Quest Monkeypox Virus DNA, Qualitative, Real-Time PCR Test and the CDC non-Variola Orthopoxvirus DNA Test        

Table showing molecular targets of the Quest Monkeypox Virus DNA, Qualitative, Real-Time PCR test and the CDC non-variola Orthopoxvirus DNA test

Swab a pustule/lesion vigorously and place the swab into a viral culture media (VCM; 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 from a single patient should be submitted separately; each should be accompanied by its own separate requisition and transported in its own sealed bag. Ship frozen (preferred) or refrigerated.

Healthcare personnel should collect specimens using personal protective equipment (PPE) in accordance with recommendations for healthcare settings.4 Specimens will not be collected in our patient service centers.

Quest VCM is equivalent to Copan Universal Transport Medium (UTM) BD UVT, Cepheid XPert Sample Collection Kit for Viruses, and Hardy-Health Link UTM. These media are manufactured in identical fashion; all raw materials utilized across all products are equivalent and present at the same ratios. 

References

  1. Li Y, Olson VA, Laue T, et al. Detection of monkeypox virus with real-time PCR assays. J Clin Virol. 2006;36(3):194-203. doi:10.1016/j.jcv.2006.03.012
  2. Li Y, Zhao H, Wilkins K, et al. Real-time PCR assays for the specific detection of monkeypox virus West African and Congo Basin strain DNA. J Virol Methods. 2010;169(1):223-227. doi:10.1016/j.jviromet.2010.07.012
  3. Diagnostic process for monkeypox virus testing. Centers for Disease Control and Prevention. Updated June 21, 2022. Accessed July 8, 2022. https://www.cdc.gov/poxvirus/monkeypox/pdf/Monkeypox-lab-process.pdf
  4. Infection prevention and control of monkeypox in healthcare settings. Centers for Disease Control and Prevention. Updated July 5, 2022. Accessed July 8, 2022.  https://www.cdc.gov/poxvirus/monkeypox/clinicians/infection-control-healthcare.html

 

This FAQ is provided for informational purposes only and is not intended as medical advice. Test selection and interpretation, diagnosis, and patient management decisions should be based on the physician’s education, clinical expertise, and assessment of the patient.

 

Document FAQS.286 Version: 1

Version 1: Effective 07/28/2022 to present

Version 0 effective 07/12/2022 to 07/28/2022