Monkeypox (MPXV)

MAKO now offers a test* specific for monkeypox, expanding the United States response for patients and providers.

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Mako Medical – offering a test* specific for monkeypox, expanding the United States response for patients and providers

Monkeypox is a disease caused by infection with the monkeypox virus. The monkeypox virus is an orthopoxvirus that is related to variola virus, which causes smallpox.  There are two types (or clades) of monkeypox virus: West African and Congo Basin. Infections in the current outbreak are from the West African type.

 

MAKO Medical Laboratories has validated a PCR-based monkeypox-specific assay developed by Thermo Fisher Scientific.  There are currently fewer than 100 laboratories across the country capable of handling monkeypox specimens before they are sent to the United States Centers for Disease Control and Prevention (CDC) for documentation purposes.

MAKO’s test is a real-time polymerase chain reaction (PCR) test and is based on the same assay principles as the CDC's FDA-cleared test. As MAKO’s test is optimized for modern instrumentation and automated processes, it will be classified as a laboratory-developed test (LDT). This will allow for rapid scaling of testing capacity if needed and reduced turnaround times. It also allows for specimen transport in viral transport medium (VTM), which better supports specimen stability.

Test Details

MAKO Order Code
Test Name
Assay
 
Turnaround Time
Sample Collection Requirements


 
725100
Monkeypox (MPXV)
Applied Biosystems Taqman Monkeypox Virus Microbe Detection Assay
Less than 48 hours
Swab the wound/lesion/pustule forcefully, place the swab in the tube with VTM, and secure the cap. Samples should be shipped immediately to the lab at room temperature.

The Applied Biosystems TaqMan Monkeypox Virus Microbe Detection Assay will provide additional testing resources to enable health authorities to track and trace the epidemiology of the current outbreak.

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Frequently Asked Questions 

1. What is the Monkey Pox Virus?
  • Monkeypox is a disease caused by infection with the monkeypox virus. The monkeypox virus is an orthopoxvirus that is related to variola virus, which causes smallpox.

2. Are there different types of Monkey Pox?
  •  There are two types (or clades) of monkeypox virus: West African and Congo Basin. Infections in the current outbreak are from the West African type.

3. When will MAKO’s Monkey Pox test be available?
  • We began testing July 18th.

4. What is MAKO’s test name?
  • Monkeypox (MPXV)

5. What is MAKO’s order code?
  • 725100

6. How do I collect a specimen for Monkey Pox?
  • Swab the wound/lesion/pustule forcefully, place the swab in the tube with VTM, and secure the cap. Samples should be shipped immediately to the lab at room temperature.

7. What do the results mean?

This is how the results appear in Apollo.

 

  • Not Detected

 

Negative (NOT Detected)
Monkeypox viral DNA was NOT detected.   Negative results do not rule out bacterial infection, co-infection with other viruses, and other sexually transmitted infections.   Results must be correlated with clinical presentation and evaluated in the context of other laboratory and epidemiologic data.

The Monkeypox (MPXV) test is intended for the presumptive qualitative detection of nucleic acid from wound/lesion swab specimens.

The Monkeypox (MPXV) test* is not approved or cleared by the FDA.

 

  • Detected

 

Positive (Detected)

Monkeypox viral DNA was detected.  Detection of monkeypox viral DNA may indicate that monkeypox is the causative agent for clinical symptoms.  Positive results do not rule out bacterial infection, co-infection with other viruses, and other sexually transmitted infections.  Results must be correlated with clinical presentation and evaluated in the context of other laboratory and epidemiologic data.
 
The Monkeypox (MPXV) test is intended for the presumptive qualitative detection of nucleic acid from wound/lesion swab specimens.

The Monkeypox (MPXV) test* is not approved or cleared by the FDA.

 

  • Invalid

 

Invalid (Recollection Required)
Human DNA internal control failed in the sample.  The results indicate insufficient DNA material captured by the swab for both human and viral DNA.  Recollection is required.   Invalid results do not rule out bacterial infection, co-infection with other viruses, and other sexually transmitted infections.   Results must be correlated with clinical presentation and evaluated in the context of other laboratory and epidemiologic data.
 
The Monkeypox (MPXV) test is intended for the presumptive qualitative detection of nucleic acid from wound/lesion swab specimens.

The Monkeypox (MPXV) test* is not approved or cleared by the FDA.

8. What are the specimen requirements?
  • Wound/lesion/pustule swab collected in 3 mL of VTM.

9. What is the transportation temperature?
  •  Ship immediately at room temperature.

10. What is the specimen stability?
  •  Stability studies are underway and will be updated as relevant.  Current recommendation is to ship samples immediately at room temperature.  If samples cannot be shipped immediately they should be stored in fridge until being shipped.

  • Our assay includes an internal control, human DNA (RNaseP) gene.  It’s presence indicates the integrity of DNA in the collected sample has been preserved.

11. Which assay is MAKO running?
  •  The Applied Biosystems TaqMan Monkeypox Virus Microbe Detection Assay 

12. How is MAKO’s MPx assay different from the OrthoPox assay?
  •  Current assays on the market are only able to confirm the presence of orthopox virus, requiring further confirmation of monkeypox by the CDC. MAKO’s assay is designed to detect monkeypox directly from specimens. Today, positive orthopox virus cases are presumed to be monkeypox, creating inefficiency in the current testing strategy.

13. Will MAKO’s test use the same methodology as the CDC’s test?
  • MAKO’s test is a real-time polymerase chain reaction (PCR) test and is based on the same assay principles as the CDC's FDA-cleared test. As MAKO’s test is optimized for modern instrumentation and automated processes, it will be classified as a laboratory-developed test (LDT)*. This will allow for rapid scaling of testing capacity if needed and reduced turnaround times. It also allows for specimen transport in viral transport medium (VTM), which better supports specimen stability.

14. Will MAKO’s test have FDA approval?
  •  Our test will be a lab-developed test (LDT)*. The FDA has declared enforcement discretion and will not require LDTs for monkeypox be submitted to the FDA.

15. Will the specimen collection requirements differ from the collection requirements for the CDC’s test?
  • Yes. Currently, the CDC’s test requires dry swab collection and a manual extraction process at the lab. MAKO is validating multiple collection conditions, including transport in viral transport media. This will make it easier to collect and transport specimens to the laboratory and facilitate faster turnaround time (TAT).

 

16. Will MAKO’s test require confirmatory testing?
  •  No, our test will not require confirmatory testing, per new guidance from the CDC for LDTs*.

 

17. What is the turnaround time?
  • Less than 48 hours upon receipt

18. Is MAKO testing for differential diagnosis?
  • MAKO continues to perform all ancillary testing for patients with possible or known underlying conditions or suspected or confirmed monkeypox infection. Tests such as sexually transmitted infection panels, HIV tests, and other tests are important for providing a differential diagnosis and optimal patient care.

 

19. Are there special shipping and handling instructions for samples with suspected Monkey Pox Testing?
  • Yes, per CDC guidance, specimens can be shipped as UN 3373 Biological Substance, Category B. When submitting a specimen from a patient with a suspected or confirmed monkeypox infection, clients should write “suspected monkeypox” on the MAKO packing list, specimen bag, and in the lab information system (LIS) order comments. This will help ensure that specimens are handled and tested using the proper precautions.

 

20. How is public health reporting handled?
  • MAKO will report as required by state laws and regulations; this meets our reporting requirements as the performing laboratory. This does not cover reporting that may or may not be required by other healthcare providers. MAKO does not maintain a list of reporting requirements for providers, and so we are not able to provide guidance on provider/client reporting.

 

21. What are symptoms of Monkey Pox?
  • Symptoms of monkeypox can include:

    • Fever

    • Headache

    • Muscle aches and backache

    • Swollen lymph nodes

    • Chills

    • Exhaustion

    • A rash that can look like pimples or blisters that appears on the face, inside the mouth, and on other parts of the body, like the hands, feet, chest, genitals, or anus.

      • The rash goes through different stages before healing completely. The illness typically lasts 2-4 weeks.

  •  Sometimes, people get a rash first, followed by other symptoms. Others only experience a rash.

  •  Symptoms usually appear one to two weeks after infection.

 

22. How can Monkey Pox be prevented?

 

  • People should take the following steps to prevent getting monkeypox:

    • Avoid close, skin- to- skin contact with people who have a rash that looks like monkeypox.

      • Do not touch the rash or scabs of person with monkeypox.

      • Do not kiss, hug, cuddle or have sex with someone with monkeypox.

      • Do not share eating utensils or cups with a person with monkeypox.

      • Do not handle or touch the bedding, towels, or clothing of a person with monkeypox.

    • Wash your hands often with soap and water or use an alcohol-based hand sanitizer.

    • Central and West Africa, avoid contact with animals that can spread monkeypox virus, usually rodents and primates. Also, avoid sick or dead animals, as well as bedding or other materials they have touched.

  •  If you are sick with monkeypox

    • Isolate at home

    • If you have an active rash or other symptoms, stay in a separate room or area away from people or pets you live with, when possible.
       

* The MAKO MPXV assay is a Laboratory Developed Test (LDT) validated according to College of American Pathologist (CAP) standards