About our Monkeypox Test

As Monkeypox cases in the US rose in 2022, MHS Labs began validation to support an appropriate national response to the outbreak.

MHS Labs now has a validated test which is a real-time polymerase chain reaction (PCR) test to detect the DNA of orthopoxviruses, including monkeypox. The test is based on the CDC assay but has been optimized for state-of-the-art instrumentation and an automated specimen extraction process. These optimizations along with our lab location will allow for faster turnaround times and increased capability to upscale testing capacity.

The test has also been validated for both dry-swab specimen collection and for collection using viral transport media to facilitate easier collection and transportation.  However, dry-swab is the recommended specimen collection.  In addition, MHS Labs deploys site collectors and couriers to speed the time to result.  The Monroeville, PA Draw Station is also available for walk-ins or appointments for sample collection. With no waiting, collection can occur and results can be delivered to you electronically via our easy-to-use portal.

For an appointment call: 412-372-2035.

CDC Guidance

Our Test based on the same assay principles as the CDC’s U.S. Food and Drug Administration FDA-cleared test. As MHS Labs test is optimized for modern instrumentation and automated processes, it is classified as a laboratory-developed test (LDT). This allows 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.

FDA Approval

Our test is a laboratory-developed test (LDT). The FDA has declared enforcement discretion and will not require LDTs for monkeypox to be submitted to the FDA.

CPT Code

The CPT code is 87593.

Effective July 26, 2022, the Current Procedural Terminology (CPT) Editorial Panel approved this new CPT code to use specifically for orthopoxvirus (monkeypox) detection to improve reporting in cases of suspected or confirmed monkeypox.

Specimen Collection

 

Specimen Collection Use a dry swab, including, but not limited to, polyester, nylon, or Dacron swabs.

Swab the lesion vigorously to collect adequate DNA. It is not necessary to deroof the lesion before swabbing.

Alternate: Place lesion swab in Viral Transport Media

Specimen Preparation If using viral transport media, swab in viral transport media (VTM): Transfer swab to viral transport media.
Unacceptable Conditions Calcium alginate swab, wooden swab. Specimens without swabs.
Specimen Stability Ambient: 24 hours; Refrigerated: 7 days; Frozen: 7 days