Monkeypox Testing at MHS Labs

For individuals needing testing:

To schedule an appointment at our Monroeville Draw Station, call 412-421-0209 or email [email protected].

Our Monroeville Draw Station is open M-F, 8a-4p.  Please contact us for other testing locations.

For care providers and organizations:

To enroll and obtain the appropriate collection kits, call at 412-373-7900, option 1 or email [email protected].

 

MHS Labs offers a Real-Time PCR test that specifically detects the Monkeypox virus. Following the guidelines of the CDC for monkeypox PCR testing, our scientific team performed rigorous validation of the test to provide accurate results, typically within 24 hours. MHS Labs prides itself on its world-class technology and R&D team, experienced, responsive, compassionate lab personnel, phlebotomists, couriers, and leadership who are dedicated to superior customer service. MHS Labs can serve patients with or without insurance.

Facilities and organizations

Since the initial outbreak, MHS Labs has focused on providing care to the most vulnerable populations: retirement communities, skilled nursing facilities, and personal care communities.

MHS Labs also helps employer groups, governments, and education institutions stay healthy with programs to respond on-site and on-demand to keep their populations healthy.

MHS Labs is helping patients take the precautionary steps needed to reduce the risk of exposure by servicing the most vulnerable population. Testing can help reduce the spread of Monkeypox and the overall number of hospitalizations resulting in better patient health and significant savings.

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.

Ordering Information

Test Name: Monkey Pox, PCR
Test Code (Order Choice): P40000
Required Collection Questions: Swab Type: Dry or VTM (=UTM)

Collection Site: This will be free text (i.e., Left Hand, Right Forearm, etc.)
Method: PCR – Polymerase Chain Reaction
Specimen Requirements: Dry Transport System Swab

BD VTM or UTM

(Cotton, Rayon, or Flock)
Collection Instructions: Choose a visible lesion and vigorously rub with the swab or brush the base of the lesion. During this process, the wound may deroof.

See Full Collection Instructions.
Unacceptable specimen types: ·        Any swab submitted with a wooden shaft will be Rejected.

·        Unlabeled or Mislabeled Specimens
Storage, Transport, Stability:

 

 Once collected the specimen is to be kept: Refrigerated

Transport Temperature: Refrigerated

Stability: 7 Days
Schedule of Testing:

 

 Six days a week, Monday thru Friday.

Completion Time: 24-48 Hours
CPT Code (s): 87593

Please contact MHS Labs at 412-373-7900, option 1 to obtain the appropriate collection kits.

Download this document here.

Specimen Collection Details

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