About our Monkeypox Test

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

SR Scientific 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, SR Scientific deploys site collectors and couriers to speed the time to result.

CDC Guidance

Our Test based on the same assay principles as the CDC’s U.S. Food and Drug Administration FDA-cleared test. As SR Scientific 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

 

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