Cue Mpox (Monkeypox)
Molecular Test

The Cue Mpox (Monkeypox) Molecular Test uses nucleic acid amplification technology (NAAT) to generate a molecular amplification reaction, which is an equivalent alternative amplification method to real time polymerase chain reaction (RT-PCR).

The Cue Mpox (Monkeypox) Molecular Test contains primers, probes, and internal controls used in molecular tests to detect monkeypox virus nucleic acid. The test was issued Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) for use by authorized laboratories or by healthcare professionals at the point-of-care. When the user inserts the Cue Sample Wand with a skin lesion sample into the Cue Test Cartridge, the test automatically begins. Heating, mixing, amplification, and detection take place within the single-use test cartridge, and results are transmitted to the user to a compatible mobile device in around 25 minutes.

For a more detailed description of how this test works, please visit Product Documentation and refer to the Instructions For Use (IFU).

Based on results of a clinical study sponsored by Cue and submitted to FDA for Emergency Use Authorization, the Cue Mpox (Monkeypox) Molecular Test is 100% accurate. Test performance was evaluated with 59 de-identified archived clinical lesion swab samples in viral transport media (VTM) (30 positive samples and 29 negative samples) collected by trained personnel from patients suspected of having mpox. Untrained personnel tested the samples. The positive percent agreement (PPA) and negative percent agreement (NPA) of the Cue Mpox (Monkeypox) Molecular Test compared to an FDA-cleared real-time PCR assay were both 100%.

The Cue Mpox (Monkeypox) Molecular Test is easy to understand and requires minimal training. Our cartridges are self-contained and come ready for immediate use with the Cue Health Monitoring System (Cue Reader). No sample preparation or reagent mixing is needed, and the Cue Health App guides users with step-by-step videos and prompts. Samples must be collected by healthcare professionals trained to collect skin lesion samples. Refer to your institution's training and certification guidelines before using Cue.

The Cue Mpox (Monkeypox) Molecular Test is authorized for use in point-of-care settings by laboratories or other organizations certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a that meet requirements to perform high, moderate, or waived complexity tests. Testing is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

For directions, precautions, and additional information, please see the Cue Mpox (Monkeypox) Molecular Test Instructions For Use (IFU).

The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the Cue Mpox (Monkeypox) Molecular Test. This test may be used for the qualitative detection of DNA from the monkeypox virus (clade I/II) in human lesion swab specimens (i.e., swabs of acute pustular or vesicular rash) from individuals suspected of having mpox by their healthcare provider.

Reimbursement varies by payor, and we are actively working with health insurance companies to ensure coverage for Cue’s tests. We encourage you to check with specific payors for pathways of reimbursement and coverage for the Cue Mpox (Monkeypox) Molecular Test.

Some providers use CPT code 87593 for reimbursement: Infectious agent detection by nucleic acid (DNA or RNA); orthopoxvirus (eg, monkeypox virus, cowpox virus, vaccinia virus), amplified probe technique, each.

The coding information contained here is for informational purposes only and is not a guarantee of coverage or reimbursement for any product or service. We recommend you consult with your CPT code advisors for guidance. To view existing CPT codes, please visit CodeMap.