Xandr Universal Pixel

Monkeypox Test

FlowHealth
SKU: FH1

$118.75 per test

This novel Monkeypox test allows for detection of the virus within the saliva of infected individuals prior to any skin changes or rash.

This novel Monkeypox test allows for detection of the virus within the saliva of infected individuals prior to any skin changes or rash.

The Fine Print

Purpose: Flow Health’s Monkeypox Test launched as the first saliva-based PCR test to identify the Orthopoxviruses, including Monkeypox.

Background: Monkeypox virus is a double-stranded DNA virus that is capable of causing flu-like symptoms prior to the appearance of any skin lesions which can take upwards of 2-3 weeks to develop after exposure. When a skin rash is present, it tends to begin with on the face and progress toward the lower extremities and genitals. The diagnostic challenge with this virus is that the earliest symptoms of body aches, fever, and chills overlap with those of COVID-19 and influenza.

Transmission of the virus can occur through skin-to-skin contact or touching surfaces that an infected person has touched. Individuals who are infected are considered to be contagious to others from when the initial symptoms appear to when all lesions have healed with fresh layer of intact skin. The major benefit of this saliva-based test is that an individual can be tested for the virus prior to the appearance of skin lesions, which again may take up to 3 weeks for the time of exposure to the virus. The hope is that earlier detection would lead to isolation and decreased transmission to others. Additionally, this test can identify an asymptomatic, infected individual after contact with the virus, allowing for isolation, contact tracing and even vaccine administration.

Within the United States, the number of confirmed monkeypox/orthopoxvirus cases is 18,417 (as of 8/22/2022) with the highest incidences within California, Texas, Florida, Georgia, Illinois, and New York. The 2022 Monkeypox outbreak on a global scale includes 49,974 cases (ww.cdc.gov). Due to the initial identification of the US outbreak predominantly within the gay male population, a social stigma pervades over access to testing and seeking medical care. Cases of monkeypox have been reported in both women and children, making all populations vulnerable and in need of access to testing.

Specimen: Saliva

Kit Type: Spectrum SDNA-1000 Saliva Collection Kit

Technology: The Monkeypox Test is a Nucleic Acid Amplification Test (NAAT) by Real-Time Polymerase Chain Reaction intended for the qualitative detection of Orthopoxviruses, a family of viruses that includes Monkeypox and smallpox. Extraction is carried out using the MagMAX™ Viral/Pathogen Nucleic Acid Isolation Kit and detection using the TaqMan® Microbial Assays—single tube on the QuantStudio 5 system by Applied Biosystems.

Limit of Detection – 250 cp/mL  Sensitivity: 100%. Specificity: 100%.

Is this test FDA approved?

This test has not been approved by the FDA at this time. This saliva-based assay is considered a Laboratory Developed Test (LDT).  Laboratory Developed Tests (LDT) do not require FDA approval if they are developed while adhering to CLIA policies.  This test is analytically validated in accordance with the CLIA Guidance Document (Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing) as a Laboratory Developed Test (LDT) by Flow Health Laboratories, LLC.

 

 

  • No products in the cart.