This test is for the qualitative detection of Mpox virus (MPXV) DNA in patients suspected of Mpox infection. MPXV is endemic in the Congo Basin and the West region of Africa, with two distinct clades causing human illness with symptoms similar to smallpox. Recently a global outbreak of Mpox has been reported with cases in several countries including the US. The current outbreak appears to be caused by the West Africa strain and causes skin lesions that can be sampled to identify the virus. MPXV spreads by close human contact and early identification of positive cases is necessary for disease containment.
Collect
Collect a white cap e-swab
Locate an appropriate suspicious lesion.
Swab or brush the lesion vigorously with the e-swab and the dry swab (for a total of 2 swabs)
Place swabs back into their respective containers
Label all containers with Cerner labels
If needed (lesions with different appearance are present) - collect a second lesion with both swabs
The swab must be inserted inside the lesion (pustule) for adequate sample collection
Unacceptable Conditions
Mislabeled specimens
Specimens collected in the wrong container
Specimens that have leaked from the tube or show signs of potential contamination
Storage/Transport Temperature
Transport and store Refrigerated (2 - 8oC) up to 5 days
Store Frozen (-20oC) for long term
Cerner Orderable(s)
Monkeypox Virus PCR
Performed
BayCare Laboratories, LLC
Methodology
Real-time PCR
Reported
Turn around time: 24 - 48 hrs
Reference Interval
Negative
Interpretive Data
This assay is for the qualitative detection of Monkeypox DNA in lesion samples of patients suspected of Mpox infection. Test results should be interpreted in conjunction with clinical presentation. This assay utilizes real-time Polymerase Chain Reaction (PCR) to amplify specific regions of the Mpox J2L/J2R gene. This test was developed, and its performance characteristics determined by the BayCare Molecular Diagnostic Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration.
Collection
Purpose
This test is for the qualitative detection of Mpox virus (MPXV) DNA in patients suspected of Mpox infection. MPXV is endemic in the Congo Basin and the West region of Africa, with two distinct clades causing human illness with symptoms similar to smallpox. Recently a global outbreak of Mpox has been reported with cases in several countries including the US. The current outbreak appears to be caused by the West Africa strain and causes skin lesions that can be sampled to identify the virus. MPXV spreads by close human contact and early identification of positive cases is necessary for disease containment.
Collect
Collect a white cap e-swab
Locate an appropriate suspicious lesion.
Swab or brush the lesion vigorously with the e-swab and the dry swab (for a total of 2 swabs)
Place swabs back into their respective containers
Label all containers with Cerner labels
If needed (lesions with different appearance are present) - collect a second lesion with both swabs
The swab must be inserted inside the lesion (pustule) for adequate sample collection
Unacceptable Conditions
Mislabeled specimens
Specimens collected in the wrong container
Specimens that have leaked from the tube or show signs of potential contamination
Storage/Transport Temperature
Transport and store Refrigerated (2 - 8oC) up to 5 days
Store Frozen (-20oC) for long term
Ordering
Cerner Orderable(s)
Monkeypox Virus PCR
Performed
BayCare Laboratories, LLC
Methodology
Real-time PCR
Reported
Turn around time: 24 - 48 hrs
Result Interpretation
Reference Interval
Negative
Interpretive Data
This assay is for the qualitative detection of Monkeypox DNA in lesion samples of patients suspected of Mpox infection. Test results should be interpreted in conjunction with clinical presentation. This assay utilizes real-time Polymerase Chain Reaction (PCR) to amplify specific regions of the Mpox J2L/J2R gene. This test was developed, and its performance characteristics determined by the BayCare Molecular Diagnostic Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration.
