VTM Certificate of Analysis

About

Charm Viral Transport Medium (VTM) is a non-propagating culture medium intended for transport of clinical material. VTM intended use is for transporting clinical specimens for testing with biochemical, molecular or antigen assays during the COVID-19 public health emergency. Charm is a VTM manufacturer listed in the FDA covid EUA website.  

A swab sample (swab not included, sourced separately) is added to the VTM vial for collection and safe transport to the testing laboratory in a containment bag (bag not included, sourced separately). Charm VTM is made following Centers for Disease Control and Prevention’s (CDC) Standard Operating Procedure (SOP): Preparation of Viral Transport Media # DSR-052-05. With refrigerated transport, VTM stabilizes SARS-CoV-2 viral RNA for 72 hours without meaningful degradation. Each polypropylene screw cap vial contains approximately 3 mL aseptic dispensed 0.22 µm filtered sterilized VTM; see Kit Contents. Vials containing sample swabs and delivered refrigerated to laboratories may be used for virus testing including COVID-19 using PCR, RNA/DNA extraction, antigen tests, or other validated diagnostic protocols.

Warning and Limitations

Charm VTM, and the information contained in the operator’s manual, has not been reviewed by the US Food and Drug Administration.

VTM is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing covered by a laboratory’s CLIA certification for high-complexity testing, and not for at home testing including at home specimen collection.

For in vitro diagnostic use only. 

Use only as intended for the collection and transport of viral clinical samples including COVID-19 clinical samples. For viral detection including SARS-CoV-2 molecular and biochemical assays.

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