Test procedure : Monkeypox virus generic real-time PCR test
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Filetype[PDF-195.90 KB]


English

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    The Poxvirus and Rabies Branch (PRB) developed this document as a test procedure for the Monkeypox virus generic real-time PCR assay. This is not a controlled document. The performance characteristics as generated at Centers for Disease Control and Prevention (CDC) are specific to the version as written. These documents are provided by PRB laboratory solely as an example for how this test performed within the PRB laboratory. The recipient testing laboratory is responsible for generating validation or verification data as applicable to establish performance characteristics as required by the testing laboratory’s policies, applicable regulations, and quality system standards. These data are only for the sample and specimen types and conditions described in this procedure. Tests or protocols may include hazardous reagents or biological agents. No indemnification for any loss, claim, damage, or liability is provided for the party receiving an assay or protocol. Use of trade names and commercial sources are for identification only and do not constitute endorsement by the Public Health Service, the United States Department of Health and Human Services, or the Centers for Disease Control and Prevention.

    The purpose of this protocol is to describe the procedure used for the detection of Monkeypox virus DNA in clinical specimens by real-time PCR. This assay detects DNA at varying concentrations, providing a qualitative result of either positive, negative, or inconclusive in the identification of Monkeypox virus infections.

    PCR-Diagnostic-Protocol-508.pdf

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