Cepheid Xpert HCV VL Fingerstick

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

SPD SCIENTIFIC PTE LTD

Class:

Class D IVD

Manufactured by:

Cepheid AB

Therapeutic area:

Microbiology

Therapeutic indications:

The Xpert HCV VL Fingerstick (FS) assay is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human capillary fingerstick EDTA whole blood and venous EDTA whole blood from HCV-infected individuals using the automated GeneXpert® Instrument Systems. The assay is intended for use as an aid in the initial diagnosis in individuals at high risk of HCV infection or anti-HCV positive individuals. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. The assay is intended for use as an aid in the management of HCV infected patients undergoing antiviral therapy. The test measures HCV RNA levels at any time during viremia and during treatment; and can be utilized to predict sustained and nonsustained virological responses to HCV therapy. The assay is not intended to be used as a blood donor screening test for HCV.

Product summary:

Models: Xpert HCV VL Fingerstick - GXHCV-FS-CE-10

Authorization date:

2020-07-01