Multiple-viruses IVDs

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Disponibil de la:

Cepheid Holdings Pty Ltd

Clasă:

Class 3

Produs de:

Cepheid 904 Caribbean Drive, Sunnyvale, California, 94089 United States Of America

Zonă Terapeutică:

CT702 - Multiple-viruses IVDs

Indicații terapeutice:

The Cepheid? Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis. This test, in conjunction with other laboratory results and clinical information, may be used as an aid in the laboratory diagnosis of enterovirus infection in patients with a clinical suspicion of meningitis or meningoencephalitis. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. CAUTION: The results obtained with the Xpert EV assay should be used only as an adjunct to clinical observations and other information available to the physician. Positive Xpert EV results do not rule out other causes of meningitis, including bacteria, mycobacteria, other viruses (e.g., herpes family viruses, arboviruses, mumps virus, etc.), and fungi.

Statutul autorizaţiei:

A

Data de autorizare:

2014-03-28