Cepheid Xpert HIV-1 Viral Load

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Fáanlegur frá:

SPD SCIENTIFIC PTE LTD

Tegund:

Class C IVD

Framleitt af:

Cepheid AB

Lækningarsvæði:

Microbiology

Ábendingar:

The Xpert HIV-1 VL assay is an in vitro reverse transcriptase polymerase chain reaction (RT-PCR) assay for the detection and quantification of Human Immunodeficiency Virus type 1 (HIV-1) RNA in human plasma from HIV-1 infected individuals, using the automated GeneXpert Instrument Systems. The assay can quantify HIV-1 RNA over the range of 40 to 10,000,000 copies/mL. The Xpert HIV-1 VL assay is validated for quantification of RNA from HIV-1 Group M (subtypes A, B, C, D, F, G, H, J, K, CRF01_AE, CRF02_AG, and CRF03_AB), Group N, and Group O. The Xpert HIV-1 VL assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels.The Xpert HIV-1 VL assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection

Vörulýsing:

Models: Xpert HIV-1 Viral Load - GXHIV-VL-CE-10

Leyfisdagur:

2020-06-04