Sentence examples for assay approved from inspiring English sources

Xpert HIV-1 Qual is a new NAAT assay approved for the identification of HIV infection in whole and dried blood.

2, 3 There is still no diagnostic assay approved for commercial use in the United States, with reference to specialized research laboratories required for HEV confirmation.

HCV was quantified using the Abbott RealTime RT-PCR assay, approved by the Food and Drug Administration, as performed in the UCSF Clinical Microbiology Laboratory on the Abbott Molecular m2000 system.

One such assay approved by the US Food and Drug Administration FDAA) is the GeneXpert system (Cepheid, Sunnyvale, CA, USA), which combines sample preparation and detection with real-time PCR in a closed and compact cartridge.

HER2 receptor protein extracellular domain (ECD, p105) is released into the circulation after cleavage by matrix metalloproteinases and its levels can be measured in the serum using an enzyme-linked immunosorbent assay approved by the FDA Siemens HealthcareErlangenGermanyrmany).

The aims of the present study were to establish the prevalence of elevated HER2 ECD levels, and determine whether there is an association between serum HER2 ECD levels and tissue HER2 overexpression in a large number of patients with primary breast cancer, using a single assay approved by the US Food and Drug Administration FDAA).

There are two different IHC assays approved for examining PD-L1 expression in formalin-fixed paraffin-embedded (FFPE) NSCLC tissue by FDA in October 2015, i.e. PD-L1 IHC 22C3 pharmDx linking to the use of pembrolizumab (Keytruda), and PD-L1 IHC 28-8 pharmDx linking to nivolumab (Opdivo) [3].

A screening of the 'Thomson Reuters IntegritySM Biomarker Database' reveals that as of May 2014, 945 candidate biomarkers of inflammation have been described, of which only seventeen, including CRP, TNF-α, serotransferrin and erythrocyte sedimentation rate, have been developed into biomarker assays approved and recommended by regulatory bodies for use in clinical studies.

HbA1c samples were analyzed with four highly intercorrelated DCCT-aligned assays: a high-performance liquid chromatography assay, two immunoassays, and an affinity assay (all approved by the National Glycohemoglobin Study Program).

Besides the LAL-assay, another officially approved assay with increasing popularity is the monocyte activation assay (MAT).

The PCR assay showed a greater sensitivity than culture identification assay in detecting Ureaplasma spp. At the time the samples were collected, culture identification assay, recently approved only for testing genital specimens with a good sensitivity, was also applied to respiratory secretions.