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In order to establish the best strategy to assess the HER-2/ neu status, numerous studies have compared the results of the two FDA approved assay methods.
The real-time PCR assay used in this study has been reported to have similar sensitivity and specificity to Hybrid Capture 2 (Qiagen, Hilden, Germany), a United States Food and Drug Administration approved assay [ 14].
The new commercially available Mycofast Revolution (ELiTech Diagnostic, France) assay is a CE approved assay (European Conformity; A mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives).
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However this finding was rarely evaluated systematically because of lack of CSF approved assays, that would allow a routine application which is not restricted to special laboratories [17].
Samples will only be used for MREC approved assays.
Two novel FDA approved assays for detecting latent TB can be considered.
Current FDA approved assays available for bladder cancer detection are: BTA stat, BTA TRAK, NMP22, FDP, Urovysion, and ImmunoCyt.
Tests for hormone receptors (estrogens and progesterone) are some of the most long-standing predictive biomarker assays for treatment selection in breast and prostate cancers; recently, the FDA approved assays for HER2, epidermal growth factor receptor and KIT [ 1].
The newly modified and simplified 48-h rotavirus isolation-based assay may serve as a base line methodology in laboratory evalaution studies, as a laboratory support methodology during drug/vaccine efficacy trials, or for the testing of sources (e.g., biopsy/autopsy tissues) not approved for assay by commercial rotavirus kits.
We performed CTC enumeration using the automated and FDA approved CellSearch assay.
Sensitive and specific FDA approved serological assay for HSV-1&2 was used (HerpeSelect by FOCUS technologies, USA).
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