scholarly journals Analytical performance of a new automated chemiluminescent magnetic immunoassays for soluble PD-1, PD-L1, and CTLA-4 in human plasma

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Megumi Goto ◽  
Kenji Chamoto ◽  
Keiko Higuchi ◽  
Saya Yamashita ◽  
Kenta Noda ◽  
...  
Keyword(s):  
Human Plasma ◽  
Analytical Performance

Analytical performance of nano-LC-SRM using nondepleted human plasma over an 18-month period

PROTEOMICS ◽  
2016 ◽  
Vol 16 (15-16) ◽  
pp. 2118-2127 ◽  
Author(s):  
Xiaomin Song ◽  
Ardeshir Amirkhani ◽  
Jemma X. Wu ◽  
Dana Pascovici ◽  
Thiri Zaw ◽  
...  
Keyword(s):  
Human Plasma ◽  
Analytical Performance

scholarly journals Analytical performance evaluation of a commercial next generation sequencing liquid biopsy platform using plasma ctDNA, reference standards, and synthetic serial dilution samples derived from normal plasma

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Suman Verma ◽  
Mathew W. Moore ◽  
Rebecca Ringler ◽  
Abhisek Ghosal ◽  
Kyle Horvath ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
Next Generation Sequencing ◽  
Human Plasma ◽  
Allele Frequency ◽  
Liquid Biopsy ◽  
Clinical Laboratory ◽  
Reference Standards ◽  
Analytical Performance ◽  
Clinical Laboratories ◽  
Generation Sequencing

Abstract Background Circulating tumor (ct) DNA assays performed in clinical laboratories provide tumor biomarker testing support for biopharmaceutical clinical trials. Yet it is neither practical nor economically feasible for many of these clinical laboratories to internally develop their own liquid biopsy assay. Commercially available ctDNA kits are a potential solution for laboratories seeking to incorporate liquid biopsy into their test menus. However, the scarcity of characterized patient samples and cost of purchasing validation reference standards creates a barrier to entry. In the current study, we evaluated the analytical performance of the AVENIO ctDNA liquid biopsy platform (Roche Sequencing Solutions) for use in our clinical laboratory. Method Intra-laboratory performance evaluation of AVENIO ctDNA Targeted, Expanded, and Surveillance kits (Research Use Only) was performed according to College of American Pathologists (CAP) guidelines for the validation of targeted next generation sequencing assays using purchased reference standards, de-identified human plasma cell-free (cf) DNA samples, and contrived samples derived from commercially purchased normal and cancer human plasma. All samples were sequenced at read depths relevant to clinical settings using the NextSeq High Output kit (Illumina). Results At the clinically relevant read depth, Avenio ctDNA kits demonstrated 100% sensitivity in detecting single nucleotide variants (SNVs) at ≥0.5% allele frequency (AF) and 50% sensitivity in detecting SNVs at 0.1% AF using 20–40 ng sample input amount. The assay integrated seamlessly into our laboratory’s NGS workflow with input DNA mass, target allele frequency (TAF), multiplexing, and number of reads optimized to support a high-throughput assay appropriate for biopharmaceutical trials. Conclusions Our study demonstrates that AVENIO ctDNA liquid biopsy platform provides a viable alternative for efficient incorporation of liquid biopsy assays into the clinical laboratory for detecting somatic alterations as low as 0.5%. Accurate detection of variants lower than 0.5% could potentially be achieved by deeper sequencing when clinically indicated and economically feasible.

Green Sensitive Spectrofluorimetric determination of Remdesvir, an FDA approved SARS-COV-2 Candidate Antiviral; Application in Pharmaceutical Dosage Forms and Spiked Human Plasma

2021 ◽  
Author(s):  
Heba Elmansi ◽  
Adel Ehab Ibrahim ◽  
Ibraam Mikhail ◽  
Fathalla Belal
Keyword(s):  
Quality Control ◽  
Human Plasma ◽  
Dosage Forms ◽  
Analytical Performance ◽  
Pharmaceutical Dosage Forms ◽  
Spiked Human Plasma ◽  
Fluorescent Spectroscopy ◽  
Spectrofluorimetric Determination

Fluorescent Spectroscopy has gained lots of interests pending the last years. Its advantages cover both; the analytical performance, as well as ecological greenness. The quality control of pharmaceuticals requires sensitive,...

scholarly journals Analytical performance of reagent for assaying tau protein in human plasma and feasibility study screening neurodegenerative diseases

2017 ◽  
Vol 7 (1) ◽  
Author(s):  
Shieh-Yueh Yang ◽  
Ming-Jang Chiu ◽  
Ta-Fu Chen ◽  
Chin-Hsien Lin ◽  
Jiann-Shing Jeng ◽  
...  
Keyword(s):  
Neurodegenerative Diseases ◽  
Human Plasma ◽  
Feasibility Study ◽  
Tau Protein ◽  
Analytical Performance
Sign in / Sign up

Export Citation Format

Share Document