Clinical diagnostic assays, may be classified as quantitative, quasi-quantitative or qualitative. The assay's description should state what the assay needs to accomplish (intended use or purpose) and what it is not intended to achieve. The type(s) of samples (whole blood, peripheral blood mononuclear cells (PBMC), bone marrow, bone marrow mononuclear cells (BMMC), tissue, fine needle aspirate, fluid, etc.), instrument platform for use and anticoagulant restrictions should be fully validated for stability requirements and specified. When applicable, assay sensitivity and specificity should be fully validated and reported; these performance criteria will dictate the number and complexity of specimen samples required for validation. Assay processing and staining conditions (lyse/wash/fix/perm, stain pre or post, time and temperature, sample stability, etc.) should be described in detail and fully validated.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1002/cyto.b.21106 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Rapid and automated interpretation of CRISPR-Cas13-based lateral flow assay test results using machine learning.
Sens Diagn
December 2024
Department of Bioengineering, Rice University Houston TX 77030 USA
CRISPR-Cas-based lateral flow assays (LFAs) have emerged as a promising diagnostic tool for ultrasensitive detection of nucleic acids, offering improved speed, simplicity and cost-effectiveness compared to polymerase chain reaction (PCR)-based assays. However, visual interpretation of CRISPR-Cas-based LFA test results is prone to human error, potentially leading to false-positive or false-negative outcomes when analyzing test/control lines. To address this limitation, we have developed two neural network models: one based on a fully convolutional neural network and the other on a lightweight mobile-optimized neural network for automated interpretation of CRISPR-Cas-based LFA test results.
View Article and Find Full Text PDFNext step towards point-of-care molecular diagnosis of female genital schistosomiasis (FGS): evaluation of an instrument-free LAMP procedure.
Front Parasitol
May 2024
Department of Parasitology, Leiden University Medical Center, Leiden, Netherlands.
Detection of spp. DNA in gynaecological samples by quantitative real-time polymerase chain reaction (qPCR) is considered to be the reference diagnostic test for female genital schistosomiasis (FGS). However, qPCR needs expensive laboratory procedures and highly trained technicians.
View Article and Find Full Text PDFCellular automata modelling of leukaemic stem cell dynamics in acute myeloid leukaemia: insights into predictive outcomes and targeted therapies.
R Soc Open Sci
January 2025
Department of Anatomy, Kanazawa Medical University, Uchinada, Ishikawa 9200293, Japan.
Acute myeloid leukaemia (AML) is a haematologic malignancy with high relapse rates in both adults and children. Leukaemic stem cells (LSCs) are central to leukaemopoiesis, treatment response and relapse and frequently associated with measurable residual disease (MRD). However, the dynamics of LSCs within the AML microenvironment is not fully understood.
View Article and Find Full Text PDFGut Microbiome and Metabolite Characteristics Associated With Different Clinical Stages in Non-Small Cell Lung Cancer Patients.
Cancer Manag Res
January 2025
Lung Cancer Center, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
Objective: Our research has pinpointed the gut microbiome's role in the progression of various pathological types of non-small cell lung cancer (NSCLC). Nonetheless, the characteristics of the gut microbiome and its metabolites across different clinical stages of NSCLC are yet to be fully understood. The current study seeks to explore the distinctive gut flora and metabolite profiles of NSCLC patients across varying TNM stages.
View Article and Find Full Text PDFAdvancing road safety strategy development: A data-driven multi-objective optimisation integrated approach.
Heliyon
July 2024
School of Engineering, University of Birmingham, Edgbaston, Birmingham, B15 2TT, United Kingdom.
Road traffic accidents pose a significant global health concern, with an alarming 1.19 million fatalities reported in 2021. Traditionally, strategies to address this challenge have relied on expert input and subjective evaluations.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!