Point-of-Care Testing
3 articles
Nitrocellulose Membrane Selection for Lateral Flow Assays: How Pore Size, Flow Rate, and Protein Binding Determine IVD Performance
How to select nitrocellulose membranes for lateral flow assay IVD products — pore size, capillary flow rate, protein binding capacity, backing type, thickness, striping parameters, lot-to-lot qualification, and regulatory considerations under FDA and EU IVDR.
Sample Pad, Conjugate Pad, and Absorbent Pad Qualification for Lateral Flow IVD Products
How to qualify sample pads, conjugate pads, and absorbent pads for lateral flow assay IVD products — material selection, pretreatment chemistry, lot-to-lot consistency testing, incoming material specifications, and regulatory requirements under FDA QMSR and ISO 13485.
Point-of-Care Testing (POCT): Regulatory Requirements, CLIA Waivers, and Market Trends
Comprehensive guide to point-of-care testing regulation — CLIA waiver requirements, FDA review pathways for POCT devices, EU IVDR classification, quality management, and the rapidly growing near-patient testing market.