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Showing 37 - 48 of 60 for “Analyticon Biotechnologies”

All Results (60)Article (47)Products (4)Companies (2)Technologies (5)Glossary (2)

Article

Combined total error in calculated clinical chemistry tests: component analytical error is magnified and decision threshold gray zones widen.

Research record from Lab Med, 2026-08-01. PMID 42776845.

Article

Comparative Analytical Performance and Clinical Agreement of Chemiluminescence Microparticle Immunoassay and Electrochemiluminescence Immunoassay for CA19-9: A Diagnostic Accuracy Study.

Research record from Diagnostics (Basel), 2026-08-19. PMID 42651039.

Article

Comparative evaluation of inductively coupled plasma mass spectrometry and a phosphatase method for lithium measurement: an analytical method-comparison study.

Research record from Front Chem, 2026-08-28. PMID 42729405.

Article

Comparison of the analytical and clinical performance of three immunoassay platforms for plasma glial fibrillary acidic protein in Alzheimer's disease.

Research record from Clin Chem Lab Med, 2026-04-02. PMID 41921527.

Article

Design and analytical validation of Nexthyro 2.0, a custom next-generation sequencing panel integrating DNA mutation profiling and RNA fusion detection for routine thyroid pathology specimens.

Research record from Virchows Arch, 2026-08-31. PMID 42671580.

Article

Development and Analytical Validation of a Smartphone-Based Quantitative Lateral Flow Immunoassay for Serum Cystatin-C.

Research record from J Clin Lab Anal, 2026-10-06. PMID 42834839.

Article

Development and Initial Analytical Evaluation of a Multiplex PCR-Based Targeted NGS Assay for Expanded Viral Detection in Clinical Respiratory Specimens.

Research record from Diagnostics (Basel), 2026-09-08. PMID 42793673.

Article

Evaluation of analytical equivalence between Ampulab and BD Vacutainer blood collection tubes across clinical chemistry, immunoassay, hematology, and coagulation panels.

Research record from Scand J Clin Lab Invest, 2026-05-05. PMID 42085024.

Article

Evaluation of Chimerism Testing by Next-Generation Sequencing Using Insertion/Deletion Markers: Analytical Validation and Examples of Clinical Utilization.

Research record from J Mol Diagn, 2026-04-22. PMID 42031332.

Glossary Term

FDA 510(k) Clearance

A US pathway in which a device maker demonstrates substantial equivalence to a legally marketed predicate. For IVD test kits, 510(k) clearance documents intended use and analytical/clinical support; it is distinct from CLIA waiver, which concerns point-of-care operation settings.

Regulatory Definitions

Article

High-throughput quantification of tacrolimus in whole blood by acoustic ejection mass spectrometry: analytical validation and comparative assessment against conventional LC-MS/MS for therapeutic drug monitoring.

Research record from Clin Chim Acta, 2026-03-26. PMID 41903863.

Article

HPV screening tenders: what to verify beyond the CE mark

What procurement teams should verify in HPV screening tenders: analytical performance floors, genotyping granularity, clinical evidence grading, and programme integration.

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