B-001 Method Development of C-Reactive Protein in the Serum of Non-Human Primates

Abstract Objective The objective of this study is to validate C-Reactive Protein (CRP) measurement in Non-Human Primate (NHP) serum using the ADVIA 1800 analyzer. Methods CRP was validated NHP Validation testing included intra-assay precision, inter-assay accuracy, linearity dilution, limit quantitation (LOQ), detection (LOD), reference interval, carry-over, correlation, and stability. Samples were collected into tubes containing no anti-coagulant. Intra-assay precision determined by analyzing two biological samples quality control levels Bio-Rad Lyphochek Immunology Plus Control 10 consecutive times (in duplicate) within a single run. Inter-assay six for days over 10-day period. Accuracy calculated data obtained from testing. For calibrator material diluted specimen analyzed duplicate. LOQ diluting low-level produce value at low end reportable range. Diluted tested same LOD assaying appropriate blank interval 21 samples. Correlation between analyzers on both once. carry-over assay high-level followed material. Stability room temperature, refrigerated, frozen (at -20°C) various durations storage. Results show that met acceptance criteria quantitation, material, %CV ±20%. total error observed (TEobs) ±20% accuracy mean acceptable range specified manufacturer. coefficient determination ≥0.9000 TEobs each dilution level lower than 20%. set lowest concentration which adding three standard deviation. 2.5th 97.5th percentile Excel software. as it ≤2%. describe any bias result interpretation. all storage conditions found be with %difference Conclusion required validation parameters. analyzer can used preclinical studies test serum.