Solution reagent kit KAI-230

diagnosticimmunoturbidimetricliquid

R1: 1 X 20 mL Buffer Reagent R2: 1 X 20 mL Latex Suspension Tests / Kit: 200 (Abbott Architect c8000) (Can Vary Based On Analyzer Model) INTENDED USE For the quantitative determination of human IgG rheumatoid factor antibodies in patient serum or plasma (citric acid, EDTA, or lithium heparin) based on immunoturbidimetric assay. The presence of IgG RF antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatoid arthritis (RA). FOR IN VITRO DIAGNOSTIC USE. REAGENT PREPARATION Reagents are ready to use and do not require reconstitution. STORAGE AND HANDLING Unopened reagents can be used until the expiration date indicated on the package and bottle labels. PERFORMANCE Precision The precision for the K-ASSAY ® RF (Ver.2) assay was determined using packaged reagents, clinical serum samples, and an Abbott Architect c8000 chemistry analyzer according to the CLSI EP5-A3 guideline. Representative data are below. Accuracy / Correlation Testing was performed on an Abbott Architect c8000 analyzer according to the CLSI EP9-A3 guideline. INTERFERENCE Testing was performed on an Abbott Architect c8000 analyzer according to the CLSI EP07-3rd edition guideline with the following results. Ascorbic Acid : No interference up to 50 mg/dL Bilirubin, Conjugated : No interference up to 20 mg/dL Bilirubin, Unconjugated : No interference up to 20 mg/dL Chyle : No interference up to 1,500 FTU Hemoglobin : No interference up to 500 mg/dL Total Cholesterol : No interference up to 400 mg/dL Total Triglycerides : No interference up to 1,000 mg/dL