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RF Calibrator (Ver.2), Disease Control, Atlanta, GA

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RF Calibrator (Ver.2), Disease Control, Atlanta, GA KAMIYA BIOMEDICAL COMPANY further information, refer to "Decontamination of Laboratory Materials Required But Not Supplied Sink Drains to Remove Azide Salts," in the Manual Guide- K-ASSAY Safety Management No. CDC-22 issued by the Center for Calibrators: K-ASSAY RF Calibrator (Ver.2), Disease Control, Atlanta, GA. Cat. No. KAI-231C. RF (Ver.2) Purified water REAGENT PREPARATION For the Quantitative Determination of Human Rheumatoid Factor (RF) in Serum and Plasma Two Reagent Clinical Chemistry Analyzer: Reagents are ready to use and do not require reconstitution. Capable of accurate absorbance readings Cat. No. KAI-230 Capable of accurately dispensing the required volumes STORAGE AND HANDLING Capable of maintaining 37°C INTENDED USE calibrators with known concentrations of proteins and using the instrument’s data reduction capability or All reagents should be stored refrigerated (2-8°C). Return all Assay Procedure The K-ASSAY RF (Ver.2) assay is for the quantitative manually plotting the change in absorbance versus reagents to 2-8°C promptly after use. Unopened reagents determination of human IgG rheumatoid factor antibodies in concentration. Concentration of the controls and patient can be used until the expiration date indicated on the Note: Allow all reagents and specimens to warm to room patient serum or plasma (citric acid, EDTA, or lithium samples are interpolated from the calibration curve. package and bottle labels. temperature. Mix all reagents gently before using. heparin) based on immunoturbidimetric assay. The presence The K-ASSAY RF (Ver.2) assay should be run using the of IgG RF antibodies, in conjunction with clinical findings and REAGENT STABILITY An example of automated application: K-ASSAY RF Calibrator (Ver.2). These 6 calibrators are other laboratory tests, is an aid in the diagnosis of used to prepare a calibration curve for quantifying the levels rheumatoid arthritis (RA). FOR IN VITRO DIAGNOSTIC Discard reagents if they become contaminated. Evidence of Sample 3.0 µL of rheumatoid factor present in the patient's serum or plasma USE. cloudiness or particulate material in solution is cause to ↓ sample. discard. • ← R1 (Buffer Reagent) 100 µL INTRODUCTION AND SUMMARY ↓ 37 °C, 5 min. KIT COMPOSITION Opened reagents can be used for 1 month if stored at • ← R2 (Latex Suspension) 100 µL 2-8°C. The K-ASSAY RF (Ver.2) assay is intended for the ↓ 37 °C, 5 min. Reagents (Liquid Stable) quantitative determination of human IgG rheumatoid factor 2-point endpoint, 700 nm INSTRUMENT (RF) antibodies by immunoturbidimetric assay. The R1: Buffer Reagent 1 x 20 mL rheumatoid factor (an autoimmune antibody in the patient's Automated Method (Example) Phosphate Buffer Measurement of absorbance is to be made with an serum or plasma) interacts with the aggregated human IgG instrument able to accurately read absorbances. Refer to the in the reagent forming immune complexes. The immune Chemistry Parameters for Automatic Analyzer R2: Latex Suspension 1 x 20 mL instrument manual from the manufacturer regarding the complexes cause an increase in light scattering, which Suspension of latex particles sensitized following: INSTRUMENT Abbott Architect c8000 correlates with the concentration of rheumatoid factor. with human γ globulin (0.7 mg/mL) ASSAY NAME ( RFv2 ) Autoantibodies of the IgG, IgM, or IgA isotype, which are Phosphate Buffer a) Use or function ASSAY TYPE ( PHOTOMETRIC ) reactive with the crystallizable fraction (Fc) of IgG, are called b) Installation procedures and requirements ASSAY AVAILABILITY ( ENABLED ) rheumatoid factors. Rheumatoid factor is found in 50-79% of WARNINGS AND PRECAUTIONS c) Principles of operation REACTION MODE ( END UP ) adults with classical rheumatoid arthritis. Quantification of d) Performance characteristics, operating instructions WAVELENGTH ( 700 ) / ( NONE ) rheumatoid factor has been shown to be useful in the clinical FOR IN VITRO DIAGNOSTIC USE. Rx only. e) Calibration procedures including materials and / or 1,2,3,4,5,6,7,8 LAST READ REQUIRED ( 33 ) diagnosis and prognosis of rheumatoid arthritis. equipment to be used Not to be used internally in humans or animals. Normal ABSORBANCE RANGE ( ) ( ) f) Operational precautions, limitations, and hazards Rheumatoid factor has been measured using a variety of precautions exercised in handling laboratory reagents should SAMPLE BLANK TYPE ( SELF ) g) Service and maintenance information methods, including agglutination, latex fixation, be followed. FLEX READ TIME ( 32 ) - ( 33 ) nephelometric, and enzyme-linked immunoabsorbent COLOR CORRECTION 9,10 Do not mix or use reagents from one test kit with those from SPECIMEN COLLECTION AND PREPARATION ( ) - ( ) assay. The K-ASSAY RF (Ver.2) uses a latex-enhanced READ TIME a different lot number. immunoturbidimetric assay format. It is recommended that specimen collection be carried out in BLANK READ TIME ( 19 ) - ( 20 ) Do not use reagents past their expiration date stated on each accordance with CLSI document M29-A3. No method can REAGENT ( RF ) PRINCIPLE OF TEST reagent container label. offer complete assurance that human blood samples will not DILUENT ( NONE ) Do not pipette by mouth. Avoid ingestion and contact with transmit infection. Therefore, all blood samples should be DILUTION DISP. MODE ( TYPE 1 ) The K-ASSAY RF (Ver.2) assay quantifies the skin. considered potentially infectious. REAGENT VOLUME R1:( 100 ) R2:( 100 ) rheumatoid factor in the patient's serum or plasma based WATER VOLUME R1:( ) R2:( ) on latex-enhanced immunoturbidimetric assay. Reagents contain human source material. Each donor unit Serum or plasma (EDTA or lithium heparin) test samples DISPENSE MODE ( TYPE 1 ) ( TYPE 1 ) Calibrators, controls, and patient samples are pipetted into used in the preparation of this product has been tested by an must be collected in the manner routinely used for clinical DILUTION NAME ( STANDARD ) sample cups. Microvolumes of samples and reagent FDA approved method and found non-reactive for HBsAg laboratory tests. Freshly drawn serum is preferred and SAMPLE ( 3.0 ) diluent are automatically pipetted into individual cuvettes. and antibody to HIV. However, it is not possible to guarantee should be used within the day of collection. Samples may that any human source material is free of these or other also be stored refrigerated (4-8°C) for 8 days or at -20°C for DILUTION FACTOR ( ) Following an initial incubation and measurement of sample 11 infectious agents. up to 3 months. Avoid repeat freeze/thawing of specimens. DEFAULT DILUTION ( SELECTED ) blank, gamma globulin containing aggregated human IgG REACTION CHECK ( RATE RATIO ) is added to the cuvettes. The sample (autoantibodies) Therefore, all products containing human source material Use plastic tubes for storing the samples, do not use MAX. ABS. VARIATION ( 0.01 ) solution and gamma globulin reagent (antigen) are then should be handled in accordance with good laboratory glass. CALIBRATION METHOD ( SPLINE ) mixed in the reaction cuvettes. Insoluble antigen-antibody practices and appropriate control. See the National Institute REPLICATES ( 3 ) (immune) complexes form. The immune complexes cause of Health Manual, "Biosafety in Microbiology and Biomedical PROCEDURE RESULT CONC. UNITS ( IU / ML ) an increase in light scattering, which correlates with the Laboratories," 2nd ed., 1988. concentration of rheumatoid factor. Following an Materials Supplied RF Calibrators (Ver.2) includes 6 levels to be used as Reagents in this kit contain < 0.1% w/v sodium azide as a incubation period lasting approximately 5 minutes, the calibrators. Input the concentrations for each calibrator. preservative. Sodium azide may form explosive compounds absorbance change of the solution is measured. Reagent 1 (R-1) Buffer Reagent 1 x 20 mL in metal drain lines. When disposing of reagents through Parameters for other automated analyzers are available. Reagent 2 (R-2) Latex Suspension 1 x 20 mL A calibration curve is generated by assaying a series of plumbing fixtures, flush with copious amounts of water. For K-ASSAY RF (Ver.2) 1 Rev. 2020-10-29 CALIBRATION Multi-Site Precision Sample INTERFERENCE LABELING SYMBOLS 1 2 3 4 For samples with RF concentrations less than 600 IU/mL, a Testing was performed on an Abbott Architect c8000 Lot Number multi-point calibration curve using the K-ASSAY RF Mean (IU/mL) 14.13 21.24 101.69 532.83 analyzer according to the CLSI EP07-3rd edition guideline Calibrator (Ver.2), Cat. No. KAI-231C, should be used. In our N 75 75 75 75 with the following results. Reagent testing on an Abbott Architect c8000, the calibration curve Expiration or “Use By” Date was stable for 43 days. It is recommended that the user S.D. 0.64 0.54 0.75 4.44 Repeatability Ascorbic Acid No interference up to 50 mg/dL confirm calibration frequency as this may depend on the C.V. % 4.5 2.5 0.7 0.8 Bilirubin, Conjugated No interference up to 20 mg/dL Catalog Number instrument and type/number of other assays being performed. S.D. 1.02 1.03 1.61 7.86 Bilirubin, Unconjugated No interference up to 20 mg/dL In Vitro Reproducibility For Diagnostics Use C.V. % 7.2 4.9 1.6 1.5 Chyle No interference up to 1,500 FTU 2-8 °C Temperature Limitation. TRACEABILITY Hemoglobin No interference up to 500 mg/dL Store between 2 and 8 degrees C Accuracy / Correlation The values of the K-ASSAY RF Calibrator (Ver.2) are Total Cholesterol No interference up to 400 mg/dL Potential Human Biohazard traceable to the NIBSC Rheumatoid Arthritis Serum, Testing was performed on an Abbott Architect c8000 Total Triglycerides No interference up to 1,000 mg/dL 64/002. Based upon this standardization, results are analyzer according to the CLSI EP9-A3 guideline. A Manufacturer reported in International Units (IU/mL). comparison of the K-ASSAY RF (Ver.2) assay and EXPECTED VALUE company A’s RF assay was performed with the following Consult Package Insert for Instructions for Use QUALITY CONTROL results: The expected value as reported is < 11 IU/mL.
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