The document outlines the Total Iron-Binding Capacity (TIBC_2) test system for in vitro diagnostic use, detailing its intended use, methodology, and safety precautions. It describes the reagents involved, sample collection guidelines, calibration, quality control, and performance characteristics of the assay. The normal range for TIBC is specified as 250 - 450 µg/dl, with recommendations for laboratories to establish their own reference ranges.
The document outlines the Total Iron-Binding Capacity (TIBC_2) test system for in vitro diagnostic use, detailing its intended use, methodology, and safety precautions. It describes the reagents involved, sample collection guidelines, calibration, quality control, and performance characteristics of the assay. The normal range for TIBC is specified as 250 - 450 µg/dl, with recommendations for laboratories to establish their own reference ranges.
The document outlines the Total Iron-Binding Capacity (TIBC_2) test system for in vitro diagnostic use, detailing its intended use, methodology, and safety precautions. It describes the reagents involved, sample collection guidelines, calibration, quality control, and performance characteristics of the assay. The normal range for TIBC is specified as 250 - 450 µg/dl, with recommendations for laboratories to establish their own reference ranges.
The document outlines the Total Iron-Binding Capacity (TIBC_2) test system for in vitro diagnostic use, detailing its intended use, methodology, and safety precautions. It describes the reagents involved, sample collection guidelines, calibration, quality control, and performance characteristics of the assay. The normal range for TIBC is specified as 250 - 450 µg/dl, with recommendations for laboratories to establish their own reference ranges.
TOTAL IRON-BINDING SAFETY PRECAUTIONS AND WARNINGS
For in vitro diagnostic use only. Do not ingest, do not pipette by
CAPACITY 2 (TIBC_2) mouth. Prevent contact with skin and eyes. Handle laboratory reagents in accordance with good laboratory practice. COLORIMETRIC METHOD RX SERIES All reagents and controls being tested should be handled as if capable of transmitting infection and disposed of accordingly. INTENDED USE A TIBC_2 test system is a device intended for the quantitative in Health and Safety Data Sheets are available on request. vitro determination of total iron-binding capacity (TIBC) concentration in serum. This product is suitable for use on the The reagents must be used only for the purpose RX series instruments which includes the RX daytona and Rx intended by suitably qualified laboratory personnel, imola. under appropriate laboratory conditions.
Cat. No. STABILITY AND PREPARATION OF REAGENTS
TI 4064 R1. Acidic Buffer 4 x 9 ml R1. Acidic Buffer R2. Neutral Buffer 4 x 4 ml Supplied ready for use. Stable up to expiry date when stored at +2 to +8C. CLINICAL SIGNIFICANCE (1,2,3,4) Measurements obtained by this device are used in the diagnosis R2. Neutral Buffer and treatment of anemia. Supplied ready for use. Stable up to expiry date when stored at +2 to +8C. PRINCIPLE Randox TIBC_2 assay uses two reagents in a sequential process MATERIALS PROVIDED that may be monitored spectrophotometrically. Acidic Buffer Neutral Buffer Step 1: The first reagent (R1) an acidic buffer containing an iron-binding MATERIALS REQUIRED BUT NOT PROVIDED dye and ferric chloride is added to the serum sample. The low Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level pH of R1 releases iron from transferrin. The iron then forms a 3 (Cat. No. HE 1532) coloured complex with the dye. The coloured complex at the Randox Calibration Serum Level 3 (Cat. No. CAL 2351) end of this first step represents both the serum iron and excess iron already present in R1.
Step 2: Reagent 2 (R2), a neutral buffer is then added, shifting the pH and resulting in a large increase in affinity of transferrin for iron. The serum transferrin rapidly binds the iron by abstracting it from the dye-iron complex. The observed decrease in absorbance of the coloured dye-iron complex is directly proportional to the total iron-binding capacity of the serum sample.
SAMPLE COLLECTION AND STORAGE
Do not use Plasma. Serum is the specimen of choice. Samples should be separated from the red cells and analyzed promptly. Samples should be stored at between +2 to +8C or at -20C for up to four weeks. Alternatively, the samples can be stored at room temperature (+22 to +28C) for two weeks.
CALIBRATION RX daytona 0.9% NaCl solution and Randox Calibration Serum Level 3 are Limit of Blank (µg/dl) 1 6.92 recommended for calibration. Limit of Detection (µg/dl) 1 14.321 Limit of Quantitation (µg/dl)1 40.00 QUALITY CONTROL Randox Assayed Multisera, Level 2 and Level 3 are recommended PRECISION for daily quality control. Two levels of controls should be assayed at least once a day. Values obtained should fall within a specified Within run precision range. If these values fall outside the range and repetition excludes Level 1 Level 2 Level 3 error, the following steps should be taken: Mean (µg/dl) 141 191 565 1. Check instrument settings and light source. SD 4.73 9.62 20.3 2. Check cleanliness of all equipment in use. CV(%) 3.3 5.0 3.6 3. Check water, contaminants i.e. bacterial growth may contribute n 80 80 80 to inaccurate results. 4. Check expiry date of kit and contents. Total precision 5. Contact Randox Laboratories Technical Services, Northern Level 1 Level 2 Level 3 Ireland +44 (0) 28 94451070. Mean (µg/dl) 141 191 565 SD 9.60 12.13 21.37 Quality control requirements should be determined in CV(%) 6.8 6.4 3.8 conformance with government regulations or accreditation n 80 80 80 requirements. CORRELATION INTERFERENCE This method (Y) was compared with another commercially The analytes below were tested up to the following levels at available method (X) and the following linear regression equation TIBC concentrations of 250 µg/dl and 450 µg/dl and were found obtained: not to interfere: Y= 0.95 X +3.45 Haemoglobin 1000 mg/dl 1000 mg/dl and a correlation coefficient of r = 0.997 Free Bilirubin 60 mg/dl 60 mg/dl Conjugate Bilirubin 60 mg/dl 60 mg/dl 120 patient samples were analysed spanning the range 48.7 to Triglycerides 2000 mg/dl 2000 mg/dl 652 µg/dl. Intralipid® 565 mg/dl 610 mg/dl Cuprimine 500 µg/dl 500 µg/dl REFERENCES Zinc 500 µg/dl 500 µg/dl 1. Tietz NW (ed). Textbook of Clinical Chemistry, Copper 6 mg/dl 6 mg/dl ed.3. Philadelphia, PA: WB Saunders; 1821, Iron 460 µg/dl 460 µg/dl 1999. Nickel 1000 µg/dl 1000 µg/dl 2. NCCLS. Determination of Serum Iron and Total Iron Desferal 6.0 µg/ml 16.2 µg/dl Binding Capacity; Proposed Standard, NCCLS Document Ascorbic Acid 5.08 mg/dl 5.95 mg/dl H17-9. Waynes, PA: NCCLS, Vol.10 No.4; 1990. NORMAL RANGE (5) 3. Starr RT. Use of an Alumina Column in estimating Total Normal Range 250 - 450 µg/dl Iron-Binding Capacity. Clin. Chem. 26: 156-158, 1980. It is recommended that each laboratory establish its own 4. Gambino R; et al. The relation between chemically reference range to reflect the age, sex, diet and geographical measured total iron-binding capacity concentrations and location of the population. immunologically measured transferrin concentrations in human serum. Clin. Chem. 43: 2408-2412, 1997. SPECIFIC PERFORMANCE CHARACTERISTICS 5. Karnam, U. S., Felder,L. R. And Raskin, J. B. Prevalence of The following performance characteristics were obtained using Occult Celiac Disease in Patients with Iron-Deficiency an RX daytona analyser. Anemia: A prospective study. Southern Medical Journal. Vol 97. No. 1 Jan 2004. P30-34. REPORTABLE RANGE Linearity data demonstrates that the reportable range for TIBC on the RX daytona is 40 to 1036 µg/dl.
Recovery Studies demonstrate that the measuring range can be
extended up to 3674 µg/dl for the RX daytona analyser within ± 10% of the TIBC concentration.
SENSITIVITY The limit of Quantitation (LoQ), the limit of Detection (LoD) and the limit of Blank (LoB) were determined consistent with CLSI guidelines EP17-A. LoQ is the lowest concentration that can be detected with a ≤20% bias and ≤20% imprecision. LoD is the lowest concentration that can be detected to determine the 15 Mar 16 pl presence or absence of TIBC. LoB is the highest concentration that is likely to be observed in a blank sample. Rev. 001
