04536355500V17.

UIBC
Unsaturated Iron-Binding Capacity
Order information
Analyzer(s) on which cobas c pack(s)
can be used
04536355190 04536355500 Unsaturated Iron‑Binding Capacity (100 tests) System‑ID 07 3763 1 cobas c 311, cobas c 501/502,
COBAS INTEGRA 400 plus
Materials required (but not provided):
cobas c 311, cobas c 501/502 COBAS INTEGRA 400 plus
12146401216 Fe Standard (1 x 75 mL) Code 566 System‑ID 07 7560 6
12149435122 Precinorm U plus (10 x 3 mL) Code 300 System‑ID 07 7999 7
12149443122 Precipath U plus (10 x 3 mL) Code 301 System‑ID 07 8000 6
05117003190 PreciControl ClinChem Multi 1 (20 x 5 mL) Code 391 System‑ID 07 7469 3
05947626190 PreciControl ClinChem Multi 1 (4 x 5 mL) Code 391 System‑ID 07 7469 3
05117216190 PreciControl ClinChem Multi 2 (20 x 5 mL) Code 392 System‑ID 07 7470 7
05947774190 PreciControl ClinChem Multi 2 (4 x 5 mL) Code 392 System‑ID 07 7470 7

English Fe(II) (excess) + 3 FerroZine Fe(II)‑(FerroZine)3

Intended use The color intensity is directly proportional to the unbound excess iron
In vitro test for the quantitative determination of the unsaturated iron‑binding concentration and indirectly proportional to the unsaturated iron binding
capacity in human serum and plasma on cobas c and COBAS INTEGRA capacity. It is determined by measuring the increase in absorbance
systems. photometrically.
Summary Precautions and warnings
Unsaturated iron‑binding capacity (UIBC) measurements, performed with For in vitro diagnostic use for health care professionals. Exercise the
this assay in human serum and plasma, are used as an aid in diagnosis of normal precautions required for handling all laboratory reagents.
iron deficiencies and iron overload. UIBC is used in combination with serum Infectious or microbial waste:
iron to determine the total iron‑binding capacity (TIBC) and transferrin Warning: handle waste as potentially biohazardous material. Dispose of
saturation (TSAT). waste according to accepted laboratory instructions and procedures.
Anemia is the most common blood disorder, with iron deficiency anemia Environmental hazards:
being the most common cause of anemia. Therefore, iron panels are Apply all relevant local disposal regulations to determine the safe disposal.
routinely run in patients with anemia. Iron plays an essential role in many Safety data sheet available for professional user on request.
biochemical processes, in particular in the production of heme for
incorporation in hemoglobin and iron‑sulfur clusters. It serves as a cofactor This kit contains components classified as follows in accordance with the
for many proteins and enzymes necessary for oxygen and energy Regulation (EC) No. 1272/2008:
metabolism.1,2
The total iron content of the body is about 3 to 3.5 g, where the majority
(> 95 %) is contained in hemoglobin of erythrocytes (or their precursors in
the bone marrow), and also intracellular storages (e.g., ferritin).1,3 Only a
small amount (~3 mg) of Fe is bound to the circulating serum protein
transferrin, a complex of ferric iron Fe(III) bound to the plasma protein Warning
apotransferrin.1,3 Normally, about one third of the iron‑binding sites of
transferrin are occupied by Fe(III). The additional amount of iron that can be H317 May cause an allergic skin reaction.
bound is the unsaturated (or latent) iron‑binding capacity UIBC. The sum of
the serum iron and UIBC represents total iron‑binding capacity TIBC. TIBC H351 Suspected of causing cancer.
is a measurement for the maximum iron concentration that transferrin can
bind. It is used to calculate the transferrin saturation TSAT, which is the Prevention:
percentage of transferrin occupied by iron, and can be calculated by a ratio
of serum iron and TIBC.4 P201 Obtain special instructions before use.
The serum TIBC varies in disorders of iron metabolism. In iron‑deficiency P261 Avoid breathing mist or vapours.
anemia the TIBC is elevated and the TSAT is lowered to 15 % or less.1 Low
serum iron associated with low TIBC is characteristic of the anemia of
chronic disorders, malignant tumors, and infections.5 UIBC and TIBC are P280 Wear protective gloves/ protective clothing/ eye protection/
also modified in various physiological and clinical conditions. During face protection/ hearing protection.
pregnancy, UIBC, TIBC and transferrin values increase, which is proposed Response:
as a mechanism to ensure adequate iron delivery to the fetus.6,7 Increased
UIBC and TIBC levels are observed in frequent blood donors,8 after a P308 + P313 IF exposed or concerned: Get medical advice/attention.
multiday high‑altitude climb,9 iron chelation therapy,10 exposure to
polychlorinated biphenyls,11 testosterone therapy,12 and Fontan surgery (for P333 + P313 If skin irritation or rash occurs: Get medical
cardiac malformations).13 Reduced UIBC and TIBC levels are associated advice/attention.
with chronic kidney disease,14 increased mortality after liver
transplantation,15 increased bacterial infection risk after kidney
transplantation,16 and emetogenic severity in cancer chemotherapy.17 P362 + P364 Take off contaminated clothing and wash it before reuse.
Test principle Product safety labeling follows EU GHS guidance.
Direct determination with FerroZine.18,19 Contact phone: all countries: +49-621-7590
Alkaline buffer
Reagent handling
Ready for use
Fe(II) + transferrin transferrin‑Fe(III) + Fe(II) Note for cobas c: Put a new cassette direct from the refrigerator on the
(excess) analyzer, do not allow cassette to come to room temperature.

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04536355500V17.0

UIBC
Unsaturated Iron-Binding Capacity

Specimen collection and preparation R3 FerroZine: 20 mmol/L; hydroxylamine: 160 mmol/L; pH 2.5
For specimen collection and preparation only use suitable tubes or R1 is in position C and R3 is in position B.
collection containers.
Only the specimens listed below were tested and found acceptable. Storage and stability
Serum. Shelf life at 2‑8 °C: See expiration date on
Plasma: Li‑heparin plasma.
cobas c pack label.
Li‑heparin plasma values are approximately 6 % lower than serum values.
On‑board in use and refrigerated on the 8 weeks
The binding of iron to transferrin is strongly influenced by anions,
specifically bicarbonate.20 In order to avoid drift of UIBC recovery in analyzer:
samples over time the environmental concentration of CO2 in the laboratory Application for serum and plasma
should be kept as constant as possible.
Specimens should be collected in the morning to avoid low results due to cobas c 311 test definition
diurnal variation.21 Assay type 2‑Point End
The sample types listed were tested with a selection of sample collection
tubes that were commercially available at the time of testing, i.e. not all Reaction time / Assay points 10 / 23‑57
available tubes of all manufacturers were tested. Sample collection systems Wavelength (sub/main) 700 / 546 nm
from various manufacturers may contain differing materials which could
affect the test results in some cases. When processing samples in primary Reaction direction Increase
tubes (sample collection systems), follow the instructions of the tube Units µmol/L (µg/dL, mg/L)
manufacturer.
Reagent pipetting Diluent (H2O)
Centrifuge samples containing precipitates before performing the assay.
See the limitations and interferences section for details about possible R1 55 µL 70 µL
sample interferences. R3 25 µL 20 µL
Stability:22,23 4 days at 15‑25 °C
7 days at 2‑8 °C Sample volumes Sample Sample dilution
Materials provided Sample Diluent (H2O)
See “Reagents – working solutions” section for reagents. Normal 20 µL – –
Materials required (but not provided) Decreased 20 µL – –
▪ See “Order information” section Increased 10 µL – –
▪ General laboratory equipment
cobas c 501/502 test definition
Assay
For optimum performance of the assay follow the directions given in this Assay type 2‑Point End
document for the analyzer concerned. Refer to the appropriate operator’s Reaction time / Assay points 10 / 34‑70
manual for analyzer‑specific assay instructions.
Wavelength (sub/main) 700 / 546 nm
The performance of applications not validated by Roche is not warranted
and must be defined by the user. Reaction direction Increase
Calculation Units µmol/L (µg/dL, mg/L)
The systems automatically calculate the analyte concentration of each Reagent pipetting Diluent (H2O)
sample.
R1 55 µL 70 µL
Conversion factors: µmol/L x 5.59 = µg/dL
R3 25 µL 20 µL
µmol/L x 0.0559 = mg/L
Expected values24 Sample volumes Sample Sample dilution
Females: 24.2‑70.1 µmol/L (135‑392 µg/dL) Sample Diluent (H2O)
Males: 22.3‑61.7 µmol/L (125‑345 µg/dL) Normal 20 µL – –
Serum/plasma iron levels are dependent on diet and subject to circadian Decreased 20 µL – –
variation.
Increased 10 µL – –
Each laboratory should investigate the transferability of the expected values
to its own patient population and if necessary determine its own reference Calibration
ranges.
Calibrators S1: H2O
cobas c systems
S2: Iron Standard
System information
Calibration mode Linear
For cobas c 311/501 analyzers:
UIBCI: ACN 779 Calibration frequency 2‑point calibration
- after reagent lot change
For cobas c 502 analyzer:
- as required following quality control
UIBCI: ACN 8779 procedures
Reagents - working solutions Enter the correction value for the calibration with Iron Standard as
R1 Ferrous chloride: 62 µmol/L; sodium hydrogen carbonate: instrument factor y = ax + b, where a = -1.0 and b = 0.
75 mmol/L; TRIS buffer: 375 mmol/L, pH 8.4; preservative Calibration interval may be extended based on acceptable verification of
calibration by the laboratory.

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UIBC
Unsaturated Iron-Binding Capacity

Traceability: This method has been standardized against a primary samples diluted using the rerun function are automatically multiplied by a
reference material (weighed in purified material) through iron. factor of 2.
Quality control Lower limits of measurement
For quality control, use control materials as listed in the "Order information" Lower detection limit of the test
section. 3 µmol/L (16.8 µg/dL, 0.17 mg/L)
In addition, other suitable control material can be used. The lower detection limit represents the lowest measurable analyte level
The control intervals and limits should be adapted to each laboratory’s that can be distinguished from zero. It is calculated as the value lying
individual requirements. Values obtained should fall within the defined 3 standard deviations above that of the lowest standard (standard 1 + 3 SD,
limits. Each laboratory should establish corrective measures to be taken if repeatability, n = 21).
values fall outside the defined limits. Note: The technical limits for this assay are defined as ‑125 μmol/L
Follow the applicable government regulations and local guidelines for (‑700 μg/dL, ‑7 mg/L) for the lower limit and ‑3 μmol/L (‑16.8 μg/dL,
quality control. ‑0.17 mg/L) for the upper limit. This is due to the instrument factor for UIBC
(a = ‑1; see also above chapter "Calibration"). Results under the lower limit
Limitations - interference of the measuring range will be flagged with ">TEST". Results above the
Criterion: Recovery within ± 6 µmol/L of initial values of samples upper limit of the measuring range will be flagged with "<TEST".
≤ 60 µmol/L and within ± 10 % for samples > 60 µmol/L.
Specific performance data
Icterus:25 No significant interference up to an I index of 60 for conjugated
and unconjugated bilirubin (approximate conjugated and unconjugated Representative performance data on the analyzers are given below.
bilirubin concentration: 1026 µmol/L or 60 mg/dL). Results obtained in individual laboratories may differ.
Hemolysis:25 No significant interference up to an H index of 40 Precision
(approximate hemoglobin concentration: 24.8 µmol/L or 40 mg/dL). Precision was determined using human samples and controls in an internal
Contamination with erythrocytes will elevate results, because the analyte protocol with repeatability (n = 21) and intermediate precision (3 aliquots
level in erythrocytes is higher than in normal sera. The level of interference per run, 1 run per day, 21 days). The following results were obtained on the
may be variable depending on the content of analyte in the lysed cobas c 501 analyzer:
erythrocytes.
Repeatability Mean SD CV
Lipemia (Intralipid):25 No significant interference up to an L index of 300.
There is poor correlation between the L index (corresponds to turbidity) and µmol/L (µg/dL) µmol/L (µg/dL) %
triglycerides concentration. PCCC1 39.9 (223) 0.5 (3) 1.2
Anticoagulants: Complexing anticoagulants such as EDTA, oxalate, and
citrate must not be used. PCCC2 56.0 (313) 0.6 (3) 1.1
Drugs: No interference was found at therapeutic concentrations using Human serum A 46.1 (258) 0.6 (3) 1.3
common drug panels.26, 27 Human serum B 102 (570) 0.5 (3) 0.4
Exception: Oxytetracycline causes artificially high UIBC values at the tested
drug level. Human serum C 15.5 (86.6) 0.7 (3.9) 4.3
Pathologically high levels of albumin (7 g/dL) decrease the apparent UIBC
value significantly.
Intermediate precision Mean SD CV
If the patient’s serum iron exceeds the binding capacity of the transferrin, a
negative UIBC value will result. µmol/L (µg/dL) µmol/L (µg/dL) %
In patients treated with iron supplements or metal‑binding drugs, the Precinorm U 23.7 (132) 0.8 (5) 3.5
drug‑bound iron may not properly react in the test, resulting in falsely low
values. Precipath U 41.7 (233) 0.7 (4) 1.7
The physiological function of deferoxamine containing drugs is to bind iron Human serum 3 16.5 (92.2) 0.8 (4.5) 4.7
to facilitate its elimination from the body. Therefore any deferoxamine
concentration interferes with the UIBC assay. Human serum 4 24.3 (136) 0.8 (5) 3.1
In the presence of high ferritin concentrations > 1200 μg/L the assumption The data obtained on cobas c 501 analyzer(s) are representative for
that serum iron is almost completely bound to transferrin is not valid cobas c 311 analyzer(s).
anymore. Therefore, such iron results should not be used to calculate Total Method comparison
Iron Binding Capacity (TIBC) or percent transferrin saturation (% SAT).28
Serum
In very rare cases, gammopathy, in particular type IgM (Waldenström’s
macroglobulinemia), may cause unreliable results.29 UIBC values for human serum and plasma samples obtained on a
cobas c 501 analyzer (y) were compared with those determined using the
For diagnostic purposes, the results should always be assessed in corresponding reagent on a Roche/Hitachi MODULAR P analyzer (x).
conjunction with the patient’s medical history, clinical examination and other
findings. Sample size (n) = 58
ACTION REQUIRED Passing/Bablok30 Linear regression
Special Wash Programming: The use of special wash steps is mandatory
when certain test combinations are run together on cobas c systems. The y = 1.01x + 1.86 µmol/L y = 1.03x + 1.23 µmol/L
latest version of the carry‑over evasion list can be found with the NaOHD- τ = 0.956 r = 0.997
SMS-SmpCln1+2-SCCS Method Sheets. For further instructions refer to the
operator’s manual. cobas c 502 analyzer: All special wash programming The sample concentrations were between 7.50 and 80.1 µmol/L (41.9 and
necessary for avoiding carry‑over is available via the cobas link, manual 448 µg/dL).
input is required in certain cases. The data obtained on cobas c 501 analyzer(s) are representative for
Where required, special wash/carry‑over evasion programming must cobas c 311 analyzer(s).
be implemented prior to reporting results with this test.
COBAS INTEGRA systems
Limits and ranges
Measuring range System information
3-125 µmol/L (16.8‑700 µg/dL, 0.17‑7 mg/L) UIBCI: Test ID 0‑564 on COBAS INTEGRA 400 plus systems
Determine samples having higher concentrations via the rerun function.
Dilution of samples via the rerun function is a 1:2 dilution. Results from

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UIBC
Unsaturated Iron-Binding Capacity

Reagents - working solutions Control after calibration Recommended

R1 Ferrous chloride: 62 µmol/L; sodium hydrogen carbonate: For quality control, use control materials as listed in the “Order information”
75 mmol/L; TRIS buffer: 375 mmol/L, pH 8.4; preservative section. In addition, other suitable control material can be used.
The control intervals and limits should be adapted to each laboratory’s
SR FerroZine: 20 mmol/L; hydroxylamine: 160 mmol/L, pH 2.5 individual requirements. Values obtained should fall within the defined
R1 is in position C and SR is in position B. limits. Each laboratory should establish corrective measures to be taken if
values fall outside the defined limits.
Storage and stability
Follow the applicable government regulations and local guidelines for
Shelf life at 2‑8 °C See expiration date on quality control.
cobas c pack label Limitations - interference
On-board in use at 10‑15 °C 2 weeks If the patient’s serum iron exceeds the binding capacity of the transferrin, a
negative UIBC value results.
Application for serum and plasma Criterion: Recovery within ± 6 µmol/L of initial values of samples
Test definition ≤ 60 µmol/L and within ± 10 % for samples > 60 µmol/L.
Icterus:25 No significant interference up to an I index of 60 for conjugated
Measuring mode Absorbance and unconjugated bilirubin (approximate conjugated and unconjugated
Abs. calculation mode Endpoint bilirubin concentration: 1026 µmol/L or 60 mg/dL).
Reaction mode R1-S-SR Hemolysis:25 No significant interference up to an H index of 100
(approximate hemoglobin concentration: 62.1 µmol/L or 100 mg/dL).
Reaction direction Increase Avoid hemolyzed specimens. Hemoglobin levels higher than 0.06 mmol/L
Wavelength A/B 552/629 nm (1.0 g/L) increase the apparent UIBC value significantly.
Lipemia (Intralipid):25 No significant interference up to an L index of 200.
Calc. first/last 33/64 There is poor correlation between the L index (corresponds to turbidity) and
Unit µmol/L triglycerides concentration. Lipemic specimens may cause negative values
and/or high absorbance flagging.
Anticoagulants: Complexing anticoagulants such as EDTA, oxalate, and
Pipetting parameters citrate must not be used.
Diluent (H2O) Drugs: No interference was found at therapeutic concentrations using
common drug panels.26, 27Exceptions: Methyldopa and oxytetracycline
R1 80 µL 30 µL cause artificially high UIBC values at the tested drug level.
The physiological function of deferoxamine containing drugs is to bind iron
Sample 30 µL 20 µL to facilitate its elimination from the body. Therefore, any deferoxamine
SR 25 µL 15 µL concentration interferes with the UIBC assay.
Total volume 200 µL Pathologically high levels of albumin (7 g/dL) decrease the apparent UIBC
value significantly.
Calibration In the presence of high ferritin concentrations > 1200 µg/L the assumption
that serum iron is almost completely bound to transferrin is not valid
Calibrator Standard 1 (high): deionized water anymore. Therefore, such iron results should not be used to calculate Total
(179 µmol/L or 1000 µg/dL)* Iron Binding Capacity (TIBC) or percent transferrin saturation (% SAT).28
Standard 2 (low): Fe Standard (89.5 µmol/L In very rare cases, gammopathy, in particular type IgM (Waldenström’s
or 500 µg/dL) macroglobulinemia), may cause unreliable results.29
For diagnostic purposes, the results should always be assessed in
Calibration mode Linear regression conjunction with the patient’s medical history, clinical examination and other
Calibration replicate Duplicate recommended findings.
Calibration frequency - after reagent lot change ACTION REQUIRED
- as required following quality control Special Wash Programming: The use of special wash steps is mandatory
when certain test combinations are run together on COBAS INTEGRA
procedures analyzers. Refer to the CLEAN Method Sheet for further instructions and for
*For technical reasons a virtual concentration of 179 µmol/L (1000 µg/dL) the latest version of the Extra wash cycle list.
is assigned to the deionized water which is used as standard 1. This Where required, special wash/carry-over evasion programming must
be implemented prior to reporting results with this test.
concentration is substracted from the results for serum and plasma using a
Lab. Correlation Offset of ‑179 (‑1000). Limits and ranges
Measuring range
The calibrators must be placed on th CAL/QC rack with standard 1 (high,
deionized water) first and standard 2 (low, FE Standard) last. 6.0‑125 µmol/L (33.5‑700 µg/dL)
Calibration interval may be extended based on acceptable verification of Lower limits of measurement
calibration by the laboratory. Lower detection limit of the test:
6.0 µmol/L (33.5 µg/dL)
Traceability: This method has been standardized against a primary
reference material (weighed in purified material) through iron. The lower detection limit represents the lowest measurable analyte level
that can be distinguished from zero. It is calculated as the value lying
Quality control 3 standard deviations above that of a zero sample (zero sample + 3 SD,
repeatability, n = 30).
Reference range Precinorm U plus or
PreciControl ClinChem Multi 1 Specific performance data
Pathological range Precipath U plus or Representative performance data on the analyzers are given below.
Results obtained in individual laboratories may differ.
PreciControl ClinChem Multi 2
Precision
Control interval 24 hours recommended
Precision was determined using human samples and controls in an internal
Control sequence User defined protocol with repeatability and intermediate precision (2 aliquots per run,

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UIBC
Unsaturated Iron-Binding Capacity

2 runs per day, 20 days). The following results were obtained on the 11 Kimáková T, Nevolná Z, Vašková J, et al. Retrospective assessment of
COBAS INTEGRA 700 analyzer: specific effects of exposure of workers to PCBs in Slovakia. Ann Agric
Environ Med 2018 Sep 25;25(3):421-427.
Level 1 Level 2
12 Dhindsa S, Ghanim H, Batra M, et al. Effect of testosterone on
Mean 25.0 µmol/L 43.4 µmol/L hepcidin, ferroportin, ferritin and iron binding capacity in patients with
hypogonadotropic hypogonadism and type 2 diabetes. Clin Endocrinol
(140 µg/dL) (242 µg/dL) (Oxf) 2016 Nov;85(5):772-780.
CV repeatability 1.6 % 0.8 % 13 Tomkiewicz-Pajak L, Plazak W, Kolcz J, et al. Iron deficiency and
CV intermediate precision 1.7 % 1.2 % hematological changes in adult patients after Fontan operation. J
Cardiol 2014 Nov;64(5):384-389.
The data obtained on COBAS INTEGRA 700 analyzer(s) are representative 14 Avci Çiçek E, Rota S, Dursun B, et al. Evaluation of serum NGAL and
for COBAS INTEGRA 400 analyzer(s). hepcidin levels in chronic kidney disease patients. Ren Fail
Method comparison 2016;38(1):35-39.
UIBC values for human serum and plasma samples obtained on a 15 Chow JK, Werner BG, Ruthazer R, et al. Increased serum iron levels
COBAS INTEGRA 400 analyzer with the COBAS INTEGRA UIBC and infectious complications after liver transplantation. Clin Infect Dis
reagent (y) were compared with those determined using the same reagents 2010 Aug 1;51(3):e16-23.
on a COBAS INTEGRA 800 analyzer (x) and those determined using the
corresponding reagent on a Roche/Hitachi MODULAR P analyzer (x). 16 Fernández-Ruiz M, López-Medrano F, Andrés A, et al. Serum iron
parameters in the early post-transplant period and infection risk in
COBAS INTEGRA 800 analyzer n = 73 kidney transplant recipients. Transpl Infect Dis 2013
Dec;15(6):600-611.
Passing/Bablok30 Linear regression
17 Miya T, Kondo H, Gemma A. Serum iron levels increased by cancer
y = 0.981x - 0.349 µmol/L y = 0.988x - 0.278 µmol/L chemotherapy correlate the chemotherapy-induced nausea and
т = 0.940 r = 0.998 vomiting. Int J Clin Oncol 2018 Dec;23(6):1196-1200.
18 Stookey LL. FerroZine - a new spectrophotometric reagent for iron.
The sample concentrations were between 9.71 and 121 µmol/L (54.3 and Anal Chem 1970;42:779-781.
676 µg/dL).
19 Persijn JP, Van der Slik W, Riethorst A. Determination of serum iron
Roche/Hitachi MODULAR P analyzer n = 69 and latent iron-binding capacity (LIBC). Clin Chim Acta 1971;35:91-98.
Passing/Bablok30 Linear regression 20 Harris WR. Thermodynamics of Anion Binding to Human Serum
y = 1.04x + 3.73 µmol/L y = 1.057x + 2.98 µmol/L Transferrin. Biochemistry 1985;24:7412-7418.
21 Fairbanks VF, Klee GG. Biochemical aspects of hematology. In: Tietz
т = 0.929 r = 0.994 NW, ed. Fundamentals of Clinical Chemistry. 3rd ed. Philadelphia: WB
The sample concentrations were between 6.00 and 87.6 µmol/L (33.5 and Saunders 1987:789-824.
490 µg/dL). 22 Weissman N, Pileggi VJ. Inorganic ions. In: Henry RJ, Cannon DC,
References Winkelman W, eds. Clinical Chemistry, Principles and Techniques. 2nd
ed. Hagerstown: Harper & Row 1974;4:639-754.
1 Swinkels DW. Iron Metabolism. In: Rifai N, Chiu RWK, Young I,
Burnham CAD, Wittwer CT, editors. Tietz Textbook of Laboratory 23 WHO Publication: Use of anticoagulants in diagnostic laboratory
Medicine, Saunders Elsevier, Philadelphia, 7th edition, 2023, chapter investigations, WHO/DIL/LAB/99.1 Rev.2:Jan 2002.
40, p. 418-418.e40. 24 Löhr B, El-Samalouti V, Junge W, et al. Reference Range Study for
2 Pantopoulos K, Porwal SK, Tartakoff A, et al. Mechanisms of Various Parameters on Roche Clinical Chemistry Analyzers. Clin Lab
mammalian iron homeostasis. Biochemistry 2012 Jul 2009;55:465-471.
24;51(29):5705-5724. 25 Glick MR, Ryder KW, Jackson SA. Graphical Comparisons of
3 Finch C. Regulators of iron balance in humans. Blood 1994 Sep Interferences in Clinical Chemistry Instrumentation.
15;84(6):1697-1702. Clin Chem 1986;32:470-475.
4 Auerbach M, Adamson JW. How we diagnose and treat iron deficiency 26 Breuer J. Report on the Symposium “Drug effects in Clinical Chemistry
anemia. Am J Hematol 2016 Jan;91(1):31-38. Methods”. Eur J Clin Chem Clin Biochem 1996;34:385-386.
5 Madu AJ, Ughasoro MD. Anaemia of Chronic Disease: An In-Depth 27 Sonntag O, Scholer A. Drug interference in clinical chemistry:
Review. Med Princ Pract 2017;26(1):1-9. recommendation of drugs and their concentrations to be used in drug
interference studies. Ann Clin Biochem 2001;38:376-385.
6 Amah-Tariah FS, Ojeka SO, Dapper DV. Haematological values in
pregnant women in Port Harcourt, Nigeria II: Serum iron and 28 Tietz NW, Rinker AD, Morrison SR. When Is a Serum Iron Really a
transferrin, total and unsaturated iron binding capacity and some red Serum Iron? A Follow-up Study on the Status of Iron Measurements in
cell and platelet indices. Niger J Physiol Sci 2011 Dec Serum. Clin Chem 1996;42(1):109-111.
20;26(2):173-178. 29 Bakker AJ, Mücke M. Gammopathy interference in clinical chemistry
7 Raza N, Sarwar I, Munazza B, et al. Assessment of iron deficiency in assays: mechanisms, detection and prevention.
pregnant women by determining iron status. J Ayub Med Coll Clin Chem Lab Med 2007;45(9):1240-1243.
Abbottabad 2011 Apr-Jun;23(2):36-40. 30 Bablok W, Passing H, Bender R, et al. A general regression procedure
8 Boinska J, Zekanowska E, Kwapisz J. Pro-hepcidin and iron for method transformation. Application of linear regression procedures
metabolism parameters in multi-time blood donors. Int J Lab Hematol for method comparison studies in clinical chemistry, Part III.
2010 Oct;32(5):483-490. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.
9 Kasprzak Z, Śliwicka E, Hennig K, et al. Vitamin D, Iron Metabolism, A point (period/stop) is always used in this Method Sheet as the decimal
and Diet in Alpinists During a 2-Week High-Altitude Climb. High Alt Med separator to mark the border between the integral and the fractional parts of
Biol 2015 Sep;16(3):230-235. a decimal numeral. Separators for thousands are not used.
10 Chen CH, Shu KH, Yang Y. Long-term effects of an oral iron chelator, Any serious incident that has occurred in relation to the device shall be
deferasirox, in hemodialysis patients with iron overload. Hematology reported to the manufacturer and the competent authority of the Member
2015;20(5):304-310. State in which the user and/or the patient is established.

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UIBC
Unsaturated Iron-Binding Capacity

Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard:
Contents of kit
Volume for reconstitution
GTIN Global Trade Item Number

Rx only For USA: Caution: Federal law restricts this

device to sale by or on the order of a
physician.
COBAS, NAVIFY, PRECICONTROL, PRECINORM and PRECIPATH are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
© 2024, Roche Diagnostics

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