08056722500V7.

ALBT2
Tina-quant Albumin CSF
Order information
Analyzer(s) on which cobas c pack(s)
can be used
08056722190 08056722500 Tina‑quant Albumin Gen.2 (500 tests) System‑ID 2006 001 cobas c 303, cobas c 503
Materials required (but not provided):
03121305122 C.f.a.s. PUC (5 x 1 mL) Code 20489
03121313122 Precinorm PUC (4 x 3 mL) Code 20240
03121291122 Precipath PUC (4 x 3 mL) Code 20241
10557897122 Precinorm Protein (3 x 1 mL) Code 20302
11333127122 Precipath Protein (3 x 1 mL) Code 20303
05117003190 PreciControl ClinChem Multi 1 (20 x 5 mL) Code 20391
05947626190 PreciControl ClinChem Multi 1 (4 x 5 mL) Code 20391
05117216190 PreciControl ClinChem Multi 2 (20 x 5 mL) Code 20392
05947774190 PreciControl ClinChem Multi 2 (4 x 5 mL) Code 20392
08063494190 Diluent NaCl 9 % (123 mL) System‑ID 2906 001
08059322190 Antigen Excess Reagent (START) (1000 tests) System‑ID 2008 001

English In severe cases of hypoalbuminemia, plasma albumin levels are below

25 g/L (380 μmol/L).3 The low plasma oncotic pressure allows water to
System information move out of the blood capillaries into the tissues (edema). Albumin
ALBT2: ACN 20060 (Albumin in serum/plasma) measurements also allow monitoring of the patient’s response to nutritional
ALBT2U: ACN 20061 (Albumin in urine) support and are a useful test of liver function.1,5,6
ALBT2C: ACN 20062 (Albumin in CSF) The kidney normally prevents loss of serum albumin into the urine.
Specific applications for Reiber diagnostic* However, albumin is still found in normal urine in small amounts. Because
size (69 kD), anionic charge, and tubular reabsorption all play a role in
ALBT2C: ACN 20062 (Albumin in CSF) albumin’s renal handling, excretion increases with altered glomerular size
ALBT2R: ACN 20067 (Albumin in CSF, application in serum/plasma) and charge selectivity as well as with tubular impairment.1
*not available in all countries In glomerular disease far higher amounts of albumin may be secreted than
in tubular disease. Urinary albumin is therefore considered the most
Intended use important marker for glomerular dysfunction.7 Nearly 40 % of insulin
In vitro test for the quantitative determination of albumin in human serum, dependent diabetes patients develop diabetic nephropathy which presents
plasma, urine and CSF (albumin CSF/serum ratio) on cobas c systems. in its earliest stage with microalbuminuria. Microalbuminuria is defined as
Inteded use of the specific applications for Reiber diagnostic* excretion above normal but lower than the detection limit of traditional
*not available in all countries dipstick tests, i.e. between 20 and 200 μg/min.8
In vitro test for the quantitative determination of albumin in human About 80 % of the protein content in CSF originates from plasma as a result
cerebrospinal fluid and corresponding human serum/plasma on cobas c of ultrafiltration. Low molecular weight proteins predominate, albumin,
systems. prealbumin, and transferrin in particular. Albumin is neither synthesized nor
metabolized within the central nervous system. Therefore, it is suitable to
Summary indicate increased permeability of the blood‑brain barrier in case of
Albumin measurement in human serum and plasma with this device can be pathological, traumatic, or inflammatory events.1
used to aid in the assessment of hyperalbuminemia (seen only in case of Impairment of the blood‑brain barrier can be evaluated using the
dehydration) or hypoalbuminemia (seen in a multitude of clinical conditions CSF/serum ratio (QAlb) which provides method independent values.9
such as inflammation, liver diseases, Inflammatory disease of the intestinal
tract, tissue damage like burns, nephrotic disease or neoplastic disease). QAlb = AlbuminCSF/Albuminserum × 1000
Albumin measurements in urine can be used to aid in the assessment of Normal QAlb values are < 6.5 for the population between 15 and 40 years
glomerular, tubular, glomerulotubular and postrenal proteinuria. old, < 8.0 for the population between 41 and 60 and < 9.0 for the population
Microalbuminuria (slightly elevated albumin excretion in urine) is of over 60 years old. QAlb values greater than or equal to the reported
particular importance in the early diagnosis of diabetic nephropathy. thresholds indicate impairment of blood brain barrier.9,10
Albumin measurement in human cerebrospinal fluid (CSF) can be used to The measurement of albumin in CSF is of further interest in the
aid in the assessment of increased permeability of the blood‑brain barrier, determination of intrathecal IgG production which is associated with
indicative of a blood brain barrier disorder. Albumin measurements in CSF demyelinating disorders and inflammatory diseases of the central nervous
aid in the determination of intrathecal IgG production associated with system (CNS) (e.g. multiple sclerosis, neurosyphilis, acute inflammatory
demyelinating disorders. polyradiculoneuropathy, subacute sclerosing panencephalitis).1
Albumin is a carbohydrate‑free protein, which constitutes 55‑65 % of total An increased IgG concentration in CSF may be caused by increased
plasma protein. It maintains plasma oncotic pressure, is involved in the permeability or increased intrathecal production. To determine the
transport and storage of a wide variety of ligands and is a source of intrathecal IgG production, several formulae have been proposed and
endogenous amino acids.1 evaluated. The linear IgG index has been broadly used in the past because
of its simplicity, but it has been replaced by non linear formulae, such as
In serum and plasma, hyperalbuminemia is of little diagnostic significance Reiber’s hyperbolic formula that better reflects human neurophysiology.11,12
except in dehydration. Hypoalbuminemia instead is very common in many Increase of the IgG index (QIgG) is a reflection of increased IgG intrathecal
diseases and is caused by several factors: impaired synthesis, either production. The most informative method indicating intrathecal synthesis of
primary as a result of a liver disease or secondary due to diminished protein IgG is the qualitative demonstration of two or more CSF‑specific oligoclonal
intake; increased catabolism because of tissue damage (severe burns) or bands.13,14
inflammation; malabsorption of amino acids or increased gastrointestinal
loss (inflammatory bowel disease such as Crohn’s disease and ulcerative Test principle
colitis); proteinuria due to nephrotic syndrome; negative protein and energy Immunoturbidimetric assay
balance due to neoplastic disease(s).2,3,4

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Tina-quant Albumin CSF

Anti‑albumin antibodies react with the antigen in the sample to form Serum, plasma
antigen/antibody complexes which, following agglutination, are measured
turbidimetrically.15 Stability:18 10 weeks at 15‑25 °C
Reagents - working solutions 5 months at 2‑8 °C
4 months at (-15)‑(-25) °C
R1 TRIS buffer: 50 mmol/L, pH 8.0; PEG: ≥ 4.2 %; EDTA: 2.0 mmol/L;
preservative Freeze only once.
R2 Polyclonal anti‑human albumin antibodies (sheep): dependent on Urine
titer; TRIS buffer: 100 mmol/L, pH 7.2; preservative Spontaneous, 24‑hour urine or 2nd morning urine
R1 is in position B and R2 is in position C. Stability:18 7 days at 15‑25 °C
Antigen Excess Reagent (Cat. No. 08059322190; for ACNs 20061 and 1 month at 2‑8 °C
20062): 6 months at (-15)‑(-25) °C
R3 Albumin in diluted serum (human); NaCl: 150 mmol/L; phosphate Freeze only once.
buffer: 50 mmol/L, pH 7.0; preservative
CSF
R3 is in position C.
Precautions and warnings Stability:19 up to 3 days at 2‑8 °C
For in vitro diagnostic use for health care professionals. Exercise the 6 months at (-15)‑(-25) °C
normal precautions required for handling all laboratory reagents. indefinitely at (-60)‑(-80) °C
Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of Freeze only once.
waste according to accepted laboratory instructions and procedures. Materials provided
Environmental hazards: See “Reagents – working solutions” section for reagents.
Apply all relevant local disposal regulations to determine the safe disposal.
Materials required (but not provided)
Safety data sheet available for professional user on request.
See “Order information” section
All human material should be considered potentially infectious. All products
derived from human blood are prepared exclusively from the blood of General laboratory equipment
donors tested individually and shown to be free from HBsAg and antibodies Assay
to HCV and HIV. The testing methods use assays that have been approved For optimum performance of the assay follow the directions given in this
by the FDA or that are in compliance with the legal rules applicable to document for the analyzer concerned. Refer to the appropriate operator’s
placing in vitro diagnostic medical devices for human use on the market in manual for analyzer‑specific assay instructions.
the European Union.
However, as no testing method can rule out the potential risk of infection The performance of applications not validated by Roche is not warranted
with absolute certainty, the material should be handled with the same level and must be defined by the user.
of care as a patient specimen. In the event of exposure, the directives of the Application for serum and plasma
responsible health authorities should be followed.16,17
Test definition
Reagent handling
Ready for use Reporting time 10 min
Storage and stability Wavelength (sub/main) 700/340 nm
Reagent pipetting Diluent (H2O)
Shelf life at 2‑8 °C: See expiration date on
cobas c pack label. R1 80 µL –
On‑board in use and refrigerated on the 26 weeks R2 16 µL –
analyzer:
Specimen collection and preparation Sample volumes Sample Sample dilution
For specimen collection and preparation only use suitable tubes or Sample Diluent (NaCl)
collection containers.
Normal 1.6 µL 1.5 µL 125 µL
Only the specimens listed below were tested and found acceptable.
Serum Decreased 1.6 µL 1.0 µL 106 µL
Plasma: Li‑heparin and K2‑EDTA plasma
Urine Increased 1.6 µL 1.5 µL 125 µL
CSF Application for urine
The sample types listed were tested with a selection of sample collection Test definition
tubes that were commercially available at the time of testing, i.e. not all
available tubes of all manufacturers were tested. Sample collection systems Reporting time 10 min
from various manufacturers may contain differing materials which could
affect the test results in some cases. When processing samples in primary Wavelength (sub/main) 700/340 nm
tubes (sample collection systems), follow the instructions of the tube Reagent pipetting Diluent (H2O)
manufacturer.
R1 80 µL –
Centrifuge samples containing precipitates before performing the assay.
See the limitations and interferences section for details about possible R2 16 µL –
sample interferences. R3 5 µL 16 µL

Sample volumes Sample Sample dilution

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Sample Diluent (NaCl) Calibration interval may be extended based on acceptable verification of
calibration by the laboratory.
Normal 4.8 µL – –
Traceability: This method has been standardized against the certified
Decreased 4.8 µL 10 µL 100 µL reference material in human serum of the IRMM (Institute for Reference
Increased 4.8 µL – – Materials and Measurements) ERM‑DA470k/IFCC.
Application for CSF Quality control
For quality control, use control materials as listed in the “Order information”
Test definition section. In addition, other suitable control material can be used.
Reporting time 10 min Serum/plasma: Precinorm Protein, Precipath Protein, PreciControl
Wavelength (sub/main) 700/340 nm ClinChem Multi 1,
Reagent pipetting Diluent (H2O) PreciControl ClinChem Multi 2
R1 80 µL – Urine: Precinorm PUC, Precipath PUC
R2 16 µL – CSF undiluted Precipath PUC
R3 5 µL 16 µL The control intervals and limits should be adapted to each laboratory’s
individual requirements. It is recommended to perform quality control
always after lot calibration and subsequently at least every 26 weeks.
Sample volumes Sample Sample dilution Values obtained should fall within the defined limits. Each laboratory should
establish corrective measures to be taken if values fall outside the defined
Sample Diluent (NaCl) limits.
Normal 4.8 µL 10 µL 110 µL Follow the applicable government regulations and local guidelines for
quality control.
Decreased 2.4 µL 2.5 µL 90 µL
Calculation
Increased 4.8 µL 10 µL 110 µL
Serum /plasma
For further information about the assay test definitions refer to the
application parameters screen of the corresponding analyzer and assay. cobas c systems automatically calculate the analyte concentration of each
Calibration sample in the unit g/L (µmol/L, mg/dL, g/dL).
Application for serum/plasma (ACN 20060) Conversion factors: g/L × 15.2 = µmol/L

Calibrators S1: H2O g/L × 100 = mg/dL

S2‑6: C.f.a.s. PUC g/L × 0.1 = g/dL

Calibration mode Non-linear Urine and CSF

Calibration frequency Full calibration cobas c systems automatically calculate the analyte concentration of each
- after reagent lot change sample in the unit mg/L (µmol/L, mg/dL, g/L).
- every 12 weeks on-board Conversion factors: mg/L × 0.0152 = µmol/L
- as required following quality control
procedures mg/L × 0.1 = mg/dL
mg/L × 0.001 = g/L
Application for urine (ACN 20061)
Calculation of the specific applications for Reiber diagnostic
Calibrators S1: H2O
cobas c systems automatically calculate the analyte concentration of each
S2‑6: C.f.a.s. PUC
sample in the unit mg/L (mg/dL, g/L).
Calibration mode Non-linear
Conversion factors: mg/L × 0.1 = mg/dL
Calibration frequency Full calibration
mg/L × 0.001 = g/L
- after reagent lot change
- every 12 weeks on-board Reiber Quotient Graph
- as required following quality control With the aid of commercially available software, Reiber Quotient Diagrams
procedures can be automatically generated.
The calculation employs a ratio diagram including hyperbolic functions as
Application for CSF (ACN 20062) differential lines according to Reiber and Felgenhauer. Results from the
determination of IgG and albumin in CSF and serum (IgG and albumin
Calibrators S1: H2O ratios)20 are plotted. (Example for IgG, CSF/serum quotient diagrams for
S2‑6: C.f.a.s. PUC IgA and IgM are also possible.)
Calibration mode Non-linear
Calibration frequency Full calibration
- after reagent lot change
- every 12 weeks on-board
- as required following quality control
procedures
Calibration of the specific applications for Reiber diagnostic
Application for serum/plasma (ACN 20067)
Transfer of calibration from CSF application (ACN 20062)

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Hemolysis: No significant interference up to an H index of 1000

(approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).
High dose hook‑effect: Using the prozone check automatically performed by
the analyzer, no false result without a flag was observed up to an albumin
concentration of 30000 mg/L.
For diagnostic purposes, the results should always be assessed in
conjunction with the patient’s medical history, clinical examination and other
findings.
ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory
when certain test combinations are run together on cobas c systems. All
special wash programming necessary for avoiding carry-over is available
via the cobas link. The latest version of the carry-over evasion list can be
found with the NaOHD/SMS/SCCS Method Sheet. For further instructions,
refer to the operator’s manual.
Limits and ranges
Measuring range
1. Reference range. 2. Blood brain barrier functional disorder without local Serum, plasma
IgG synthesis. 3. Blood brain barrier functional disorder with concomitant
IgG synthesis in the CNS. 4. IgG synthesis in the CNS without blood brain 3‑101 g/L (46‑1540 µmol/L)
barrier functional disorder. 5. As confirmed empirically, there are no values Determine samples having higher concentrations via the rerun function.
in this region (i.e. values here are due to errors introduced by blood Dilution of samples via the rerun function is a 1:1.27 dilution. Results from
sampling or analytical errors). Generally speaking, cases not associated samples diluted using the rerun function are automatically multiplied by a
with local IgG synthesis in the CNS lie below the bold line (hyperbolic factor of 1.27.
function). The percentage values indicate what percentage of the total IgG Urine
in CSF (minimum) originates in the CNS relative to the statistically‑defined
0 % differential lines. 3‑400 mg/L (0.05‑6.08 µmol/L)
Limitations - interference Determine samples having higher concentrations via the rerun function.
Dilution of samples via the rerun function is a 1:11 dilution. Results from
Serum/plasma samples diluted using the rerun function are automatically multiplied by a
Criterion: Recovery within ± 10 % of initial value at an albumin factor of 11.
concentration of 35 g/L. CSF
Icterus:21 No significant interference up to an I index of 60 for conjugated 36‑4800 mg/L (0.55‑73.0 µmol/L)
and unconjugated bilirubin (approximate conjugated and unconjugated
bilirubin concentration: 1026 µmol/L or 60 mg/dL). Determine samples having higher concentrations via the rerun function.
Dilution of samples via the rerun function is a 1:6.2 dilution. Results from
Hemolysis:21 No significant interference up to an H index of 1000 samples diluted using the rerun function are automatically multiplied by a
(approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL). factor of 6.2.
Lipemia (Intralipid):21 No significant interference up to an L index of 1500. Lower limits of measurement
There is poor correlation between the L index (corresponds to turbidity) and
triglycerides concentration. Limit of Blank, Limit of Detection and Limit of Quantitation
Rheumatoid factors: No significant interference from rheumatoid factors up Serum, plasma
to a concentration of 1200 IU/mL.
Limit of Blank = 1 g/L (15 µmol/L)
Drugs: No interference was found at therapeutic concentrations using
common drug panels.22,23 Limit of Detection = 3 g/L (46 µmol/L)
In very rare cases, gammopathy, in particular type IgM (Waldenström’s Limit of Quantitation = 3 g/L (46 µmol/L)
macroglobulinemia), may cause unreliable results.24
Urine Urine
Criterion: Recovery within ± 10 % of initial value at an albumin Limit of Blank = 2 mg/L (0.03 µmol/L)
concentration of 20 mg/L.
Limit of Detection = 3 mg/L (0.05 µmol/L)
Icterus: No significant interference up to a conjugated bilirubin
concentration of 855 µmol/L or 50 mg/dL. Limit of Quantitation = 12 mg/L (0.18 µmol/L)
Hemolysis: No significant interference up to an H index of 400 (approximate
hemoglobin concentration: 248 µmol/L or 400 mg/dL). CSF
No significant interference from acetone ≤ 60 mmol/L, ammonia chloride Limit of Blank = 20 mg/L (0.3 µmol/L)
≤ 0.11 mol/L, calcium ≤ 40 mmol/L, creatinine ≤ 0.18 mol/L, γ‑globulin Limit of Detection = 36 mg/L (0.5 µmol/L)
≤ 500 mg/L, glucose ≤ 0.19 mol/L, phosphate ≤ 70 mmol/L, urea
≤ 0.8 mol/L, uric acid ≤ 5.95 mmol/L and urobilinogen ≤ 378 µmol/L. Limit of Quantitation = 50 mg/L (0.8 µmol/L)
Drugs: No interference was found at therapeutic concentrations using The Limit of Blank, Limit of Detection and Limit of Quantitation were
common drug panels.22 determined in accordance with the CLSI (Clinical and Laboratory Standards
High dose hook‑effect: Using the prozone check automatically performed by Institute) EP17‑A2 requirements.
the analyzer, no false result without a flag was observed up to an albumin The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of
concentration of 40000 mg/L. analyte‑free samples over several independent series. The Limit of Blank
CSF corresponds to the concentration below which analyte‑free samples are
found with a probability of 95 %.
Criterion: Recovery within ± 10 % of initial value at an albumin
concentration of 240 mg/L. The Limit of Detection is determined based on the Limit of Blank and the
standard deviation of low concentration samples.
Icterus: No significant interference up to an I index of 60 for conjugated
bilirubin (approximate conjugated bilirubin concentration: 1026 µmol/L or The Limit of Detection corresponds to the lowest analyte concentration
60 mg/dL). which can be detected (value above the Limit of Blank with a probability of
95 %).

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The Limit of Quantitation is the lowest analyte concentration that can be Precision
reproducibly measured with a total error of 20 %. It has been determined Precision was determined using human samples and controls in
using low concentration albumin samples. accordance with the CLSI (Clinical and Laboratory Standards Institute)
Expected values EP05‑A3 requirements with repeatability (n = 84) and intermediate precision
(2 aliquots per run, 2 runs per day, 21 days). Results for repeatability and
Serum/plasma intermediate precision were obtained on the cobas c 503 analyzer.
g/L
Serum/plasma
Consensus values:25
Repeatability Mean SD CV
Adults 35‑52 g/L g/L g/L %
Reference intervals according to Tietz:26 PCCC1a) 30.9 0.290 0.9
Newborns (0‑4 days): 28‑44 g/L PCCC2b) 44.2 0.371 0.8
Children (4 days‑14 years): 38‑54 g/L Serum 1 5.10 0.0552 1.1
Serum 2 24.5 0.309 1.3
µmol/L*
Serum 3 39.1 0.327 0.8
Consensus values:25
Serum 4 49.3 0.397 0.8
Adults 532‑790 µmol/L
Serum 5 80.4 1.02 1.3
Reference intervals according to Tietz:26
Intermediate precision Mean SD CV
Newborns (0‑4 days): 426‑669 µmol/L g/L g/L %
Children (4 days‑14 years): 578‑821 µmol/L PCCC1a) 30.4 0.376 1.2
*calculated by unit conversion factor
PCCC2b) 44.2 0.573 1.3
Urine
Serum 1 5.10 0.0595 1.2
mg/L Serum 2 24.5 0.385 1.6
2nd morning urine:27 Serum 3 39.1 0.458 1.2
Adults: < 20 mg albumin/g creatinine or Serum 4 49.3 0.467 0.9
< 2.26 g albumin/mol creatinine Serum 5 80.4 1.07 1.3
Children (3‑5 years):28 < 20 mg/L albumin a) PreciControl ClinChem Multi 1
< 30 mg albumin/g creatinine b) PreciControl ClinChem Multi 2

Urine
24‑hour urine:29 < 20 mg/L
Repeatability Mean SD CV
< 30 mg/24 h
mg/L mg/L %
µmol/L Precinorm PUC 30.4 0.187 0.6
2nd morning urine:27,* Precipath PUC 119 0.748 0.6
Adults: < 0.304 µmol albumin/g creatinine Urine 1 15.3 0.145 0.9
< 34.35 µmol albumin/mol creatinine Urine 2 17.9 0.194 1.1
Children (3‑5 years):28 < 0.304 µmol/L albumin Urine 3 55.7 0.442 0.8
< 0.456 µmol albumin/g creatinine Urine 4 180 1.27 0.7
Urine 5 349 3.85 1.1
24‑hour urine:29,* < 0.304 µmol/L
< 0.456 µmol/24 h Intermediate precision Mean SD CV
*calculated by unit conversion factor
mg/L mg/L %

Albumin CSF/serum ration (QALB × 103) Precinorm PUC 29.4 0.346 1.2
Precipath PUC 119 1.11 0.9
Adults9 up to 15 years 5.0
Urine 1 15.3 0.329 2.1
up to 40 years 6.5
Urine 2 17.9 1.03 5.7
up to 60 years 8.0
Urine 3 56.2 0.926 1.6
Each laboratory should investigate the transferability of the expected values
to its own patient population and if necessary determine its own reference Urine 4 183 1.79 1.0
ranges. Urine 5 354 7.58 2.1
Specific performance data
Representative performance data on the analyzers are given below. These CSF
data represent the performance of the analytical procedure itself. Repeatability Mean SD CV
Results obtained in individual laboratories may differ due to heterogenous mg/L mg/L %
sample materials, aging of analyzer components and mixture of reagents
running on the analyzer. Precipath PUC 117 2.32 2.0
CSF 1 108 2.78 2.6

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CSF 2 226 2.93 1.3 CSF

CSF 3 338 2.81 0.8 Sample size (n) = 75
CSF 4 2256 18.1 0.8 Passing/Bablok30 Linear regression
CSF 5 3911 42.8 1.1 y = 1.019x + 1.61 mg/L y = 0.991x + 15.2 mg/L
τ = 0.986 r = 1.000
Intermediate precision Mean SD CV
mg/L mg/L % The sample concentrations were between 42.0 and 4545 mg/L.
Precipath PUC 121 2.78 2.3 References
1 Rifai N, Horvath AR, Wittwer CT. Tietz Textbook of Clinical Chemistry
CSF 1 108 3.28 3.0 and Molecular Diagnostics. 6th Edition. Elsevier Missouri, Saunders.
CSF 2 232 5.95 2.6 2017.1888 p.
CSF 3 340 6.07 1.8 2 Levitt DG, Levitt MD. Human serum albumin homeostasis: a new look
at the roles of synthesis, catabolism, renal and gastrointestinal
CSF 4 2226 33.9 1.5 excretion, and the clinical value of serum albumin measurements. Int J
Gen Med 2016 Jul 15;9:229-255. doi: 10.2147/IJGM.S102819.
CSF 5 3911 96.7 2.5
3 Gatta A, Verardo A, Bolognesi M. Hypoalbuminemia. Intern Emerg Med
The data obtained on cobas c 503 analyzer(s) are representative for 2012 Oct;7 Suppl 3:S193-199.doi: 10-1007/s11739-012-0802-0.
cobas c 303 analyzer(s).
4 Furfaro F, Bezzio C, Maconi G. Protein-losing enteropathy in
Method comparison inflammatory bowel diseases. Minerva Gastroenterol Dietol 2015
Albumin values for human serum, plasma, urine and CSF samples obtained Dec;61(4):261-265. Epub 2015 Oct 7.
on a cobas c 503 analyzer (y) were compared with those determined using 5 Cederholm T, Barazzoni R, Austin P, et al. ESPEN guidelines on
the corresponding reagent on a cobas c 501 analyzer (x). definitions and terminology of clinical nutrition. Clin Nutr 2017
Serum/plasma Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004.
Sample size (n) = 1306 6 Johnson PJ, Berhane S, Kagebayashi C, et al. Assessment of liver
function in patients with hepatocellular carcinoma: a new evidence-
Passing/Bablok30 Linear regression based approach-the ALBI grade. J Clin Oncol 2015 Feb
y = 0.995x + 1.06 g/L y = 0.995x + 1.18 g/L 20;33(6):550-558. doi: 10.1200/JCO.2014.57.9151.
τ = 0.912 r = 0.995 7 Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular
Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the
The sample concentrations were between 4.20 and 101 g/L. Management of Glomerular Diseases. Kidney Int 2021
Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021.
Urine
Sample size (n) = 72 8 Macisaac RJ, Ekinci El, Jerums G. Markers of and risk factors for the
development and progression of diabetic kidney disease. Am J Kidney
Passing/Bablok30 Linear regression Dis 2014 Feb;63(2 Suppl 2):S39-62. doi: 10.1053/j.ajkd.2013.10.048
y = 0.984x + 0.314 mg/L y = 0.980x + 0.362 mg/L 9 Reiber H. External Quality Assessment in Clinical Neurochemistry:
Survey of Analysis for Cerebrospinal Fluid (CSF) Proteins based on
τ = 0.987 r = 0.999 CSF/Serum Quotients. Clin Chem 1995;41(2):256-263.
The sample concentrations were between 3.51 and 375 mg/L. 10 Reiber H, Otto M, Trendelenburg C, et al. Reporting cerebrospinal fluid
data: knowledge base and interpretation software. Clin Chem Lab Med
CSF 2001 Apr;39(4):324-332. doi: 10.1515/CCLM.2001.051.
Sample size (n) = 75
11 Freedman MS, Thompson EJ, Deisenheimer F, et al. Recommended
Passing/Bablok30 Linear regression standard of cerebrospinal fluid analysis in the diagnosis of multiple
sclerosis: a consensus statement. Arch Neurol 2005
y = 0.970x + 11.3 mg/L y = 0.937x + 25.0 mg/L Jun;62(6):865-870. doi: 10.1001/archneur.62.6.865.
τ = 0.988 r = 1.000 12 Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple
The sample concentrations were between 43.4 and 4634 mg/L. sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol 2018
Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2.
Albumin values for human serum, plasma, urine and CSF samples obtained
on a cobas c 303 analyzer (y) were compared with those determined using 13 Gastaldi M, Zardini E, Leante R, et al. Cerebrospinal fluid analysis and
the corresponding reagent on a cobas c 501 analyzer (x). the determination of oncoclonal bands. Neurol Sci 2017 Oct;38(Suppl
2):217-224. doi: 10.1007/s10072-017-3034-2.
Serum/plasma 14 Boufidou F, Vakrakou AG, Anagnostouli M, et al. An Updated
Sample size (n) = 74 Evaluation of Intrathecal IgG Synthesis Markers in Relation to
Passing/Bablok30 Linear regression Oligoclonal Bands. Diagnostics (Basel) 2023 Jan 20;13(3):389. doi:
10.3390/diagnostics13030389.
y = 0.984x + 1.30 g/L y = 0.963x + 1.97 g/L 15 Multicenter study of Tina-quant Albumin in urine and β-N-acetyl-
τ = 0.950 r = 0.999 glucosaminidase (β-NAG) in urine. Workshop Munich, November
29-30, 1990 Wien Klin Wschr 1991;103 Suppl.189:1-64.
The sample concentrations were between 3.96 and 100 g/L.
16 Occupational Safety and Health Standards: Bloodborne pathogens.
Urine (29 CFR Part 1910.1030). Fed. Register.
Sample size (n) = 73 17 Directive 2000/54/EC of the European Parliament and Council of
Passing/Bablok30 Linear regression 18 September 2000 on the protection of workers from risks related to
exposure to biological agents at work.
y = 1.025x + 0.0660 mg/L y = 1.000x + 2.45 mg/L
18 Use of Anticoagulants in Diagnostic Laboratory Investigations. WHO
τ = 0.990 r = 0.999 Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
The sample concentrations were between 8.30 and 387 mg/L.

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Tina-quant Albumin CSF

19 Tietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia,
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24 Bakker AJ, Mücke M. Gammopathy interference in clinical chemistry
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Clin Chem Lab Med 2007;45(9):1240-1243.
25 Dati F, Schumann G, Thomas L, et al. Consensus of a group of
professional societies and diagnostic companies on guidelines for
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470). Eur J Clin Chem Clin Biochem 1996;34:517-520.
26 Wu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. WB
Saunders Company, 2006:66.
27 Hofmann W, Guder WG. A diagnostic program for quantitative analysis
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28 Hubbuch A. Results of a multicenter study of preliminary reference
ranges for albumin in urine of children and adults. Wien Klin
Wochenschrift Suppl. 1991;189:48-49.
29 Hasslacher C. Diagnostische Überwachung und Therapie in den
Stadien der diabetischen Nierenerkrankung. Akt Endokr Stoffw
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30 Bablok W, Passing H, Bender R, et al. A general regression procedure
for method transformation. Application of linear regression procedures
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A point (period/stop) is always used in this Method Sheet as the decimal
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