03271749500V20.

Elecsys HCG+β
cobas e 411
03271749190 03271749500 100 cobas e 601
cobas e 602

English but not provided” section) using the algorithm as described by Wald8 and
the respective assay‑specific parameters.7,8,9,10,11,12,13,14
System information
For cobas e 411 analyzer: test number 761 Elevated hCG concentrations not associated with pregnancy are found in
For cobas e 601 and cobas e 602 analyzers: Application Code patients with diseases such as tumors of the germ cells, ovaries, bladder,
Number 148 pancreas, stomach, lungs, and liver.2,15
In the following the prevalence (%) of elevated serum hCG + hCG+β values
Please note in various malignancies is listed: Testicular or placental
choriocarcinoma (100), hydatidiform mole (97), nonseminomatous testicular
The measured hCG value of a patient’s sample can vary depending on germ cell tumor (48‑86), seminoma (10‑22), pancreatic cancer
the testing procedure used. The laboratory finding must therefore always adenocarcinoma (11‑80) and islet‑cell carcinoma (22‑50), gastric
contain a statement on the hCG assay method used. hCG values cancer (0‑52), ovarian cancer, epithelial (18‑41), colon cancer (0‑37), lung
determined on patient samples by different testing procedures cannot be cancer (0‑36), breast cancer (7‑25), hepatoma, liver cancer (17‑21), tumors
directly compared with one another and could be the cause of erroneous of small intestine (13), and renal carcinoma (10).14,16
medical interpretations. hCG assays detecting the intact hCG plus the free β‑subunit are well
established markers as an aid in the management of patients with
If there is a change in the hCG assay procedure used while monitoring trophoblastic tumors16 and together with AFP in patients with testicular and
therapy, then the hCG values obtained upon changing over to the new other germ cell tumors. 17
procedure must be confirmed by parallel measurements with both The combination of the specific monoclonal antibodies used in the Elecsys
methods. HCG+β assay recognize the holo‑hormone, “nicked” forms of hCG, the
β‑core fragment and the free β‑subunit. The ruthenium‑labeled and
Intended use biotinylated antibodies used are directed against different epitopes of the
Immunoassay for the in vitro quantitative determination of the sum of hCG molecule.
human chorionic gonadotropin (hCG) plus the hCG β‑subunit in human Test principle
serum and plasma.
Sandwich principle. Total duration of assay: 18 minutes.
This assay is intended for use as an aid in:
▪ 1st incubation: 10 µL of sample, biotinylated monoclonal hCG‑specific
▪ Early detection and monitoring of pregnancy. The test is also intended antibodies, and a monoclonal hCG‑specific antibody labeled with a
for the use as one component in combination with other parameters to ruthenium complexa) react to form a sandwich complex.
evaluate the risk of trisomy 21 (Down syndrome). Further testing is
required for diagnosis of chromosomal aberrations. ▪ 2nd incubation: After addition of streptavidin-coated microparticles, the
complex becomes bound to the solid phase via interaction of biotin and
▪ Oncology, to serve the management of patients with trophoblastic streptavidin.
diseases. This assay is useful in the detection and monitoring of
hCG‑producing tumor cells of either ovarian, placental or testicular ▪ The reaction mixture is aspirated into the measuring cell where the
origin. microparticles are magnetically captured onto the surface of the
The electrochemiluminescence immunoassay “ECLIA” is intended for use electrode. Unbound substances are then removed with
on Elecsys and cobas e immunoassay analyzers. ProCell/ProCell M. Application of a voltage to the electrode then induces
chemiluminescent emission which is measured by a photomultiplier.
Summary ▪ Results are determined via a calibration curve which is instrument-
Similarly to LH (Luteinizing hormone), FSH (Follicle‑stimulating hormone) specifically generated by 2‑point calibration and a master curve provided
and TSH (Thyroid‑stimulating hormone), human chorionic gonadotropin via the reagent barcode or e‑barcode.
(hCG) is a member of the glycoprotein family and consists of 2 subunits (α‑ a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )
and β‑chains) which are associated to form the intact hormone.1 The
α‑chains in all four of these glycoprotein hormones are virtually identical, Reagents - working solutions
whereas the β‑chains have greatly differing structures and are responsible The reagent rackpack is labeled as HCG‑BETA.
for the respective specific hormonal functions.2
hCG is produced in the placenta during pregnancy. In non‑pregnant M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL:
women, it can also be produced by tumors of the trophoblast, germ cell Streptavidin-coated microparticles 0.72 mg/mL; preservative.
tumors with trophoblastic components and some non‑trophoblastic tumors.3
R1 Anti-hCG-Ab~biotin (gray cap), 1 bottle, 9 mL:
Human chorionic gonadotropin consists of a number of isohormones4 with
differing molecular size. The biological action of hCG serves to maintain the Biotinylated monoclonal anti‑hCG antibodies (mouse) 2.6 mg/L;
corpus luteum during pregnancy. It also influences steroid production. The phosphate buffer 40 mmol/L, pH 7.5; preservative.
serum of pregnant women contains mainly intact hCG.5
Elevated values here serve as an indication of chorionic carcinoma, R2 Anti-hCG-Ab~Ru(bpy) (black cap), 1 bottle, 10 mL:
hydatidiform mole or multiple pregnancy. Monoclonal anti‑hCG antibody (mouse) labeled with ruthenium
Depressed values indicate threatening or missed abortion,6 ectopic complex 4.6 mg/L; phosphate buffer 40 mmol/L, pH 6.5; preservative.
pregnancy, gestosis or intra‑uterine death.
Measurement of hCG+β makes also a contribution to the risk assessment Precautions and warnings
for trisomy 21 (Down syndrome) in the second trimester of pregnancy For in vitro diagnostic use for health care professionals. Exercise the
together with AFP (Alpha‑fetoprotein) and other parameters, such as exact normal precautions required for handling all laboratory reagents.
gestational age and maternal weight. In a trisomy 21 affected pregnancy Infectious or microbial waste:
the maternal serum concentration of AFP is decreased whereas the Warning: handle waste as potentially biohazardous material. Dispose of
maternal serum hCG+β concentration is approximately twice the normal waste according to accepted laboratory instructions and procedures.
median.7 The risk for a trisomy 21 affected pregnancy in the second
trimester can be calculated by a suitable software (see “Materials required, Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

2024-10, V 20.0 English 1/5

Elecsys HCG+β
Safety data sheet available for professional user on request. Do not use heat‑inactivated samples.
This kit contains components classified as follows in accordance with the Do not use samples and controls stabilized with azide.
Regulation (EC) No. 1272/2008: Ensure the samples, calibrators and controls are at 20‑25 °C prior to
measurement.
Due to possible evaporation effects, samples, calibrators and controls on
the analyzers should be analyzed/measured within 2 hours.
Materials provided
Warning See “Reagents – working solutions” section for reagents.
Materials required (but not provided)
H317 May cause an allergic skin reaction.
▪ 03302652190, HCG+β CalSet, for 4 x 1.0 mL
Prevention:
▪ 11731416190, PreciControl Universal, for 4 x 3.0 mL or
P261 Avoid breathing dust/fume/gas/mist/vapours/spray. 11776452122, PreciControl Tumor Marker, for 4 x 3.0 mL
▪ 11732277122, Diluent Universal, 2 x 16 mL sample diluent or
P272 Contaminated work clothing should not be allowed out of
03183971122, Diluent Universal, 2 x 36 mL sample diluent
the workplace.
▪ General laboratory equipment
P280 Wear protective gloves. ▪ cobas e analyzer
Response: For risk calculation of trisomy 21:
▪ A suitable software, e.g.
P333 + P313 If skin irritation or rash occurs: Get medical 05126193, SsdwLab (V5.0 or later), single user licence
advice/attention. 05195047, SsdwLab (V5.0 or later), multi user licence
P362 + P364 Take off contaminated clothing and wash it before reuse. ▪ 04481798190, Elecsys AFP, 100 tests
▪ 04491742190, Elecsys AFP, 200 tests
Disposal:
▪ 04487761190, AFP CalSet II, for 4 x 1 mL
P501 Dispose of contents/container to an approved waste Additional materials for the cobas e 411 analyzer:
disposal plant.
▪ 11662988122, ProCell, 6 x 380 mL system buffer
Product safety labeling follows EU GHS guidance.
▪ 11662970122, CleanCell, 6 x 380 mL measuring cell cleaning
Contact phone: all countries: +49-621-7590 solution
Avoid foam formation in all reagents and sample types (specimens, ▪ 11930346122, Elecsys SysWash, 1 x 500 mL washwater additive
calibrators and controls).
▪ 11933159001, Adapter for SysClean
Reagent handling
▪ 11706802001, AssayCup, 60 x 60 reaction cups
The reagents in the kit have been assembled into a ready‑for‑use unit that
cannot be separated. ▪ 11706799001, AssayTip, 30 x 120 pipette tips
All information required for correct operation is read in from the respective ▪ 11800507001, Clean‑Liner
reagent barcodes. Additional materials for cobas e 601 and cobas e 602 analyzers:
Storage and stability ▪ 04880340190, ProCell M, 2 x 2 L system buffer
Store at 2‑8 °C. ▪ 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning
Do not freeze. solution
Store the Elecsys reagent kit upright in order to ensure complete ▪ 03023141001, PC/CC‑Cups, 12 cups to prewarm ProCell M and
availability of the microparticles during automatic mixing prior to use. CleanCell M before use
Stability: ▪ 03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run
finalization and rinsing during reagent change
unopened at 2‑8 °C up to the stated expiration date
▪ 03004899190, PreClean M, 5 x 600 mL detection cleaning solution
after opening at 2‑8 °C 12 weeks
▪ 12102137001, AssayTip/AssayCup, 48 magazines x 84 reaction
on the analyzers 4 weeks cups or pipette tips, waste bags
Specimen collection and preparation ▪ 03023150001, WasteLiner, waste bags
Only the specimens listed below were tested and found acceptable. ▪ 03027651001, SysClean Adapter M
Serum collected using standard sampling tubes or tubes containing Additional materials for all analyzers:
separating gel. ▪ 11298500316, ISE Cleaning Solution/Elecsys SysClean,
Li‑heparin, K2‑EDTA and K3‑EDTA plasma. 5 x 100 mL system cleaning solution
Plasma tubes containing separating gel can be used. Assay
Criterion: Slope 0.9‑1.1 + coefficient of correlation ≥ 0.95 (Pearson). For optimum performance of the assay follow the directions given in this
Stable for 3 days at 2‑8 °C, 12 months at ‑20 °C (± 5 °C). Freeze only once. document for the analyzer concerned. Refer to the appropriate operator’s
manual for analyzer‑specific assay instructions.
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 Resuspension of the microparticles takes place automatically prior to use.
available tubes of all manufacturers were tested. Sample collection systems Read in the test-specific parameters via the reagent barcode. If in
from various manufacturers may contain differing materials which could exceptional cases the barcode cannot be read, enter the 15-digit sequence
affect the test results in some cases. When processing samples in primary of numbers.
tubes (sample collection systems), follow the instructions of the tube cobas e 601 and cobas e 602 analyzers: PreClean M solution is
manufacturer. necessary.
Centrifuge samples containing precipitates before performing the assay.

2/5 2024-10, V 20.0 English

Elecsys HCG+β
Bring the cooled reagents to approximately 20 °C and place on the reagent Lower detection limit of the test
disk (20 °C) of the analyzer. Avoid foam formation. The system Lower detection limit: ≤ 0.100 mIU/mL
automatically regulates the temperature of the reagents and the
opening/closing of the bottles. The lower detection limit represents the lowest measurable analyte level
that can be distinguished from zero. It is calculated as the value lying two
Calibration standard deviations above that of the lowest standard (master calibrator,
Traceability: This method has been standardized against the 4th standard 1 + 2 SD, repeatability study, n = 21).
International Standard for Chorionic Gonadotropin from the National Dilution
Institute for Biological Standards and Control (NIBSC) code 75/589.
Samples with hCG concentrations above the measuring range can be
Every Elecsys reagent set has a barcoded label containing specific diluted with Diluent Universal. The recommended dilution is 1:100 (either
information for calibration of the particular reagent lot. The predefined automatically by the analyzers, or manually). The concentration of the
master curve is adapted to the analyzer using the relevant CalSet. diluted sample must be > 100 mIU/mL.
Calibration frequency: Calibration must be performed once per reagent lot After manual dilution, multiply the result by the dilution factor.
using fresh reagent (i.e. not more than 24 hours since the reagent kit was
registered on the analyzer). After dilution by the analyzers, the software automatically takes the dilution
into account when calculating the sample concentration.
Calibration interval may be extended based on acceptable verification of
calibration by the laboratory. Expected values
Renewed calibration is recommended as follows: Results from a multicenter study in clinical centers in Belgium, France, and
Germany using the Elecsys HCG+β assay ( 03271749190) are listed
▪ after 1 month (28 days) when using the same reagent lot below (Study No. B01P019).
▪ after 7 days (when using the same reagent kit on the analyzer) Serum samples from healthy individuals:
▪ as required: e.g. quality control findings outside the defined limits ▪ ≤ 1 mIU/mL hCG for 97.5 % of the values obtained from 181 healthy,
Quality control non‑pregnant premenopausal women. The corresponding upper 95 %
For quality control, use PreciControl Universal or PreciControl Tumor confidence limit ranges up to 5.3 mIU/mL.
Marker. ▪ ≤ 7 mIU/mL hCG for 97.5 % of the values obtained from 143 healthy,
In addition, other suitable control material can be used. postmenopausal women. The corresponding upper 95 % confidence
limit ranges up to 8.3 mIU/mL.
Controls for the various concentration ranges should be run individually at
least once every 24 hours when the test is in use, once per reagent kit, and ▪ < 2 mIU/mL hCG for 97.5 % of the values obtained from 290 men. The
following each calibration. corresponding upper 95 % confidence limit ranges up to 2.6 mIU/mL.
The control intervals and limits should be adapted to each laboratory’s ▪ During pregnancy (weeks of pregnancy - defined as completed weeks of
individual requirements. Values obtained should fall within the defined pregnancy beginning with the start of the last menstruation phase), the
limits. Each laboratory should establish corrective measures to be taken if following values have been determined.
values fall outside the defined limits. Data are given only for the weeks of gestation for which the case numbers
If necessary, repeat the measurement of the samples concerned. (n) were greater than 10.
Follow the applicable government regulations and local guidelines for Weeks of gestation N HCG mIU/mL
quality control.
Median 5-95th percentile
Calculation
The analyzer automatically calculates the analyte concentration of each 3 25 17.5 5.8-71.2
sample (either in mIU/mL or IU/L). 4 43 141 9.5-750
Limitations - interference 5 23 1398 217-7138
The assay is unaffected by icterus (bilirubin < 410 µmol/L or < 24 mg/dL),
hemolysis (Hb < 0.621 mmol/L or < 1.0 g/dL), lipemia (Intralipid 6 19 3339 158-31795
< 1400 mg/dL) and biotin (< 327 nmol/L or < 80 ng/mL). 7 13 39759 3697-163563
Criterion: Recovery within ± 10 % of initial value. 8 23 90084 32065-149571
Samples should not be taken from patients receiving therapy with high
biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin 9 23 106257 63803-151410
administration. 10 20 85172 46509-186977
No interference was observed from rheumatoid factors up to a 12 17 66676 27832-210612
concentration of 3400 IU/mL and samples from dialysis patients.
There is no high-dose hook effect at hCG concentrations up to 14* 67 34440 13950-62530
750000 mIU/mL. 15* 666 28962 12039-70971
In vitro tests were performed on 16 commonly used pharmaceuticals. No 16* 766 23930 9040-56451
interference with the assay was found.
In rare cases, interference due to extremely high titers of antibodies to 17* 190 20860 8175-55868
analyte‑specific antibodies, streptavidin or ruthenium can occur. These 18* 64 19817 8099-58176
effects are minimized by suitable test design.
* For the gestational weeks 14 to 18, which are the relevant weeks for the
For diagnostic purposes, the results should always be assessed in trisomy 21 risk assessment, the values from serum samples of
conjunction with the patient’s medical history, clinical examination and other 1753 pregnant women in total were evaluated from measurements with the
findings. Elecsys HCG+β assay and the Elecsys AFP assay in the 5 clinical centers.
Limits and ranges The maternal age and weight and the gestational age in days was given for
Measuring range each sample.
0.100‑10000 mIU/mL (defined by the lower detection limit and the maximum The individual results were analyzed for normal distribution of the log MoM
of the master curve). Values below the lower detection limit are reported as (Multiple of Median) values. The standard deviations of the MoM values are
< 0.100 mIU/mL. Values above the measuring range are reported as comparable to published data.
> 10000 mIU/mL (or up to 1000000 mIU/mL for 100‑fold diluted samples). Median values and the 5th and 95th percentile were calculated for the
Lower limits of measurement completed gestational weeks - see within the table above.

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Elecsys HCG+β
Distribution of Elecsys HCG+β results from healthy subjects and patients c) TM = Tumor Marker
with benign and malignant diseases:
cobas e 601 and cobas e 602 analyzers
The results from patients with benign and malignant diseases are
summarized data from measurements with the Elecsys HCG+β assay Repeatability Intermediate precision
( 03271749190) and the Elecsys HCG+β assay ( 11973193122). Sample Mean SD CV Mean SD CV
Concentration N Percent (%) mIU/mL mIU/mL % mIU/mL mIU/mL %
mIU/mL ≤2 > 2 - ≤ 7 > 7 - ≤ 100 > 100 > 1000 Human serum 1 8.52 0.24 2.8 4.73 0.35 7.4
Healthy subjects 614 Human serum 2 796 13.6 1.7 899 29.4 3.3
Males 290 97.9 2.1 0 0 0 Human serum 3 7012 188 2.7 8082 344 4.3
Females 181 98.9 1.1 0 0 0 PreciControl U1 7.20 0.18 2.5 8.49 0.29 3.4
premenopause PreciControl U2 19.6 0.55 2.8 22.5 1.05 4.6
PreciControl TM1 21.4 0.39 1.8 24.2 1.11 4.6
Females 143 53.1 46.2 0.7 0 0
PreciControl TM2 2012 47.0 2.3 2316 84.2 3.6
postmenopause
Method comparison
A comparison of the Elecsys HCG+β assay (y) with the Elecsys HCG STAT
Malignant 839 assay (x) using human sera gave the following correlations:
diseases Number of samples measured: 81
Chorioncarcinoma 64 10.9 10.9 21.9 10.9 45.3
Passing/Bablok18 Linear regression
Seminoma 29 89.7 3.4 6.9 0 0
y = 1.00x + 7.40 y = 0.95x + 53.4
Germ cell tumor 109 78.0 3.7 0.9 5.5 11.9
τ = 0.986 r = 0.999
Yolk sac tumor 45 20.0 6.7 22.2 8.9 42.2
The sample concentrations were between 3 and 8550 mIU/mL.
Ovarian cancer 38 76.3 18.4 5.3 0 0
Analytical specificity
Gestational 169 19.5 10.7 29.6 20.1 20.1 For the monoclonal antibodies used, the following cross-reactivities were
trophoblastic found:
diseases
Substance Additive concentration Cross-reactivity
Mole 72 1.4 4.2 26.4 27.8 40.3
mIU/mL %
LH 4000 n. d.d)
Others 313 52.7 13.1 8.6 11.8 13.7
FSH 4000 0.1
Note: For prenatal testing it is recommended that the median values be
re‑evaluated periodically (1 to 3 years) and whenever methodology TSH 2000 n. d.
changes. d) n. d. = not detectable
Each laboratory should investigate the transferability of the expected values Functional sensitivity
to its own patient population and if necessary determine its own reference < 0.6 mIU/mL
ranges.
The functional sensitivity is the lowest analyte concentration that can be
Specific performance data reproducibly measured with an intermediate precision CV of 20 %.
Representative performance data on the analyzers are given below.
Results obtained in individual laboratories may differ. References
1 Schwarz S, Berger P, Wick G. The Antigenic Surface of Human
Precision Chorionic Gonadotropin as Mapped by Murine Monoclonal Antibodies.
Precision was determined using Elecsys reagents, pooled human sera and Endocrinology 1986;118(1):189-197.
controls in a modified protocol (EP5‑A) of the CLSI (Clinical and Laboratory 2 Sturgeon CM, McAllister EJ. Analysis of hCG: clinical applications and
Standards Institute): 6 times daily for 10 days (n = 60); repeatability on assay requirements. Ann Clin Biochem 1998;35:460-491.
MODULAR ANALYTICS E170 analyzer, n = 21. The following results were
obtained: 3 Hoermann R, Berger P, Spoettl G, et al. Immunological Recognition
and Clinical Significance of Nicked Human Chorionic Gonadotropin in
cobas e 411 analyzer Testicular Cancer. Clin Chem 1994;40(12):2306-2312.
Repeatability Intermediate 4 Choi J, Schmitz J. Luteinizing hormone and human chorionic
precision gonadotropin: Origins of difference. Mol Cell Endocrinology.
2014;383:203–213.
Sample Mean SD CV SD CV
5 Cole LA. Immunoassay of human chorionic gonadotropin, its free
mIU/mL mIU/mL % mIU/mL % subunits, and metabolites. Clin Chem 1997;43(12):2233-2243.
Human serum 1 4.36 0.21 4.9 0.26 5.9 6 Thomas CMG, Reijnders FJL, Segers MFG, et al. Human
Human serum 2 822 13.0 1.6 15.6 1.9 Choriogonadotropin (HCG): Comparisons between Determinations of
Intact HCG, Free HCG β-Subunit, and “Total” HCG + β in Serum during
Human serum 3 7040 133 1.9 189 2.7 the First Half of High-Risk Pregnancy. Clinical Chemistry
PreciControl Ub)1 8.17 0.16 1.9 0.24 2.9 1990;36(4):651-655.
PreciControl U2 21.5 0.71 3.3 0.78 3.6 7 Schlebusch H. Prenatal screening for Down’s syndrome. In: Thomas L
(ed.). Clinical Laboratory Diagnosis, TH-Books, Frankfurt, 1st English
PreciControl TMc)1 23.1 0.52 2.3 0.68 2.9 edition 1998:1124-1125, deutsche Auflage 1998:1149-1150.
PreciControl TM2 2150 28.9 1.3 44.1 2.1
b) U = Universal

4/5 2024-10, V 20.0 English

Elecsys HCG+β
8 Cuckle HS, Wald NJ, Thompson SG. Estimating a woman’s risk of
having a pregnancy associated with Down’s syndrome using her age
and serum alpha-fetoprotein level. Br J Obstet Gynaecol
Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim
1987;94:387-402. www.roche.com
9 Reynolds TM, Penney MD. The mathematical basis of multivariate risk +800 5505 6606
screening: with special reference to screening for Down’s syndrome
associated pregnancy. Ann Clin Biochem 1989;26:452-458.
10 Cuckle HS, Wald NJ, Nanchahal K, et al. Repeat maternal serum
alpha-fetoprotein testing in antenatal screening programmes for Down’s
syndrome. Br J Obstet Gynaecol 1989;96:52-60.
11 Dunstan FDJ, Gray JC, Nix ABJ, et al. Detection rates and false
positive rates for Down’s Syndrome screening: How precisely can they
be estimated and what factors influence their value? Statistics Medicine
1997;16:1481-1495.
12 Lamson SH, Hook B. Comparison of Mathematical Models for the
Maternal Age Dependence of Down’s Syndrome Rates. Hum Genet Vol
1981;59:232-234.
13 Cuckle HS. Improved parameters for risk estimation in Down’s
syndrome screening. Prenat Diagn 1995;15:1057-1065.
14 Thomas L. Human chorionic gonadotropin (hCG). In: Thomas L (ed.).
Clinical Laboratory Diagnosis, TH-Books, Frankfurt, 1st English edition
1998:1119-1121, 8th German edition 2012:11876-1877.
15 Marcillac I, Troalen F, Bidart JM, et al. Free Human Chorionic
Gonadotropin β Subunit in Gonadal and Nongonadal Neoplasms.
Cancer Res 1992;52:3901-3907.
16 Mann K, Hörmann R. hCG (human chorionic gonadotropin). In: Thomas
L (ed.). Clinical Laboratory Diagnosis, TH-Books, Frankfurt, 1st English
edition 1998:971-976, 8th German edition 2012:1668-1669.
17 Sturgeon C. Practice Guidelines for Tumor Marker Use in the Clinic.
Clin Chem 2002;48(8):1151-1159.
18 Bablok W, Passing H, Bender R, et al. A general regression procedure
for method transformation. Application of linear regression procedures
for method comparison studies in clinical chemistry, Part III.
J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.
For further information, please refer to the appropriate operator’s manual for
the analyzer concerned, the respective application sheets, the product
information and the Method Sheets of all necessary components (if
available in your country).
A point (period/stop) is always used in this Method Sheet as the decimal
separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
Any serious incident that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or the patient is established.
The Summary of Safety & Performance Report can be found here:
https://ec.europa.eu/tools/eudamed
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume after reconstitution or mixing
GTIN Global Trade Item Number

COBAS, COBAS E, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark of
Fresenius Kabi AB.
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.
© 2021, Roche Diagnostics

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