Elecsys Anti-HCV II

MODULAR ANALYTICS E170

cobas e 411
06427405 119 200
cobas e 601
cobas e 602

English a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )

System information Reagents - working solutions

For cobas e 411 analyzer: test number 1020 The reagent rackpack (M, R1, R2) is labeled as A‑HCV II.
For MODULAR ANALYTICS E170, cobas e 601 and cobas e 602
analyzers: Application Code Number 286 M Streptavidin-coated microparticles (transparent cap), 1 bottle, 12 mL:

Intended use Streptavidin-coated microparticles 0.72 mg/mL; preservative.

The Elecsys Anti-HCV II assay is an in vitro diagnostic test for the R1 HCV-specific antigens~biotin (gray cap), 1 bottle, 18 mL:
qualitative detection of antibodies to hepatitis C virus (HCV) in human
serum and plasma. This assay is indicated as an aid in the diagnosis of Biotinylated HCV‑specific antigens, HEPESb) buffer, pH 7.4;
infection with HCV. This assay is also indicated as a donor screening test to preservative.
detect antibodies to HCV in serum or plasma specimens from individual
human blood donors.This assay may also be used to detect antibodies to R2 HCV-specific antigens~Ru(bpy) (black cap), 1 bottle, 18 mL:
HCV in serum and plasma specimens to screen donors of cells (excluding HCV-specific antigens labeled with ruthenium complex ≥ 0.3 mg/L,
blood cells and derivatives), tissues and organs intended for transplantation. HEPES buffer, pH 7.4; preservative.
The electrochemiluminescence immunoassay “ECLIA” is intended for use
b) HEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
on Elecsys and cobas e immunoassay analyzers.
Note: Please note that the catalogue number appearing on the package A‑HCV II Cal1 Negative calibrator 1 (white cap), 2 bottles of 1.3 mL each:
insert retains only the first 8 digits of the licensed 11-digit Catalogue
Number: 06427405190 for the Elecsys Anti-HCV II assay. The last 3 digits Human serum, preservative.
-190 have been replaced by -119 for logistic purposes A‑HCV II Cal2 Positive calibrator 2 (black cap), 2 bottles of 1.3 mL each:
Summary Human serum positive for anti‑HCV Ab; preservative. Non-
The hepatitis C virus (HCV), first identified in 1989, is a leading cause of reactive for HBsAg, anti‑HIV 1/2.
liver disease and a major healthcare concern with over 170 million persons
(roughly 3 % of the human population), infected worldwide.2,3 The highest Precautions and warnings
prevalence is found in Africa, the Eastern Mediterranean and Asian For in vitro diagnostic use.
regions.3,4 HCV is a member of the Flaviviridae family and has a single- Exercise the normal precautions required for handling all laboratory
stranded, positive-sense RNA genome.5 Currently over 67 subtypes have reagents.
been identified and these have been classified into 7 genotypes (1‑7).6 Disposal of all waste material should be in accordance with local guidelines.
Due to the high rate of asymptomatic infections, clinical diagnosis is difficult Safety data sheet available for professional user on request.
and screening assays are of major importance.7 Infection with HCV can lead All human material should be considered potentially infectious.
to acute and chronic hepatitis disease. Approximately 70‑85 % of HCV
infections progress to chronic disease, although this varies according to All products derived from human blood are prepared exclusively from the
patient gender, age, race and immune status.5,8 Chronic HCV infection may blood of donors tested individually and shown to be free from HBsAg and
lead to cirrhosis and hepatocellular carcinoma,9 therefore, early anti‑HCV antibodies to HCV (A‑HCV II Cal1 only) and HIV.
detection is the first step in the management of chronic hepatitis and in the The testing methods used assays approved by the FDA or cleared in
selection of patients needing treatment.7 HCV infection can be detected by compliance with the European Directive 98/79/EC, Annex II, List A.
measuring the amount of HCV RNA, alanine aminotransferase (ALT) and The serum containing anti‑HCV (A‑HCV II Cal2) was inactivated using
HCV‑specific immunoglobulins (anti‑HCV) in patient serum or plasma β‑propiolactone and UV‑radiation.
samples. This can also indicate if the infection is acute or chronic.5,8
However, as no inactivation or testing method can rule out the potential risk
Anti‑HCV antibody tests are used alone or in combination with other tests of infection with absolute certainty, the material should be handled with the
(e.g. HCV RNA) to detect an infection with HCV and to identify blood and same level of care as a patient specimen. In the event of exposure, the
blood products of individuals infected with HCV. The Elecsys Anti‑HCV II directives of the responsible health authorities should be followed.12,13
assay is a third-generation test.10,11 The Elecsys Anti‑HCV II assay uses
peptides and recombinant proteins representing HCV core, NS3 and NS4 Avoid foam formation in all reagents and sample types (specimens,
antigens for the determination of anti‑HCV antibodies. calibrators and controls).
The Elecsys Anti‑HCV II assay has a high dilution sensitivity. Avoid any
Test principle sample cross-contamination during sample pre-analytics.
Sandwich principle. Total duration of assay: 18 minutes.
▪ 1st incubation: 50 µL of sample, 55 µL of a reagent containing Reagent handling
biotinylated HCV‑specific antigens and 55 µL of a reagent containing The reagents in the kit are ready‑for‑use and are supplied in bottles
HCV‑specific antigens labeled with a ruthenium complexa) react to form compatible with the system.
a sandwich complex. cobas e 411 analyzer: The calibrators should only be left on the analyzer
▪ 2nd incubation: After addition of streptavidin-coated microparticles, the during calibration at 20‑25 °C. After use, close the bottles as soon as
complex becomes bound to the solid phase via interaction of biotin and possible and store upright at 2‑8 °C.
streptavidin. Due to possible evaporation effects, not more than 5 calibration procedures
▪ The reaction mixture is aspirated into the measuring cell where the per bottle set should be performed.
microparticles are magnetically captured onto the surface of the MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers:
electrode. Unbound substances are then removed with Unless the entire volume is necessary for calibration on the analyzers,
ProCell/ProCell M. Application of a voltage to the electrode then induces transfer aliquots of the ready‑for‑use calibrators into empty snap-cap bottles
chemiluminescent emission which is measured by a photomultiplier. (CalSet Vials). Attach the supplied labels to these additional bottles. Store
▪ Results are determined automatically by the software by comparing the the aliquots at 2‑8 °C for later use.
electrochemiluminescence signal obtained from the reaction product of Perform only one calibration procedure per aliquot.
the sample with the signal of the cutoff value previously obtained by
calibration.
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Elecsys Anti-HCV II
All information required for correct operation is read in from the respective
reagent barcodes.
Please note: Both the vial labels, and the additional labels (if available) Centrifuge samples containing precipitates before performing the assay.
contain 2 different barcodes. The barcode between the yellow markers is for Ensure the samples, calibrators and controls are at 20‑25 °C prior to
cobas 8000 systems only. If using a cobas 8000 system, please turn the measurement.
vial cap 180° into the correct position so the barcode can be read by the Due to possible evaporation effects, samples, calibrators and controls on
system. Place the vial on the instrument as usual. the analyzers should be analyzed/measured within 2 hours.
Storage and stability The performance of the Elecsys Anti-HCV II assay has not been
Store at 2‑8 °C. established with cadaveric samples or body fluids other than serum and
Do not freeze. plasma.
Store the Elecsys reagent kit upright in order to ensure complete Materials provided
availability of the microparticles during automatic mixing prior to use. See “Reagents – working solutions” section for reagents.
Stability of the reagent rackpack ▪ 2 x 6 bottle labels
unopened at 2‑8 °C up to the stated expiration date Materials required (but not provided)
after first opening at 2‑8 °C 8 weeks ▪ 03290379190, PreciControl Anti‑HCV, for 16 x 1.3 mL
on the analyzers 31 days if continuously stored ▪ General laboratory equipment
onboard (20‑25 °C) ▪ MODULAR ANALYTICS E170 or cobas e analyzer
or Accessories for cobas e 411 analyzer:
7 weeks and up to 80 hours in total ▪ 11662988122, ProCell, 6 x 380 mL system buffer
onboard (20‑25 °C) if stored
▪ 11662970122, CleanCell, 6 x 380 mL measuring cell cleaning
alternately in the refrigerator and on solution
the analyzer
▪ 11930346122, Elecsys SysWash, 1 x 500 mL washwater additive
Stability of the calibrators ▪ 11933159001, Adapter for SysClean
unopened at 2‑8 °C up to the stated expiration date ▪ 11706802001, AssayCup, 60 x 60 reaction cups
after opening at 2‑8 °C 8 weeks ▪ 11706799001, AssayTip, 30 x 120 pipette tips
▪ 11800507001, Clean‑Liner
on cobas e 411 at 20‑25 °C up to 5 hours
Accessories for MODULAR ANALYTICS E170, cobas e 601 and
on MODULAR ANALYTICS E170, use only once cobas e 602 analyzers:
cobas e 601 and cobas e 602 at ▪ 04880340190, ProCell M, 2 x 2 L system buffer
20‑25 °C
▪ 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning
Store calibrators upright in order to prevent the calibrator solution from solution
adhering to the snap‑cap.
▪ 03023141001, PC/CC‑Cups, 12 cups to prewarm ProCell M and
Specimen collection and preparation CleanCell M before use
Only the specimens listed below were tested and found acceptable. ▪ 03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run
Serum collected using standard sampling tubes or tubes containing finalization and rinsing during reagent change
separating gel. ▪ 03004899190, PreClean M, 5 x 600 mL detection cleaning solution
Li‑heparin, Na‑heparin, K2‑EDTA, K3‑EDTA, ACD, CPDA and Na‑citrate ▪ 12102137001, AssayTip/AssayCup, 48 magazines x 84 reaction
plasma as well as plasma tubes containing separating gel. cups or pipette tips, waste bags
Criterion: Correct assignment of positive and negative samples within a
recovery of 80‑120 % of serum value. ▪ 03023150001, WasteLiner, waste bags
CPD and CP2D plasma. ▪ 03027651001, SysClean Adapter M
Criterion: Correct assignment of positive and negative samples within a Accessories for all analyzers:
recovery of 80‑130 % of serum value.
▪ 11298500316, ISE Cleaning Solution/Elecsys SysClean,
Stability: 5 x 100 mL system cleaning solution
For living patients and donor specimens obtained while the donor’s heart is
still beating: Stable for 7 days at 20‑25 °C, 14 days at 2‑8 °C, 3 months at Assay
‑20 °C (± 5 °C). The samples may be frozen 6 times. For optimum performance of the assay follow the directions given in this
document for the analyzer concerned. Refer to the appropriate operator’s
The sample types listed were tested with a selection of sample collection manual for analyzer‑specific assay instructions.
tubes or systems that were commercially available at the time of testing, i.e. Resuspension of the microparticles takes place automatically prior to use.
not all available tubes of all manufacturers were tested. Sample collection Read in the test‑specific parameters via the reagent barcode. If in
systems from various manufacturers may contain differing materials which exceptional cases the barcode cannot be read, enter the 15‑digit sequence
could affect the test results in some cases. When processing samples in of numbers (except for the cobas e 602 analyzer).
primary tubes (sample collection systems), follow the instructions of the MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers:
tube manufacturer. PreClean M solution is necessary.
Bring the cooled reagents to approximately 20 °C and place on the reagent
disk (20 °C) of the analyzer. Avoid foam formation. The system
automatically regulates the temperature of the reagents and the
opening/closing of the bottles.
Place the calibrators in the sample zone.
All the information necessary for calibrating the assay is automatically read
into the analyzer.

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Elecsys Anti-HCV II
After calibration has been performed, store the calibrators at 2‑8 °C or Criterion: Recovery of positive samples within ± 20 % of initial value,
discard (MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 cutoff‑index for negative samples ± 0.2 of initial value.
analyzers). Samples should not be taken from patients receiving therapy with high
Calibration biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin
No internationally accepted standard for anti‑HCV exists. administration.
Every Elecsys Anti‑HCV II reagent set has a barcoded label containing No interference was observed from rheumatoid factors up to a
specific information for calibration of the particular reagent lot. The concentration of 1200 IU/mL.
predefined master curve is adapted to the analyzer using the A‑HCV II Cal1 In vitro tests were performed on 18 commonly used pharmaceuticals and
and A‑HCV II Cal2. 3 drugs used in HCV therapy. No interference with the assay was found.
Calibration frequency: Calibration must be performed once per reagent lot In rare cases, interference due to extremely high titers of antibodies to
using fresh reagent (i.e. not more than 24 hours since the reagent kit was analyte‑specific antibodies, streptavidin or ruthenium can occur. These
registered on the analyzer). effects are minimized by suitable test design.
Calibration interval may be extended based on acceptable verification of Studies have been performed to assess the high-dose hook effect. Out of
calibration by the laboratory. 765 positive samples no false negative result was found. Occurrence of
Renewed calibration is recommended as follows: high-dose hook effect cannot be completely excluded.
For diagnostic purposes, the results should always be assessed in
▪ after 1 month (28 days) when using the same reagent lot conjunction with the patient’s medical history, clinical examination and other
▪ after 7 days (when using the same reagent kit on the analyzer) findings.
▪ as required: e.g. quality control findings outside the defined limits Due to a long time period from infection to seroconversion, negative
Range for electrochemiluminescence signals (counts) for the calibrators: anti‑HCV test results may occur during early infection. If acute hepatitis C
Negative calibrator (A‑HCV II Cal1): 400‑3000 (all analyzers) infection is suspected, measuring of HCV RNA by reverse transcriptase
Positive calibrator (A‑HCV II Cal2): 25000‑350000 (all analyzers) polymerase chain reaction (RT‑PCR e.g. by COBAS AMPLICOR) may give
evidence of HCV infection.
Quality control The detection of anti‑HCV antibodies indicates a present or past infection
For quality control, use PreciControl Anti‑HCV. with hepatitis C virus, but does not differentiate between acute, chronic or
In addition, other suitable control material can be used. resolved infection. It is recognized within the scientific community that
presently available methods for anti‑HCV detection are not sensitive
Controls for the various concentration ranges should be run individually at enough to detect all potentially infectious units of blood or possible cases of
least once every 24 hours when the test is in use, once per reagent kit, and HCV infection. The antibody concentration may be beneath the detection
following each calibration. limit of this assay or the patient´s antibodies do not react with the antigens
The control intervals and limits should be adapted to each laboratory’s used in this test. In addition, non-specific results cannot be ruled out with
individual requirements. Values obtained should fall within the defined the Elecsys Anti‑HCV II assay.
limits. Each laboratory should establish corrective measures to be taken if
values fall outside the defined limits. Specific performance data
If necessary, repeat the measurement of the samples concerned. Representative performance data on the analyzers are given below.
Results obtained in individual laboratories may differ.
Follow the applicable government regulations and local guidelines for
quality control. Precision
Note: Precision was determined using Elecsys reagents, samples and controls in
For technical reasons re-assigned target values valid only for a specific a protocol (EP5‑A2) of the CLSI (Clinical and Laboratory Standards
reagent and control lot combination must be entered manually on all Institute): 2 runs per day in duplicate each for 21 days (n = 84). The
analyzers (except for the cobas e 602 analyzer). Therefore always refer to following results were obtained:
the value sheet included in the reagent kit or PreciControl kit to make sure
that the correct target values are used. cobas e 411 analyzer
When a new reagent or control lot is used, the analyzer will use the original Repeatabilityc) Intermediate
values encoded in the control barcodes. precisiond)
Calculation Sample Mean SD CV Mean SD CV
The analyzer automatically calculates the cutoff based on the measurement COIe) COI % COI COI %
of A‑HCV II Cal1 and A‑HCV II Cal2.
The result of a sample is given either as reactive or non-reactive as well as HSf), negative 0.071 0.001 1.6 0.071 0.003 4.1
in the form of a cutoff-index (signal sample/cutoff). HS, weakly positive 1.86 0.049 2.7 1.86 0.085 4.6
Interpretation of the results HS, positive 20.0 0.476 2.4 20.0 1.04 5.2
Samples with a cutoff-index < 0.9 are non reactive in the Elecsys PreciControl A‑HCV1 0.097 0.001 1.4 0.097 0.004 3.8
Anti‑HCV II assay.
Samples with a cutoff-index ≥ 0.9 and < 1.0 are considered borderline in the PreciControl A‑HCV2 4.39 0.113 2.6 4.39 0.185 4.2
Elecsys Anti‑HCV II assay. c) Repeatability = within-run precision
Samples with a cutoff-index ≥ 1.0 are reactive in the Elecsys Anti‑HCV II d) Intermediate precision = within-laboratory precision
assay. e) COI = Cutoff index
All initially reactive or borderline samples should be redetermined in f) HS = Human serum
duplicate using the Elecsys Anti‑HCV II assay. If no reactivity is found in
both cases, the sample is negative for anti‑HCV. If the result from either of MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers
the two measurements is reactive or borderline then the sample is Repeatability Intermediate
repeatedly reactive. Repeatedly reactive samples must be investigated by
supplemental methods (e.g. immunoblot or detection of HCV RNA). If one precision
or both measurements remain borderline the analysis of a follow-up sample Sample Mean SD CV Mean SD CV
is recommended. COI COI % COI COI %
Limitations - interference HS, negative 0.034 0.006 16.3 0.034 0.007 20.4
The assay is unaffected by icterus (bilirubin < 1129 µmol/L or < 66 mg/dL),
hemolysis (Hb < 0.621 mmol/L or < 1.00 g/dL), lipemia (Intralipid HS, weakly positive 1.89 0.017 0.9 1.89 0.033 1.8
< 2000 mg/dL) and biotin (< 172 nmol/L or < 42 ng/mL).

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Elecsys Anti-HCV II
MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers N Elecsys Elecsys Positive or
Repeatability Intermediate Anti‑HCV II Anti‑HCV II indeterminate by
precision IRh) RRi) immunoblot and/or
COI ≥ 1 COI ≥ 1 HCV RNA
Sample Mean SD CV Mean SD CV
COI COI % COI COI % European blood 6850 15 15 2 confirmed positive,
donors 3 indeterminate
HS, positive 20.9 0.138 0.7 20.9 0.339 1.6
Hospitalized 3922 153j) 152k) 128 confirmed
PreciControl A‑HCV1 0.055 0.001 1.1 0.055 0.001 2.3 patients positive,
PreciControl A‑HCV2 4.00 0.028 0.7 4.00 0.160 4.0 8 indeterminate
Analytical specificity Dialysis patients 731 19 18 12 confirmed
1037 samples containing potentially interfering substances or derived from positive
high-risk groups were tested with the Elecsys Anti‑HCV II assay comprising Pregnant 629 3 3 2 confirmed positive
specimens:
women
▪ containing antibodies against HBV, HAV, HEV, EBV, CMV, HSV, HIV,
VZV, Parvovirus, Mumps, Dengue, tick‑borne encephalitis virus (TBEV), h) IR = Initially Reactive
Rubella, Toxoplasma gondii, Treponema pallidum i) RR = Repeatedly Reactive
j) 4 (positive) samples had to be excluded from calculation due to “qns” for immunoblot analysis;
▪ containing autoantibodies and elevated titers of rheumatoid factor, IgG, qns = quantity not sufficient
IgM or IgA antibodies
k) 4 (positive) samples had to be excluded from calculation due to “qns” for immunoblot analysis
▪ positive for HBsAg and E. coli
▪ after vaccination against HBV and Influenza
References
▪ non-viral liver diseases
▪ alcoholic liver disease
2 Choo QL, Kuo G, Weiner AJ, et al. Isolation of a cDNA clone derived
▪ high-risk groups: hemophiliacs, homosexuals and intravenous drug from a blood-borne non-A, non-B viral hepatitis genome. Science
abusers 1989;244:359-362.
N Elecsys Positive by Negative by 3 Lavanchy D. The global burden of hepatitis C. Liver Int
Anti‑HCV II immunoblot or immunoblot 2009;29(s1):74-81.
reactive indeterminate 4 Hepatitis C WHO report WHO/SCD/SCR/LYO/2003
Specimens 1037 59 58 positive 1g) http://www.who.int/csr/disease/hepatitis/Hepc.pdf
containing 5 Hoofnagle JH. Course and outcome of hepatitis C. Hepatology
potentially 2002;36:21-29.
interfering 6 Smith DB, Bukh J, Kuiken C, et al. Expanded classification of hepatitis
substances C virus into 7 genotypes and 67 subtypes: updated criteria and
assignment web resource. Hepatology 2013;59:318-327.
g) EBV IgM positive patients: 1 out of 69 samples 7 Strader DB, Wright T, Thomas DL, et al. Diagnosis, management, and
Clinical sensitivity treatment of hepatitis C. Hepatology 2004;39(4):1147-1171.
Of 765 samples from HCV infected patients with different stages of disease 8 Lemon SM, Walker CM, Alter MJ, et al. Fields Virology. Lippincot
and infected with different HCV genotypes (type 1, 2, 3, 4, 5 and 6), all Williams and Wilkins, Philadelphia. Hepatitis C virus; 2007:1253-1304.
samples were found to be reactive with the Elecsys Anti‑HCV II assay.
9 Di Bisceglie AM. Hepatitis C and hepatocellular carcinoma. Hepatology
Group N Reactive 1997;26(Suppl 1):34-38.
HCV infected persons with 224 224 10 Couroucé A-M. Development of Screening and Confirmation Tests for
Antibodies to Hepatitis C Virus. In: Reesink HW (ed.): Hepatitis C Virus.
different stages of disease Curr Stud Hematol Blood Transf. Basel, Karger, 1998;62:64-75.
HCV genotypes (type 1, 2, 541 541 11 Vernelen K, Claeys H, Verhaert H, et al. Significance of NS3 and NS5
3, 4, 5, 6) antigens in screening for HCV antibody. The Lancet
1994;343(8901):853.
In the above study the diagnostic sensitivity was 100 %. The 95 % lower
confidence limit was 99.61 %. 12 Occupational Safety and Health Standards: Bloodborne pathogens.
(29 CFR Part 1910.1030). Fed. Register.
Seroconversion sensitivity
Seroconversion sensitivity of the Elecsys Anti‑HCV II assay has been 13 Directive 2000/54/EC of the European Parliament and Council of
shown by testing 60 commercial seroconversion panels. The Elecsys 18 September 2000 on the protection of workers from risks related to
Anti‑HCV II assay detected more positive bleedings than all other registered exposure to biological agents at work.
anti‑HCV assays tested and was more sensitive in the recognition of early
HCV infection than the Elecsys Anti‑HCV assay and the other registered
anti‑HCV screening assays.
Clinical specificity
In a group of randomly selected European blood donors the specificity of For further information, please refer to the appropriate operator’s manual for
the Elecsys Anti‑HCV II assay was found 99.85 % (RR). The 95 % the analyzer concerned, the respective application sheets, the product
confidence interval (2‑sided) was 99.73‑99.93 %. information and the Method Sheets of all necessary components (if
available in your country).
The diagnostic specificity of the Elecsys Anti‑HCV II assay in a group of
hospitalized patients was found 99.66 %. The 95 % confidence interval A point (period/stop) is always used in this Method Sheet as the decimal
(2‑sided) was 99.41‑99.82 %. separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.

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Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see
https://usdiagnostics.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, PRECICONTROL and AMPLICOR 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.
© 2018, Roche Diagnostics

Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim

www.roche.com

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