ms_06368921190V8.

Elecsys Anti-HCV II
MODULAR ANALYTICS E170
cobas e 411
06368921 190 100
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, 6.5 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. Biotinylated HCV‑specific antigens, HEPESb) buffer, pH 7.4;
preservative.
The electrochemiluminescence immunoassay “ECLIA” is intended for use
on Elecsys and cobas e immunoassay analyzers. R2 HCV-specific antigens~Ru(bpy) (black cap), 1 bottle, 18 mL:
Regulatory approval HCV-specific antigens labeled with ruthenium complex ≥ 0.3 mg/L,
This assay has been CE marked according to Directive 98/79/EC. Test HEPES buffer, pH 7.4; preservative.
performance has been established and certified by a Notified Body
according to the Common Technical Specifications (CTS) for diagnostic use b) HEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
and for screening of blood donations and, according to Paul-Ehrlich-Institut
(PEI) recommendation1, for use of cadaveric blood specimens (specimens A‑HCV II Cal1 Negative calibrator 1 (white cap), 2 bottles of 1.3 mL each:
collected post-mortem, non-heart-beating). Human serum, preservative.
Summary A‑HCV II Cal2 Positive calibrator 2 (black cap), 2 bottles of 1.3 mL each:
The hepatitis C virus (HCV), first identified in 1989, is a leading cause of
liver disease and a major healthcare concern with over 170 million persons Human serum positive for anti‑HCV Ab; preservative. Non-
(roughly 3 % of the human population), infected worldwide.2,3 The highest reactive for HBsAg, anti‑HIV 1/2.
prevalence is found in Africa, the Eastern Mediterranean and Asian
regions.3,4 HCV is a member of the Flaviviridae family and has a single- Precautions and warnings
stranded, positive-sense RNA genome.5 Currently over 67 subtypes have For in vitro diagnostic use.
been identified and these have been classified into 7 genotypes (1‑7).6 Exercise the normal precautions required for handling all laboratory
Due to the high rate of asymptomatic infections, clinical diagnosis is difficult reagents.
and screening assays are of major importance.7 Infection with HCV can Disposal of all waste material should be in accordance with local guidelines.
lead to acute and chronic hepatitis disease. Approximately 70‑85 % of HCV Safety data sheet available for professional user on request.
infections progress to chronic disease, although this varies according to All human material should be considered potentially infectious.
patient gender, age, race and immune status.5,8 Chronic HCV infection may All products derived from human blood are prepared exclusively from the
lead to cirrhosis and hepatocellular carcinoma,9 therefore, early anti‑HCV blood of donors tested individually and shown to be free from HBsAg and
detection is the first step in the management of chronic hepatitis and in the antibodies to HCV (A‑HCV II Cal1 only) and HIV.
selection of patients needing treatment.7 HCV infection can be detected by The testing methods used assays approved by the FDA or cleared in
measuring the amount of HCV RNA, alanine aminotransferase (ALT) and compliance with the European Directive 98/79/EC, Annex II, List A.
HCV‑specific immunoglobulins (anti‑HCV) in patient serum or plasma
samples. This can also indicate if the infection is acute or chronic.5,8 The serum containing anti‑HCV (A‑HCV II Cal2) was inactivated using
β‑propiolactone and UV‑radiation.
Anti‑HCV antibody tests are used alone or in combination with other tests
(e.g. HCV RNA) to detect an infection with HCV and to identify blood and However, as no inactivation or testing method can rule out the potential risk
blood products of individuals infected with HCV. The Elecsys Anti‑HCV II of infection with absolute certainty, the material should be handled with the
assay is a third-generation test.10,11 The Elecsys Anti‑HCV II assay uses same level of care as a patient specimen. In the event of exposure, the
peptides and recombinant proteins representing HCV core, NS3 and NS4 directives of the responsible health authorities should be followed.12,13
antigens for the determination of anti‑HCV antibodies. Avoid foam formation in all reagents and sample types (specimens,
Test principle calibrators and controls).
Sandwich principle. Total duration of assay: 18 minutes. The Elecsys Anti‑HCV II assay has a high dilution sensitivity. Avoid any
sample cross-contamination during sample pre-analytics.
▪ 1st incubation: 50 µL of sample, 55 µL of a reagent containing
biotinylated HCV‑specific antigens and 55 µL of a reagent containing Reagent handling
HCV‑specific antigens labeled with a ruthenium complexa) react to form The reagents in the kit are ready‑for‑use and are supplied in bottles
a sandwich complex. compatible with the system.
▪ 2nd incubation: After addition of streptavidin-coated microparticles, the cobas e 411 analyzer: The calibrators should only be left on the analyzer
complex becomes bound to the solid phase via interaction of biotin and during calibration at 20‑25 °C. After use, close the bottles as soon as
streptavidin. possible and store upright at 2‑8 °C.
▪ The reaction mixture is aspirated into the measuring cell where the Due to possible evaporation effects, not more than 5 calibration procedures
microparticles are magnetically captured onto the surface of the per bottle set should be performed.
electrode. Unbound substances are then removed with MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers:
ProCell/ProCell M. Application of a voltage to the electrode then induces Unless the entire volume is necessary for calibration on the analyzers,
chemiluminescent emission which is measured by a photomultiplier. transfer aliquots of the ready‑for‑use calibrators into empty snap-cap bottles
▪ Results are determined automatically by the software by comparing the (CalSet Vials). Attach the supplied labels to these additional bottles. Store
electrochemiluminescence signal obtained from the reaction product of the aliquots at 2‑8 °C for later use.
the sample with the signal of the cutoff value previously obtained by Perform only one calibration procedure per aliquot.
calibration.
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All information required for correct operation is read in from the respective could affect the test results in some cases. When processing samples in
reagent barcodes. primary tubes (sample collection systems), follow the instructions of the
Please note: Both the vial labels, and the additional labels (if available) tube manufacturer.
contain 2 different barcodes. The barcode between the yellow markers is Centrifuge samples containing precipitates before performing the assay.
for cobas 8000 systems only. If using a cobas 8000 system, please turn Ensure the samples, calibrators and controls are at 20‑25 °C prior to
the vial cap 180° into the correct position so the barcode can be read by the measurement.
system. Place the vial on the instrument as usual.
Due to possible evaporation effects, samples, calibrators and controls on
Storage and stability the analyzers should be analyzed/measured within 2 hours.
Store at 2‑8 °C. The performance of the Elecsys Anti-HCV II assay has not been
Do not freeze. established with body fluids other than serum and 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
Specimen collected from living patients, blood donors, or individual organ, ▪ 03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run
tissue or cell donors may be used, including donor samples obtained while finalization and rinsing during reagent change
the donor’s heart is still beating.
Performance for the use of cadaveric blood specimens (specimens ▪ 03004899190, PreClean M, 5 x 600 mL detection cleaning solution
collected post-mortem, non-heart-beating) was established according to ▪ 12102137001, AssayTip/AssayCup, 48 magazines x 84 reaction
Paul-Ehrlich-Institut recommendation1 with samples obtained within cups or pipette tips, waste bags
24 hours after death.14 Qualitative differences of neat (non-reactive) or
spiked (reactive) specimens from cadaveric compared to living donors were ▪ 03023150001, WasteLiner, waste bags
not observed. ▪ 03027651001, SysClean Adapter M
Criterion: Mean value of cadaveric specimens compared to specimens from Accessories for all analyzers:
living donors within a recovery of 75‑125 %. ▪ 11298500316, ISE Cleaning Solution/Elecsys SysClean,
Only the specimens listed below were tested and found acceptable. 5 x 100 mL system cleaning solution
Serum collected using standard sampling tubes or tubes containing Assay
separating gel. For optimum performance of the assay follow the directions given in this
Li‑heparin, Na‑heparin, K2‑EDTA, K3‑EDTA, ACD, CPDA and Na‑citrate document for the analyzer concerned. Refer to the appropriate operator’s
plasma as well as plasma tubes containing separating gel. manual for analyzer‑specific assay instructions.
Criterion: Correct assignment of positive and negative samples within a Resuspension of the microparticles takes place automatically prior to use.
recovery of 80‑120 % of serum value. Read in the test‑specific parameters via the reagent barcode. If in
CPD and CP2D plasma. exceptional cases the barcode cannot be read, enter the 15‑digit sequence
Criterion: Correct assignment of positive and negative samples within a of numbers (except for the cobas e 602 analyzer).
recovery of 80‑130 % of serum value. MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers:
Stability: PreClean M solution is necessary.
For living patients and donor specimens obtained while the donor’s heart is Bring the cooled reagents to approximately 20 °C and place on the reagent
still beating: Stable for 7 days at 20‑25 °C, 14 days at 2‑8 °C, 3 months at disk (20 °C) of the analyzer. Avoid foam formation. The system
‑20 °C (± 5 °C). The samples may be frozen 6 times. automatically regulates the temperature of the reagents and the
For cadaveric specimens: Stable for 3 days at 20‑25 °C, 7 days at 2‑8 °C. opening/closing of the bottles.
The samples may be frozen 3 times.
Place the calibrators in the sample zone.
The sample types listed were tested with a selection of sample collection
tubes or systems that were commercially available at the time of testing, i.e. All the information necessary for calibrating the assay is automatically read
not all available tubes of all manufacturers were tested. Sample collection into the analyzer.
systems from various manufacturers may contain differing materials which

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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 3
and A‑HCV II Cal2. 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 (COI; 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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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 References
▪ after vaccination against HBV and Influenza 1 Proposal for the Validation of Anti-HIV-1/2 or HIV Ag/Ab Combination
▪ non-viral liver diseases Assays, anti-HCV-Assays, HBsAg and Anti-HBc assays for Use with
Cadaveric Samples; PEI 08/05/2014.
▪ 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 14 Commission Directive 2006/17/EC of 8 February 2006 implementing
HCV infection than the Elecsys Anti‑HCV assay and the other registered Directive 2004/23/EC of the European Parliament and of the Council as
anti‑HCV screening assays. regards certain technical requirements for the donation, procurement
and testing of human tissues and cells.
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, CALSET 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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