ms_04784596190V10.

Elecsys CMV IgG

MODULAR ANALYTICS E170
cobas e 411
04784596 190 100
cobas e 601
cobas e 602

English At risk for CMV infection and disease are also immunocompromised
patients such as transplant recipients and HIV infected patients where the
System information virus can cause life-threatening diseases.11,12 The CMV status of transplant
For cobas e 411 analyzer: test number 570 donors and recipients is very important, as it will determine prophylactic and
For MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 pre-emptive treatment strategies against CMV. CMV-negative transplant
analyzers: Application Code Number 009 recipients should receive donations from CMV-negative individuals or
Please note leukocyte depleted blood products. During latency, CMV resides in infected
cells and the free viral DNA load is usually low. The CMV status can still be
The measured CMV IgG value of a patient’s sample can vary depending determined by testing for CMV IgG antibodies.
on the testing procedure used. The laboratory finding must therefore Within the appropriate clinical context, the first step in diagnosing acute
always contain a statement on the CMV IgG assay method used. primary CMV infection is most commonly made by the detection of
CMV IgG values determined on patient samples by different testing anti‑CMV‑specific IgG and IgM antibodies.5 Samples being reactive for IgM
antibodies indicate an acute, recent or reactivated infection.2,4,5,12 For
procedures cannot be directly compared with one another and could be further analysis of a primary CMV infection the determination of the
the cause of erroneous medical interpretations. Therefore, the results CMV IgG avidity is used as an aid.2,4,5,12 A positive IgM result in
reported by the laboratory to the physician should include: “The following combination with a low avidity index for IgG is a strong indication of a recent
results were obtained with the Elecsys CMV IgG assay. Results from primary CMV infection.4,5,12 Seroconversion to CMV IgM and IgG may also
assays of other manufacturers cannot be used interchangeably.” indicate a recent CMV infection.2,3,4,5,12
Test principle
Intended use
Sandwich principle. Total duration of assay: 18 minutes.
Immunoassay for the in vitro quantitative determination of IgG antibodies to
cytomegalovirus in human serum and plasma. ▪ 1st incubation: 20 µL of sample, biotinylated recombinant CMV‑specific
Results with this assay are used to indicate past or recent infection with antigens, and CMV‑specific recombinant antigens labeled with a
CMV. ruthenium complexa) form a sandwich complex.
The electrochemiluminescence immunoassay “ECLIA” is intended for use ▪ 2nd incubation: After addition of streptavidin-coated microparticles, the
on Elecsys and cobas e immunoassay analyzers. complex becomes bound to the solid phase via interaction of biotin and
streptavidin.
Regulatory status
▪ The reaction mixture is aspirated into the measuring cell where the
This assay has been CE marked according to Directive 98/79/EC. Test microparticles are magnetically captured onto the surface of the
performance has been established for diagnostic use and for testing of electrode. Unbound substances are then removed with
blood donations. ProCell/ProCell M. Application of a voltage to the electrode then induces
Summary chemiluminescent emission which is measured by a photomultiplier.
Cytomegalovirus (CMV), a member of the herpes virus family, is ubiquitous ▪ Results are determined via a calibration curve which is instrument-
in all human populations, causing infections which are followed by life-long specifically generated by 2‑point calibration and a master curve provided
latency in the host with occasional reactivations.1,2 The seroprevalence of via the reagent barcode or e‑barcode.
antibodies in adults ranges from 40‑100 % with inverse correlation to a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )
socioeconomic status.1,2,3 CMV is transmitted through body fluids, including
blood, genital secretions and breast milk. Saliva and urine of infected Reagents - working solutions
individuals also represent a prominent source of infection, and children, The reagent rackpack (M, R1, R2) is labeled as CMVIGG.
especially those attending day care facilities, are a major vector for viral
spread.2,3,4,5,6 In immunocompetent individuals primary CMV infection is M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL:
usually mild or asymptomatic.2,5 Patients commonly present with a Streptavidin-coated microparticles 0.72 mg/mL; preservative.
mononucleosis-like syndrome, including fever, sore throat, cervical
lymphadenopathy, malaise, headache, muscle ache and joint pains.2,3,4,5,7 R1 CMV‑Ag~biotin (gray cap), 1 bottle, 9 mL:
During pregnancy, CMV can cause congenital infection which may result in
permanent physical and/or neurological sequelae in the child.5 CMV Biotinylated CMV-specific antigen (recombinant, E. coli), > 400 µg/L,
infection can be primary, i.e. newly acquired, or secondary, i.e. due to MES buffer 50 mmol/L, pH 6.5; preservative.
reactivation of the latent virus or re-infection with a different viral strain.3,5 R2 CMV‑Ag~Ru(bpy) (black cap), 1 bottle, 9 mL:
Primary CMV infection is reported in 1‑4 % of seronegative women during
pregnancy and the risk of transmission to the fetus is estimated to be about CMV‑specific antigen (recombinant, E. coli) labeled with ruthenium
30‑40 %.3,4 Reactivation of CMV infection during pregnancy is reported in complex > 400 µg/L; MES buffer 50 mmol/L, pH 6.5; preservative.
10‑30 % of seropositive women and, in this circumstance, the risk of
transmission of the virus is about 1‑3 %.3,4,5 Overall, prenatal CMV infection
occurs in 0.6‑0.7 % of all life births in the developed world.4,5,8 The majority CMVIGG Cal1 Negative calibrator 1 (white cap), 2 bottles of 1.0 mL each:
of babies born with congenital CMV infection are asymptomatic at birth.8,9,10 Human serum, non‑reactive for anti‑CMV IgG; buffer;
Of these 5‑15 % still develop irreversible impairments, most frequently preservative.
hearing loss, that can occur several months or even years after birth.5,8,9,10
For babies symptomatic at birth prognosis is very poor as they are likely to CMVIGG Cal2 Positive calibrator 2 (black cap), 2 bottles of 1.0 mL each:
develop severe mental impairment and/or hearing loss.5,8,9,10 Different
studies have shown that the risk of symptomatic congenital disease in the Human serum, reactive for anti‑CMV IgG,
fetus or newborn infant is high, when maternal primary infection takes place approx. 40 U/mL; buffer; preservative.
in early pregnancy before week 20 of gestation, and lower thereafter.4,5 The
congenital CMV infection caused by recurrent maternal infection seldom Precautions and warnings
leads to symptomatic disease at birth.4,5 For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory
reagents.

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Elecsys CMV IgG

Disposal of all waste material should be in accordance with local guidelines. Criterion: Mean recovery of serum value: negative/borderline samples
Safety data sheet available for professional user on request. ± 0.2 U/mL; reactive samples: 80‑120 % for samples containig solid
All human material should be considered potentially infectious. anticoagulants and 55‑95 % for samples containing liquid anticoagulants.
Both calibrators (CMVIGG Cal1, CMVIGG Cal2) have been prepared Sampling devices containing liquid anticoagulants have a dilution effect
exclusively from the blood of donors tested individually and shown to be resulting in lower values (U/mL) for individual patient specimens.
free from HBsAg and antibodies to HCV and HIV. In order to minimize dilution effects it is essential that respective sampling
devices are filled completely according to manufacturer’s instructions.
The serum containing anti‑CMV IgG (CMVIGG Cal2) was sterile filtrated.
Stable for 4 weeks at 2‑8 °C, 7 days at 25 °C, 6 months at ‑20 °C (± 5 °C).
The testing methods used assays approved by the FDA or cleared in The samples may be frozen 5 times.
compliance with the European Directive 98/79/EC, Annex II, List A.
The sample types listed were tested with a selection of sample collection
However, as no testing method can rule out the potential risk of infection tubes or systems that were commercially available at the time of testing, i.e.
with absolute certainty, the material should be handled with the same level not all available tubes of all manufacturers were tested. Sample collection
of care as a patient specimen. In the event of exposure, the directives of the systems from various manufacturers may contain differing materials which
responsible health authorities should be followed.13,14 could affect the test results in some cases. When processing samples in
Avoid foam formation in all reagents and sample types (specimens, primary tubes (sample collection systems), follow the instructions of the
calibrators and controls). tube manufacturer.
Reagent handling Specimens should not be subsequently altered with additives (biocides,
The reagents in the kit are ready‑for‑use and are supplied in bottles anti-oxidants or substances that could possibly change the pH of the
compatible with the system. sample) in order to avoid erroneous findings.
cobas e 411 analyzer: The calibrators should only be left on the analyzer Pooled samples and other artificial material may have different effects on
during calibration at 20‑25 °C. After use, close the bottles as soon as different assays and thus may lead to discrepant findings.
possible and store upright at 2‑8 °C. Centrifuge samples containing precipitates and frozen samples before
Due to possible evaporation effects, not more than 5 calibration procedures performing the assay. Lyophilized samples and heat‑inactivated samples
per bottle set should be performed. can be used.
MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers: Ensure the samples, calibrators and controls are at 20‑25 °C prior to
Unless the entire volume is necessary for calibration on the analyzers, measurement.
transfer aliquots of the ready‑for‑use calibrators into empty snap‑cap bottles Due to possible evaporation effects, samples, calibrators and controls on
(CalSet Vials). Attach the supplied labels to these additional bottles. Store the analyzers should be analyzed/measured within 2 hours.
the aliquots at 2‑8 °C for later use. The performance of the Elecsys CMV IgG assay has not been established
Perform only one calibration procedure per aliquot. with cadaveric samples or body fluids other than serum and plasma.
All information required for correct operation is read in from the respective Materials provided
reagent barcodes. See “Reagents – working solutions” section for reagents.
Please note: Both the vial labels, and the additional labels (if available)
contain 2 different barcodes. The barcode between the yellow markers is Materials required (but not provided)
for cobas 8000 systems only. If using a cobas 8000 system, please turn ▪ 04784600190, PreciControl CMV IgG, 16 x 1.0 mL
the vial cap 180° into the correct position so the barcode can be read by the ▪ 11732277122, Diluent Universal, 2 x 16 mL sample diluent or
system. Place the vial on the instrument as usual. 03183971122, Diluent Universal, 2 x 36 mL sample diluent
Storage and stability ▪ 11776576322, CalSet Vials, 2 x 56 empty snap-cap bottles
Store at 2‑8 °C.
▪ General laboratory equipment
Do not freeze.
▪ MODULAR ANALYTICS E170 or cobas e analyzer
Store the Elecsys reagent kit upright in order to ensure complete
availability of the microparticles during automatic mixing prior to use. Accessories for cobas e 411 analyzer:
▪ 11662988122, ProCell, 6 x 380 mL system buffer
Stability of the reagent rackpack
▪ 11662970122, CleanCell, 6 x 380 mL measuring cell cleaning
unopened at 2‑8 °C up to the stated expiration date solution
after opening at 2‑8 °C 12 weeks ▪ 11930346122, Elecsys SysWash, 1 x 500 mL washwater additive
on the analyzers 3 weeks ▪ 11933159001, Adapter for SysClean
▪ 11706802001, AssayCup, 60 x 60 reaction cups
Stability of the calibrators
▪ 11706799001, AssayTip, 30 x 120 pipette tips
unopened at 2‑8 °C up to the stated expiration date ▪ 11800507001, Clean‑Liner
after opening at 2‑8 °C 8 weeks Accessories for MODULAR ANALYTICS E170, cobas e 601 and
on cobas e 411 at 20‑25 °C up to 5 hours cobas e 602 analyzers:
on MODULAR ANALYTICS E170, use only once ▪ 04880340190, ProCell M, 2 x 2 L system buffer
cobas e 601 and cobas e 602 at ▪ 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning
20‑25 °C solution
▪ 03023141001, PC/CC‑Cups, 12 cups to prewarm ProCell M and
Store calibrators upright in order to prevent the calibrator solution from CleanCell M before use
adhering to the snap‑cap.
▪ 03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run
Specimen collection and preparation finalization and rinsing during reagent change
Only the specimens listed below were tested and found acceptable.
▪ 12102137001, AssayTip/AssayCup, 48 magazines x 84 reaction
Serum collected using standard sampling tubes or tubes containing cups or pipette tips, waste bags
separating gel.
▪ 03023150001, WasteLiner, waste bags
Li‑heparin, Na‑heparin, K2‑EDTA, K3‑EDTA, ACD, CPD, CP2D, CPDA and
Na‑citrate plasma. ▪ 03027651001, SysClean Adapter M
Accessories for all analyzers:

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Elecsys CMV IgG

▪ 11298500316, ISE Cleaning Solution/Elecsys SysClean, Reactive: ≥ 1.0 U/mL
5 x 100 mL system cleaning solution Samples with concentrations < 0.5 U/mL are considered non-reactive in the
Assay Elecsys CMV IgG assay. These individuals are considered not to be
For optimum performance of the assay follow the directions given in this infected with CMV and therefore susceptible to primary infection.
document for the analyzer concerned. Refer to the appropriate operator’s Samples with concentrations between 0.5 U/mL and < 1.0 U/mL are
manual for analyzer‑specific assay instructions. considered indeterminate. These samples should be retested. In case the
Resuspension of the microparticles takes place automatically prior to use. result is still indeterminate, a second sample should be collected e.g. within
Read in the test‑specific parameters via the reagent barcode. If in 2 weeks.
exceptional cases the barcode cannot be read, enter the 15‑digit sequence Samples with concentrations ≥ 1.0 U/mL are considered positive for
of numbers (except for the cobas e 602 analyzer). IgG antibodies to CMV and indicate either acute or past infection. Such
Bring the cooled reagents to approximately 20 °C and place on the reagent individuals are potentially at risk of transmitting the virus (e.g. mother to
disk (20 °C) of the analyzer. Avoid foam formation. The system fetus) but are at current not necessarily contagious.
automatically regulates the temperature of the reagents and the For the diagnosis of acute CMV infection further tests have to be performed
opening/closing of the bottles. e.g. the determination of CMV IgM antibodies and the CMV IgG avidity. A
Place the calibrators in the sample zone. positive IgM result in combination with a low avidity index for IgG is a strong
indication of a primary CMV infection within the last 4 months.
All the information necessary for calibrating the assay is automatically read
into the analyzer. The diagnosis may be supported by a significant increase of the CMV IgG
antibody titer from a first to a second sample taken e.g. within 3‑4 weeks.
After calibration has been performed, store the calibrators at 2‑8 °C or
discard (MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 Note: An indeterminate or low positive result may already indicate an early
analyzers). acute CMV infection (also if the sample is non‑reactive for CMV IgM
antibodies).
Calibration The anti‑CMV IgG results in a given specimen, as determined by assays
Traceability: This method has been standardized against the internal Roche from different manufacturers, can vary due to differences in assay and
standard for CMV IgG. No international standard is available for CMV. reagent methods. Therefore, the results reported by the laboratory to the
Every Elecsys CMV IgG reagent set has a barcoded label containing physician should include: “The following results were obtained with the
specific information for calibration of the particular reagent lot. The Elecsys CMV IgG assay. Results from assays of other manufacturers
predefined master curve is adapted to the analyzer using CMVIGG Cal1 cannot be used interchangeably.”
and CMVIGG Cal2. Limitations - interference
Calibration frequency: Calibration must be performed once per reagent lot A negative test result does not completely rule out the possibility of an
using CMVIGG Cal1, CMVIGG Cal2 and fresh reagent (i.e. not more than infection with CMV. Individuals may not exhibit any detectable
24 hours since the reagent kit was registered on the analyzer). IgG antibodies at the early stage of acute infection.
Calibration interval may be extended based on acceptable verification of The detection of CMV‑specific IgG antibodies in a single sample indicates a
calibration by the laboratory. previous exposure to CMV but is not always sufficient to distinguish
Renewed calibration is recommended as follows: between an acute or latent infection (irrespective of the level of the
IgG antibody titer).
▪ after 1 month (28 days) when using the same reagent lot
In rare cases of primary CMV infection IgG antibody may be present before
▪ after 7 days (when using the same reagent kit on the analyzer) a specific IgM antibody response is detected. It is recommended that a
▪ as required: e.g. quality control findings with PreciControl CMV IgG follow-up sample be tested after 2 weeks. If the CMV IgG antibody titer
outside the defined limits remains stable, a primary infection can be excluded.15,16
▪ more frequently when this is required by pertinent regulations Elecsys CMV IgG results should be used in conjunction with the patient’s
medical history, clinical symptoms and other laboratory tests, e.g.
Quality control CMV‑specific IgM results, CMV IgG avidity results.
For quality control, use PreciControl CMV IgG. The results in HIV patients, in patients undergoing immunosuppressive
Controls for the various concentration ranges should be run individually at therapy, or in patients with other disorders leading to immune suppression,
least once every 24 hours when the test is in use, once per reagent kit, and should be interpreted with caution.
following each calibration. Specimens from neonates, cord blood, pretransplant patients or body fluids
The control intervals and limits should be adapted to each laboratory’s other than serum and plasma, such as urine, saliva or amniotic fluid have
individual requirements. Values obtained should fall within the defined not been tested.
limits. Each laboratory should establish corrective measures to be taken if Among a panel of 142 positive samples within the measuring range no
values fall outside the defined limits. high‑dose hook effect was observed (no increasing signals upon dilution).
If necessary, repeat the measurement of the samples concerned. However, the occurrence of a high-dose hook effect cannot be excluded in
Follow the applicable government regulations and local guidelines for other cohorts.
quality control. The assay is unaffected by icterus (bilirubin ≤ 1129 µmol/L or ≤ 66 mg/dL),
Note: The controls are not barcode‑labeled and therefore the controls must hemolysis (Hb ≤ 0.310 mmol/L or ≤ 0.500 g/dL), lipemia (Intralipid
run on all instruments as non‑Roche controls. The control values and ≤ 2000 mg/dL) and biotin (≤ 246 nmol/L or ≤ 60 ng/mL).
ranges have to be entered manually. Please refer to the corresponding Criterion: Mean recovery of positive samples within ± 20 % of serum value.
section in the operator’s manual. Samples should not be taken from patients receiving therapy with high
The exact lot‑specific target values and ranges are printed on the value biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin
sheet which is included in the control kit or reagent kit (or electronically administration.
available). No interference was observed from rheumatoid factors up to a
Calculation concentration of 1500 IU/mL.
The analyzer automatically calculates the analyte concentration of each In vitro tests were performed on 18 commonly used pharmaceuticals and in
sample in U/mL. addition on ganciclovir and valganciclovir. No interference with the assay
was found.
Interpretation of the results
Results obtained with the Elecsys CMV IgG assay can be interpreted as In rare cases, interference due to extremely high titers of antibodies to
follows: immunological components, streptavidin or ruthenium can occur. These
effects are minimized by suitable test design.
Non-reactive: < 0.5 U/mL
Indeterminate: 0.5‑< 1.0 U/mL

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Elecsys CMV IgG

For diagnostic purposes, the results should always be assessed in Precision
conjunction with the patient’s medical history, clinical examination and other Precision was determined using Elecsys reagents, human sera and controls
findings. in a protocol (EP5‑A) of the CLSI (Clinical and Laboratory Standards
Limits and ranges Institute): 2 runs per day in duplicate each for 21 days (n = 84); repeatability
n = 21. The following results were obtained:
Measuring range
0.25‑500 U/mL (defined by the Limit of Detection and the maximum of the cobas e 411 analyzer
master curve). Values below the Limit of Blank are reported as
< 0.15 U/mL. Values above the Limit of Blank but below the Limit of Repeatability Intermediate
Detection will not be flagged by the instrument. Values above the precision
measuring range are reported as > 500 U/mL (or up to 10000 U/mL for Sample Mean SD CV Mean SD CV
20‑fold diluted samples).
U/mL U/mL % U/mL U/mL %
Lower limits of measurement
Limit of Blank and Limit of Detection HSb), low positive 1.07 0.009 0.8 1.17 0.038 3.3
Limit of Blank = 0.15 U/mL HS, medium positive 53.8 0.629 1.2 54.8 2.14 3.9
Limit of Detection = 0.25 U/mL HS, high positive 444 7.58 1.7 437 14.3 3.3
The Limit of Blank and Limit of Detection were determined in accordance PCc) CMV IgG 1 1.37 0.012 0.9 1.40 0.045 3.2
with CLSI (Clinical and Laboratory Standards Institute) EP17‑A
requirements. PC CMV IgG 2 24.6 0.218 0.9 24.6 0.811 3.3
The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of b) HS = human serum
analyte‑free samples over several independent series. The Limit of Blank c) PC = PreciControl
corresponds to the concentration below which analyte‑free samples are
found with a probability of 95 %. MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers
The Limit of Detection is determined based on the Limit of Blank and the Repeatability Intermediate
standard deviation of low concentration samples. The Limit of Detection precision
corresponds to the lowest analyte concentration which can be detected
(value above the Limit of Blank with a probability of 95 %). Sample Mean SD CV Mean SD CV
Dilution U/mL U/mL % U/mL U/mL %
Samples with anti‑CMV IgG concentrations above the measuring range can HS, low positive 1.10 0.015 1.3 1.14 0.045 4.0
be diluted with Diluent Universal. The recommended dilution is 1:20 (either
automatically by the MODULAR ANALYTICS E170 and cobas e analyzers HS, medium positive 56.3 1.50 2.7 53.1 2.37 4.5
or manually). The concentration of the diluted sample must be ≥ 15 U/mL. HS, high positive 458 3.16 0.7 460 16.2 3.5
After manual dilution, multiply the result by the dilution factor. PC CMV IgG 1 1.38 0.033 2.4 1.38 0.045 3.2
After dilution by the analyzers, the software automatically takes the dilution
into account when calculating the sample concentration. PC CMV IgG 2 25.9 0.456 1.8 24.1 0.890 3.7
Manual dilution can also be made with human serum negative for CMV IgG. Analytical specificity
Note: Antibodies to CMV are heterogeneous. This may lead to non-linear 439 potentially cross reacting samples were tested with the Elecsys
dilution behavior. CMV IgG assay and a comparison CMV IgG assay comprising the following
specimens:
Expected values
The prevalence of IgG antibodies to CMV varies considerably depending ▪ containing antibodies against HBV**, HAV, HCV*, HIV, HTLV, EBV**,
upon geographical location and socioeconomic status of the population HSV*, VZV**, Parvo B19***, Rubella, Treponema pallidum**,
studied. Toxoplasma gondii**
The Elecsys CMV IgG assay was used to test 616 samples from clinical ▪ containing autoantibodies*** (ANA, anti‑tissue, RF)
routine in Germany (site 1) and 520 samples from clinical routine in Israel An overall agreement of 96.6 % (422/437) was found in these specimens
(site 2). Out of these 334 (54.2 %, Germany) and 415 samples (79.8 %, with the Elecsys CMV IgG assay and the comparison test. 110 samples
Israel) were found positive or indeterminate with the Elecsys CMV IgG were found concordantly negative and 312 samples were found positive.
assay. 2 samples were found indeterminate either with the Elecsys CMV IgG
A distribution of these values is given in the following table: assay or the comparison test.
* HSV, HCV: 2 discordant samples were found in each group.
U/mL Site 1, Germany, n = 616 Site 2, Israel, n = 520 ** HBV, EBV, VZV, Treponema pallidum, Toxoplasma gondii: 1 discordant sample was found in each group.

N % of total N % of total *** Parvo B19, autoantibodies: 3 discordant samples were found in each group.

< 0.5 282 45.8 105 20.2 Agreement in primary infections

0.5-< 1 4 0.6 2 0.4 A total of 368 frozen samples from pregnant women (acute, recent and late
phase) including sequential and single samples analyzed by commercially
≥ 1-< 10 15 2.4 2 0.4 available CMV IgG assays were tested with the Elecsys CMV IgG assay at
10-< 100 62 10.1 71 13.7 4 different sites.
100-< 300 91 14.8 114 21.9 Agreement to comparative assays
300-< 500 65 10.6 84 16.2 Site N Agreementd) Concordant Concordant Discrepant
> 500 97 15.0 142 27.3 % reactive non‑reactive
Each laboratory should investigate the transferability of the expected values 1e) 181 96.1 172 2 7
to its own patient population and if necessary determine its own reference 2f) 57 96.5 52 3 2
ranges.
40g) 97.5 39 0 1
Specific performance data 3
Representative performance data on the analyzers are given below. 36h) 94.4 34 0 2
Results obtained in individual laboratories may differ.
4i) 54 90.7 43 6 5

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d) All indeterminate samples counted positive. 8 Lombardi G, Garofoli F, Stronati M. Congenital cytomegalovirus
e) 6 samples were found discordant positive with the Elecsys CMV IgG assay; 1 sample was infection: treatment, sequelae and follow-up. J Matern Fetal Neonatal
found discordant negative with the Elecsys CMV IgG assay. Med 2010;23Suppl3:45-48.
f) 1 sample was found discordant positive with the Elecsys CMV IgG assay; 1 sample was found
discordant negative with the Elecsys CMV IgG assay. 9 Elliott SP. Congenital cytomegalovirus infection: an overview. Infect
g) 1 sample was found discordant negative with the Elecsys CMV IgG assay.
Disord Drug Targets 2011;11:432-436.
h) 1 sample was found discordant negative with the Elecsys CMV IgG assay and indeterminate 10 Lazzarotto T, Guerra B, Gabrielli L, et al. Update on the prevention,
with the comparison assay. diagnosis and management of cytomegalovirus infection during
i) 4 samples were found discordant negative with the Elecsys CMV IgG assay; 1 sample was pregnancy. Clin Microbiol Infect 2011;17:1285-1293.
found discordant indeterminate with the Elecsys CMV IgG assay; the comparison assay was
negative. 11 Plosa EJ, Esbenshade JC, Fuller MP, et al. Cytomegalovirus infection.
Pediatr Rev 2012;33:156-163.
Agreement in past infection
A total of 158 frozen samples from pregnant women with past CMV 12 Ross SA, Novak Z, Pati S, et al. Overview of the diagnosis of
infection analyzed by commercially available CMV IgG assays were tested cytomegalovirus infection. Infect Disord Drug Targets 2011;11:466-474.
with the Elecsys CMV IgG assay at 4 different sites. A 100 % agreement for 13 Occupational Safety and Health Standards: Bloodborne pathogens.
the Elecsys CMV IgG assay was found with the competitor assays. (29 CFR Part 1910.1030). Fed. Register.
Agreement in pre-selected negative samples 14 Directive 2000/54/EC of the European Parliament and Council of
A total of 162 frozen samples from pregnant women in which a CMV 18 September 2000 on the protection of workers from risks related to
infection was excluded and analyzed by commercially available CMV IgG exposure to biological agents at work.
assays were tested with the Elecsys CMV IgG assay at 4 different sites. In 15 Revello MG, Gerna G. Diagnosis and Management of Human
3 sites a 100 % agreement of the Elecsys CMV IgG assay was found with Cytomegalovirus Infection in the Mother, Fetus, and Newborn Infant.
the competitor assays, whereas at site 4 the Elecsys CMV IgG assay Clin Microbiol Rev 2002;15(4):680-715.
showed 1 discrepant positive and 1 discrepant indeterminate result
(agreement 96 %). 16 Weber B, Fall EM, Berger A, et al. Screening of blood donors for
human cytomegalovirus (HCMV) IgG antibody with an enzyme
Method comparison immunoassay using recombinant antigens. J Clin Virol
A total of 1668 fresh samples obtained from clinical routine (blood donors 1999;14:173-181.
and pregnancy testing) were tested with the Elecsys CMV IgG assay at For further information, please refer to the appropriate operator’s manual for
3 different sites in comparison to commercially available CMV IgG assays. the analyzer concerned, the respective application sheets, the product
Agreement to comparative assays information and the Method Sheets of all necessary components (if
available in your country).
Site N Agreementj) Concordant Concordant Discrepant A point (period/stop) is always used in this Method Sheet as the decimal
% reactive non‑reactive separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
1k) 532 98.9 206 320 6
Symbols
2l) 616 96.8 316 279 21
Roche Diagnostics uses the following symbols and signs in addition to
3m) 520 99.4 413 103 4 those listed in the ISO 15223‑1 standard (for USA: see
https://usdiagnostics.roche.com for definition of symbols used):
j) All indeterminate samples counted positive.
k) 4 samples were found indeterminate with the Elecsys CMV IgG assay and negative with the Contents of kit
comparison assay; 2 samples were found discrepant negative with the Elecsys CMV IgG assay.
l) 13 samples were found discrepant positive with the Elecsys CMV IgG assay; 4 samples were Analyzers/Instruments on which reagents can be used
found indeterminate with the Elecsys CMV IgG assay and negative with the comparison assay;
2 samples were found discrepant negative with the Elecsys CMV IgG assay; 1 sample was found Reagent
negative with the Elecsys CMV IgG assay and indeterminate with the comparison assay;
1 sample was found positive with the Elecsys CMV IgG assay and indeterminate with the Calibrator
comparison assay.
m) 1 sample was found indeterminate with the Elecsys CMV IgG assay and negative with the
Volume after reconstitution or mixing
comparison assay; 2 samples were found discrepant negative with the Elecsys CMV IgG assay;
1 sample was found indeterminate with the Elecsys CMV IgG assay and positive with the GTIN Global Trade Item Number
comparison assay.
COBAS, COBAS E, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark of
References Fresenius Kabi AB.
1 Cannon MJ, Schmid DS, Hyde TB. Review of cytomegalovirus All other product names and trademarks are the property of their respective owners.
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