04481798500V17.

Elecsys AFP
cobas e 411
04481798190 04481798500 100 cobas e 601
cobas e 602

English also rise during regeneration of the liver, moderately elevated values are
found in alcohol‑mediated liver cirrhosis and acute viral hepatitis.12
System information Surveillance of patients at risk for developing HCC by abdominal
For cobas e 411 analyzer: test number 311 ultrasonography in combination with AFP is recommended by several
For cobas e 601 and cobas e 602 analyzers: Application Code clinical practice guidelines.13,14,15
Number 050
Trisomy 21
Please note Measurement of AFP makes a contribution to the risk assessment for
trisomy 21 (Down syndrome) in the second trimester of pregnancy together
The measured AFP value of a patient’s sample can vary depending on with hCG+β and other parameters, such as exact gestational age and
the testing procedure used. The laboratory finding must therefore always maternal weight.3 In a trisomy 21 affected pregnancy the maternal serum
contain a statement on the AFP assay method used. AFP values concentration of AFP is decreased whereas the maternal serum hCG+β
determined on patient samples by different testing procedures cannot be concentration is approximately twice the normal median.16 The risk for a
directly compared with one another and could be the cause of erroneous trisomy 21 affected pregnancy in the second trimester can be calculated by
a suitable software (see “Materials required, but not provided” section)
medical interpretations. If there is a change in the AFP assay procedure using the algorithm as described by Cuckle et al.17 and the respective assay
used while monitoring therapy, then the AFP values obtained upon specific parameters.18,19,20,21,22
changing over to the new procedure must be confirmed by parallel
Test principle
measurements with both methods.
Sandwich principle. Total duration of assay: 18 minutes.
Intended use ▪ 1st incubation: 10 µL of sample, a biotinylated monoclonal AFP-specific
Immunoassay for the in vitro quantitative determination of α1‑fetoprotein in antibody, and a monoclonal AFP-specific antibody labeled with a
human serum and plasma. ruthenium complexa) react to form a sandwich complex.
This assay is intended for the use as: ▪ 2nd incubation: After addition of streptavidin-coated microparticles, the
▪ An aid in the diagnosis of hepatocellular carcinoma (HCC). complex becomes bound to the solid phase via interaction of biotin and
streptavidin.
▪ An aid in the management of patients with non‑seminomatous germ cell
tumors. ▪ The reaction mixture is aspirated into the measuring cell where the
microparticles are magnetically captured onto the surface of the
▪ One component in combination with other parameters to evaluate the electrode. Unbound substances are then removed with
risk of trisomy 21 (Down syndrome). Further testing is required for ProCell/ProCell M. Application of a voltage to the electrode then induces
diagnosis of chromosomal aberrations. chemiluminescent emission which is measured by a photomultiplier.
The electrochemiluminescence immunoassay “ECLIA” is intended for use ▪ Results are determined via a calibration curve which is instrument-
on Elecsys and cobas e immunoassay analyzers. specifically generated by 2‑point calibration and a master curve provided
Summary via the reagent barcode or e‑barcode.
Alpha1‑fetoprotein (AFP), an albumin‑like glycoprotein with a molecular a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )
weight of approximately 70 kDa, is formed in the yolk sac during fetal life, in Reagents - working solutions
non‑differentiated liver cells, and the fetal gastro‑intestinal tract.1,2 The reagent rackpack is labeled as AFP.
Tumors that synthesize AFP are mainly testicular non-seminomatous germ
cell tumors (NSGCT), yolk sac tumors of the ovary and hepatocellular M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL:
carcinoma (HCC). Moreover AFP is an important part in the risk
assessment for trisomy 21 in the second trimester of pregnancy together Streptavidin-coated microparticles 0.72 mg/mL; preservative.
with hCG+β and other parameters.3 R1 Anti-AFP-Ab~biotin (gray cap), 1 bottle, 10 mL:
Testicular cancer Biotinylated monoclonal anti-AFP antibodies (mouse) 4.5 mg/L;
Careful monitoring of the serum tumor markers AFP and human chorionic phosphate buffer 100 mmol/L, pH 6.0; preservative.
gonadotropin (hCG) is essential in the management of patients with germ
cell tumors (GCT), as these markers are important for diagnosis, as R2 Anti-AFP-Ab~Ru(bpy) (black cap), 1 bottle, 10 mL:
prognostic indicators, in monitoring treatment response, and in the
detection of early relapse.4 In addition, hCG and AFP are important Monoclonal anti-AFP antibodies (mouse) labeled with ruthenium
parameters for estimating the survival rate of patients with advanced complex 12.0 mg/L; phosphate buffer 100 mmol/L, pH 6.0;
NSGCTs and are also recommended by the National Academy of Clinical preservative.
Biochemistry for the management of such patients.5
Hepatocellular carcinoma Precautions and warnings
Hepatocellular carcinoma (HCC) is frequently the result of advanced liver For in vitro diagnostic use.
disease and can develop in patients with and without cirrhosis.6 AFP has Exercise the normal precautions required for handling all laboratory
long been recognized as a biomarker for HCC, and has played a prominent reagents.
role in the diagnosis of HCC. Substantially elevated AFP values can Disposal of all waste material should be in accordance with local guidelines.
indicate primary liver cell carcinoma and it has been shown that AFP levels Safety data sheet available for professional user on request.
increase with tumor size.7 Diagnosis of HCC has primarily relied on the This kit contains components classified as follows in accordance with the
presence of typical features seen on contrast-enhanced imaging studies, Regulation (EC) No. 1272/2008:
histopathological assessment, and serum AFP levels.8 While AFP is
elevated during hepato‑carcinogenesis, it can also be found in other tumors
such as testicular, embryonic or gastric cancer.9,10 AFP has reported
sensitivities ranging from 39 to 65 %, and specificities from 76 to 94 % in
HCC patients.11 The divergence in sensitivity and specificity of AFP in these
studies is probably due to a variety of factors including different etiologies, Warning
variable study designs, and different cutoff values. As the AFP values can
2022-02, V 17.0 English 1/6
04481798500V17.0

Elecsys AFP
H317 May cause an allergic skin reaction. Ensure the samples, calibrators and controls are at 20‑25 °C prior to
measurement.
H412 Harmful to aquatic life with long lasting effects. Due to possible evaporation effects, samples, calibrators and controls on
Prevention: the analyzers should be analyzed/measured within 2 hours.
Materials provided
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
See “Reagents – working solutions” section for reagents.
P273 Avoid release to the environment. Materials required (but not provided)
▪  04487761190, AFP CalSet II, for 4 x 1.0 mL
P280 Wear protective gloves.
▪  11776452122, PreciControl Tumor Marker, for 4 x 3.0 mL or
Response:  11731416190, PreciControl Universal, for 4 x 3.0 mL
P333 + P313 If skin irritation or rash occurs: Get medical ▪  11732277122, Diluent Universal, 2 x 16 mL sample diluent or
advice/attention.  03183971122, Diluent Universal, 2 x 36 mL sample diluent
▪ General laboratory equipment
P362 + P364 Take off contaminated clothing and wash it before reuse. ▪ cobas e analyzer
Disposal: For risk calculation of trisomy 21:
P501 Dispose of contents/container to an approved waste ▪ A suitable software, e.g.
disposal plant.  05126193, SsdwLab (V5.0 or later), single user licence
 05195047, SsdwLab (V5.0 or later), multi user licence
Product safety labeling follows EU GHS guidance. ▪  03271749190, Elecsys HCG+β, 100 tests
Contact phone: all countries: +49-621-7590
▪  03302652190, HCG+β CalSet, for 4 x 1 mL
Avoid foam formation in all reagents and sample types (specimens, Additional materials for the cobas e 411 analyzer:
calibrators and controls).
▪  11662988122, ProCell, 6 x 380 mL system buffer
Reagent handling
The reagents in the kit have been assembled into a ready‑for‑use unit that ▪  11662970122, CleanCell, 6 x 380 mL measuring cell cleaning
cannot be separated. solution
All information required for correct operation is read in from the respective ▪  11930346122, Elecsys SysWash, 1 x 500 mL washwater additive
reagent barcodes. ▪  11933159001, Adapter for SysClean
Storage and stability ▪  11706802001, AssayCup, 60 x 60 reaction cups
Store at 2‑8 °C. ▪  11706799001, AssayTip, 30 x 120 pipette tips
Do not freeze. ▪  11800507001, Clean‑Liner
Store the Elecsys reagent kit upright in order to ensure complete Additional materials for cobas e 601 and cobas e 602 analyzers:
availability of the microparticles during automatic mixing prior to use.
▪  04880340190, ProCell M, 2 x 2 L system buffer
Stability: ▪  04880293190, CleanCell M, 2 x 2 L measuring cell cleaning
unopened at 2‑8 °C up to the stated expiration date solution
after opening at 2‑8 °C 12 weeks ▪  03023141001, PC/CC‑Cups, 12 cups to prewarm ProCell M and
CleanCell M before use
on cobas e 411 and cobas e 601 8 weeks
▪  03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run
on cobas e 602 4 weeks finalization and rinsing during reagent change
Specimen collection and preparation ▪  12102137001, AssayTip/AssayCup, 48 magazines x 84 reaction
cups or pipette tips, waste bags
Only the specimens listed below were tested and found acceptable.
Serum collected using standard sampling tubes or tubes containing ▪  03023150001, WasteLiner, waste bags
separating gel. ▪  03027651001, SysClean Adapter M
Li‑heparin, K2‑EDTA and K3‑EDTA plasma. Additional materials for all analyzers:
Plasma tubes containing separating gel can be used. ▪  11298500316, ISE Cleaning Solution/Elecsys SysClean,
Criterion: Slope 0.9‑1.1 + intercept within < ± 2x analytical sensitivity 5 x 100 mL system cleaning solution
(LDL) + coefficient of correlation > 0.95. Assay
Stable for 5 days at 20‑25 °C, 14 days at 2‑8 °C, 6 months at For optimum performance of the assay follow the directions given in this
‑20 °C (± 5 °C). The samples may be frozen 3 times. document for the analyzer concerned. Refer to the appropriate operator’s
The suitability of plasma samples for estimating the risk of trisomy 21 has manual for analyzer‑specific assay instructions.
not been evaluated. Resuspension of the microparticles takes place automatically prior to use.
The sample types listed were tested with a selection of sample collection Read in the test-specific parameters via the reagent barcode. If in
tubes that were commercially available at the time of testing, i.e. not all exceptional cases the barcode cannot be read, enter the 15-digit sequence
available tubes of all manufacturers were tested. Sample collection systems of numbers.
from various manufacturers may contain differing materials which could Bring the cooled reagents to approximately 20 °C and place on the reagent
affect the test results in some cases. When processing samples in primary disk (20 °C) of the analyzer. Avoid foam formation. The system
tubes (sample collection systems), follow the instructions of the tube automatically regulates the temperature of the reagents and the
manufacturer. opening/closing of the bottles.
Centrifuge samples containing precipitates before performing the assay. Calibration
Do not use heat‑inactivated samples. Traceability: This method has been standardized against the 1st IRP WHO
Do not use samples and controls stabilized with azide. Reference Standard 72/225.

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Elecsys AFP
Every Elecsys reagent set has a barcoded label containing specific Lower limits of measurement
information for calibration of the particular reagent lot. The predefined Lower detection limit of the test
master curve is adapted to the analyzer using the relevant CalSet.
Lower detection limit: 0.50 IU/mL (0.61 ng/mL)
Calibration frequency: Calibration must be performed once per reagent lot
using fresh reagent (i.e. not more than 24 hours since the reagent kit was The Lower Detection Limit represents the lowest measurable analyte level
registered on the analyzer). that can be distinguished from zero. It is calculated as the value lying two
standard deviations above that of the lowest standard (master calibrator,
Calibration interval may be extended based on acceptable verification of standard 1 + 2 SD, repeatability study, n = 21).
calibration by the laboratory.
Dilution
Renewed calibration is recommended as follows:
Samples with AFP concentrations above the measuring range can be
▪ after 1 month (28 days) when using the same reagent lot diluted with Diluent Universal. The recommended dilution is 1:50 (either
▪ after 7 days (when using the same reagent kit on the analyzer) automatically by the analyzers or manually). The concentration of the
diluted sample must be > 20 IU/mL (> 24 ng/mL).
▪ as required: e.g. quality control findings outside the defined limits
After manual dilution, multiply the result by the dilution factor.
Quality control After dilution by the analyzers, the software automatically takes the dilution
For quality control, use PreciControl Tumor Marker or PreciControl into account when calculating the sample concentration.
Universal.
Expected values
In addition, other suitable control material can be used.
Results of following studies using the Elecsys AFP assay see below:
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 a) Multicenter study “Elecsys 2010 analyzer” status September 1997 and
following each calibration. reference range study in Germany and France, data evaluated in
September 1998.
The control intervals and limits should be adapted to each laboratory’s
individual requirements. Values obtained should fall within the defined Following AFP values were found in serum samples from 646 healthy test
limits. Each laboratory should establish corrective measures to be taken if subjects:
values fall outside the defined limits. ≤ 5.8 IU/mL or ≤ 7.0 ng/mL for 95 % of the results.
If necessary, repeat the measurement of the samples concerned. AFP median values for completed weeks of pregnancy (defined as
Follow the applicable government regulations and local guidelines for completed weeks of pregnancy beginning with the start of the last
quality control. menstruation phase):
Calculation Weeks 14 15 16 17 18 19
The analyzer automatically calculates the analyte concentration of each N 382 1782 2386 975 353 146
sample either in IU/mL, ng/mL, kIU/L or additionally in IU/L with
cobas e 601 and cobas e 602 analyzers. IU/mL 23.2 25.6 30.0 33.5 40.1 45.5

Conversion factors: IU/mL x 1.21 = ng/mL ng/mL 27.9 30.9 36.1 40.4 48.3 54.8

ng/mL x 0.83 = IU/mL b) Multicenter study to determine reference values for evaluating the risk of
trisomy 21 in maternal serum (study No. BO1P019, status March 2003).
Limitations - interference Values from serum samples of 1753 pregnant women in total (relevant
The assay is unaffected by icterus (bilirubin < 1112 µmol/L or < 65 mg/dL), gestational weeks 14 to 18) were evaluated.
hemolysis (Hb < 1.4 mmol/L or < 2.2 g/dL), lipemia (Intralipid < 1500 mg/dL) Measurements with the Elecsys HCG+β assay and the Elecsys AFP assay
and biotin (< 738 nmol/L or < 180 ng/mL). were conducted in 5 clinical centers in Belgium, France, and Germany.
Criterion: Recovery within ± 10 % of initial value. The gestational age in days determined by ultrasound was given for each
Samples should not be taken from patients receiving therapy with high sample. From a log-linear regression analysis of all 1753 AFP values
biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin versus gestational age the following median values were calculated for the
administration. middle of the respective weeks (e.g. week 14 + 3 days):
No interference was observed from rheumatoid factors up to a Weeks 14 15 16 17 18
concentration of 1500 IU/mL.
There is no high-dose hook effect at AFP concentrations up to IU/mL 20.9 24.0 27.6 31.7 36.4
1 million IU/mL (1.21 million ng/mL). ng/mL 25.3 29.0 33.3 38.3 44.0
In vitro tests were performed on 26 commonly used pharmaceuticals. No
interference with the assay was found. Note: For prenatal testing it is recommended that the median values be re-
evaluated periodically (1 to 3 years) and whenever methodology changes.
In rare cases, interference due to extremely high titers of antibodies to
analyte‑specific antibodies, streptavidin or ruthenium can occur. These The transferability of the reference values to plasma samples has not been
effects are minimized by suitable test design. verified.
For diagnostic purposes, the results should always be assessed in Each laboratory should investigate the transferability of the expected values
conjunction with the patient’s medical history, clinical examination and other to its own patient population and if necessary determine its own reference
findings. ranges.
Elecsys AFP as an aid in the diagnosis of HCC
Limits and ranges
A prospective multicenter study (Roche study No. RD002542 and
Measuring range RD002543) to evaluate the clinical performance of Elecsys AFP as an aid in
0.500-1000 IU/mL or 0.605-1210 ng/mL (defined by the lower detection limit the diagnosis of HCC included 376 patients with liver disease, of which 168
and the maximum of the master curve). Values below the detection limit are had HCC and 208 had liver disease but no diagnosis of HCC (control).
reported as < 0.500 IU/mL or < 0.605 ng/mL. Values above the measuring
range are reported as > 1000 IU/mL or > 1210 ng/mL (or up to 50000 IU/mL Median Gender Race
or 60500 ng/mL for 50‑fold diluted samples). age (% male)

Asian Caucasian Black Other Missing

(%) (%) (%) (%) (%)

Control 53 60.6 47.6 48.6 1.4 0 2.4

2022-02, V 17.0 English 3/6

04481798500V17.0

Elecsys AFP
Median Gender Race d) th th
Label Etiology N Min/Max Mean ±SD Median 25 -75
age (% male)
perc.
HCC 64 83.9 42.3 56.5 0 0.6 0.6 1-C Hepatitis C 27 1.3/6.33 3.23±1.43 2.49 2.21-4.73
(1.57/7.66) (3.9±1.73) (3.01) (2.67-5.73)
a) Range of AFP concentration in HCC cases compared to controls
1-D e) 30 1.01/10.9 3.36±2.36 2.48 1.74-3.96
The following table and graph show the range of AFP concentration in NASH
samples from HCC patients staged according to Barcelona clinic liver (1.22/13.2) (4.06±2.86) (3.00) (2.11-4.79)
cancer classification (BCLC)23 compared to controls. For the 168 patients 1-E f) 0 - - - -
ALD
with a diagnosis of HCC, the AFP concentration increased with disease
progression, especially in late stage disease. All concentrations in the table 1-F Others 0 - - - -
are in IU/mL and (ng/mL), while concentrations in the graph are in IU/mL. 2-A Cirrhosis 139 1.04/44687 1536±6096 16.6 4.82-320
The thick line in the box plots represents the median value. (1.26/54071) (1859±7377) (20.1) (5.84-387)
th th b) 2-B Hepatitis B 14 2.25/1711 296±536 38.2 -
Disease stage N Min/Max Mean Median 25 -75 perc.
± SD (2.73/2070) (358±649) (46.2)
c) 208 0.85/327.84 5.33±23.15 2.42 1.86-3.89 2-C Hepatitis C 3 1.86/999 348±564 43.1 -
Control
(1.03/396.69) (6.45 ±28.01) (2.92) (2.25-4.71) (2.25/1209) (421±683) (52.1)
Early (Stage 0 + A) 77 1.04/5224 252±799 9.7 3.72-39.6 2-D NASH 1 - 3.55 (4.3) - -
(1.26/6322) (305 ±966) (11.7) (4.5-47.9)
2-E ALD 2 3.87/33288 16646±23535 16646 -
BCLC Stage 0 10 1.04/258 58.4±98.9 9.67 - (4.69/40278) (20141±28478) (20141)
(1.26/312) (70.7±120) (11.7)
2-F Others 9 1.98/16115 3216±5924 210 -
BCLC Stage A 67 1.48/5224 281±852 9.7 3.72-39.6 (2.4/19499) (3891±7168) (254)
(1.79/6322) (340 ±1031) (11.7) (4.5-47.9)
d) All etiologies except cirrhosis are non-cirrhotic
Late (Stages B, C and D) 91 1.3/44687 2874±8259 119 5.95-909
e) Non-alcoholic steatohepatitis
(1.57/54071) (3478 ±9994) (144) (7.2-1100)
f) Alcoholic liver disease
BCLC Stage B 26 2.85/34944 1989±7301 15.5 5.33-132
(3.45/42282) (2407±8834) (18.8) (6.45-160)

BCLC Stage C 57 1.3/44687 2313±7079) 150 6.14-959 y 30000

(1.57/54071) (2798 ±8566) (182) (7.43-1160) 10000
3000
BCLC Stage D 8 557/34531 9751±15043 999 - 1000
(674/41782) (11799 ±18201) (1209) 300
100
b) not calculated if sample size is 20 or below
30
c) In the graphical representation below, this group is designated with an “X” 10
3
1
y 1-A 1-B 1-C 1-D 1-E 1-F 2-A 2-B 2-C 2-D 2-E 2-F
30000
10000 x
3000
1000 y ---> AFP (IU/mL)
300
c) Clinical performance of the Elecsys AFP assay in detecting HCC
100
30 The sensitivity and specificity of the Elecsys AFP assay in detecting HCC at
10 a cut-off of 165 IU/mL (200 ng/mL) and 16.5 IU/mL (20 ng/mL), and the
3 results of the Receiver Operating Characteristics (ROC) analysis are shown
1 below.
X O A ii B C D
g) h)
x All HCC Early Stage HCC Late Stage HCC
AFP Sensitvity 31.5% 15.6% 45.1%

x ---> X: Control; O: Stage 0; A: Stage A; B: Stage B; C: Stage C; cut-off 200 ng/mL (95 % CI) (24.6%, 39.2%) (8.3%, 25.6%) (34.6%, 55.8%)
D: Stage D Specificity 99.5%
y ---> AFP (IU/mL) (95 % CI) (97.4%, 100%)
b) AFP concentration and disease etiology
AFP Sensitvity 51.8% 36.4% 64.8%
The AFP concentration as function of etiology for the two patient groups cut-off 20 ng/mL (95 % CI) (44%, 59.5%) (25.7%, 48.1%) (54.1%, 74.6%)
(Control, 1-A to 1-F and HCC, 2-A to 2F) is shown in the following table and
graph. All concentrations in the table are in IU/mL and (ng/mL), while Specificity 98.1%
concentrations in the graph are in IU/mL. The thick line in the box plots (95 % CI) (95.1%, 99.5%)
represents the median value.
i) 88% 84.5% 90.9%
ROC AUC
d) th th (84.5%, 91.5%) (79.3%, 89.7%) (86.8%, 95.1%)
Label Etiology N Min/Max Mean ±SD Median 25 -75
perc.
g) BCLC stages 0, A
1-A Cirrhosis 79 0.851/66.9 4.92±8.59 2.63 1.85-4.34
h) BCLC stages B,C,D
(1.03/80.9) (5.95±10.4) (3.19) (2.24-5.25)
i) Area under the Curve
1-B Hepatitis B 72 1.03/328 7.4±38.3 2.31 1.73-3.11 d) AFP values in different types of benign and malignant disorders
(1.25/397) (8.95±46.4) (2.79) (2.1-3.76) The following table and graph show the AFP concentration in IU/mL and
(ng/mL) in a panel of samples from patients with either a benign liver

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Elecsys AFP
disease, an immune disorder, or a malignancy other than HCC (N total 397; cobas e 411 analyzer
median age 54 years, 58 % female, 39 % Asian and 61 % Caucasian).
Repeatability Intermediate
Label Etiology N Min/Max Mean Median
th
25 -75
th precision
± (SD) perc. Sample Median SD CV SD CV
A 87 0.843/999 14.3±107 2.20 1.73-3.48
Benign liver IU/mL ng/mL IU/mL ng/mL % IU/mL ng/mL %
j) (1.02/1209 ) (17.3±129) (2.66) (2.10-4.21)
diseases
HSn) 1 12.8 15.5 0.26 0.31 2.0 0.39 0.47 3.1
B Rheumatoid arthritis 38 1.11/11.7 2.80±1.84 2.28 1.77-2.99
(1.34/14.2) (3.39±2.22) (2.75) (2.14-3.62) HS 2 42.6 51.5 0.63 0.76 1.5 1.02 1.24 2.4
C Crohn’s disease 37 0.676/10.0 3.21±2.40 2.42 1.63-3.58 HS 3 566 685 11.2 13.5 2.0 15.6 18.9 2.8
(0.819/12.1) (3.88±2.90) (2.93) (1.97-4.34) PC TMo) 1 8.01 9.69 0.22 0.27 2.8 0.28 0.33 3.4
D Ulcerative colitis 30 1.20/7.27 2.58±1.35 2.37 1.63-2.94 PC TM2 86.8 105.0 1.92 2.33 2.2 2.33 2.82 2.7
(1.45/8.80) (3.12±1.63) (2.86) (1.97-3.56)
n) HS = human serum 
E 26 0.909/7.93 3.16±1.72 2.62 2.02-3.97
Other autoimmune o) PC TM = PreciControl Tumor Marker
k) (1.10/9.60) (3.83±2.08) (3.16) (2.44-4.80)
diseases
cobas e 601 and cobas e 602 analyzers
F Lung cancer 24 1.01/5.18 2.50±0.978 2.40 1.90-3.03
(1.22/6.27) (3.02±1.18) (2.90) (2.30-3.67) Repeatability Intermediate precision
G Breast cancer 27 0.859/7.67 3.06±1.60 2.59 1.85-4.01 Sample Mean SD CV Mean SD CV
(1.04/9.27) (3.70±1.93) (3.13) (2.24-4.85) IU/ ng/ IU/ ng/ % IU/ ng/ IU/ ng/ %
H Renal cancer 10 0.58/6.43 2.73±1.96 2.21 - mL mL mL mL mL mL mL mL
(0.702/7.78) (3.30±2.37) (2.67) HS 1 14.8 17.8 0.27 0.33 1.8 14.1 17.0 0.53 0.64 3.8
I Cholangio-car­ 27 1.06/83.8 7.48±15.9 3.51 2.15-4.82
HS 2 46.7 56.5 0.65 0.79 1.4 44.6 53.9 1.14 1.38 2.6
cinoma (1.28/101) (9.05±19.3) (4.25) (2.60-5.84)
HS 3 745 901 11.7 14.2 1.6 711 860 23.4 28.3 3.3
J Pancreatic cancer 10 1.03/6.65 2.83±2.02 1.92 -
(1.25/8.05) (3.43±2.45) (2.32)
PC TM1 9.35 11.3 0.21 0.25 2.2 9.1 11.0 0.26 0.31 2.8
K 55 0.512/13.1 3.00±1.95 2.68 2.02-3.43
PC TM2 104 126 2.49 3.01 2.4 103 125 2.54 3.07 2.5
Other
(0.62/15.9) (3.63 ±2.35) (3.24) (2.44-4.15)
gastrointestinal Method comparison
l)
cancers A comparison of the Elecsys AFP assay,  07026706190 (cobas e 801
L 26 0.999/9.19 3.24±2.02 2.62 1.86-3.96 analyzer; y) with the Elecsys AFP assay,  04481798190 (cobas e 601
Gynecological
m) (1.21/11.1) (3.92±2.44) (3.16) (2.25-4.79) analyzer; x) gave the following correlations (IU/mL):
cancers
Number of serum samples measured: 165
j) polycystic liver disease, simple cysts, focal nodular hyperplasia, hemangioma, hepatocellular
adenoma, non-cirrhotic alcohol liver disease Passing/Bablok24 Linear regression
k) systemic lupus erythematosus, autoimmune thyroiditis
y = 0.961x - 0.106 y = 0.964x - 0.589
l) colorectal, gastric and esophageal cancer
m) ovarian, endometrial and cervical cancer τ = 0.980 r = 0.999
The sample concentrations were between 0.783 and 954  IU/mL.
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