07679831500V3.

Elecsys Androstenedione
cobas e 411
07679831190 07679831500 100 cobas e 601
cobas e 602

English M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL:

System information Streptavidin-coated microparticles 0.72 mg/mL; preservative.
For cobas e 411 analyzer: test number 1530 R1 Anti-androstenedione-Ab~biotin (gray cap), 1 bottle, 10 mL:
For cobas e 601 and cobas e 602 analyzers: Application Code
Number 304 Biotinylated monoclonal anti‑androstenedione antibody (recombinant,
Intended use sheep) 10 ng/mL; phosphate buffer 50 mmol/L, pH 6.5; preservative.
Immunoassay for the in vitro quantitative determination of androstenedione R2 Androstenedione‑peptide~Ru(bpy) (black cap), 1 bottle, 9 mL:
in human serum and plasma. The determination of androstenedione is used
as an aid in diagnosis and differential diagnosis of androgens related Androstenedione coupled to a synthetic peptide labeled with
endocrine function in conjunction with other clinical and laboratory findings. ruthenium complex 3 ng/mL; phosphate buffer 50 mmol/L, pH 6.5;
The electrochemiluminescence immunoassay “ECLIA” is intended for use preservative.
on cobas e immunoassay analyzers.
Precautions and warnings
Summary For in vitro diagnostic use for health care professionals. Exercise the
Androstenedione (ASD) is a 19‑carbon androgenic steroid hormone normal precautions required for handling all laboratory reagents.
produced by the adrenal glands and the gonads. Steroid hormones Infectious or microbial waste:
represent a class of signaling molecules that help to control a variety of Warning: handle waste as potentially biohazardous material. Dispose of
processes, including metabolism, inflammation, immune functions, salt and waste according to accepted laboratory instructions and procedures.
water balance and the development of sexual characteristics. Steroid
hormones are fat-soluble, therefore, they can pass through the lipid Environmental hazards:
membrane into the circulation. They are subsequently delivered to their site Apply all relevant local disposal regulations to determine the safe disposal.
of action before exerting their cellular effects by binding to specific steroid Safety data sheet available for professional user on request.
receptors. They can be grouped into glucocorticoids, mineralocorticoids, For USA: Caution: Federal law restricts this device to sale by or on the
androgens, estrogens and progestogens, based on the receptors to which order of a physician.
they bind.1 The production of androstenedione by the adrenal glands is
governed by the adrenocorticotropic hormone (ACTH), whereas production This kit contains components classified as follows in accordance with the
of gonadal androstenedione is controlled by gonadotropins. Regulation (EC) No. 1272/2008:
Androstenedione is formed as an intermediate step in the biochemical
pathway for production of the sex hormones testosterone, estrone and
estradiol. Therefore, it is the common precursor for male and female sex
hormones.2
Measurement of androstenedione levels is useful in the evaluation of
adrenal gland function, androgen production, ovarian/testicular function, as Warning
well in the diagnosis and monitoring of patients who have suspected
cortisol-related enzyme deficiencies resulting in hyperandrogenism. As per H317 May cause an allergic skin reaction.
the most recent guidelines androstenedione is indicated for the
investigation of hyperandrogenism in women suspected of having polycystic Prevention:
ovary syndrome (PCOS), if total or free testosterone is not elevated.3
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
Test principle
Competition principle. Total duration of assay: 18 minutes. P272 Contaminated work clothing should not be allowed out of
▪ 1st incubation: By incubating the sample (10 µL) with an the workplace.
androstenedione‑specific biotinylated antibody and an ASD conjugate
labeled with a ruthenium complexa), immunocomplexes are formed. The P280 Wear protective gloves.
still-vacant sites of the biotinylated antibodies become occupied, with Response:
formation of an antibody‑hapten complex, the amount of which is
dependent upon the analyte concentration in the sample. P333 + P313 If skin irritation or rash occurs: Get medical
▪ 2nd incubation: After addition of streptavidin-coated microparticles, the advice/attention.
complex becomes bound to the solid phase via interaction of biotin and
streptavidin. P362 + P364 Take off contaminated clothing and wash it before reuse.
▪ The reaction mixture is aspirated into the measuring cell where the Disposal:
microparticles are magnetically captured onto the surface of the
electrode. Unbound substances are then removed with P501 Dispose of contents/container to an approved waste
ProCell/ProCell M. Application of a voltage to the electrode then induces disposal plant.
chemiluminescent emission which is measured by a photomultiplier.
Product safety labeling follows EU GHS guidance.
▪ Results are determined via a calibration curve which is instrument-
specifically generated by 2‑point calibration and a master curve provided Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336
via the reagent barcode or e‑barcode. Avoid foam formation in all reagents and sample types (specimens,
a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) ) calibrators and controls).
Reagents - working solutions Reagent handling
The reagent rackpack is labeled as ASD. The reagents in the kit have been assembled into a ready‑for‑use unit that
cannot be separated.
All information required for correct operation is read in automatically from
the respective reagent barcodes.

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Elecsys Androstenedione
Storage and stability ▪ 04880340190, ProCell M, 2 x 2 L system buffer
Store at 2‑8 °C. ▪ 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning
Do not freeze. solution
Store the Elecsys reagent kit upright in order to ensure complete ▪ 03023141001, PC/CC‑Cups, 12 cups to prewarm ProCell M and
availability of the microparticles during automatic mixing prior to use. CleanCell M before use
Stability: ▪ 03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run
finalization and rinsing during reagent change
unopened at 2‑8 °C up to the stated expiration date ▪ 03004899190, PreClean M, 5 x 600 mL detection cleaning solution
after opening at 2‑8 °C 8 weeks ▪ 12102137001, AssayTip/AssayCup, 48 magazines x 84 reaction
on the analyzers 8 weeks cups or pipette tips, waste bags
▪ 03023150001, WasteLiner, waste bags
Specimen collection and preparation
Only the specimens listed below were tested and found acceptable. ▪ 03027651001, SysClean Adapter M
Additional materials for all analyzers:
Serum collected using standard sampling tubes or tubes containing
separating gel. ▪ 11298500316, ISE Cleaning Solution/Elecsys SysClean,
Serum separation tubes containing polyester‑based polymer gels are not 5 x 100 mL system cleaning solution
suitable.4 ▪ 11298500160, ISE Cleaning Solution/Elecsys SysClean,
Li‑heparin, K2‑EDTA and K3‑EDTA plasma as well as plasma separation 5 x 100 mL system cleaning solution (for USA)
tubes. Plasma separation tubes containing polyester‑based polymer gels Assay
are not suitable.4 For optimum performance of the assay follow the directions given in this
Criterion: Slope 0.9‑1.1 + coefficient of correlation ≥ 0.95. document for the analyzer concerned. Refer to the appropriate operator’s
Stable for 5 days at 20‑25 °C, 14 days at 2‑8 °C, 6 months at manual for analyzer‑specific assay instructions.
‑20 °C (± 5 °C). Freeze only once. Resuspension of the microparticles prior to use and the reading in of the
The sample types listed were tested with a selection of sample collection test‑specific parameters via the reagent barcode take place automatically.
tubes that were commercially available at the time of testing, i.e. not all No manual input is necessary. If in exceptional cases the barcode cannot
available tubes of all manufacturers were tested. Sample collection systems be read, enter the 15‑digit sequence of numbers
from various manufacturers may contain differing materials which could cobas e 601 and cobas e 602 analyzers: PreClean M solution is
affect the test results in some cases. When processing samples in primary necessary.
tubes (sample collection systems), follow the instructions of the tube Bring the cooled reagents to approximately 20 °C and place on the reagent
manufacturer. disk (20 °C) of the analyzer. Avoid foam formation. The system
Centrifuge samples containing precipitates before performing the assay. automatically regulates the temperature of the reagents and the
Do not use heat‑inactivated samples. opening/closing of the bottles.
Do not use samples and controls stabilized with azide. Calibration
Ensure the samples, calibrators and controls are at 20‑25 °C prior to Traceability: The Elecsys Androstenedione assay has been standardized by
measurement. isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-
Due to possible evaporation effects, samples, calibrators and controls on MS/MS). The method is traceable to the certified reference material
the analyzers should be analyzed/measured within 2 hours. NMIA M955 from the National Measurement Institute of Australia.
Sample stability claims were established by experimental data by the Every Elecsys reagent set has a barcoded label containing specific
manufacturer or based on reference literature and only for the information for calibration of the particular reagent lot. The predefined
temperatures/time frames as stated in the method sheet. It is the master curve is adapted to the analyzer using the relevant CalSet.
responsibility of the individual laboratory to use all available references Calibration frequency: Calibration must be performed once per reagent lot
and/or its own studies to determine specific stability criteria for its using fresh reagent (i.e. not more than 24 hours since the reagent kit was
laboratory. registered on the analyzer).
Materials provided Calibration interval may be extended based on acceptable verification of
calibration by the laboratory.
See “Reagents – working solutions” section for reagents.
Renewed calibration is recommended as follows:
Materials required (but not provided)
▪ after 1 month (28 days) when using the same reagent lot
▪ 07679866190, CalSet Androstenedione, for 4 x 1.0 mL
▪ after 7 days (when using the same reagent kit on the analyzer)
▪ 08740062190, PreciControl Maternal Care, for 6 x 3.0 mL
▪ as required: e.g. quality control findings outside the defined limits
▪ 08740062160, PreciControl Maternal Care, for 6 x 3.0 mL (for USA)
Quality control
▪ 05192943190, Diluent Universal 2, 2 x 36 mL sample diluent
For quality control, use PreciControl Maternal Care.
▪ General laboratory equipment In addition, other suitable control material can be used.
▪ cobas e analyzer Controls for the various concentration ranges should be run individually at
Additional materials for the cobas e 411 analyzer: least once every 24 hours when the test is in use, once per reagent kit, and
▪ 11662988122, ProCell, 6 x 380 mL system buffer following each calibration.
The control intervals and limits should be adapted to each laboratory’s
▪ 11662970122, CleanCell, 6 x 380 mL measuring cell cleaning individual requirements. Values obtained should fall within the defined
solution limits. Each laboratory should establish corrective measures to be taken if
▪ 11930346122, Elecsys SysWash, 1 x 500 mL washwater additive values fall outside the defined limits.
▪ 11933159001, Adapter for SysClean If necessary, repeat the measurement of the samples concerned.
▪ 11706802001, AssayCup, 60 x 60 reaction cups Follow the applicable government regulations and local guidelines for
quality control.
▪ 11706799001, AssayTip, 30 x 120 pipette tips
▪ 11800507001, Clean‑Liner
Additional materials for cobas e 601 and cobas e 602 analyzers:

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Elecsys Androstenedione
Calculation Limit of Blank = 0.262 nmol/L (0.0750 ng/mL)
The analyzer automatically calculates the analyte concentration of each Limit of Detection = 0.525 nmol/L (0.150 ng/mL)
sample (either in nmol/L, ng/mL or in μg/L with cobas e 601 and cobas e Limit of Quantitation = 1.05 nmol/L (0.30 ng/mL)
602 analyzers).
The Limit of Blank, Limit of Detection and Limit of Quantitation were
Conversion factors: nmol/L x 0.286 = ng/mL (µg/L) determined in accordance with the CLSI (Clinical and Laboratory Standards
Institute) EP17‑A2 requirements.
ng/mL x 3.497 = nmol/L
The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of
Limitations - interference analyte‑free samples over several independent series. The Limit of Blank
The effect of the following endogenous substances and pharmaceutical corresponds to the concentration below which analyte‑free samples are
compounds on assay performance was tested. Interferences were tested found with a probability of 95 %.
up to the listed concentrations and no impact on results was observed. The Limit of Detection is determined based on the Limit of Blank and the
standard deviation of low concentration samples. The Limit of Detection
Endogenous substances corresponds to the lowest analyte concentration which can be detected
Compound Concentration tested (value above the Limit of Blank with a probability of 95 %).
The Limit of Quantitation is defined as the lowest amount of analyte in a
Bilirubin ≤ 1129 µmol/L or ≤ 66 mg/dL sample that can be accurately quantitated with a total allowable error of
Hemoglobin ≤ 0.621 mmol/L or ≤ 1000 mg/dL ≤ 30 %.
Intralipid ≤ 1200 mg/dL Dilution
Samples with androstenedione concentrations above the measuring range
Biotin ≤ 14326 nmol/L or ≤ 3500 ng/mL can be diluted with Diluent Universal 2 or a suitable human serum with a
Rheumatoid factors ≤ 1200 IU/mL low analyte concentration. The recommended dilution is 1:10. The
concentration of the diluted sample must be > 4.19 nmol/L (> 1.20 ng/mL).
IgG ≤ 7.0 g/dL
After manual dilution, multiply the result by the dilution factor.
IgA ≤ 1.6 g/dL After dilution by the analyzers, the software automatically takes the dilution
IgM ≤ 1.0 g/dL into account when calculating the sample concentration.
Human serum albumin ≤ 5.0 g/dL Expected values
Expected values were determined at 2 trial sites. Samples used in the study
Criterion: Recovery ≤ 0.06 ng/mL if initial value with samples < 0.60 ng/mL were derived from clinical cohorts/sample collections with defined
or within ± 10 % of initial value with samples > 0.60 ng/mL. inclusion/exclusion criteria.
Pharmaceutical substances
Test subjects N 5th percentile Median 95th percentile
In vitro tests were performed on 17 commonly used pharmaceuticals. No
ng/mL ng/mL ng/mL
interference with the assay was found.
A strong interaction with Exemestane (INN international nonproprietary Apparently healthy women 84 0.490 0.825 1.31
name, WHO) was found. Do not use samples from patients under
Exemestane treatment. Test subjects N 2.5th percentile Median 97.5th percentile

In addition, the following special drugs were tested. No interference with the ng/mL ng/mL ng/mL
assay was found. Postmenopausal women 140 0.187 0.451 1.07

Special drugs Polycystic ovary syndrome 125 0.645 1.54 3.47

(PCOS)
Drug Concentration tested
mg/L Apparently healthy men 138 0.280 0.640 1.52

ACTH 0.150 Apparently healthy children 140 < 0.150 < 0.150 0.519

Clomiphene 40.7 Test subjects N 5th percentile Median 95th percentile

Follicle stimulating hormone (FSH) 0.077 nmol/L nmol/L nmol/L

Flutamide 450 Apparently Healthy women 84 1.71 2.89 4.58

Metformin 1800
Test subjects N 2.5th percentile Median 97.5th percentile
Drug interferences are measured based on recommendations given in CLSI nmol/L nmol/L nmol/L
guidelines EP07 and EP37 and other published literature. Effects of
concentrations exceeding these recommendations have not been Postmenopausal women 140 0.654 1.58 3.74
characterized. Polycystic ovary syndrome 125 2.26 5.39 12.1
In rare cases, interference due to extremely high titers of antibodies to (PCOS)
analyte‑specific antibodies, streptavidin or ruthenium can occur. These
Apparently healthy men 138 0.979 2.24 5.32
effects are minimized by suitable test design.
For diagnostic purposes, the results should always be assessed in Apparently healthy children 140 < 0.525 < 0.525 1.81
conjunction with the patient’s medical history, clinical examination and other
findings. Each laboratory should investigate the transferability of the expected values
to its own patient population and if necessary determine its own reference
Limits and ranges ranges.
Measuring range Specific performance data
0.525‑34.9 nmol/L or 0.150‑10.0 ng/mL (defined by the Limit of Detection Representative performance data on the analyzers are given below.
and the maximum of the master curve). Values below the Limit of Detection Results obtained in individual laboratories may differ.
are reported as < 0.525 nmol/L or < 0.150 ng/mL. Values above the
measuring range are reported as > 34.9 nmol/L or > 10.0 ng/mL. Precision
Lower limits of measurement Precision was determined using Elecsys reagents, pooled human sera and
controls in a protocol (EP05‑A3) of the CLSI (Clinical and Laboratory
Limit of Blank, Limit of Detection and Limit of Quantitation

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Elecsys Androstenedione
Standards Institute): 2 runs per day in duplicate each for 21 days (n = 84). cobas e 601 and cobas e 602 analyzers
The following results were obtained:
Repeatability Intermediate
cobas e 411 analyzer precision
Repeatability Intermediate Sample Mean SD CV SD CV
precision ng/mL ng/mL % ng/mL %
Sample Mean SD CV SD CV Human serum 4 5.39 0.099 1.8 0.201 3.7
nmol/L nmol/L % nmol/L % Human serum 5 9.15 0.195 2.1 0.355 3.9
Human serum 1 1.61 0.056 3.4 0.073 4.6 PreciControl MC 1 0.487 0.011 2.3 0.023 4.7
Human serum 2 3.38 0.080 2.4 0.115 3.4 PreciControl MC 2 2.85 0.056 2.0 0.109 3.8
Human serum 3 11.9 0.406 3.4 0.507 4.3 PreciControl MC 3 7.37 0.220 3.0 0.339 4.6
Human serum 4 20.2 0.657 3.3 0.734 3.6
Method comparison
Human serum 5 31.5 1.03 3.3 1.33 4.2 A comparison of the Elecsys Androstenedione assay (y) with ID‑LC‑MS/MS
PreciControl MCb) 1 1.76 0.056 3.1 0.080 4.5 (x) gave the following correlations (nmol/L):
Number of samples measured: 332
PreciControl MC 2 10.5 0.283 2.7 0.357 3.4
PreciControl MC 3 27.6 0.878 3.2 1.17 4.2 Passing/Bablok5 Linear regression
b) MC = Maternal Care y = 1.04x + 0.004 y = 1.03x + 0.025
τ = 0.922 r = 0.996
cobas e 411 analyzer
The sample concentrations (ID‑LC‑MS/MS concentrations) were between
Repeatability Intermediate 0.49 and 35.3 nmol/L (0.14 and 10.1 ng/mL).
precision
Analytical specificity
Sample Mean SD CV SD CV
For the Elecsys Androstenedione assay, the following cross-reactivities
ng/mL ng/mL % ng/mL % (CR; in %) were found at the respective additive concentration (AC; in
Human serum 1 0.461 0.016 3.4 0.021 4.6 ng/mL), tested with androstenedione concentration of approximately
1.4 ng/mL (4.9 nmol/L):
Human serum 2 0.966 0.023 2.4 0.033 3.4
Human serum 3 3.39 0.116 3.4 0.145 4.3 CR AC
(%) (ng/mL)
Human serum 4 5.77 0.188 3.3 0.210 3.6
Androsterone 0.019 10000
Human serum 5 9.00 0.294 3.3 0.380 4.2
Aldosterone n.d.c) 10000
PreciControl MC 1 0.504 0.016 3.1 0.023 4.5
Cortisol n.d. 10000
PreciControl MC 2 3.00 0.081 2.7 0.102 3.4
Dihydrotestosterone (DHT) 0.275 2500
PreciControl MC 3 7.89 0.251 3.2 0.335 4.2
Dihydroepiandrosterone (DHEA) 0.394 1600
cobas e 601 and cobas e 602 analyzers Estriol n.d. 10000
Repeatability Intermediate 16-Epiestriol 0.001 10000
precision Estradiol n.d. 10000
Sample Mean SD CV SD CV Estriol-3-glucuronide n.d. 10000
nmol/L nmol/L % nmol/L %
Estriol-16-glucuronide n.d. 10000
Human serum 1 1.56 0.045 2.9 0.070 4.5
Estrone 0.030 10000
Human serum 2 3.23 0.059 1.8 0.122 3.8
17-OH-Progesterone 0.021 10000
Human serum 3 11.2 0.262 2.4 0.413 3.7
Progesterone 0.011 10000
Human serum 4 18.8 0.346 1.8 0.703 3.7
Testosterone 0.383 1000
Human serum 5 32.0 0.682 2.1 1.24 3.9
Dexamethasone n.d. 10000
PreciControl MC 1 1.70 0.038 2.3 0.080 4.7
Prednisolone n.d. 10000
PreciControl MC 2 9.97 0.196 2.0 0.381 3.8
Fludrocortisone n.d. 10000
PreciControl MC 3 25.8 0.769 3.0 1.19 4.6
Spironolactone 0.013 10000
cobas e 601 and cobas e 602 analyzers Cyproterone acetate n.d. 10000
Repeatability Intermediate Finasteride 0.001 10000
precision Ethinyl estradiol n.d. 10000
Sample Mean SD CV SD CV Cholesterol n.d. 10000
ng/mL ng/mL % ng/mL %
Dehydroepiandrosterone-3-sulfate (DHEA-S) n.d. 10000
Human serum 1 0.446 0.013 2.9 0.020 4.5
Prednisone n.d. 10000
Human serum 2 0.923 0.017 1.8 0.035 3.8
Pregnenolone n.d. 10000
Human serum 3 3.19 0.075 2.4 0.118 3.7

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Elecsys Androstenedione
COBAS, COBAS E, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark of
CR AC Fresenius Kabi AB.
(%) (ng/mL) All other product names and trademarks are the property of their respective owners.
Norethindrone 0.002 10000 Additions, deletions or changes are indicated by a change bar in the margin.
© 2022, Roche Diagnostics
Corticosterone n.d. 10000
11-Keto-testosterone 0.001 10000
Adrenosterone 0.221 2800
Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim
4-Androstene-11β-ol-3,17-dione 0.141 4400 www.roche.com

Cortisone 0.001 10000 +800 5505 6606

Fulvestrant n.d. 10000

Distribution in USA by:
Progestin (Medroxyprogesterone acetate) 0.001 10000 Roche Diagnostics, Indianapolis, IN
US Customer Technical Support 1-800-428-2336
Canrenone 0.046 10000
c) n. d. = not detectable
References
1 Luu-The, V. Assessment of steroidogenesis and steroidogenic enzyme
functions. J Steroid Biochem Mol Biol 2013;137:176-182.
2 Devlin TM. Textbook of Biochemistry: with Clinical Correlations (7th
ed.). Hoboken, NJ: John Wiley & Sons. 2010: p. 432.
3 Teede HJ, Misso ML, Costello MF, et al. International PN
Recommendations from the international evidence-based guideline for
the assessment and management of polycystic ovary syndrome. Hum
Reprod. 2018;33(9):1602-1618.
4 Hepburn S, Wright MJ, Boyder C, et al. Sex steroid hormone stability in
serum tubes with and without separator gels. Clin Chem Lab Med
(CCLM) 54.9 2016: 1451-1459.
5 Bablok W, Passing H, Bender R, et al. A general regression procedure
for method transformation. Application of linear regression procedures
for method comparison studies in clinical chemistry, Part III.
J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.
For further information, please refer to the appropriate operator’s manual for
the analyzer concerned, the respective application sheets and the Method
Sheets of all necessary components (if available in your country).
A point (period/stop) is always used in this Method Sheet as the decimal
separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
Any serious incident that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or the patient is established.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume for reconstitution
GTIN Global Trade Item Number

FOR US CUSTOMERS ONLY: LIMITED WARRANTY

Roche Diagnostics warrants that this product will meet the specifications
stated in the labeling when used in accordance with such labeling and will
be free from defects in material and workmanship until the expiration date
printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL
DAMAGES.

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