30 451 13414 F - en - 2015/01

VIDAS Cortisol S (CORS)

VIDAS® Cortisol S is an automated quantitative test for use on the VIDAS family instruments, for the quantitative
determination of cortisol in human serum, plasma (lithium heparin or EDTA) or urine using the ELFA technique(Enzyme
Linked Fluorescent Assay).
The VIDAS Cortisol S test aids in diagnosing or treating adrenocortical disorders.
SUMMARY AND EXPLANATION PRINCIPLE
Glucocorticoids are synthesized in the adrenal cortex and VIDAS Cortisol S is an automated assay for the VIDAS
cortisol is the main glucocorticoid (1, 2). The system, which enables cortisol in human serum or plasma
concentration of serum cortisol is principally regulated by to be directly quantitatively measured.
a negative feedback mechanism which controls the The assay of urine samples (collected over a 24-hour
release of ACTH (adrenocorticotropic hormone) (3). period) is performed after extracting the cortisol with
The amount of circulating cortisol is normally subject to a dichloromethane.
circadian rhythm: the levels of cortisol are highest early in The assay principle combines the enzyme immunoassay
the morning and return to a minimum around midnight (4). competition method with a final fluorescent detection (ELFA).
®
Cortisol has a half-life of 60 to 70 minutes; it mainly The Solid Phase Receptacle (SPR ) serves as the solid
circulates bound (90%) to a carrier protein called phase as well as the pipetting device. Reagents for the
transcortin. Cortisol affects the carbohydrate, protein and assay are ready-to-use and pre-dispensed in the sealed
lipidic metabolisms; it also regulates water and electrolyte reagent strips.
retention. Corticotropic disorders lead to adrenal hyper or All of the assay steps are performed automatically by the
hypofunction, resulting in hyper or hypocorticism instrument. The reaction medium is cycled in and out of
Hypercorticism may be connected with hyper-secretion of the SPR several times.
cortisol (adrenocortical tumor, Cushing's corticotropic The sample is transferred into the well containing the
adenoma), or result from corticotherapy (5, 6). conjugate: alkaline phosphatase-labeled cortisol derivative.
Hypocorticism is observed in cases of adrenal The cortisol in the sample will compete with the cortisol
insufficiency, caused either by the failure of the adrenal derivative in the conjugate for sites on the specific anti-
gland to secrete sufficient quantities of hormones cortisol antibody which is fixed onto the interior of the SPR.
(Addison's disease), or by insufficient production of ACTH. During the final detection step, the substrate
(4-Methyl-umbelliferyl phosphate) is cycled in and out of
the SPR. The conjugate enzyme catalyzes the hydrolysis
of this substrate into a fluorescent product
(4-Methyl-umbelliferone), the fluorescence of which is
measured at 450 nm. The intensity of the fluorescence is
inversely proportional to the concentration of antigen
present in the sample.
At the end of the assay, the results are automatically
calculated by the instrument in relation to the calibration
curve stored in memory, and then printed out.
CONTENT OF THE KIT (60 TESTS):
60 CORS strips STR Ready-to-use.
60 CORS SPRs SPR Ready-to-use.
2 x 30 Interior of SPR coated with polyclonal anti-cortisol immunoglobulins (rabbit).
CORS control C1 Ready-to-use.
1 x 2 mL (liquid) Human serum* + cortisol + 1 g/L sodium azide.
MLE data indicate the confidence interval in ng/ml (“Control C1 Dose Value Range”).
CORS calibrator S1 Ready-to-use.
2 x 3 mL (liquid) Human serum* + cortisol + 1 g/L sodium azide.
MLE data indicate the concentration in ng/ml (“Calibrator (S1) Dose Value”) and the
confidence interval in "Relative Fluorescence Value” (“Calibrator (S1) RFV Range”).
Specifications for the factory master data required to calibrate the test:
 MLE data (Master Lot Entry) provided in the kit,
or
 MLE bar code printed on the box label.
1 Package insert provided in the kit or downloadable from [Link]/techlib.
* This product has been tested and shown to be negative for HBs antigen, and antibodies to HIV1, HIV2 and HCV. However, since no
existing test method can totally guarantee their absence, this product must be treated as potentially infectious. Therefore, usual safety
procedures should be observed when handling.

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The SPR The reagent strip

The SPR is coated during production with polyclonal anti- The strip consists of 10 wells covered with a labeled, foil
cortisol antibodies (rabbit). Each SPR is identified by the seal. The label comprises a bar code which mainly
code “CORS”. Only remove the required number of SPRs indicates the assay code, kit lot number and expiration
from the pouch and carefully reseal the pouch after date. The foil of the first well is perforated to facilitate the
opening. introduction of the sample. The last well of each strip is a
cuvette in which the fluorometric reading is performed.
The wells in the center section of the strip contain the
various reagents required for the assay.
Description of the CORS strip
Wells Reagents
1 Sample well.
2-3-4 Empty wells.
5 Conjugate: alkaline phosphatase-labeled cortisol derivative + releasing agent + 1 g/L
sodium azide (600 µL).
6 Wash solution: Tris, NaCl (0.05 mol/L) pH 7.4 + 1 g/L sodium azide (600 µL).
7 Wash solution: Tris-Tween, NaCl (0.05 mol/L) pH 7.4 + 1 g/L sodium azide (600 µL).
8 Wash solution: DEA* (1.1 mol/L or 11.5 %) pH 9.8 + 1 g/L sodium azide (600 µL).
9 Empty well.
10 Reading cuvette with substrate: 4-Methyl-umbelliferyl phosphate (0.6 mmol/L) +
diethanolamine (DEA**) (0.62 mol/L or 6.6%, pH 9.2) + 1 g/L sodium azide (300 µL).

* Signal Word: DANGER

Hazard statement
H318 : Causes serious eye damage.
H373 : May cause damage to organs through prolonged or repeated exposure.
H315 : Causes skin irritation.
H302 : Harmful if swallowed.
Precautionary statement
P280 :Wear protective gloves/protective clothing/eye protection/face protection.
P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing.
P309 + P311 : IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
** Signal Word: DANGER

Hazard statement
H318 : Causes serious eye damage.
Precautionary statement
P280 :Wear protective gloves/protective clothing/eye protection/face protection.
P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing.
For further information, refer to the Material Safety Data Sheet.

REAGENTS, MATERIALS AND DISPOSABLES

REQUIRED BUT NOT PROVIDED For urine extraction procedure:
- Pipette with disposable tip to dispense 100 µL, 150 µL - Serum free (ref. 66 581),
and 1 mL. - dichloromethane,
- Powderless, disposable gloves. - polypropylene or polyethylene tubes,
- For other specific materials and disposables, please - glass tubes.
refer to the Instrument User’s Manual.
- Instrument of the VIDAS family.

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WARNINGS AND PRECAUTIONS SPECIMENS

 For in vitro diagnostic use only. Specimen type and collection:
 For professional use only. Human serum, plasma (sodium heparin, EDTA) or urine
 This kit contains products of human origin. No collected over a 24-hour period (with or without boric
known analysis method can totally guarantee the acid).
absence of transmissible pathogenic agents. It is
therefore recommended that these products be Sample preparation
treated as potentially infectious and handled Follow the tube manufacturer’s recommendations for use.
observing the usual safety precautions (see - Plain tubes: wait for samples to coagulate and
Laboratory Biosafety Manual - WHO - Geneva - centrifuge to eliminate fibrin.
latest Edition). - Frozen stored sample: after thawing, all these samples
 This kit contains products of animal origin. Certified must be centrifuged.
knowledge of the origin and/or sanitary state of the
animals does not totally guarantee the absence of Note: blood sampling tube results may vary from one
transmissible pathogenic agents. It is therefore manufacturer to another depending on the materials and
recommended that these products be treated as additives used.
potentially infectious and handled observing the usual It is the responsibility of each laboratory to validate the
safety precautions (do not ingest or inhale). type of sample tube used and to follow the manufacturer’s
 Do not use the SPRs if the pouch is pierced. recommendations for use.
 Do not use visibly deteriorated STRs (damaged foil or
Specimen stability
plastic).
 Do not use reagents after the expiration date indicated Samples can be stored at 2-8°C in stoppered tubes for up
on the label. to 3 days; if longer storage is required, freeze the sera or
 Do not mix reagents (or disposables) from different lots. plasma at -25  6°C. A study performed on frozen
 Use powderless gloves, as powder has been reported samples over a period of 2 months showed that the
to cause false results for certain enzyme immunoassay quality of results is not affected. Two freeze/thaw cycles
tests. have been validated.
 Kit reagents contain sodium azide which can react with Stability of urine samples
lead or copper plumbing to form explosive metal azides.
If any liquid containing sodium azide is disposed of in Urine samples can be stored frozen at -25  6°C for
the plumbing system, drains should be flushed with 14 days.
Sample-related interference
water to avoid build-up.
 The wash buffer (well 8) contains a harmful agent With serum or plasma
(diethanolamine 11.5%). Refer to the hazard statements
"H" and the precautionary statements "P" above. None of the following factors have been found to
 The cuvette with substrate (well 10) contains an irritant significantly influence this assay:
agent (diethanolamine 6.6 Refer to the hazard - hemolysis (after spiking samples with hemoglobin up to
statements "H" and the precautionary statements "P" 300 µmol/L (monomer) or 484 mg/dL),
above. - lipemia (after spiking samples with lipids up to 30 g/L
 Spills should be wiped up thoroughly after treatment equivalent in triglycerides),
with liquid detergent or a solution of household bleach - bilirubinemia (after spiking samples with bilirubin up to
containing at least 0.5% sodium hypochlorite. See the 510 µmol/L or 30 mg/dL).
User’s Manual for cleaning spills on or in the instrument. However, it is recommended not to use samples that are
Do not autoclave solutions containing bleach. clearly hemolyzed, lipemic or icteric, and if possible to
 The instrument should be regularly cleaned and collect a new sample.
decontaminated (see the User’s Manual).
With urine
STORAGE CONDITIONS None of the following factors have been found to
significantly influence this assay:
 Store the VIDAS Cortisol S kit at 2-8°C. - presence of glucose (after spiking urines with glucose:
 Do not freeze reagents. up to 55 mmol/L or 990 mg/dL),
 Store all unused reagents at 2-8°C. - proteinuria (after spiking urines with human albumin: up
 After opening the kit, check that the SPR pouch is to 5 g/L),
correctly sealed and undamaged. If not, do not use the - hemoglobinuria (after spiking urines with hemoglobin: up
SPRs. to 300 µmol/L (monomer) or 484 mg/dL),
 Carefully reseal the pouch with the desiccant inside - creatinuria (after spiking urines with creatinine: up to
after use to maintain stability of the SPRs and return 265 mmol/L),
the complete kit to 2-8°C. - presence of sodium chloride (after spiking urines with
 If stored according to the recommended conditions, all NaCl: up to 750 mmol/L),
the components are stable until the expiration date - presence of urea (after spiking urines with urea: up to
indicated on the label. 830 mmol/L).

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INSTRUCTION FOR USE Assay procedure

For complete instructions, see the User’s Manual. 1. Remove the required reagents from the
Reading VIDAS® Protocole Test Change (PTC) refrigerator.
protocol data and MLE data 2. Use one "CORS" strip and one "CORS" SPR for each
When using the assay for the first time: sample, control or calibrator to be tested. Make sure
With the external instrument barcode reader, the storage pouch has been carefully resealed
1. Scan the PTC barcode(s) at the end of the package after the required SPRs have been removed.
insert. or downloadable from 3. The test is identified by the "CORS" code on the
[Link]/techlib. This reading allows VIDAS® instrument. The calibrator must be identified by "S1",
PTC protocol data to be transferred to the instrument and tested in triplicate. If the control needs to be
software for its update. tested, it should be identified by "C1".
2. Scan the MLE data on the box label.
Note: If the MLE data have been read before the 4. Mix the calibrator, control and samples (serum,
VIDAS® PTC protocol, read the MLE data again. plasma, extracted urine) using a vortex-type mixer.
When opening a new lot of reagents: 5. For this test, the calibrator, control, and sample
Enter the specifications (or factory master data) into the test portion is 100 µL.
instrument using the master lot entry (MLE) data. 6. Insert the "CORS" SPRs and "CORS" strips into the
If this operation is not performed before initiating the tests, instrument. Check to make sure the color labels with
the instrument will not be able to print results. the assay code on the SPRs and the Reagent Strips
Note: the master lot data need only be entered once match.
for each lot. 7. Initiate the assay immediately. All the assay steps
It is possible to enter MLE data manually or are performed automatically by the instrument.
automatically depending on the instrument (refer to the
User’s Manual). 8. Reclose the vials and return them to 2–8°C after
pipetting.
Calibration
9. The assay will be completed within approximately
Calibration, using the calibrator provided in the kit, must 40 minutes. After the assay is completed, remove the
be performed each time a new lot of reagents is opened, SPRs and strips from the instrument.
after the master lot data have been entered. Calibration
should then be performed every 14 days. This operation 10. Dispose of the used SPRs and strips into an
provides instrument-specific calibration curves and appropriate recipient.
compensates for possible minor variations in assay signal
throughout the shelf-life of the kit (see User’s Manual). RESULTS AND INTERPRETATION
The calibrator, identified by S1, must be tested in Once the assay is completed, results are analyzed
triplicate. The calibrator value must be within the set RFV automatically by the computer. Fluorescence is measured
"Relative Fluorescence Value" range. If this is not the twice in the Reagent Strip’s reading cuvette for each
case, recalibrate. sample tested. The first reading is a background reading
Procedure of the substrate cuvette before the SPR is introduced into
the substrate. The second reading is taken after
Urine extraction procedure incubating the substrate with the enzyme remaining on
24-hour urine testing is performed following extraction of the interior of the SPR. The RFV (Relative Fluorescence
cortisol by the dichloromethane. This urine extraction step Value) is calculated by subtracting the background
eliminates certain interferences linked with the urine reading from the final result. This calculation appears on
matrice. the result sheet.
Proceed as follows: The results are automatically calculated by the instrument
using calibration curves which are stored by the
1. Prepare the required number of polypropylene (or instrument (4-parameter logistic model); the
polyethylene) tubes in the racks. concentrations are expressed in ng/mL.
2. For each 24-hour old urine sample, homogenize and The VIDAS Cortisol S assay is calibrated against the ID-
dispense 1 mL of the sample into each tube. GCMS reference method (Isotope Dilution - Gas
3. Add 1 mL of dichloromethane to each tube after Chromatography Mass Spectrometry) (7).
having saturated the pipette tip with dichloromethane. Samples with concentrations greater than 650 ng/mL
4. Shake for 20 to 30 seconds using a vortex-type should be retested after dilution by 1/3 (1 volume of
mixer. sample + 2 volumes of "Serum free" (ref. 66 581)).
5. When the two phases have separated, aspirate the Multiply the result by the dilution factor to obtain the
aqueous phase. sample concentration.
To calculate the quantity of cortisol in urine in µg per
6. Carefully collect 150 µL of the organic layer
24 hours:
(dichloromethane) using a saturated tip and place in a
pre-marked glass tube. µg/24h = ng/mL x mL of urine / 24 hours
7. Evaporate using a stream of air or nitrogen. 1000
8. Dissolve each dry extract in 150 µL of "Serum free" Interpretation of test results should be made taking into
(ref. 66 581) and leave to incubate for 30 minutes at consideration the patient’s history, and the results of any
room temperature. Shake immediately on a vortex- other tests performed.
type mixer, and again before performing the assay.
9. Then apply the assay procedure given below.

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QUALITY CONTROL RANGE OF EXPECTED VALUES

A control is included in each VIDAS Cortisol S kit. These figures are given as a guide; it is recommended
This control must be performed immediately after opening that each laboratory establishes its own expected values
a new kit to ensure that reagent performance has not from a rigorously selected population.
been altered. Each calibration must also be checked
Conversion factor
using this control. The instrument will only be able to
check the control value if it is identified by C1. nmol/L x 0.362 = ng/mL
Results cannot be validated if the control value deviates ng/mL (µg/L) x 2.76 = nmol/L
from the expected values.
Plasma or serum concentration
The urine extraction procedure must be validated by
testing an in-house or a commercially available control Cortisol levels follow a circadian rhythm, and it is therefore
with a known concentration. important to take into account the time of sample
collection (4).
Note A study was performed using serum samples collected in
It is the responsibility of the user to perform Quality Control the morning and the afternoon from healthy male (n=118)
in accordance with any local applicable regulations. and female (n=121) subjects. The expected values,
LIMITATIONS OF THE METHOD defined by the 95% confidence interval limits for results
obtained with VIDAS Cortisol S on the population studied,
Levels of cortisol, which are artificially high owing to the are:
cross reactivity of polyclonal anti-cortisol antibodies used - morning (8-10 a.m.) on 118 healthy subjects:
in the test, may be obtained for patients treated with 54.94 – 287.56 ng/mL.
prednisolone or prednisone or for patients undergoing a - afternoon (4-7 p.m.) on 121 healthy subjects:
metopirone test which generates an increase in 24.61 – 171.52 ng/mL.
11-deoxycortisol.
Interference may be encountered with certain sera Urine concentration
containing antibodies directed against reagent The expected values, defined by the 95% confidence
components. VIDAS Cortisol S assay results should be interval limits for results obtained with VIDAS Cortisol S
interpreted as part of a complete clinical evaluation. using 58 24-hour urine samples collected from healthy
male (n=28) and female (n=30) subjects, are:
9.66 – 120.63 µg / 24 hours.

PERFORMANCE
Studies performed using VIDAS Cortisol S gave the following results:
Measurement range
The measurement values of the VIDAS Cortisol S kit range from 2 to 650 ng/mL.
Detection limit
The analytical detection limit, defined as the smallest concentration of serum cortisol which is significantly different from
the zero concentration with a probability of 95 %, is 2 ng/mL.
The functional detection limit, defined as the measured concentration of serum cortisol with a 20% inter-lot variation
coefficient, is obtained at 5.15 ng/mL.
Precision
Five serum samples and five extracted urine samples were tested in duplicate in 10 different runs (2 runs per day) with
2 reagent lots on two instruments (N=80).
The repeatability (intra-run precision), inter-run reproducibility (inter-run precision) and the inter-lot reproducibility (total
precision = intra-run, inter-run, inter-day, inter-instrument, inter-lot) were calculated using this protocol, based on the
recommendations of NCCLS document EP5-A2:
Intra-run precision Inter-run precision Total precision
Sample Mean Standard CV (%) Standard CV (%) Standard CV (%)
concentration deviation deviation deviation
ng/mL
Serum 1 20.09 1.41 7.02 1.41 7.02 2.61 12.98
Serum 2 39.37 2.95 7.50 2.95 7.50 3.69 9.38
Serum 3 125.68 7.04 5.60 8.16 6.49 9.33 7.42
Serum 4 332.27 27.40 8.25 31.77 9.56 33.30 10.02
Serum 5 517.64 34.03 6,57 37.91 7.32 42.21 8.15
Urine 1 17.65 1.32 7.48 1.47 8.33 2.79 15.81
Urine 2 49.27 3.11 6.32 3.11 6.32 3.96 8.03
Urine 3 96.30 5.72 5.94 6.36 6.60 7.17 7.45
Urine 4 221.92 16.85 7.59 17.04 7.68 17.35 7.82
Urine 5 530.85 41.67 7.85 41.67 7.85 43.97 8.28

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Specificity
During the study performed, the 50% displacement, in Tested compounds Cross-reactivity %
comparison with the zero standard, was calculated using
dose-response curves for the tested components and the Prednisolone 30
calibration curve for cortisol. The following results were 11-Deoxycortisol 8.7
obtained: Cortisone 4.2
Prednisone 2
6-methyl prednisolone 1.8
Corticosterone 1.4
21-deoxycortisol 1.2
11-deoxycorticosterone 0.33
17-hydroxyprogesterone 0.18
Dexamethasone <0.1
Tetrahydrocortisol <0.1
Tetrahydrocortisone <0.1
Progesterone <0.1
Testosterone <0.1

Accuracy
3 samples were diluted in "Serum free" (ref. 66 581) and tested singly in 3 runs. The ratio of the mean concentration
measured over the expected concentration is expressed as a mean recovery percentage.

Samples Dilution factor Mean measured Mean expected Mean recovery

concentration concentration percentage (%)
(ng/mL) (ng/mL)
pur 154.92 154.92 100.0
3/4 116.86 116.19 100.6
1 2/3 102.08 103.28 98.8
1/2 68.96 77.46 89.0
1/3 41.59 51.64 80.5
pur 291.23 291.23 100.0
3/4 220.77 218.43 101.1
2 2/3 191.67 194.16 98.7
1/2 127.73 145.62 87.7
1/3 83.32 97.08 85.8
pur 570.43 570.43 100.0
3/4 432.91 427.83 101.2
3 2/3 382.08 380.29 100.5
1/2 297.55 285.22 104.3
1/3 186.39 190.14 98.0

Comparison with the ID-GCMS reference method

®
64 serum samples, including the European Reference Material ERM -DA451/IFCC panel, were tested using
VIDAS Cortisol S and the ID-GCMS reference method (X). The comparison between the two methods was analyzed
using the coefficient of correlation and the Passing & Bablok method:
Coefficient of correlation: r = 0.99
VIDAS Cortisol S = 0.976X + 1.154
Comparison with another test method
 210 serum samples, spread over the measuring range, were tested in parallel using VIDAS Cortisol S and another
commercially available kit (X). The comparison between the two methods was analyzed using the coefficient of
correlation and the Passing & Bablok method:
Coefficient of correlation: r = 0.95
VIDAS Cortisol S = 0.877X + 7.308
 110 urine samples, ranging between 4.63 and 409.18 ng/mL, were tested in parallel using VIDAS Cortisol S with an
extraction step, and another commercially available kit (X) without an extraction step. The comparison between the
two methods was analyzed using the coefficient of correlation and the Passing & Bablok method:
Coefficient of correlation: r = 0.78
VIDAS Cortisol S = 0.456X – 1.457

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WASTE DISPOSAL
INDEX OF SYMBOLS
Dispose of used or unused reagents as well as any
other contaminated disposable materials following  Symbol Meaning
procedures for infectious or potentially infectious
products. Catalog number
It is the responsibility of each laboratory to handle
waste and effluents produced according to their nature In Vitro Diagnostic Medical Device
and degree of hazardousness and to treat and dispose
of them (or have them treated and disposed of) in Manufacturer
accordance with any applicable regulations.

LITERATURE REFERENCES Temperature limit

1. PESCOVITZ O. H., CUTLER G. B., LORIAUX D. L. -
Synthesis and secretion of corticosteroids. Principles and
Practice of Endocrinology and Metabolism, Becker K. L. - Use by date
Ed. LIPPINCOTT J. B., 1990, - Chapitre 74, 579-591.
2. FRASER R. Biosynthesis of adrenocortical steroids. In: Batch code
VHT Jones (Eds), Adrenal gland, series: Comprehensive
endocrinology, 2nd edition, New York: Raven Press, 1992, Consult Instructions for Use
117-130.
3. METAIS P., AGNERAY J., FERARD G., FRUCHART J.C.,
Contains sufficient for <n> tests
JARDILLIER J.C., REVOL A., SIEST G., STAHL A. (Eds).
In : Biochimie clinique, Tome 3, Paris : SIMEP, 1988 - 436-
487. Date of manufacture
4. SELMAOUI B., TOUITOU Y. Reproducibility of the
circadian rhythms of serum cortisol and melatonin in
healthy subjects: a study of three different 24-h cycles over WARRANTY
six weeks. LIFE SCIENCES 2003 ; 73: 3339-3349.
5. ODAGIRI E., DEMURA R., DEMURA H., SUDA T.,
ISHIWATARI N., ABE Y., JIBIKI K., SHIZUME K. - The BIOMÉRIEUX DISCLAIMS ALL WARRANTIES,
changes in plasma cortisol and urinary free control by an EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
overnight dexamethasone suppression test in patients with WARRANTIES OF MERCHANTABILITY AND
Cushing's disease. Endocrinol. Jpn., 1988 ; 35: 795-802. FITNESS FOR A PARTICULAR USE. BIOMÉRIEUX
6. SHAPIRO M., SHENKMAN L. Variable hormonogenesis in SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR
Cushing's syndrome. Q J Med., 1991, New series 79, CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL
(288), 351-363. BIOMERIEUX’S LIABLITY TO CUSTOMER UNDER
7. THIENPONT L et al. Development, validation and ANY CLAIM EXCEED A REFUND OF THE AMOUNT
certification by isotope dilution-gas chromatography-mass PAID TO BIOMERIEUX FOR THE PRODUCT OR
spectrometry of lyophilized human serum reference SERVICE WHICH IS THE SUBJECT
materials for cortisol (CRM 192 and 193) and
progesterone (CRM 347 and 348). Clin Chem
1991;37:540-6.

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REVISION HISTORY
Change type categories :
N/A Not applicable (First publication)
Correction Correction of documentation anomalies
Technical change Addition, revision and/or removal of information related to the product
Administrative Implementation of non-technical changes noticeable to the user
Note: Minor typographical, grammar, and formatting changes are not included in the
revision history.

Release
Part Number Change Type Change Summary
date
INDEX OF SYMBOLS
Administrative REVISION HISTORY
2015/01 13414F CONTENT OF THE KIT (60 TESTS)
Technical WARNINGS AND PRECAUTIONS
INSTRUCTIONS FOR USE

BIOMERIEUX, the blue logo, SPR and VIDAS are used, pending and/or registered trademarks belonging to bioMérieux, or one of its
subsidiaries, or one of its companies.
Any other name or trademark is the property of its respective owner.

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