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Deslv4188 estradiol free in saliva 120215 m

Estradiol free in
Saliva ELISA

DEM-DESLV4188
Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188
Contents / Inhaltsverzeichnis


1
PRINCIPLE OF THE TEST .3 WARNINGS AND PRECAUTIONS .3 SPECIMEN COLLECTION AND PREPARATION .6 ASSAY PROCEDURE .7 EXPECTED NORMAL VALUES .8 QUALITY CONTROL .8 PERFORMANCE CHARACTERISTICS .9 LIMITATIONS OF USE . 12 LEGAL ASPECTS . 13 REFERENCES / LITERATURE . 13 SYMBOLS USED WITH DEMEDITEC ELISAS . 21 Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188 1 INTRODUCTION
Intended Use
Enzyme immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva. Results may be used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy. Summary and Explanation
Estradiol (1,3,5(10)-estratriene-3,17β-diol; 17β-estradiol; E21) is a C18 steroid hormone with a phenolic A ring. This steroid hormone has a molecular weight of 272.4. It is the most potent natural Estrogen, produced mainly by the Graffian fol icle of the female ovary and the placenta, and in smal er amounts by the adrenals, and the male testes (1-3) Estradiol (E2) is secreted into the blood stream where 98% of it circulates bound to sex hormone binding globulin (SHBG) and to a lesser extent to other serum proteins such as albumin. Only a smal fraction circulates as free hormone or in the conjugated form (4,5). Estrogenic activity is effected via estradiol-receptor complexes which trigger the appropriate response at the nuclear level in the target sites. These sites include the fol icles, uterus, breast, vagine, urethra, hypothalamus, pituitary and to a lesser extent the liver and skin. In non-pregnant women with normal menstrual cycles, estradiol secretion follows a cyclic, biphasic pattern with the highest concentration found immediately prior to ovulation (6,7). The rising estradiol concentration is understood to exert a positive feedback influence at the level of the pituitary where it influences the secretion of the gonadotropins, follicle stimulating hormone (FSH), and luteinizing hormone (LH), which are essential for fol icular maturation and ovulation, respectively (8). Fol owing ovulation, estradiol levels fall rapidly until the luteal cel s become active resulting in a secondary gentle rise and plateau of estradiol in the luteal phase. During pregnancy, maternal serum Estradiol levels increase considerably, to wel above the pre-ovulatory peak levels and high levels are sustained throughout pregnancy (9). 2 PRINCIPLE OF THE TEST
The Demeditec Salivary Estradiol ELISA kit is based on the competition principle and the microplate
separation.
An unknown amount of Estradiol present in the sample and a fixed amount of Estradiol conjugated with
horse-radish peroxidase compete for the binding sites of a polyclonal Estradiol antiserum coated onto the
wells.
After two hours incubation the microtiter plate is washed to stop the competition reaction. Having added the
substrate solution the concentration of Estradiol is inversely proportional to the optical density measured.
3 WARNINGS AND PRECAUTIONS
1. This kit is for in vitro diagnostic use only. For professional use only.
2. All reagents of this test kit which contain human serum or plasma have been tested and confirmed
negative for HIV I/II, HBsAg and HCV by FDA approved procedures. Al reagents, however, should be treated as potential biohazards in use and for disposal. 3. Before starting the assay, read the instructions completely and carefully. Use the valid version of the package insert provided with the kit. Be sure that everything is understood. 4. The microplate contains snap-off strips. Unused wells must be stored at 2 °C to 8 °C in the sealed foil pouch and used in the frame provided. 5. Pipetting of samples and reagents must be done as quickly as possible and in the same sequence for 6. Use reservoirs only for single reagents. This especially applies to the substrate reservoirs. Using a reservoir for dispensing a substrate solution that had previously been used for the conjugate solution may turn solution colored. Do not pour reagents back into vials as reagent contamination may occur. 7. Mix the contents of the microplate wells thoroughly to ensure good test results. Do not reuse microwells. 8. Do not let wel s dry during assay; add reagents immediately after completing the rinsing steps. 9. Allow the reagents to reach room temperature (21-26°C) before starting the test. Temperature will affect the absorbance readings of the assay. However, values for the patient samples will not be affected. 10. Never pipet by mouth and avoid contact of reagents and specimens with skin and mucous membranes. 11. Do not smoke, eat, drink or apply cosmetics in areas where specimens or kit reagents are handled. 12. Wear disposable latex gloves when handling specimens and reagents. Microbial contamination of reagents or specimens may give false results. Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188 13. Handling should be done in accordance with the procedures defined by an appropriate national biohazard safety guideline or regulation. 14. Do not use reagents beyond expiry date as shown on the kit labels. 15. All indicated volumes have to be performed according to the protocol. Optimal test results are only obtained when using calibrated pipettes and microtiterplate readers. 16. Do not mix or use components from kits with different lot numbers. It is advised not to exchange wel s of different plates even of the same lot. The kits may have been shipped or stored under different conditions and the binding characteristics of the plates may result slightly different. 17. Avoid contact with Stop Solution containing 0.5 M H2SO4. It may cause skin irritation and burns. 18. Some reagents contain Proclin, BND and MIT as preservatives. In case of contact with eyes or skin, flush immediately with water. 19. TMB substrate has an irritant effect on skin and mucosa. In case of possible contact, wash eyes with an abundant volume of water and skin with soap and abundant water. Wash contaminated objects before reusing them. If inhaled, take the person to open air. 20. Chemicals and prepared or used reagents have to be treated as hazardous waste according to the national biohazard safety guideline or regulation. 21. For information on hazardous substances included in the kit please refer to Material Safety Data Sheets. Material Safety Data Sheets for this product are available upon request directly from DEMEDITEC. 4 REAGENTS
Reagents provided
1. Microtiterwells, 12x8 (break apart) strips, 96 wells;
Wel s coated with a anti-Estradiol antibody (polyclonal). 2. Standard (Standard 0-5), 6 vials, 1 mL each, ready to use;
Concentration: 0.0; 1, 5, 10, 50, 100 pg/mL * contain 0.03% Proclin 300, 0.015% BND and 0.010% MIT as preservative. 3. Control Low & High, 2 vials, 1.0 mL each, ready to use;
Control values and ranges please refer to vial label or QC-Datasheet. * contain 0.03% Proclin 300, 0.015% BND and 0.010% MIT as preservative. 4. Enzyme Conjugate, 1 vial, 26 mL, ready to use;
Estradiol conjugated to horseradish peroxidase; * contains 0.03% Proclin 300, 0.015% BND and 0.010% MIT as preservative. 5. Substrate Solution, 1 vial, 25 mL, ready to use;
Tetramethylbenzidine (TMB). 6. Stop Solution, 1 vial, 14 mL, ready to use;
contains 1 N acidic solution. Avoid contact with the stop solution. It may cause skin irritations and burns. 7. Wash Solution, 1 vial, 30 mL; Concentrate for 1200 mL.
= 5-bromo-5-nitro-1,3-dioxane = 2-methyl-2H-isothiazol-3-one
Note: Additional Standard 0 for sample dilution is available upon request.
Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188 Material required but not provided
− Calibrated EIA reader adjusted to read at 450 nm − Calibrated variable precision micropipettes (100 µL and 200 µL) − Distil ed or Deionized water − 0.9% NaCl solution − Timer (60 min. range) − Reservoirs (disposable) − Test tube or microtube rack in a microplate configuration − Semi-logarithmic graph paper or software for data reduction Storage Conditions
When stored at 2 °C to 8 °C unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date. Opened reagents must be stored at 2 °C to 8 °C. Microtiter wells must be stored at 2 °C to 8 °C. Once the foil bag has been opened, care should be taken to close it tightly again. Opened kits retain activity for two month if stored as described above. Reagent Preparation
Bring al reagents to room temperature before use.
Wash Solution
Add deionized water to the 40X concentrated Wash Solution.
Dilute 30 mL of concentrated Wash Solution with 1170 mL deionized water to a final volume of 1200 mL.
The diluted Wash Solution is stable for 2 weeks at room temperature.
Disposal of the Kit
The disposal of the kit must be made according to the national regulations. Special information for this product is given in the Material Safety Data Sheet. Damaged Test Kits
In case of any severe damage to the test kit or components, DEMEDITEC has to be informed in writing, at the latest, one week after receiving the kit. Severely damaged single components should not be used for a test run. They have to be stored until a final solution has been found. After this, they should be disposed according to the official regulations. Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188 5 SPECIMEN COLLECTION AND PREPARATION
Samples containing sodium azide should not be used in the assay. The saliva samples should be completely
colorless. Even the slightest red color shows blood contamination. Such blood contamination wil give falsely
elevated concentration values. In case of visible blood contamination the patient should discard the sample,
rinse the sampling device with tap water, also rinse the mouth with (preferably) cold water, wait for 10
minutes and take a new sample. Do not chew anything during the sampling period. Any pressure on the
teeth may result in falsely elevated measurements due to an elevated content of gingival liquid in the saliva
sample.
Specimen Collection
For the correct col ection of saliva we are recommending to only use appropriate devices made from ultra-pure polypropylene. Do not use any PE devices or Salivettes for sampling; this in most cases wil result in significant interferences. Glass tubes can be used as well, but in this case special attention is necessary for excluding any interference caused by the stopper. Please contact Demeditec Diagnostics for more details. As food might contain significant amounts of steroid hormones samples preferably should be taken while fasting. If fasting should be a problem at least any food of animal origin (meat or dairy products) should be avoided prior to finalizing the collection. In the morning breakfast should be done only after finalizing the col ection procedure. During the day the col ection period should be timed just before an anticipated meal. As the steroid hormone secretion in saliva as well in serum shows an obvious dynamic secretion pattern throughout the day it is important to always collect 5 samples during a 2 hour period; this means every 30 minutes one sample. If possible the volume of each single sample should be a minimum of 0.5 ml (better 1 ml). Saliva flow may be stimulated by drinking water. This is al owed and even recommended before and during the collection period. Drinking of water is not al owed during the last 5 minutes before taking the single samples. The typical timing for a morning col ection period would be as follows. Wake-up at 6:00 AM, drinking water and brushing teeth, 1st sample at 6:15 AM, followed by samples at 6:45 AM, 7:15 AM, 7:45 AM, and 8:15 AM, followed by breakfast at 8:25 AM. The typical timing for an afternoon col ection period would be like: 1st sample at 5:00 PM, fol owed by samples at 5:30 PM, 6:00 PM, 6:30 PM, 7:00 PM, followed by dinner at 7:10 PM. Modest variation in the collection timing will not be critical, and the col ection time-frame can be extended up to 3 hours. Specimen Storage and Preparation
Saliva samples in general are stable at ambient temperature for several days. Therefore mailing of such samples by ordinary mail without cooling will not create a problem. Storage at 4°C can be done for a period of up to one week. Whenever possible samples preferable should be kept at a temperature of -20°C. Even repeated thawing and freezing is no problem. Each sample has to be frozen, thawed, and centrifuged at least once anyhow in order to separate the mucins by centrifugation. Upon arrival of the samples in the lab the samples have to stay in the deep freeze at least overnight. Next morning the frozen samples are warmed up to room temperature and mixed careful y. Then the samples have to be centrifuged for 5 to 10 minutes. Now the clear colorless supernatant is easy to pipette. If the sample should show even a slight reddish tinge it should be discarded. Otherwise the concentration value most probably will be falsely elevated. Due to the episodic variations of the steroid secretion we highly recommend the strategy of multiple sampling. If such a set of multiple samples has to be tested the lab (after at least one freezing, thawing, and centrifugation cycle) has to mix the aliquots of the 5 single samples in a separate sampling device and perform the testing from this mixture. Specimen Dilution
If in an initial assay, a specimen is found to contain more than the highest standard, the specimens can be diluted with 0.9 % NaCl and re-assayed as described in Assay Procedure. For the calculation of the concentrations this dilution factor has to be taken into account. Example: a) Dilution 1:10: 10 µL saliva + 90 µL 0.9 % NaCl (mix thoroughly) b) Dilution 1:100: 10 µL of dilution a + 90 µL 0.9 % NaCl (mix thoroughly). Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188 6 ASSAY PROCEDURE
General Remarks
− All reagents and specimens must be allowed to come to room temperature before use. Al reagents must be mixed without foaming. − Once the test has been started, al steps should be completed without interruption. − Use new disposal plastic pipette tips for each standard, control or sample in order to avoid cross − Absorbance is a function of the incubation time and temperature. Before starting the assay, it is recommended that al reagents are ready, caps removed, al needed wel s secured in holder, etc. This wil ensure equal elapsed time for each pipetting step without interruption. − As a general rule the enzymatic reaction is linearly proportional to time and temperature. Test Procedure
Each run must include a standard curve.
All standards, samples, and controls should be run in duplicate. All standards, samples, and controls should
be run concurrently so that al conditions of testing are the same.
1. Secure the desired number of Microtiter wel s in the holder.
2. Dispense 100 µL of each Standard, Control and samples with new disposable tips into appropriate
3. Incubate for 30 minutes at room temperature
4. Dispense 200 µL of Enzyme Conjugate into each sample and standard well
Mix the plate thoroughly for 10 seconds. It is important to have a complete mixing in this step. 5. Incubate for 120 minutes at room temperature.
6. Briskly shake out the contents of the wells.
Rinse the wells 3 times with diluted Wash Solution (400 µL per wel ). Strike the wel s sharply on
absorbent paper to remove residual droplets.
Important note: The sensitivity and precision of this assay is markedly influenced by the correct
performance of the washing procedure!
7. Add 200 µL of Substrate Solution to each well.
8. Incubate for 30 minutes at room temperature.
9. Stop the enzymatic reaction by adding 100 µL of Stop Solution to each well.
10. Determine the absorbance (OD) of each well at 450±10 nm with a microtiter plate reader.
It is recommended that the wells be read within 10 minutes after adding the Stop Solution.
Calculation of Results
1. Calculate the average absorbance values for each set of standards, controls and patient samples. 2. Using semi-logarithmic graph paper, construct a standard curve by plotting the mean absorbance obtained from each standard against its concentration with absorbance value on the vertical (Y) axis and concentration on the horizontal (X) axis. 3. Using the mean absorbance value for each sample, determine the corresponding concentration from the 4. Automated method: The results in the IFU have been calculated automatical y using a 4 PL (4 Parameter Logistics) curve fit. 4 Parameter Logistics is the preferred method. Other data reduction functions may give slightly different results. 5. The concentration of the samples can be read directly from this standard curve. Samples with concentrations higher than that of the highest standard have to be further diluted or reported as > 100 pg/mL. For the calculation of the concentrations this dilution factor has to be taken into account. Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188
6.3.1 Example of Typical Standard Curve
The fol owing data is for demonstration only and cannot be used in place of data generations at the time of
assay.
Standard
Absorbance Units
Standard 0 (0 pg/mL) Standard 1 (1 pg/mL) Standard 2 (5 pg/mL) Standard 3 (10 pg/mL) Standard 4 (50 pg/mL) Standard 5 (100 pg/mL) 7 EXPECTED NORMAL VALUES
In order to determine the normal range of SLV Estradiol, saliva samples from152 adult male and 186 female
apparently healthy subjects, ages 21 to 75 years, were col ected in the morning and analyzed using the
Demeditec SLV Estradiol ELISA kit. The fol owing ranges were calculated from this study.
Age group
Salivary Estradiol [pg/mL]
Fol icular phase: n = 48 Mid cycle: n = 40 Luteal phase: n = 58 Postmenopausal: n = 40 Therapy should not be decided based on results alone. The results should be correlated to other clinical observations and diagnostic tests. Salivary Estradiol values show a clear circadian rhythm. We therefore recommend the saliva samples be obtained the same hour each day. Furthermore, we recommend that each laboratory establish its own range for the population tested, because the values differ between age, new born, children, adolescents and adults. 8 QUALITY CONTROL
Good laboratory practice requires that controls be run with each calibration curve. A statistical y significant
number of controls should be assayed to establish mean values and acceptable ranges to assure proper
performance.
It is recommended to use control samples according to state and federal regulations. The use of control
samples is advised to assure the day to day validity of results. Use controls at both normal and pathological
levels.
The controls and the corresponding results of the QC-Laboratory are stated in the QC certificate added to
the kit. The values and ranges stated on the QC sheet always refer to the current kit lot and should be used
for direct comparison of the results.
It is also recommended to make use of national or international Quality Assessment programs in order to
ensure the accuracy of the results.
Employ appropriate statistical methods for analysing control values and trends. If the results of the assay do
not fit to the established acceptable ranges of control materials patient results should be considered invalid.
In this case, please check the fol owing technical areas: Pipetting and timing devices; photometer, expiration
dates of reagents, storage and incubation conditions, aspiration and washing methods.
After checking the above mentioned items without finding any error contact your distributor or Demeditec
directly.
Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188 9 PERFORMANCE CHARACTERISTICS
Assay Dynamic Range
The range of the assay is between 0.8 – 93 pg/mL. Specificity
The fol owing materials have been evaluated for cross reactivity. The percentage indicates cross reactivity at 50% displacement compared to Estradiol. Cross reaction [%]
Estradiol Estadiol-3-sulfate Estradiol-3-glucoronide Estriol-16-glucoronide Estrone-3-sulfate Dehydroepiandrosterone 11-Desoxycortisol 11-Desoxycorticosterone 21-Desoxycortisol Dihydrotestosterone Dihydroepiandrosterone 20-Dihydroprogesterone 11-Hydroxyprogesterone 17 alpha-Hydroxyprogesterone 17 alpha-Pregnenolone 17 alpha Progesterone Sensitivity
The lowest detectable level of Estradiol that can be distinguished from the Zero Standard is 0.4 pg/mL at the 95 % confidence limit. Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188 9.4.1 Intra Assay
The intra-assay variation was determined by 20 replicate measurements of 4 saliva samples using
Demeditec ELISA kit.
The within assay variability is shown below: Mean (pg/mL)
SD (pg/mL)
9.4.2 Inter Assay
The inter-assay (between-run) variation was determined by duplicate measurements of five saliva samples
over 10 different days runs.
The between assay variability is shown below: Mean (pg/mL)
SD (pg/mL)
9.4.3 Inter-Lot
The Inter-Lot (between-lot) variation was determined by triplicate measurements of five saliva samples in
three different kit lots.
The between lot variability is shown below:
Mean (pg/mL)
SD (pg/mL)
Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188 Recovery
Recovery of the Demeditec ELISA was determined by adding increasing amounts of the analyte to three different saliva samples containing different amounts of endogenous analyte. Each sample (non-spiked and spiked) was assayed and analyte concentrations of the samples were calculated from the standard curve. The percentage recoveries were determined by comparing expected and measured values of the samples. Endogenous Added
Measured OD Measured Conc. Expected Conc. Recovery
Estradiol
Estradiol Mean of duplicate
Linearity
Four samples (saliva) containing different amounts of analyte were serial y diluted up to 1:128 with 0.9% NaCl and assayed with the Demeditec ELISA. The percentage recovery was calculated by comparing the expected and measured values for SLV estradiol. An assay linearity of 0.8 – 93 pg/mL has been identified as the usable range. Samples above this range must be diluted and re-run. Concentration (pg/mL) Average % recovery Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188 Comparison Studies
A study was performed to compare the Demeditec Salivary Estradiol test to a commercial y available test using saliva samples from 230 men and women 20 to 70 years. The samples were run in duplicate on the Demeditec test and another commercial y available LIA method to determine the concentration of Estradiol in the samples. A correlation of r = 0.9951 was obtained versus this method with a regression formula shown below. Demeditec Estradiol correlation
y = 0,8512x + 0,0774
10 LIMITATIONS OF USE
Reliable and reproducible results will be obtained when the assay procedure is performed with a complete
understanding of the package insert instruction and with adherence to good laboratory practice.
Any improper handling of samples or modification of this test might influence the results.
The patient should not eat, drink, chew gum or brush teeth for 30 minutes before sampling. Otherwise rinse mouth thoroughly with cold water 5 min prior to sample col ection. Do not collect samples when oral diseases, inflammation or lesions exist (blood contamination). 10.1 Interfering Substances
Blood contamination of more than 0.16% in saliva samples will affect results, and usually can be seen by
eye. Therefore, samples containing any visible blood should not be used.
Concentrations of Sodium Azide ≥ 0.02% interferes in this assay and may lead to false results. 10.2 High-Dose-Hook Effect
No hook effect was observed in this test.
Version 08-09/11 / DMC Updated 120215 Demeditec Estradiol free in Saliva ELISA DESLV4188 11 LEGAL ASPECTS
Only for countries where the declaration of European Conformity (CE mark) is applicable.
11.1 Reliability of Results
The test must be performed exactly as per the manufacturer's instructions for use. Moreover the user must
strictly adhere to the rules of GLP (Good Laboratory Practice) or other applicable national standards and/or
laws. This is especial y relevant for the use of control reagents. It is important to always include, within the
test procedure, a sufficient number of controls for validating the accuracy and precision of the test.
The test results are valid only if all controls are within the specified ranges and if al other test parameters are
also within the given assay specifications. In case of any doubt or concern please contact DEMEDITEC.
11.2 Therapeutic Consequences
Therapeutic consequences should never be based on laboratory results alone even if al test results are in
agreement with the items as stated under point 11.1. Any laboratory result is only a part of the total clinical
picture of a patient.
Only in cases where the laboratory results are in acceptable agreement with the overall clinical picture of the
patient should therapeutic consequences be derived.
The test result itself should never be the sole determinant for deriving any therapeutic consequences.
11.3 Liability
Any modification of the test kit and/or exchange or mixture of any components of different lots from one test
kit to another could negatively affect the intended results and validity of the overal test. Such modification
and/or exchanges invalidate any claim for replacement.
Claims submitted due to customer misinterpretation of laboratory results subject to point 11.2. are also
invalid. Regardless, in the event of any claim, the manufacturer's liability is not to exceed the value of the
test kit. Any damage caused to the test kit during transportation is not subject to the liability of the
manufacturer.
12 REFERENCES / LITERATURE
1. Tsang B.K., et al. (1980) Steroid biosyntheses by isolated human ovarian follicular cel s in vitro,
J. Clin. Endocrinol. Metab. 51, 1407 – 11 2. Gore-Langton R. E. et al. (1988): Follicular steroidogenesis and its control. In: The physiology of Reproduction. ED.: Knobil et al. pp.331-385, Raven press, New York 3. Hall, P.F. (1988): Steroid synthesis: Organization and Regulation. In: The Physiology of Reproduction. Ed.: Knobil et al., pp 975 – 988, Raven press, New York 4. Siiteri P.K. et al. (1982): The serum transport of steroid hormones. Rec. Progr. Horm. Res. 38, 457 – 510 5. Martin B. et al. (1981): Binding of steroids by proteins in fol icular fluid of the human ovary. J. Clin. Endocrinol. Metab. 35, 443 – 447 6. Baird D.T. (1976): Ovarian steroid secretion and metabolism in women. In: The Endocrine function of the human ovary. Eds.: James V.H.T., Serio M. and Guisti G., pp. 125 – 33, Academic press, New York 7. McNtty K.P. et al. (1976): Concentration of estrogens and androgens in human ovarian venous plasma and follicular fluid throughout the menstrual cycle. J. Endocrinol. 71, 77 –85 8. March C.M. et al. (1979): Roles of estradiol and progesterone in eliciting mid-cycle luteinizing hormone and follicle stimulating hormone surges. J. Clin. Endocrinol. Metab. 49, 507 – 12 9. Simpson E.R. and McDonald P.C. (1981): Endocrinology of pregnancy. In: Textbook of Endocrinology, Ed.: Wil iams R.H. pp. 412 – 22, Saunders Company, Philadelphia Version 08-09/11 / DMC Updated 120215

Demeditec Estradiol free in Saliva ELISA DESLV4188 SYMBOLS USED WITH DEMEDITEC ELISAS

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Conforme aux normes European Conformity Conformidad europea Conformità europea Consult instructions for Gebrauchsanweisung Consultare le istruzioni instructions d'utilisation Instrucciones In vitro diagnostic Usage Diagnostic Para uso Diagnóstico Per uso Diagnostica in In-vitro-Diagnostikum Seulement dans le Sólo para uso en For research use only Solo a scopo di ricerca Forschungszwecke cadre de recherches Catalogue number Número de catálogo Lot. No. / Batch code Contains sufficient for Ausreichend für "n" Contenu suffisant pour Contenido suficiente Contenuto sufficiente <n> tests/ para <n> ensayos Storage Temperature Lagerungstemperatur Date limite d'utilisation Fecha de caducidad Data di scadenza Legal Manufacturer Distributed by Volume/No. Volume/Quantità Microtiterwells Plaques de micro- Placas multipocil o Antiserum Substrate Substrate Solution Solution substrat Solución de sustrato Soluzione di substrato Solution Stop Solution Solution d'arrêt Solución de parada Soluzione d´ arresto Zero Standard Assay Buffer Tampón de ensayo Tampone del test Wash Solution Solution de lavage Solución de lavado Soluzione di lavaggio 1N NaOH (idrossido di Sample Diluent Solution pour dilution Solución para dilución Diluente dei campioni de l'échantil on Conjugate Solution pour dilution Solución para dilución Conjugate Diluent Diluente del tracciante Version 08-09/11 / DMC Updated 120215

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