Instructions for Use Noradrenalin elisa
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Instructions for Use Noradrenalin ELISA Manual and automated enzyme immunoassay for the in-vitro-diagnostic quantitative determination of noradrenalin (norepinephrine) in human plasma and urine. RE59261 96 2-8°C I B L I N T E R N A T I O N A L G M B H Flughafenstrasse 52a Phone: +49 (0)40-53 28 91-0 IBL@IBL-International.com D-22335 Hamburg, Germany Fax: +49 (0)40-53 28 91-11 www.IBL-International.com Noradrenalin ELISA (RE59261) ENGLISH
Version 2014-12 1 / 9
Manual and automated enzyme immunoassay for the in-vitro diagnostic quantitative determination of noradrenalin (norepinephrine) in human plasma and urine.
The catecholamines adrenalin, noradrenalin and dopamine are synthesized in the adrenal medulla, the sympathetic nervous system and in the brain. They influence virtually all tissues and are involved together with other hormonal and neuronal systems in the regulation of a wide variety of physiological processes. As catecholamines and their metabolites metanephrine and normetanephrine are secreted in increasing amounts in a number of diseases, they may be used for diagnostic purposes. In this context, diagnosis and the follow-up of tumor diseases of the nervous system are of special importance. This applies primarily to the pheochromocytoma, but also the neuroblastoma and the ganglioneuroma. Because of the extraction step at the beginning of the assay, the customer is able to use all kinds of animal species material. It works for rats, mice and others. The chemical structure of the catecholamines is identical in all animals. 3. TEST PRINCIPLE Solid phase enzyme-linked immunosorbent assay (ELISA) based on the sandwich principle. The wells are coated with a goat anti rabbit antibody. The added liquid antibody, directed towards an epitope of an antigen molecule binds to the plate within the incubation time. The antigen of the sample is incubated in the coated well with enzyme conjugated second antibody (E-Ab), directed towards a different region of the antigen molecule. After the substrate reaction the intensity of the developed color is proportional to the amount of the antigen. Results of samples can be determined directly using the standard curve.
1. For in-vitro diagnostic use only. For professional use only. 2. 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. 3. In case of severe damage of the kit package please contact IBL or your supplier in written form, latest one week after receiving the kit. Do not use damaged components in test runs, but keep safe for complaint related issues. 4. Obey lot number and expiry date. Do not mix reagents of different lots. Do not use expired reagents. 5. Follow good laboratory practice and safety guidelines. Wear lab coats, disposable latex gloves and protective glasses where necessary. 6. Reagents of this kit containing hazardous material may cause eye and skin irritations. See MATERIALS SUPPLIED and labels for details. Material Safety Data Sheets for this product are available on the IBL- Homepage or upon request directly from IBL. 7. Chemicals and prepared or used reagents have to be treated as hazardous waste according to national biohazard and safety guidelines or regulations. 8. The cleaning staff should be guided by the professionals regarding potential hazards and handling. 9. Avoid contact with Stop solution. It may cause skin irritations and burns. 10. All reagents of this kit containing human serum or plasma have been tested and were found negative for anti-HIV I/II, HBsAg and anti-HCV. However, a presence of these or other infectious agents cannot be excluded absolutely and therefore reagents should be treated as potential biohazards in use and for disposal.
The kit is shipped at ambient temperature and should be stored at 2-8 °C. Keep away from heat or direct sun light. The storage and stability of specimen and prepared reagents is stated in the corresponding chapters. The microtiter strips are stable up to the expiry date of the kit in the broken, but tightly closed bag when stored at 2–8 °C. Noradrenalin ELISA (RE59261) ENGLISH
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The in-vivo catecholamine and metanephrines release is influenced by several foods and drugs. Vitamin B, coffee and bananas, alpha-methyldopa, MAO and COMT inhibitors as well as medications related to hypertension should be discontinued for at least 72 h prior to specimen collection.
The blood sample should be stored at 2-8°C until centrifuged to separate the plasma within 2 h after blood collection. The usual precautions for venipuncture should be observed. It is important to preserve the chemical integrity of a blood specimen from the moment it is collected until it is assayed. Do not use grossly hemolytic, icteric or grossly lipemic specimens. Samples appearing turbid should be centrifuged before testing to remove any particulate material. Storage: 2-8°C ≤ -20°C (Aliquots) Keep away from heat or direct sun light. Avoid repeated freeze-thaw cycles. Ship samples frozen. Stability: 6 hours 1 month
Urine It is possible to use spontaneous as well as 24 h urine. The total volume of urine excreted during a 24 h period should be collected and mixed in a single bottle containing 10-15 mL of 6 N HCl as preservative. Determine total volume for calculation of results. Mix and centrifuge samples before use in the assay. Storage: ≤ -20°C (Aliquots) Keep away from heat or direct sun light. Avoid repeated freeze-thaw cycles. Stability: 6 months 7. MATERIALS SUPPLIED
The reagents provided with this kit are sufficient for up to 48 single determinations in the extraction procedure (6 standards, 2 controls, 40 patient samples) and up to 48 duplicates in the ELISA for each adrenalin and noradrenalin in plasma and urine. Additional reagents are available upon request.
Symbol Component 1 x 12x8 MTP Microtiter Plate Break apart strips. Coated with anti-rabbit IgG (goat, polyclonal).
1 x 6 x 2.5 mL CAL A-F Standard A-F Adrenalin: 0; 1.5; 5.0; 15; 50; 150 ng/mL (0; 8; 27; 82; 273; 819 nmol/L) Noradrenalin: 0; 5.0; 15; 50; 150; 500 ng/mL (0; 30; 89; 296; 887; 2955 nmol/L) Dopamine: 0; 60; 180; 585; 2300; 11470 ng/mL (0; 392; 1175; 3819; 15014; 74876 nmol/L) Ready to use. Contains: [-] Adrenalin, [-] Noradrenalin, [-] Dopamine (biologically active), and 0.1 M HCl.
1 x 2 x 2.5 mL CONTROL 1+2 Control 1+2 Ready to use. Contains: [-] Adrenalin, [-] Noradrenalin, [-] Dopamine (biologically active), 0.1 M HCl. Exact concentrations see vial labels or QC certficate.
1 x 400 µL ENZCONJ CONC Enzyme Conjugate Concentrate (50x) Contains: streptavidin alkaline phosphatase, Tris buffer, HCl, 0.01 % NaN 3 . 2 x EXTRPLATE Extraction Plate (Macrotiter Plate) 24 wells each. Coated with boronate affinity gel. 1 x 60 mL
Pink colored. Ready to use. Contains: 0.016 % NaN 3 .
2 x 1.25 mL COMT LYO COMT lyophilized Contains: Catechol-O-methyltransferase (porcine liver), NaN 3 .
COENZ Coenzyme Solution Ready to use. Contains: S-Adenosyl-L-Methionine, stabilizers.
1 x 3 mL ENZBUF Enzyme Buffer Ready to use. Contains: Tris buffer, HCl, stabilizers.
2 x 13 mL RELEASEBUF Release Buffer Yellow Colored. Ready to use. Contains: 0.1 M HCl, indicator.
1 x 3 mL ACYLREAG Acylation Reagent Ready to use. Contains: dimethylformamide, Ethanol. Caution! Toxic. Highly flammable.
1 x 100 mL WASHBUF CONC Wash Buffer Concentrate (10x) Contains: Tris buffer, HCl, Tween, 0.2 % NaN 3 . Noradrenalin ELISA (RE59261) ENGLISH
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1 x 2 mL COMT ADD COMT Additive Contains: human plasma, stabilizers, 0.01 % Thimerosal. 1 x 8.0 mL ANTISERUM NAD Noradrenalin Antiserum Blue colored. Ready to use. Contains: antibodies against Noradrenalin (rabbit), Buffer, stabilizers.
1 x 25 mL PNPP SUBS PNPP Substrate Solution Ready to use. Contains: p-nitrophenyl phosphate (PNPP).
1 x 15 mL PNPP STOP PNPP Stop Solution Ready to use. Contains: 1 M NaOH, 0.25 M EDTA.
3 x
FOIL Adhesive Foil
MATERIALS REQUIRED BUT NOT SUPPLIED 1. Micropipettes (Multipette Eppendorf or similar devices, < 3 % CV). Volume: 10; 10-100; 100-1000 µL 2. Orbital shaker (200-900 rpm) (e.g. EAS 2/4, SLT) 3. Vortex mixer 4. 8-Channel Micropipettor with reagent reservoirs 5. Wash bottle, automated or semi-automated microtiter plate washing system 6. Microtiter plate reader capable of reading absorbance at 405 nm (reference wavelength 600-650 nm) 7. Bidistilled or deionised water 8. Paper towels, pipette tips and timer 9. Disposable tubes for sample dilution 10. 0.1 M HCl, for sample dilution (Urine)
1. Any improper handling of samples or modification of the test procedure may influence the results. The indicated pipetting volumes, incubation times, temperatures and pretreatment steps have to be performed strictly according to the instructions. Use calibrated pipettes and devices only. 2. Once the test has been started, all steps should be completed without interruption. Make sure that required reagents, materials and devices are prepared ready at the appropriate time. Allow all reagents and specimens to reach room temperature (18-25 °C) and gently swirl each vial of liquid reagent and sample before use. Mix reagents without foaming. 3. Avoid contamination of reagents, pipettes and wells/tubes. Use new disposable plastic pipette tips for each component and specimen. Do not interchange caps. Always cap not used vials. Do not reuse wells/tubes or reagents. 4. Some components contain ≤ 250 µL solution. Take care that the solution is completely on the bottom of the vial before opening. 5. It is advised to determine samples in duplicate to be able to identify potential pipetting errors. 6. Use a pipetting scheme to verify an appropriate plate layout. A pipetting scheme covering both sample pretreatment and assay is available at the IBL-Homepage. 7. Incubation time affects results. All wells should be handled in the same order and time sequences. It is recommended to use an 8-channel Micropipettor for pipetting of solutions in all wells. 8. Microplate washing is important. Improperly washed wells will give erroneous results. It is recommended to use a multichannel pipette or an automatic microplate washing system. Do not allow the wells to dry between incubations. Do not scratch coated wells during rinsing and aspiration. Rinse and fill all reagents with care. While rinsing, check that all wells are filled evenly with Wash Buffer, and that there are no residues in the wells. 9. Humidity affects the coated wells/tubes. Do not open the pouch until it reaches room temperature. Unused wells/tubes should be returned immediately to the resealed pouch including the desiccant.
Noradrenalin ELISA (RE59261) ENGLISH
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The contents of the kit for 96 determinations can be divided into 2 separate runs.
This has no influence on test results.
equipment used as powder or as solutions, e.g. VIRKON ® must be avoided in any case. They will strongly disturb assay performance. VIRKON ® is a trademark of DuPont. 10.1.1. Dilution of Samples Samples suspected to contain concentrations above the highest standard have to be diluted as follows: Sample to be diluted with Remarks Plasma > highest standard bidist. water prior to extraction step Urine > highest standard 0.1 N HCl prior to extraction step 10.1.2. Extraction of Samples, Standards and Controls (Extraction Plate) (manual version) 1. Pipette 20 µL of each Standard, Control and urine sample and 500 µL of each plasma sample into the respective wells of the extraction plate. Add 500 µL of bidist. water to all wells except for the plasma samples to correct differences of volumes. 2. Pipette 1000 µL of Extraction Buffer into each well. 3. Cover plate with adhesive foil. Extract 30 min at RT (18-25°C) on an orbital shaker (600–900 rpm). During extraction the surface of the liquid should wet the adhesive foil, but the liquid level should not exceed 2/3 of the well. Splashing does not affect results.
Remove fluid completely. 8. Pipette 150 µL of Extraction Buffer into each well. To each well add 50 µL of Acylation Reagent. Mix immediately after pipetting. 9. Extract 20 min at RT (18-25°C) (without adhesive foil) on an orbital shaker (400–600 rpm). 10. Immediately empty plate and eliminate residual fluid on a paper towel. Remove fluid completely. 11. Pipette 2 mL of bidist. water into each well. 12. Cover plate with new adhesive foil. Shake 5 min at RT (18-25°C) on an orbital shaker (600–900 rpm). Splashing does not affect results. 13. Remove adhesive foil. Immediately empty plate and eliminate residual fluid on a paper towel. Remove fluid completely. 14. Pipette 300 µL of Release Buffer into each well. 15. Shake 30 min at RT (18-25°C) (without adhesive foil) on an orbital shaker (400–600 rpm). Prepared samples should be assayed the same day. If this is not possible, you can store the extraction plate covered with adhesive foil at 2-8°C over night.
The volumes stated below are for one run with 6 strips (48 determinations). Dilute / dissolve Component with Diluent Relation Remarks Storage Stability 25 mL
WASHBUF CONC 225 mL bidist. water 1:10 Mix vigorously. 2-8°C 4 weeks
120 µL ENZCONJ CONC 6 mL
WASHBUF
(diluted) 1:51 Prepare freshly and use only once. Mix without foaming. 18-25°C
5 hours Noradrenalin ELISA (RE59261) ENGLISH
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Dissolve each kit component of lyophilized COMT in 1.25 mL bidist. water and mix the dissolved COMT.* Then pipette 1.25 mL of Coenzyme Solution followed by 1.25 mL of Enzyme Buffer and 0.40 mL COMT
Use 1 vial for 48 determinations of noradrenalin. If measuring both adrenalin and noradrenalin, pool two (2) vials for 48 determinations of adrenalin and 48 determinations of noradrenalin. Solution may be turbid. Mix without foaming. * If only an aliquot of the COMT solution is needed, the rest of the COMT solution should be frozen immediately in aliquots at -20° C. The COMT solution is stable under these conditions for 1-2 months.
It is recommended to start with adrenalin if measuring both adrenalin and noradrenalin. If pipetting with positive displacement, give the residual fluid from the tip of the pipette back to the corresponding wells of the extraction plate, otherwise the extracts may not be sufficient for noradrenalin determination. It is useful to hold the extraction plate in a sloping position. Before use of the Microtiter plates, define and label the wells for Adrenalin and Noradrenalin.
Working with cell culture supernatants depends on the matrix as well as concentrations expected: According to the urine protocol (extraction of at least 20 µL supernatant) a sensitivity of 0.6 ng/mL can be expected. In case of a matrix with addition of serum (FCS), plasma protocol (extraction of 500 µL supernatant) can
be used
with the
sensitivities corresponding to the
plasma protocol (see 16. PERFORMANCE). For tissue homogenates no perchloric acid should be used for homogenization. For further details ask IBL. 10.2.2.2. Noradrenalin for urine and plasma 1. Pipette 25 µL of freshly prepared COMT Enzyme Solution into each well of the Microtiter Plate. Shake plate briefly. 2. Pipette 25 µL of each extracted Standard, Control and sample into the respective wells. During this step hold the pipette tips directly into the COMT solution. Color changes to pink. Shake plate briefly. 3. Pipette 50 µL of Noradrenalin Antiserum (blue colored) into each well. 4. Cover plate with adhesive foil. Incubate 120 min at RT (18-25°C) on an orbital shaker (400–600 rpm). 5. Remove adhesive foil. Discard incubation solution. Wash plate 4 x with 250-300 µL of diluted Wash Buffer. Remove excess solution by tapping the inverted plate on a paper towel. 6. Pipette 100 µL of freshly prepared Enzyme Conjugate into each well. 7. Cover plate with new adhesive foil. Incubate 60 min at RT (18-25°C) on an orbital shaker (400–600 rpm). 8. Remove adhesive foil. Discard incubation solution. Wash plate 4 x with 250-300 µL of diluted Wash Buffer. Remove excess solution by tapping the inverted plate on a paper towel. 9. For adding of Substrate and Stop Solution use, if available, an 8-channel Micropipettor. Pipetting should be carried out in the same time intervals for Substrate and Stop Solution. Use positive displacement and avoid formation of air bubbles.
contents by gently shaking the plate. 13. Measure optical density with a photometer at 405 nm (Reference-wavelength: 620-650 nm) within 60 min after pipetting of the Stop Solution. No air bubbles should be visible. Noradrenalin ELISA (RE59261) ENGLISH
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The contents of the kit for 96 determinations can be divided into 2 separate runs.
This has no influence on test results.
equipment used as powder or as solutions, e.g. VIRKON ® must be avoided in any case. They will strongly disturb assay performance. VIRKON ® is a trademark of DuPont. 11.1.1. Dilution of Samples Samples suspected to contain concentrations above the highest standard have to be diluted as follows: Sample to be diluted with Remarks Plasma > highest standard bidist. water prior to extraction step Urine > highest standard 0.1 N HCl prior to extraction step 11.1.2. Extraction of Samples, Standards and Controls (Extraction Plate) (automated version) 1. Pipette 30 µL of each Standard, Control and urine sample and 750 µL of each plasma sample into the respective wells of the extraction plate. Add 750 µL of bidist. water to all wells except for the plasma samples to correct differences of volumes. 2. Pipette 1000 µL of Extraction Buffer into each well. 3. Cover plate with adhesive foil. Extract 30 min at RT (18-25°C) on an orbital shaker (600-900 rpm). During extraction the surface of the liquid should wet the adhesive foil, but the liquid level should not exceed 2/3 of the well. Splashing does not affect results.
Remove fluid completely. 8. Pipette 150 µL of Extraction Buffer into each well. To each well add 50 µL of Acylation Reagent. Mix immediately after pipetting. 9. Extract 20 min at RT (18-25°C) (without adhesive foil) on an orbital shaker (400–600 rpm). 10. Immediately empty plate and eliminate residual fluid on a paper towel. Remove fluid completely. 11. Pipette 2 mL of bidist. water into each well. 12. Cover plate with new adhesive foil. Shake 5 min at RT (18-25°C) on an orbital shaker (600-900 rpm). Splashing does not affect results. 13. Remove adhesive foil. Immediately empty plate and eliminate residual fluid on a paper towel. Remove fluid completely. 14. Pipette 450 µL of Release Buffer into each well. 15. Shake 30 min at RT (18-25°C) (without adhesive foil) on an orbital shaker (400–600 rpm). Prepared samples should be assayed the same day. If this is not possible, you can store the extraction plate covered with adhesive foil at 2-8°C over night.
The volumes stated below are for one run with 6 strips (48 determinations). Dilute / dissolve Component with Diluent Relation Remarks Storage Stability 50 mL
WASHBUF CONC 450 mL bidist. water 1:10 Mix vigorously. 2-8°C 4 weeks
190 µL ENZCONJ CONC 9.5 mL
WASHBUF
(diluted) 1:51 Prepare freshly and use only once. Mix without foaming. 18-25°C
5 hours Noradrenalin ELISA (RE59261) ENGLISH
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Dissolve each kit component of lyophilized COMT in 1.25 mL bidist. water and mix the dissolved COMT.* Then pipette 1.25 mL of Coenzyme Solution followed by 1.25 mL of Enzyme Buffer and 0.40 mL COMT
Use 1 vial for 48 determinations of noradrenalin. If measuring both adrenalin and noradrenalin, pool two (2) vials for 48 determinations of adrenalin and 48 determinations of noradrenalin. Solution may be turbid. Mix without foaming. * If only an aliquot of the COMT solution is needed, the rest of the COMT solution should be frozen immediately in aliquots at -20° C. The COMT solution is stable under these conditions for 1-2 months.
Working with cell culture supernatants depends on the matrix as well as concentrations expected: According to the urine protocol (extraction of at least 20 µL supernatant) a sensitivity of 0.6 ng/mL can be expected. In case of a matrix with addition of serum (FCS), plasma protocol (extraction of 500 µL supernatant) can
be used
with the
sensitivities corresponding to the
plasma protocol (see 16. PERFORMANCE). For tissue homogenates no perchloric acid should be used for homogenization. For further details ask IBL. 11.2.1.2. Noradrenalin for urine and plasma 1. Pipette 25 µL of freshly prepared COMT Enzyme Solution into each well of the Microtiter Plate. Shake plate 1 min. 2. Pipette 25 µL of each extracted Standard, Control and sample into the respective wells. Shake plate 1 min. 3. Pipette 50 µL of Noradrenalin Antiserum (blue colored) into each well. 4. Cover plate. Incubate 120 min at RT (18-25°C) on an orbital shaker (400–600 rpm). 5. Discard incubation solution. Wash plate 6 x with 250-300 µL of diluted Wash Buffer. 6. Pipette 100 µL of Enzyme Conjugate into each well. 7. Cover plate. Incubate 60 min at RT (18-25°C) on an orbital shaker (400–600 rpm). 8. Discard incubation solution. Wash plate 6 x with 250-300 µL of diluted Wash Buffer. 9. Pipetting should be carried out in the same time intervals for Substrate and Stop Solution. 10. Pipette 200 µL of PNPP Substrate Solution into each well. 11. Incubate 40 min at RT (18-25°C) on an orbital shaker (400–600 rpm). If temperature in automat exceeds 25°C, shorten incubation time to 30 min to avoid signal overflow.
contents by gently shaking the plate.
The test results are only valid if the test has been performed following the instructions. Moreover the user must strictly adhere to the rules of GLP (Good Laboratory Practice) or comparable standards/laws. User and/or laboratory must have a validated system to get diagnosis according to GLP. All kit controls must be found within the acceptable ranges as stated on the labels and the QC certificate. If the criteria are not met, the run is not valid and should be repeated. Each laboratory should use known samples as further controls. It is recommended to participate at appropriate quality assessment trials. In case of any deviation the following technical issues should be proven: Expiration dates of (prepared) reagents, storage conditions, pipettes, devices, incubation conditions and washing methods.
Noradrenalin ELISA (RE59261) ENGLISH
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0.000
0.500 1.000
1.500 2.000
1 10 100 1000 (ng/L)
(OD) 13. CALCULATION OF RESULTS The obtained OD of the standards (y-axis, linear) are plotted against their concentration (x-axis, logarithmic) either on semi-logarithmic graph paper or using an automated method. A good fit is provided with cubic spline, 4 Parameter Logisitcs or Logit-Log. For the calculation of the standard curve, apply each signal of the standards. The concentration of the kit Controls and of the urine samples can be read directly from the corresponding standard curve. Due to the pipetting volume of 500 µL (automated version: 750 µL) for plasma in comparison to 20 µL (automated version: 30 µL) for the standards, the results for plasma samples have to be divided by 25. For units in pg/mL please multiply by 1000. In case of diluted samples the values have to be multiplied with the corresponding dilution factor. Samples showing concentrations above the highest standard have to be diluted as described in PRE-TEST SETUP INSTRUCTIONS and reassayed. Calculate the 24 h excretion for each urine sample: µg/24 h = µg/L x L/24 h Conversion: 1000 pg/mL = 1 ng/mL Noradrenalin (µg/L) x 5.911 = nmol/L
(Example. Do not use for calculation!) Standard Noradrenalin (ng/mL) OD Mean OD/OD
max
(%) A 0 0.223 0.0 B 5 0.322 6.7
C 15
0.539 21.3
D 50
0.984 51.2
E 150
1.438 81.8
F 500
1.708 100
14. EXPECTED VALUES The results themselves should not be the only reason for any therapeutical consequences. They have to be correlated to other clinical observations and diagnostic tests. Apparently healthy subjects show the following values: (5 % - 95 % percentile) It is recommended that each laboratory establishes its own range of normal values.
Urine Plasma
µg/d nmol/d
pg/mL nmol/L
Noradrenalin < 90 < 535 < 600 < 3.55 15. LIMITATIONS OF THE PROCEDURE Specimen collection has a significant effect on the test results. See SPECIMEN COLLECTION AND STORAGE for details. For cross-reactivities, see PERFORMANCE. The following blood components do not have a significant effect (+/-20% of expected) on the test results up to the below stated concentrations:
Hemoglobin 2.0 mg/mL Bilirubin 1.0 mg/mL Triglyceride 91 mg/mL
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Substance Noradrenalin Cross-reactivity of other substances tested < 0.02 % Adrenalin < 0.02 Noradrenalin 100 Metanephrine < 0.002 Normetanephrine < 0.005 Analytical Sensitivity (Limit of Detection) Urine
0.6 ng/mL Mean signal (Zero-Standard) + 2SD Plasma 20 pg/mL Precision
Range (ng/mL) CV (%)
Intra-Assay Urine 16 – 256 7.3 Plasma
0.560 – 12.83 7.4
Inter-Assay Urine
15.4 – 391.5 12.1
Plasma 0.569 – 1.945 12.5
Range (ng/mL) Serial dilution up to Range (%) Urine 5.1 - 423 1:32 85 – 115 Plasma 0.02 – 8.2 1:32 89 - 111 No High dose hook effect detected.
Mean (%) Range (%) % Recovery after spiking Urine 100.9
81 – 116 Plasma
97.5 83 – 111 Method Comparison versus HPLC IBL = 0.75 x HPLC + 4.8 r = 0.945; n = 134
1. Creces J., Appleton Ch.: Catecholamines and their Metabolites: Evaluation of a commercial ELISA. Clin. Biochem., QML Pathology, Brisbane QLD (2004) 2. Westermann J, Hubl W, Kaiser N, Salewski L, Simple, rapid and sensitive determination of epinephrine and norepinephrine in urine and plasma by non-competitive enzyme immunoassay, compared with HPLC method. Clin. Lab., 48: 61-71 (2002)
Symbols / Symbole / Symbôles / Símbolos / Símbolos / Σύµβολα
IBL International GmbH Flughafenstr. 52A, 22335 Hamburg, Germany Tel.: + 49 (0) 40 532891 -0 Fax: -11 E-MAIL: IBL@IBL-International.com WEB: http://www.IBL-International.com IBL International Corp. 194 Wildcat Road, Toronto, Ontario M3J 2N5, Canada Tel.: +1 (416) 645 -1703 Fax: -1704 E-MAIL: Sales@IBL-International.com WEB:
http://www.IBL-International.com LIABILITY: Complaints will be accepted in each mode –written or vocal. Preferred is that the complaint is accompanied with the test performance and results. Any modification of the test procedure or exchange or mixing of components of different lots could negatively affect the results. These cases invalidate any claim for replacement. 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 kit during transportation is not subject to the liability of the manufacturer
Symbols Version 3.5 / 2012-01-20 REF
Cat.-No.: / Kat.-Nr.: / No.- Cat.: / Cat.-No.: / N.º Cat.: / N.–Cat.: / Αριθµός-Κατ.: LOT
Lot-No.: / Chargen-Bez.: / No. Lot: / Lot-No.: / Lote N.º: / Lotto n.: / Αριθµός -Παραγωγή:
Use by: / Verwendbar bis: / Utiliser à: / Usado por: / Usar até: / Da utilizzare entro: / Χρησιµοποιείται από:
No. of Tests: / Kitgröße: / Nb. de Tests: / No. de Determ.: / N.º de Testes: / Quantità dei tests: / Αριθµός εξετάσεων: CONC Concentrate / Konzentrat / Concentré / Concentrar / Concentrado / Concentrato / Συµπύκνωµα LYO
Lyophilized / Lyophilisat / Lyophilisé / Liofilizado / Liofilizado / Liofilizzato / Λυοφιλιασµένο IVD
In Vitro Diagnostic Medical Device. / In-vitro-Diagnostikum. / Appareil Médical pour Diagnostics In Vitro. / Dispositivo Médico para Diagnóstico In Vitro. / Equipamento Médico de Diagnóstico In Vitro. / Dispositivo Medico Diagnostico In vitro. / Ιατρική συσκευή για In-Vitro ∆ιάγνωση. Evaluation kit. / Nur für Leistungsbewertungszwecke. / Kit pour évaluation. / Juego de Reactivos para Evaluació. / Kit de avaliação. / Kit di evaluazione. / Κιτ Αξιολόγησης.
Read instructions before use. / Arbeitsanleitung lesen. / Lire la fiche technique avant emploi. / Lea las instrucciones antes de usar. / Ler as instruções antes de usar. / Leggere le istruzioni prima dell’uso. / ∆ιαβάστε τις οδηγίες πριν την χρήση.
Keep away from heat or direct sun light. / Vor Hitze und direkter Sonneneinstrahlung schützen. / Garder à l’abri de la chaleur et de toute exposition lumineuse. / Manténgase alejado del calor o la luz solar directa. / Manter longe do calor ou luz solar directa. / Non esporre ai raggi solari. / Να φυλάσσεται µακριά από θερµότητα και άµεση επαφή µε το φως του ηλίου.
Store at: / Lagern bei: / Stocker à: / Almacene a: / Armazenar a: / Conservare a: / Αποθήκευση στους :
Manufacturer: / Hersteller: / Fabricant: / Productor: / Fabricante: / Fabbricante: / Παραγωγός:
Caution! / Vorsicht! / Attention! / ¡Precaución! / Cuidado! / Attenzione! / Προσοχή! Symbols of the kit components see MATERIALS SUPPLIED. Die Symbole der Komponenten sind im Kapitel KOMPONENTEN DES KITS beschrieben. Voir MATERIEL FOURNI pour les symbôles des composants du kit. Símbolos de los componentes del juego de reactivos, vea MATERIALES SUMINISTRADOS. Para símbolos dos componentes do kit ver MATERIAIS FORNECIDOS. Per i simboli dei componenti del kit si veda COMPONENTI DEL KIT. Για τα σύµβολα των συστατικών του κιτ συµβουλευτείτε το ΠΑΡΕΧΟΜΕΝΑ ΥΛΙΚΑ. Yüklə 145,17 Kb. Dostları ilə paylaş:
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