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(*) availability of safety sheets for the reagents containing dangerous substances

ACE - Fluid Mono ( Angiotensine – Converting – Enzyme )
Quantitative Photometric Test

Order Information
Catalogue No.
Package size

• Serum and Heparin-Plasma
(EDTA plasma cannot be used!)
ANALYTICAL PROCEDURE
ACE is a halide activated membrane bound Exopeptidase that has a central role in the control of blood pressure. ACE catalyses the conversion of Angiotensin I to the powerful vasoconstrictor Angiotensin II and also inactivates circulating Bradykinin. ACE is present in the vascular beds of most organs, however, the highest levels are found in the endothelial cells of pulmonary Let reagent reach working temperature before use
capillaries. ACE is considered to be the principal source of the Pipette into test tubes or cuvettes
The presence (I) or absence (D) of a 287 base pair fragment on the gene for ACE gives rise to three ACE genotypes, II, DD and ID. Since the discovery of the I/D polymorphism, further studies have shown that serum ACE activity is influenced by genotype. DD individuals have nearly twice the ACE activity of II individuals, with values from ID individuals being intermediate. The measurement of serum ACE is widely used to aid in the Mix well and incubate for 5 minutes at 37°C. differential diagnosis of clinically active pulmonary Sarcoidosis and Read the absorbance of calibrator (Acal1) and sample (As1). for monitoring the effectiveness of steroid therapy. ACE Exactly after another 5 minutes at 37°C read again calibrator measurement is also becoming widely used for monitoring the effects of ACE inhibitors in the treatment of hypertension and heart Determine difference of absorbance for sample and calibrator: PRINCIPLE
The mti-diagnostics ACE reagent is based on the method first described by Holmquist et al. In this method the direct substrate N- [3-(2-furyl)-acryloyl] – L-phenylalanylglyclglycine CALCULATION
(FAPGG) is hydrolysed to FAP and Glycylglycine as Results are calculated, usually automatically by the instrument. The hydrolysis of FAPPG by ACE results in a decrease in REFERENCE VALUES
37°C 30°C
Reagent Composition:
1. Dilute samples with activity higher than 150 U/L with saline solution 1+3 ; repeat determination and multiply result by 4. 2. Attention to interferring substances: see references 2. 3. Avoid the use of anticoagulants containing fluorides and EDTA. CALIBRATION
* FAPGG = furylacryloylphenylalanylglycylglycine Calibration is required. any ACE calibrator is recommended. For calibration frequency on automated instruments refer to the instrument manufacturer’s specifications. However, calibration Stability:
The reagents, stored at 2-8°C, are stable up to the expiry date
stability is contingent upon optimum instrument performance and the use of reagents which have been stored as recommended in the stability and storage section of this package insert. Note: Please store the reagent light protected
Recalibration is recommended at anytime if one of the following Additional Reagents – not included in the kit:

- ACE CALIBRATOR 
• Preventative maintenance is performed or a critical component is - ACE NORMAL CONTROL  - ACE ELEVATED CONTROL  • Control values have shifted or are out of range and a new vial of Preparation of working reagent :
LINEARITY

STABILITY: Up to 5 weeks stored at 2-8°C if not contamined
ACE may be determined between 3 - 150 U/L. For concentrations ≥ 150 U/L, dilute the sample 1+3 with saline Close immediately after handling.
sol., repeat the determination and multiply the result x 4. mti-diagnostics GmbH ,Limburger Str. 45, D-65510 Idstein , ++49(0)6126-9595 262  ++49(0)6126-9595 264 C E
WEB : www.mti-diagnostics.de eMail : mti@mti-diagnostics.de ACE - Fluid Mono ( Angiotensine – Converting – Enzyme )
Comparison studies were carried out using a similar commercially QUALITY CONTROL
available reagent as a reference. Serum samples were assayed in To ensure adequate quality control, normal and elevated control parallel and the results compared by least squares regression. The • At least once per day or as established by the laboratory. • When a new bottle of reagent is used. • After preventative maintenance is performed or a critical • With every calibration. Control results falling outside the upper or lower limits of the established ranges indicate the assay may be out of control. The following corrective actions are recommended • Repeat the same controls. • If repeated control results are outside the limits, prepare fresh MEASURING RANGE
• If results are still out of control, recalibrate with fresh calibrator, When run as recommended the assay is linear between 1 and 120 • If results are still out of control, perform a calibration with fresh ANALYTICAL SENSITIVITY
When run as recommended the sensitivity of this assay is 0.084 • If results are still out of control, contact Technical Services or ΔmA/min per U/L (1cm light path, 340 nm). LITERATURE
1. Muller BR. Ann Clin. Biochem 2002;39:436-43
LIMITATIONS
2. Studdy PR and Bird R. Ann Clin. Biochem 1989;26:13-18 Studies to determine the level of interference from haemoglobin, 3. Beneteau B et al. Clin. Chem 1986;32:884-6 bilirubin and Lipemia were carried out. The following results were 4. Butter J and Stuart S. Clin. Chem 1993;39:312-6 5. Maguire GA and Price CP Ann Clin. Biochem 1985;22:204-10 Haemoglobin: No interference haemoglobin up to 725 mg/dL.
6. Young DS, Effects of Drugs on Clinical Laboratory Tests. Third Free Bilirubin: No interference from free bilirubin up to 222 µmol/L
7. Wachtel M et al, Creation and Verification of Reference Conjugated Bilirubin: No interference from conjugated bilirubin up
Intervals. Laboratory Medicine 1995; 26:593-7. 8. National Committee for Clinical Laboratory Standards. User Lipemia: No interference from Lipemia, measured as triglycerides,
evaluation of Precision Performance of Clinical Chemistry Devices. NCCLS, 1984, NCCLS Publication EP5-T. For a more comprehensive review of factors affecting ACE assays 9. Recommendations of the Working Group on Preanalytical Quality of the German Society for Clinical Chemistry and the ACE inhibitors, such as Captopril and Teprotides will inhibit serum German Society for Laboratory Medicine. The Quality of Diagnostic Samples. 1st Edition 2001:16.
EXPECTED VALUES


The quoted values should serve as a guide only. It is recommended
that each laboratory verify this range or derive a reference interval
for the population it serves.
PERFORMANCE DATA
The following data was obtained using the mti-diagnostics ACE
Liquid Stable Reagent on a well maintained automated clinical
chemistry analyser. Users should establish product performance on
their specific analyser used.
IMPRECISION
Imprecision was evaluated over a period of 20 days using two levels
of commercial control and following the NCCLS EP5-T procedure.


METHOD COMPARISON

mti-diagnostics GmbH ,Limburger Str. 45, D-65510 Idstein , ++49(0)6126-9595 262  ++49(0)6126-9595 264 C E
WEB : www.mti-diagnostics.de eMail : mti@mti-diagnostics.de

Source: http://www.mti-diagnostics.de/downloads/Bulkware_AV/B-AV-ACE-Adenos.engl.pdf

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