ALLERGEN Total IgE REF - Radim S.p.A.

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SUBS│TMB SOLN│STOP BUF│WASH│10X Substrate HS: one vial (13 ml) of a stabilized mixture of TMB (3,3' 5,5' Tetramethylbenzidine) and H2O2 (Hydrogen Peroxide). Ready to use. Stop Solution: one vial (13 ml) of 0.3 M sulphuric acid. Ready to use. Wash Buffer 10X: one vial (100 ml) of a washing solution, concentrated 10X, with Amphoteric.B 2.5 µg/ml. Prepare the working solution by mixing the content of the vial with 900 ml of distilled water. 5.0 STORAGE AND STABILITY AFTER INITIAL OPENING During the shipment and in final storage, store all the components of the kit at 2...8°C, according to kit labels and shipping documents. The expiry date is printed on the external label. All the reagents of the kit are stable, after the first opening, up to the expiration date reported on the label when properly stored at 2…8°C and for 2 weeks at room temperature (18…25°C). 6.0 MATERIAL AND EQUIPMENT REQUIRED BUT NON PROVIDED Warning: the user should check the compliance with assay requirements of all the materials and equipments which are used in conjunction with the kit. Additionally, the efficiency of equipments should be periodically controlled, according to GLP and to Standard Operating Procedures (SOP). • 25 and 100 µl micropipettes • automatic plate washer • high quality distilled water • microtiter plate reader equipped for the measurement of the absorbance at 450 and 405 nm (reference filter at 620 nm), adsorbent pad or paper. 7.0 WARNING AND PRECAUTIONS 7.1 SAFETY PRECAUTIONS • All the reagents in this kit are for in vitro diagnostic use only. • It is recommended that only experienced laboratory personnel should use this test, and handle it in accordance with these IFUs and the GLPs. • Operators must wear gloves and protective clothing when using patient sera or serum-based products. • The human blood products supplied as components of this kit have been obtained from donors who were tested individually and found to be negative for the presence of Human Immunodeficiency Virus Antibodies (HIV-Ab) as well as for Hepatitis B surface Antigen (HBsAg) and Hepatitis C antibodies (HCV-Ab) using reliable methods. Since no test method can offer complete assurance that Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) or other infectious agents are absent, all human blood products should be considered potentially infectious. Handling should be in accordance with the procedures defined by an appropriate national biohazard safety guide-line or regulation, where it exists, (i.e. USA Center for Disease Control/National Institutes of Health Manual “Biosafety in Microbiological and Biomedical Laboratories”, 1984). • Calibrators contain equine serum; this serum has been obtained from safe animals but, because no test method can offer complete assurance that infectious agents are absent, it is recommended that serum-containing products be handled with precautions. • Reagents of this kit contain antimicrobial agents and the TMB Substrate solution contains tetramethylbenzidine. Avoid contact with the skin and eyes. Rinse immediately with plenty of water if any contact occurs. • The Stop Solution contains 0.3M sulphuric acid. Avoid contact with skin and eyes. Rinse immediately with plenty of water if contact occurs. • Do not pipette by mouth. A1002 – ALLERGEN Total IgE M541 – Rev. 1 – 06/2010 – Pag. 12/32
• Do not smoke, eat or apply cosmetics in areas in which specimens or kit reagents are handled. • Avoid microbial contamination of reagents during pipetting by using disposable pipette tips. • Any liquid that has been brought into contact with potentially infectious material has to be discarded in a container with a disinfectant. Disposal must be performed in accordance with local legislation. 7.2 TECHNICAL PRECAUTIONS 1. Correct use of reagents and proper pipetting • The kit has to be strictly employed for the intended use. • Do not use reagents beyond their expiration dates. Strips and solution should not be used if the foil bag is damaged or liquids have leaked. • The TMB/H2O2 single solution is colourless or very slightly blue. On ageing the substrate becomes slightly yellow-orange but this does NOT affect its performances. If accidental contamination occurs, the solution starts to develop a blue colour and must therefore be discarded. The TMB/H2O2 single solution is not sensitive to light. Direct sunlight can however oxidize the solution to a blue colour. Such a colour disappears after 4 hours storage in the dark after which the solution can again be used. • Use only disposable tips. • Ensure that no cross-contamination occurs between wells. Keep all pipettes and any other equipment used for conjugate completely separate from the Substrate HS reagent. • When pipetting Conjugate or Substrate HS, aliquot for the required numbers of wells should be taken to avoid multiple entry of pipette tips into the reagent bottles. Never pour unused reagents back into the original bottles. 2. Adherence to assay procedure and specifications • The obtained values have to be always compared to the ones reported in QC sheet. Do not use the kit to determine values outside the range indicated in the IFU. • The test protocol must be followed strictly. Observe the indicated incubation times and temperature and the washing procedure, these are critical steps. • Include the positive and negative controls in every test run to monitor for reagent stability and correct assay performance. Please refer also to section 10.5 Quality Control. 8.0 SPECIMEN COLLECTION AND STORAGE • Either serum or plasma can be used with this diagnostic kit. EDTA, heparin and Sodium Citrate are suitable as anti-coagulants. However, samples to be tested not only for Total IgE but also for Specific IgE should not contain heparin since this anticoagulant may lead to underestimation of Specific IgE values. • Whole blood specimens should be separated from red blood cells and plasma or serum as soon as possible in order to avoid haemolysis. Also clots must be removed. • Patient samples should be obtained by non-traumatic venipuncture using a vacuum tube or sterile syringe. The usual precautions in the collection of venipuncture samples should be observed. If a syringe is used, the blood should be transferred immediately to a vacuum tube (plain redtop or serum separator). • Serum and plasma samples can be stored overnight at 2...8°C. For long-term storage, they should be frozen below -20°C. • Avoid repetitive freezing and thawing. A1002 – ALLERGEN Total IgE M541 – Rev. 1 – 06/2010 – Pag. 13/32
Page 1 and 2: ALLERGEN Total IgE REF A1002 Italia
Page 3 and 4: DOSAGGIO IMMUNOENZIMATICO PER LA DE
Page 5 and 6: • La Soluzione bloccante contiene
Page 7 and 8: Si raccomanda di fare attenzione al
Page 9 and 10: 13.0 CARATTERISTICHE DEL DOSAGGIO 1
Page 11: ENZYME IMMUNOASSAY FOR QUANTITATIVE
Page 15 and 16: 10.0 CALCULATIONS OF RESULTS 10.1 O
Page 17 and 18: 13.2 SENSITIVITY The sensitivity li
Page 19 and 20: ENZYMIMMUNOASSAY ZUM QUANTITATIVEN
Page 21 and 22: • Die Reagenzien dieses Kits enth
Page 23 and 24: • DIE INKUBATIONSTEMPERATUR Die I
Page 25 and 26: 13.0 TESTCHARAKTERISTIKA 13.1 PRÄZ
Page 27 and 28: SIMBOLI, SYMBOLS, SYMBOLES, SÍMBOL
Page 29 and 30: BIBLIOGRAFIA / BIBLIOGRAPHY/LITERAT
Page 31 and 32: A1002 - ALLERGEN Total IgE M541 - R

ALLERGEN Total IgE REF - Radim S.p.A.

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