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

• 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