英文：Serum amyloid A protein. WHO International Standard
描述：1. INTENDED USE
Calibrant for serum amyloid A assays
This preparation is not for administration to humans or animals in
the human food chain.
This preparation contains material of human origin. It has been tested and
found negative for HBsAg and anti-HIV. The preparation gave a
positive antibody test and a positive PCR test for HCV RNA. As with
all materials of biological origin, this preparation should be regarded as
potentially hazardous to health. It should be used and discarded
according to your own laboratory's safety procedures. Such safety
procedures should include the wearing of protective gloves and
avoiding the generation of aerosols. Care should be exercised in
opening ampoules or vials, to avoid cuts.
0.15 International Units (IU) per ampoule.
Country of origin of biological material: United Kingdom.
Each ampoule contains the residue after freeze-drying of 1.0ml of a
solution that contained:
156mg/L of purified SAA in normal human serum.
The material has not been sterilised and contains no bacteriostat.
Unopened ampoules should be stored at –20ºC
Please note: because of the inherent stability of lyophilized
material, NIBSC may ship these materials at ambient temperature.
6. DIRECTIONS FOR OPENING
Tap the ampoule gently to collect the material at the bottom (labelled)
end. Ensure ampoule is scored all round at the narrow part of the
neck, with a diamond or tungsten carbide tipped glass knife file or
other suitable implement before attempting to open. Place the
ampoule in the ampoule opener, positioning the score at position 'A';
shown in the diagram below. Surround the ampoule with cloth or
layers of tissue paper. Grip the ampoule and holder in the hand and
squeeze at point 'B'. The ampoule will snap open. Take care to avoid
cuts and projectile glass fragments that enter eyes. Take care that no
material is lost from the ampoule and that no glass falls into the
Side view of ampoule opening device containing an ampoule
positioned ready to open. 'A' is the score mark and 'B' the point of
7. USE OF MATERIAL
No attempt should be made to weigh out any portion of the
materialFor all practical purposes each ampoule contains the same amount of the
same materials. Dissolve the total contents in a known amount of distilled
water and make further dilutions in a suitable buffer solution with carrier
protein (free of peptidase), where extensive dilution is required, to minimise
loss by surface adsorption.
No attempt should be made to weigh out any portion of the freeze-dried
For economy of use it is recommended that the solution be subdivided into
several small containers, which are frozen rapidly to below –40°C and then
stored below –40°C in the dark. Repeated freeze thawing should be
Suitable precautions should be taken in the use and disposal of the ampoule
and its contents.
NIBSC follows the policy of WHO with respect to its reference materials.
It is the policy of WHO not to assign an expiry date to their international
reference materials. They remain valid with the assigned potency and
status until withdrawn or amended. Reference materials are held at
NIBSC within assured, temperature-controlled storage facilities.
Reference Materials should be stored on receipt as indicated on the
label. In addition, once reconstituted, diluted or aliquoted, users should
determine the stability of the material according to their own method of
preparation, storage and use. Users who have data supporting any
deterioration in the characteristics of any reference preparation are
encouraged to contact NIBSC.
Preparation described in: Wilkins, J., Gallimore, J.R., Tennent, G.A.,
Hawkins, P.N., Limburg, P.C., van Rijswijk, M.H., Moore, E.G., and Pepys,
M.B. (1984) Rapid automated enzyme immunoassay of serum amyloid A.
Clin. Chem. 40:1284-1290.
The SAA contained in this ampoule was provided by Professor M B Pepys,
Immunological Medicine Unit, Department of Medicine, Royal Postgraduate
Medical School, Hammersmith Hospital, Du Cane Road, London W12 ONN.