| Kit Size |
Product Description: |
| 1 x 5 ml |
NC 05 |
| 4 x 5 ml |
NC 20 |
CHARACTERSTICS
Bovine multi sera are lyophillised control sera based on bovine
serum. Multi sera can be supplied as an assayed serum for control
accuracy or as precision serum for control of reproducibility. Constituent
concentration are in the low, normal and elevated ranges.
ASSAYED CONTROL SERUM
Each batch of assayed serum is submitted to approximately 1200
laboratories and the values are assigned from a consensus mean.
With each batch a control range is provided for individual parameters
and each parameter method and when available a value for automated
analysers. The control range is equivalent to the assigned mean
+ 2 S.D.
PRECISION CONTROL SERUM
Each batch of precision control serum is submitted to selected
laboratories and values are assigned from a consensus of results
obtained by these laboratories
PREPARATION
Multi sera is sealed under vacuum. Open the vial carefully,
avoiding any loss of material and reconstitute in the appropriate
accurately measured volume of freshly distilled water at +20 to
+25°C, Replace the rubber stopper, close vial and leave to stand
for 30 minutes out of bright light before use. Ensure that contents
are completely dissolved by swirling gently. After 30 minutes invert
vial to ensure that all traces of dry material are dissolved. Do
not shake the vial. The serum should only be reconstituted using
this procedure.
STABILITY
The serum is stable upto the expiry date when store at a constant
temperature 2-8°C. The expiry date is illustrated on the side
of each pack. Once reconstituted the components of the serum are
stable for 24 hours at +25°C, 7 days at 2-8°C, or at least
1 month when frozen once at -20°C.
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NOTES
Alkaline Phosphatase levels in the reconstituted serum will rise
over the stability period. It is recommended that the reconstituted
serum be allowed to stand for 1 hour at +25°C before measurement.
For Total & Prostatic Acid Phosphatase the material should be
stabilized by adding 1 drop (25-30 ml) of 0.7 M Acetic acid solution
to 1 ml of serum. After stabilization the material is stable for at
least 2 hours at +25°C, at least 2 days at 2-8°C and atleast
1 month at when frozen at -20°C. Bilirubin in the serum is light
sensitive and it is recommended that the serum be stored in the dark.
Stored in the dark it is stable for at least 8 hours at 2-8°C.
Do not store at +15°C - 25°C. do not freeze.
Creatinine Kinase is the least stable of the enzymes and assays should
be completed as soon as possible. The enzyme is stable in the serum
for 12 hours at 2-8°C. The level of Creatinine Kinase obtained
can also depend on the temperature of the distilled water used for
reconstitution. We recommend water at +20-+25°C.
Bacterial contamination of the reconstituted serum will cause reductions
in the stability of many components.
SAFETY
This control is manufactured from bovine serum. Human additives
which include prostatic acid Phosphatase and prostrate specific
antigen have been tested at donor level and found to be non reactive
for HBsAg, HIV and HCV antibodies.
However as no method can offer complete assurance as to the absence
of infectious agents, this material and all patient samples should
be handled as through capable of transmitting infectious disease.
For IN VITRO diagnostics use only.
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