PRODUCT CHARACTERISTICS
SPINCHEM 1 or SPINCHEM 2 is a human lyophilised serum.
With most constituent concentrations and activities in the normal
(Spinchem 1) or pathologic (Spinchem 2) range.
It’s intended for control of accuracy for use with manual and
automated analytical procedures.
REAGENTS
Human serum. Enzymes (human, bovine and porcine).
Nonprotein constituents and bacteriostatic agents.
The concentration / activities of the components are lot-specific.
The exact values and ranges valid for reagents are given
informational purpose in the value sheet.
PRECAUTIONS
Contains human sourced material. No known test method can
offer complete assurance that products derived from human
blood will not transmit infectious agents. Consider all blood
derivatives potentially infectious.
Avoid contact with skin and eyes. In case of contact with eyes,
rinse immediately with plenty of water and seek medical device.
Wear suitable gloves and eye/face protection. In case of an
accident, seek medical device immediately and show this
container or label.
PREPARATION
-Using a Class A volumetric pipette, carefully add the exact
amount of distilled or deionized water as specified on the vial
label to the control material.
-Swirl the vial gently and allow to stand at room temperature for 5
to 10 minutes.
-Swirl contents until homogeneous. DO NOT VORTEX. Remove
the sample required for testing.
Improper handling and/or storage of the control can affect results.
Inaccurate reconstitution of the control and errors in assay
technique can cause erroneous results.
STORAGE AND STABILITY
The Control serum is stable until the expiration date on the label
when stored tightly closed at 2-8ºC and contaminations are
prevented during their use. Do not use reagents over the
expiration date or if there is visible evidence of microbial grown.
Store tightly capped when not use.
- After reconstitution is stable for:
At 2ºC to 8ºC 10 days
- Direct Bilirubin (stored protected from light):
At 2ºC to 8ºC 5 days
- Alkaline phosphatase may increase in activity with time.
