Serum control multicomponent for clinical chemistry assays
IVD
Store at 2 - 8ºC.
PRODUCT CHARACTERISTICS
SPINTROL H NORMAL or PATHOLOGIC is a human lyophilised serum.
With most constituent concentrations and activities in the normal or pathologic range. It’s
intended for control of accuracy for use with manual and automated analytical procedures.
REAGENTS
Human serum. Biological additives. Bacteriostatics 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
The individual units comprising lot or lots of components from human origin, have
been tested for HBsAg and antibodies to HIV and HCV found negative / non reactive
by an FDA approved test.
However, handle cautiously as potentially infectious.
PREPARATION
-Reconstitute (→) with 5,0 mL of distilled water.
-Mix thoroughly, avoiding foam forming.
-Bring to room temperature for about 30 min. before use.
Improper handing and/or storage can affect results. Inaccurate reconstitution 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 15ºC to 25ºC 12 hours. At 2ºC to 8ºC 5 days. At -25ºC to -15ºC 28 days (when frozen once).
-Bilirubin and Acid Phosphatase (stored protected from light):
At 15ºC to 25ºC 8 hours. At 2ºC to 8ºC 24 hours. At -25ºC to -15ºC 2 weeks (when frozen once).
-ALT:
At 15ºC to 25ºC 12 hours. At 2ºC to 8ºC 5 days. At -25ºC to -15ºC 2 weeks (when frozen once).
