Chema Diagnostica - Model Autocal H -Human Based Calibration Serum

Package components
Calibrator (lyophilized)
5x3ml/10x3ml

Reactive components in calibrator
Human serum with chemical additives and extracts of tissue of human and animal origin. The origin of biological additives is as follow:

• Alkaline phosphatase
• ALT/GPT
• AST/GOT
• Albumin
• Amylase, total
• Amylase, pancreatic
• Cholesterol
• Cholinesterase
• Creatine kinase
• Gamma-GT
• GLDH
• LDH
• Lipase
• Triglycerides
• human placenta (recombinant)
• porcine heart
• porcine heart
• bovine plasma
• porcine pancreas
• porcine pancreas
• bovine plasma
• human serum
• rabbit muscle
• porcine kidney
• bacterial recombinant
• porcine heart
• human pancreas (recombinant)
• chicken egg yolk

Calibration values
The calibration values were determined using the method mentioned in the enclosed value sheet. Determinations were performed under strictly standardized conditions on Roche analyzers using Roche and Chema reagents and Roche master calibrators. The calibration values were obtained via single assays performed in different laboratories in several independent series. The calibrator value specified is the mean of the values obtained.

Precautions and warnings
For in vitro diagnostic use only.
Exercise the normal precautions required for handling all laboratory reagents. This product has been prepared exclusively from the blood of donors tested individually and shown by FDA approved methods to be free from HBsAg and antibodies to HCV and HIV. However as no test method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as a patient sample. In the event of exposure the directive of the responsible health authorities should be followed (a,b).

Disposal
This product is made to be used in professional laboratories. Please consult local regulations for a correct waste disposal. P50I: Dispose of contents according to national/international regulations.

Handling
Carefully open one bottle of calibrator, avoiding the loss of lyophilizate. and pipette exactly 3.0 ml of distilled water. Carefully close the bottle and dissolve the content completely by occasional gentle swirling within 30 minutes. Avoid the formation of foam.

Storage and stability
Store at 2-8°C.
Stability of lyophilized calibrator serum at 2-8°C: up to the stated expiration date. Criterion of the stability data specified by the manufacturer: recovery within * 5% of initial value.