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Biosystems Control Serum Level 1- 2

INTENDED USE

The Biochemistry Control Serum is intended for quality control purposes
only and is supplied with suggested intervals of acceptable values.

COMPOSITION

Biochemistry Control Serum. For 5 mL. Lyophilized human serum
containing component concentrations

Suitable for the quality control of the clinical laboratories, and without preservatives which might interfere with
the tests.

Components from human origin have been tested and found to be negative for the presence of antibodies anti-HIV and anti-HCV,

As well as for HBs antigen. However, they should be handled cautiously as potentially infectious.

Biosystems Control Serum Level 1- 2

1. Open a vial very carefully, avoiding any loss of the lyophilized material.
2. Pipette exactly 5.00 mL of distilled water into the vial. The component
values depend on the accuracy of this reconstitution step.
3. Close the vial with the stopper and let stand for 20 minutes at room
temperature.
4. Swirl gently, avoiding the formation of foam, to ensure complete
dissolution of contents.
5. The reconstituted control serum is to be treated like the patient serum.

STORAGE AND STABILITY

Store at 2-8ºC.
The lyophilized Biochemistry Control Serum is stable until the expiration
date given in the label.

The components of the reconstituted material are stable for at least 7 days
at 2-8ºC, for most components, excepting:

 AST is stable 8 hours at 2-8ºC.
 Alkaline phosphatase values rise about 10-20% during the first 2 hours
after reconstitution.
For longer periods, keep frozen. Avoid repeated freeze-thaw cycles.

Biosystems Control Serum Level 1- 2

SPECIFIED VALUES

The assigned concentration values for components and their traceability
are shown in the enclosed value sheets.

Traceability of the results can be assured only if the BioSystems reagents and recommended measurement
procedures are used.

The suggested intervals of acceptable values have been calculated from previous experience in interlaboratory variability and are given for orientation only.

Each laboratory should establish its own precision parameters.

Biosystems Control Serum Level 1- 2

ROUTINE BIOCHEMISTRY

ELECTROLYTES

• Calcium
  • 11571CALCIUM-ARSENAZO
  • 11811CALCIUM-CRESOLPHTHALEIN
  • 11527CALCIUM-MTB
• Iron
  • 11546IRON-CHROMAZUROL
  • 11509IRON-FERROZINE
• Iron Binding Capacity
  • 11554TOTAL IRON BINDING CAPACITY
  • 11835UNSATURATED IRON BINDING CAPACITY (UIBC)
• Magnesium
  • 11797MAGNESIUM
• Phosphorus
  • 11508PHOSPHORUS

ENZYMES

• a-Amylase
  • 11583alpha-AMYLASE – DIRECT
  • 11534alpha-AMYLASE – EPS
• a-Amylase Pancreatic
  • 11799alpha-AMYLASE – PANCREATIC
• Acid Phosphatase (ACP)
  • 11548ACP
• Alanine Aminotransferase (ALT-GPT)
  • 11568ALT-GPT
• Alkalin Phosphatase (ALP)
  • 11598ALP-AMP
  • 11597ALP-DEA
• Aspartate Aminotransferase (AST-GOT)
  • 11567AST-GOT
• Creatine Kinase (CK)
  • 11791CK
• Creatine Kinase (CK-MB)
  • 11792CK-MB
• g-Glutamiltransferase (GGT)
  • 11584GGT
• Lactate Dehydrogenase (LDH)
  • 11580LDH
  • 11586LDH-IFCC
• Lipase
  • 11793LIPASE

SPECIFIC PROTEINS

• Anti-Streptolysin O (ASO)
  • 31323ASO
• C Reactive Protein (CRP)
  • 31321CRP
• C Reactive Protein hs (CRP-hs)
  • 31927CRP-hs
• Complement Component C3
  • 31079C3
• Complement Component C4
  • 31080C4
• HbA1C
  • 31047HEMOGLOBIN A1C-DIRECT (HbA1C-DIR)
• Immunoglobulin A (IgA)
  • 31077Ig A
• Immunoglobulin G (IgG)
  • 31076Ig G
• Immunoglobulin M (IgM)
  • 31078Ig M
• Lipoproteins
  • 31095APOLIPOPROTEIN A-1 (Apo A-1)
  • 31098APOLIPOPROTEIN B (Apo B)
• Microalbuminuria
  • 31324ALBUMIN (MICROALBUMINURIA)
• Rheumatoid Factor (RF)
  • 31322RF
• Transferrin
  • 31092TRANSFERIN
  • 31093TRANSFERRIN

SUBSTRATES

• Albumin
  • 11573ALBUMIN
• Bilirubin
  • 11511BILIRUBIN (DIRECT)
  • 11555BILIRUBIN (TOTAL AND DIRECT)
  • 11544BILIRUBIN (TOTAL)
• Cholesterol
  • 11539CHOLESTEROL
• Cholesterol HDL
  • 11523CHOLESTEROL HDL
  • 11557CHOLESTEROL HDL DIRECT
  • 11648CHOLESTEROL HDL PRECIPITATING REAGENT
• Cholesterol LDL
  • 11585CHOLESTEROL LDL DIRECT
  • 11579CHOLESTEROL LDL PRECIPITATING REAGENT
• Creatinine
  • 11802CREATININE
  • 11734CREATININE-ENZ
• Glucose
  • 11656GLUCOSE-HEXOKINASE
  • 11803GLUCOSE-OXIDASE
• Protein (Urine-CSF)
  • 11559PROTEIN (URINE)
• Total Protein
  • 11572PROTEIN (TOTAL)
• Triglycerides
  • 11828TRIGLYCERIDES
• Urea
  • 11537UREA-COLOR
  • 11517UREA-UV
• Uric Acid
  • 11540URIC ACID

Biosystems Control Serum Level 1- 2

Biosystems Coagulation reagents include the main diagnostic tests and they are characterized by high stability and a good performance using low volume consumption.

These reagents can be performed in semiautomatic and automatic coagulation instruments, independently of the kind of clot detection method (optical and mechanic).