Controls
ClinChem Control Set
Intended Use:
The ClinChem Control Set is intended to be used as unassayed quality control material for laboratory test procedures for the analytes listed below.
Description
| Name | Quantity | Ready to Use(1) | Lyophilized(2) |
|---|---|---|---|
| ClinChem Control Low | 5 mL | 2130053 | 2130087 |
| ClinChem Control Medium | 5 mL | 2130054 | 2130088 |
| ClinChem Control High | 5 mL | 2130057 | 2130089 |
| ClinChem Control Set | 2 x 3 Level | 2130072 | 2130086 |
(1) For Investigational Use Only. The performance characteristics of this product have not been established.
(2) in vitro Diagnostic Product
Stability
Unopened Vial: 24 months when stored at recommended storage conditions.
Open/Reconstituted Vial: 30 days when stored at 2—8 °C.
Each control contains human serum, purified biochemical materials, chemicals, and
< 0.1% sodium azide as preservative.
Results
The ClinChem Control Set is used to verify the correct functioning of laboratory tests and the analyzers used to perform them for the analytes listed below. These values are provided solely for the convenience of the evaluator prior to the assessment of the control.
Typical Values
| Level | ||||
|---|---|---|---|---|
| Analyte | Low | Med | High | Units |
| Albumin | 2.7 | 3.5 | 4.4 | g/dL |
| Alkaline Phosphatase | 55 | 200 | 350 | U/L |
| ALT/SGPT | 1.8 | 60 | 105 | U/L |
| Amylase | 50 | 250 | 450 | U/L |
| AST/SGOT | 55 | 175 | 300 | U/L |
| Bilirubin (Direct) | 0.5 | 1.6 | 2.7 | mg/dL |
| Bilirubin (Total) | 0.7 | 2.0 | 3.2 | mg/dL |
| Calcium | 5.8 | 7.8 | 11.0 | mg/dL |
| Chloride | 78 | 100 | 122 | mEq/L |
| Cholesterol | 100 | 160 | 250 | mg/dL |
| CK (Creatine Kinase) | 78 | 250 | 425 | U/L |
| Creatinine | 1.0 | 2.8 | 5.0 | mg/dL |
| GGT | 33 | 110 | 180 | U/L |
| Glucose | 80 | 150 | 230 | mg/dL |
| Iron | 60 | 140 | 250 | ug/dL |
| LDH (Lactate Dehydrogenase) | 78 | 250 | 425 | U/L |
| Magnesium | 1.0 | 2.5 | 4.3 | mg/dL |
| Phosphorous | 1.8 | 4.8 | 7.0 | mg/dL |
| Potassium | 1.8 | 4.8 | 7.0 | mEq/L |
| Sodium | 108 | 128 | 150 | mEq/L |
| Total Protein | 4.8 | 6.2 | 7,8 | g/dL |
| Triglycerides | 45 | 105 | 190 | mg/dL |
| Urea Nitrogen | 15 | 30 | 45 | mg/dL |
| Uric Acid | 2.5 | 5.0 | 7.5 | mg/dL |