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Applied Scope
This product is applied to monitor the concentration of total cholesterol (TC), triglyceride (TG), uric acid (UA), creatinine (CR), urea(BU), blood glucose(GLU), blood ketone(BK) and hemoglobin(HB) in human whole blood (peripheral whole blood or venous whole blood) in vitro by families, medical units, etc. This product is only used for daily self-monitoring. The test results cannot be considered as the basis of clinical diagnosis, screening and medication guidance.
Model
DCA
Packing Content
Content:
One unit of DCA dry chemistry analyzer;
One box of total cholesterol strip, 25strips/box;
One box of triglycerides strip, 25strips/box;
One box of blood glucose strip, 25strips/box;
One box of uric acid strip, 25strips/box;
One box of urea nitrogen strip, 25strips/box;
One box of creatinine strip, 25strips/box;
Performance
The accuracy of the analyzer should meet the followed table.
Accuracy
Item | Measuring range | Allowed deviation |
Uric acid | 119μmol/L~420μmol/L (2.0mg/dL~7.1mg/dL) |
Not more than ±84.0μmol/L (±1.41mg/dL) |
421μmol/L~1190μmol/L (7.1mg/dL~20.0mg/dL) |
Not more than ±20% | |
Creatinine |
44μmol/L~264μmol/L (0.5mg/dL~3.0mg/dL) |
Not more than ±52.8μmol/L (±0.60mg/dL) |
265μmol/L~1320μmol/L (3.0mg/dL~15.0mg/dL) |
Not more than ±20% | |
urea | 4.00mmol/L~20.00mmol/L (11.2mg/dL~56.0mg/dL) |
Not more than ±4.00mmol/L (±11.20mg/dL) |
20.01mmol/L~40.00mmol/L (56.0mg/dL~112.0mg/dL) |
Not more than ±20% | |
Total cholesterol | 2.59mmol/L~5.17mmol/L (100mg/dL~200mg/dL) |
Not more than ±1.03mmol/L (±40mg/dL) |
5.18mmol/L~10.35mmol/L (200mg/dL~400mg/dL) |
Not more than ±20% | |
Triglycerides | 0.51mmol/L~1.13mmol/L (45mg/dL~100mg/dL) |
Not more than ±0.23mmol/L (±20mg/dL) |
1.14mmol/L~5.65mmol/L (101mg/dL~500mg/dL) |
不超过±20% Not more than ±20% |
|
Blood glucose | 0.6mmol/L~4.2mmol/L (10mg/dL~75mg/dL) |
Not more than ±0.83mmol/L (±15mg/dL) |
4.2mmol/L~27.8mmol/L (76mg/dL~500mg/dL) |
No more than ±20% | |
Blood ketone | 0.20mmol/L~1.00mmol/L (2.08mg/dL~10.40mg/dL) |
Not more than ±0.20mmol/L (±2.08mg/dL) |
1.00mmol/L~6.00mmol/L (10.41mg/dL~62.40mg/dL) |
Not more than ±20% | |
Hemoglobin | 45g/L~100g/L | Not more than ±10g/L |
101g/L~256g/L | Not more than ±10% |
The repeatability of the analyzer should meet the followed table.
Repeatability
Item | Measuring range | Precision |
Uric acid | 119μmol/L~420μmol/L (2.0mg/dL~7.1mg/dL) |
SD<31.6μmol/L (±0.53mg/dL) |
421μmol/L~1190μmol/L (7.1mg/dL~20.0mg/dL) |
CV<7.5% | |
Creatinine | 44μmol/L~264μmol/L (0.5mg/dL~3.0mg/dL) |
SD<19.8μmol/L (±0.23mg/dL) |
265μmol/L~1320μmol/L (3.0mg/dL~15.0mg/dL) |
CV<7.5% | |
urea | 4.00mmol/L~20.00mmol/L (11.2mg/dL~56.0mg/dL) |
SD<1.50mmol/L (±4.20mg/dL) |
20.01mmol/L~40.00mmol/L (56.0mg/dL~112.0mg/dL) |
CV<7.5% | |
Total cholesterol | 2.59mmol/L~5.17mmol/L (100mg/dL~200mg/dL) |
SD<0.39mmol/L (<15.1mg/dL) |
5.18mmol/L~10.35mmol/L (200mg/dL~400mg/dL) |
CV<7.5% | |
Triglycerides | 0.51mmol/L~1.13mmol/L (45mg/dL~100mg/dL) |
SD<0.08mmol/L (<7.5mg/dL) |
1.14mmol/L~5.65mmol/L (101mg/dL~500mg/dL) |
CV<7.5% | |
Blood glucose | 0.6mmol/L~4.2mmol/L (10mg/dL~75mg/dL) |
SD<0.42mmol/L (<7.7 mg/dL) |
4.2mmol/L~27.8mmol/L (76mg/dL~500mg/dL) |
CV<7.5% | |
Blood ketone | 0.20mmol/L~1.00mmol/L (2.08mg/dL~10.40mg/dL) |
SD<0.08mmol/L (<0.78mg/dL) |
1.00mmol/L~6.00mmol/L (10.41mg/dL~62.40mg/dL) |
CV<7.5% | |
Hemoglobin | 45g/L~100g/L | SD<8g/L |
101g/L~256g/L | CV<8% |