Infopia ELEMENT MULTI Instructions For Use Manual page 8

Element Multi Test Strip Information
LIMITATIONS OF SYSTEM for glucose test
The Element Multi Glucose Test Strips provide accurate results when
the following constraints are observed:
• Do not use neonate samples.
• Inaccurate results may occur when in shock, hypotensive, hyperglycemic, or
hyperosmolar state with or without ketosis.
• Glucose test strips used above altitudes of 10,000 feet will have an effect on
test results.
Please note the following interferences that may affect test results:
Element Multi Glucose
• test strip results can be used with hematocrit
levels in the range of 20% to 60%. If the hematocrit range is out of the
range(20%~60%), then the test results may be lower or higher than actual
value.
• Interferences: Acetaminophen, Uric and, Ascorbic acid (Vitamin C), and other
reducing substances when occurring in normal blood or normal therapeutic
concentrations do not significantly affect results. However, abnormally high
concentrations may cause inaccurately high results.
• Lipemic samples; Cholesterol up to 500 mg/dL or triglyceride up to 3000mg/dl
do not significantly affect the results. Values beyond these levels should be
interpreted with caution.
• Blood samples that contain a high concentration of dissolved oxygen may
lower the test result.
• EDTA containing tube is recommended as an anticoagulant tube.
Performance Characteristics:
The performance of the glucose test strips has been evaluated in laboratory and
in clinical tests (Please refer to strip instructions for use for more details).
Measurement Range: The measurement range of the Element Multi Glucose
Testing is 10 to 600 mg/dL (0.6-33.3mmol/L).
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Accuracy:
The accuracy results obtained with the Element Multi glucose and cholesterol
measuring system were compared to glucose results obtained with the Hitachi
meter 747, a laboratory instrument. Glucose levels were measured on 160
patients at three different clinical centers.
System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)
Within ± 5mg/dL Within ± 10mg/dL
(within ± 0.28 mmol/L) (within ± 0.56 mmol/L)
20/28(71%)
System accuracy results for glucose concentration ≥ 75 mg/dL(4.2 mmol/L)
Within ± 5mg/dL Within ± 10mg/dL
76/132(58%) 111/132(84%)
Precision:
Precision Results for venous blood samples.
Mean (mg/dL) 40
CV (%) 3.7
Precision Results for control solutions.
Mean (mg/dL) 47
CV (%) 3.3
Within ± 15mg/dL
(within ± 0.83 mmol/L)
26/28 (93%) 28/28 (100 %)
Within ± 20mg/dL
Within ± 15mg/dL
132/132(100%)
128/132 (97%)
81 135 233
2.7 3.1 3.3
106 307
3.1 3.1
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350
1.8