In-vitro diagnostics (IVD)
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Intended use
Measurement of total cholesterol, triglyceride, glucose in serum, plasma or whole blood
Measuring principle
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Total cholesterol This product is a cholesterol test paper based on enzyme method.
2. Triglyceride
This product is a Triglyceride test paper based on enzyme method.
3. Glucose
This product is a glucose test paper based on enzyme method
Performance
(1) Sensitivity (by calibration curve method)
When purified water is used as a sample, the sensitivity (absorbance) is 0.1 or less.
When a certain concentration of standard solution is used as a sample, the absorbance is as follows.
Glucose 80 mg/dL, O.D. (absorbance) 0.1〜0.5
Triglyceride 50 mg/dL, O.D. (absorbance) 0.1〜0.5
Total cholesterol 130 mg/dL, O.D. (absorbance) 0.1〜0.5
(2) Accuracy (by calibration curve method)
For all items, when measuring the reference serum at a known concentration, it is within ± 25% of the known concentration.
(3) Reproducibility
For all items, when the same sample is measured 5 times or more at the same time, the CV value of O.D. (absorbance) is within
15%.
(4) Measurement range (by calibration curve method)
Glucose 70 mg/dL〜160 mg/dL
Triglyceride 70 mg/dL〜 250 mg/dL
Total cholesterol 130 mg/dL 〜 300 mg/dL
Storage method and expiration date
1. Storage Method: 2 ~ 25 °C
2. Validity Period: 6 months from the date of manufacture
Packaging unit
KOMPASU View MD3 25 tests
Separately sold items
Sample measuring room accessory A: slider x 25
Sample measuring room accessory B: standard color chart x 1
Reference
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Treatment guideline for hyperlipidemia from Japan Medical Association
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Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases (2012
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Thomas, L(Hrsg). 3.3 Blutglucose. Labor und Diagnose Frankfurt TH Books Verlagsgesellschaft 5 erw Auflage. 2000, p.134~135.
Measurement example
Measurement using the color chart
Measurement using a smartphone
You can also check the results with the KOMPASU app
A sample image of results