In-vitro diagnostics (IVD)

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Package insert

Flyer

Intended use

Measurement of total cholesterol, triglyceride, glucose in serum, plasma or whole blood

Measuring principle

  1. Total cholesterol                                                                                                                          This product is a cholesterol test paper based on enzyme method.

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2. Triglyceride
    This product is a Triglyceride test paper based on enzyme method.

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3. Glucose
    This product is a glucose test paper based on enzyme method 

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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

  1. Treatment guideline for hyperlipidemia from Japan Medical Association

  2. Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases (2012

  3. 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

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