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

References

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.

Intended use

カラーチャートを用いた場合

スマートフォンを用いた場合

You can also check the results with the KOMPASU app

A sample image of results

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