In-vitro diagnostics (IVD)

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Intended use
Measurement of zinc, albumin, and magnesium in serum, plasma, and whole blood
Measuring principle
1. Zinc Zinc (Zn2 +) reacts with the chelating agent, 2-(5-Bromo-2-pyridiylazo)-5-[N-n-propyl-N-(3-sulfopropyl)amino]phenol sodium (5-Br-PAPS), to form a complex, resulting in color change. The zinc concentration is calculated from the change in absorbance, etc. due to the color change.
2. Albumin
Albumin in the test sample binds to bromcresol green (BCG), generating a blue color. The albumin concentration is
calculated from the change in absorbance, etc. due to the color change.
3. Magnesium
In this product, magnesium in the sample binds to xylidyl blue I (XBI) to form a red complex. The Magnesium concentration
is calculated from the change in absorbance, etc. due to the color change.
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.
Zinc 80 μg/dL, O.D. (absorbance) 0.1 〜 0.5
Albumin 3.9 g/dL, O.D. (absorbance) 0.1 〜 0.5
Magnesium 1.8 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)
Zinc 40 μg/dL 〜 160 μg/dL
Albumin 1.8 g/dL 〜 5.5 g/dL
Magnesium 0.7 mg/dL 〜 3.4 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 NU3 25 tests
References
1.)Hiroko Kodama, Journal of Japanese Society of Clinical Nutrition, 40 (2), 120 -167, 2018
2.)Kanai's Manual of Clinical Laboratory Medicine, 31st edition. p479, -480 (1998) by Kanahara Publishing Co., Ltd.
3.)Kanai's Manual of Clinical Laboratory Medicine, 35th edition. p586 (2020) by Kanahara Publishing Co., Ltd.
Measurement example
Package insert
You can also check the results with the KOMPASU app
A sample image of results
