Rayto Life and Analytical Sciences Co., Ltd.

Reagent Inspection and Analysis Report

Product Name Total Bilirubin Reagent (Diazonium Salt Method)

Specification R1：60ml×5，R2：6ml×1 / /
Semi-Auto or Auto Chemistry
Batch Applicable
Sample Size 3 boxes 20191022 Analyzer produced by Rayto Life
No. Instrument
and Analytical Sciences Co., Ltd.
Shelf Date of
Date of Inspection 2019.10.28 2021.04.21 2019.10.22
Life Production
Inspection Standard (Technical Requirements of
Inspection Item Inspection Results
Product)
R1 and R2 are both colorless, transparent
1 Appearance liquid, without cloudiness or undissolved ☑Conformable □Inconformable
materials.

The net content of liquid reagents should not be

2 Net content ☑Conformable □Inconformable
less than the indicated value.

Absorbance At 37℃, wavelength of 550nm±20nm and optic

3 of reagent path length of 10mm, the absorbance of reagent Result: 0.005A
blank blank should be ≤ 0.10A. ☑Conformable □Inconformable
Rate of
At test temperature of 37℃, wavelength of 550
change in
nm±20nm and optic path length of 10mm, the Result: 0.0007A/min
4 absorbance
rate of change in absorbance of reagent blank
of reagent ☑Conformable □Inconformable
should be ≤ 0.002A/min.
blank

5 Accuracy The relative deviation should not exceed ±10%. Result: -0.39%
☑Conformable □Inconformable
Result: Low-level: 1.77%
6 Repeatability Coefficient of Variation (CV) ≤ 5% High-level: 0.78%
☑Conformable □Inconformable
When testing the 65umol/L calibrator or sample,
Sensitivity for Result: 0.3272A
7 at the optic path length of 10mm, the
analysis
absorbance difference (△A) should be ≥ 0.29A. ☑Conformable □Inconformable
Within the range of 0.8umol/L ~ 342 umol/L
Linearity Result: 0.9993
8 (37℃), the correlation coefficient (r) should be ≥
range
0.990. ☑Conformable □Inconformable

Conclusion Conforming

Inspected by/ on Yanling Ji/2019.10.28 Checked by/ on Wanming Xian/2019.10.28