INSTRUCTION OF CARBON DIOXIDE (CO2)
Carbon Dioxide (CO2) ASSAY KIT BY ENZYMATIC METHOD
[ PRODUCT NAME ]
Carbon Dioxide (CO2) Assay Kit by Enzymatic
Method
[ Packing specifications ]
Basing on the bottle type, product model can be
classified into 7170, 7060, 7020, Beckman, Toshiba,
Mindray, Dupont, Innova, Siemens, KHB, Abbott,
General type, etc.
R：60ml×4
R：20ml×4
R：30ml×1
R：20ml×6
R：90ml×3
R：1×170T
R：50ml×4
R：2×170T
R：100ml×1
R：4×170T
R：60ml×3
R：6×170T
R：40ml×4
R：1×510T
R：60ml×1
R：3×510T
R：60ml×6
R：4×510T
R：20ml×1
R：6×510T
R：20ml×2
[ Intended Use ]
This product is used to determination CO2 in human
serum.
[ PRINCIPLE ]
Catalyzed by phosphoenolpyruvate carboxylase
(PEPC), HCO3− in serum reacts with
phosphoenolpyruvate (PEP) to generate oxaloacetic
acid and phosphoric acid. Then oxaloacetic acid
becomes malic acid and NADH is oxidized into NAD
+ at the same time under the catalysis of malic
dehydrogenase (MDH). At wavelength 405 nm, the
declining rate of absorbance is proportional to the
carbon dioxide concentration in sample. Carbon
dioxide concentration in the sample can be
calculated by comparing the calibrator result with
same processing.
PEPC+Mg2+
PEP+HCO3− →
Phosphoric acid
Oxaloacetic
MDH
Oxaloacetic acid +NADH+H+ →
[ Composition ]
R1：Detection Reagent 1
Tris buffer
PEP
MgSO4
NADH
MDH
PEPC
Preservatives
Calibrator & Control
Calibrator：1.0ml×1
acid
+
malic acid +NAD+
50.0mmol/L
0.8g/L
0.65g/L
0.4g/L
1KU/L
2 KU/L
1g/L
Optional
[ Storage And Stability ]
Stored for up to 12 months at 2-8°C, protect from
light. After opening, the reagent remains stable for 7
days at 2-8°C, protect from light.
[ Applicable Instrument ]
This assay kit is suitable for automatic or
semi-automatic biochemical analyzer with 405nm
wavelength.
[ Sample Requirements ]
Serum without hemolysis. Samples testing should
be completed at the same day after collected.
Otherwise, the samples should be cryopreserved
and avoid repeated freeze-thaw cycles. CO2 in the
samples remain stable for 7 days at 2-8°C and for 3
months at cryopreservation condition
[ TEST METHOD ]
1. BASIC PARAMETERS：
Method: two-point rate assay
Temperature: 37℃
Primary wavelength: 405nm
Secondary wavelength: none
Sample: 3μl
R：300μl
Response direction: Negative
Reaction time: 10 min
Calibration mode: Two points calibration
2. Assay Procedure
Blank（B）
Sample（U） Calibrator（Ci）
ddH2O（μl）
3
－
－
Sample（μl）
－
3
－
Calibrator（μl）
－
－
3
300
300
Reagent R（μl） 300
Mix well ， 37 ℃ for 2 minutes. Measure the
absorbance value A1 at 405 nm and measure the
absorbance value A2 after 2 minutes.
Calculate ΔA/min＝ (A2-A1)/2min
ASSAY PROCEDURE SUMMARY：
←Detection→
Set blank well
Time：
10 min
Temperature：37℃
Primary wavelength 405nm
Secondary wavelength none
↑
R：300μl
Sample：3μl
↑
3. CALCULATIONS
Based on two points calibrator concentration and
the corresponding absorbance change rate ΔA/min,
the two point linear calibration model is used to
define the working curve, sample absorbance
change rate on the working curve with the
corresponding concentration is concentration of
sample.
[ Reference Range ]
22.0 mmol/L-29.0 mmol/L
Recommendations:
Each
laboratory
should
establish its own reference range.
[ Explanation for the test result ]
1. The test results reflect only the status at the
sampling time. Clinicians need to be combined with
clinical data and other relevant test results to make
judgment.
2. There is no significant effect on the test result
when the sample contains Ascorbic acid≤0.5g/L；
Bilirubin≤0.5g/L；
Hemoglobin≤5.0g/L; Triglycerides≤20g/L.
[ Test Method Limitations ]
Dilute with physiological saline and multiply the
result by the dilution factor when the concentration
of CO2 is over 50.0mmol/L.
[ PERFORMANCE ]
1. DETECTION RANGE ： 2.0mmol/L-50.0mmol/L,
r≥0.990.
2. PRECISION：Intra-assay CV≤8%,
Inter-assay CV≤10%
3. ACCURACY：Inaccuracy≤10％。
4. Blank absorbance：Absorbance values ≥0.900 at
405nm wavelength and optical path 10mm.
[ PRECAUTIONS ]
1. For in vitro diagnostic use only。
2. Reagents become cloudy or blank absorbance
values< 0.9, should be discarded.
3. The reagent and sample amount can be changed
with same ratio according to needs.
4. Reagents and components of different batches
are not interchangeable.
5. The test equipment must be clean to avoid
contamination.
6. The waste solution generated by the test and
decomposition difficultly packaging materials should
be collected and sent to local waste treatment
station.
[ Reference ]
Yingwu Ye et al. National Guide to Clinical
Laboratory Procedures (Third Edition). Southeast
University Press. 2006: 379-381.
[ MANUFACTURER ]
Wuhan Life Origin Biotech. Co., Ltd.
Wuhan Hi-tech Medical Devices Park,
Building B11, #818 Gaoxin Road,
Donghu Hi-Tech Development Area,
Wuhan, Hubei Province 430206, P.R. China
Tel：027-87926888 | Fax：027-87196150
Website: http://en.szybio.com
Email: [email protected]
[ Medical Devices manufacturer license number ]
Hubei SFDA No. 20100488
[ Medical Devices Registration Certificate Number ]
Hubei SFDA 2013 No. 2401572
[ Product standards]
YZB / E 0919-2013
[Specification approval date ]
January 06, 2014