CE-P097-04

Lactate Assay Kit 3.The production date and expiry date are shown on the
label.
（ LAC） 4.Once opened, the reagents are stable for 28 days
Method:Lactate Oxidase Method when refrigerated on the analyzer or refrigerator.
APPLICABLE INSTRUMENT
Cat.No Size Analyzer This kit is theoretically suitable for all biochemistry
For Hitachi917& analyzers and spectrophotometers covering the
EGS8127T 4×50 ml
OlympusAU640/400/600 wavelength range of 546nm.
For Hitachi 717 It is recommended to use this kit on a biochemistry
EGB8126T 4×50 ml
&ShimadzuCL7200/8000 analyzer for testing according to laboratory conditions.
EGH8127T 4×50 ml For Hitachi902 SAMPLE COLLECTION AND PREPARATION
Fresh serum or plasma (EDTA or heparin anticoagulant).
For Siemens
36×3.8 Stability of serum samples: Stored at 4 ℃ for 7
EGD8127T Dupont/Siemens Behring
ml days;The measured values of plasma samples
Series
increased with the extension of time.It can be stabilized
For Mindray
EGLAC460 at -20℃ for 4 weeks.
1x20ml BS120/180/190/200/220/2
BS ASSAY PROCEDURE
30/240/430/460/830
Test condition(Hitachi 917)：
EGGLAC 1x20ml For Semi Auto Analyser
Main
INTENDED USE 546nm Sample（S） 2L
wavelength
For in vitro quantitative determination of Lactate in
Secondary Reagent 1
serum or plasma. 700nm 200L
wavelength （R1）
CLINICAL SIGNIFICANCE
Lactic acid is an intermediate product of glucose Reaction
37℃ Reaction type End point
metabolism, and the level of lactic acid concentration is temperature
an indirect indicator reflecting glucose metabolism, Cuvette
1cm
peripheral circulation, and tissue blood and oxygen diameter
supply. The increase of lactic acid in the body can Operate Procedure:
cause lactic acidosis, and blood lactic acid level can be Add to cuvette：
examined, which is mainly used to judge the severity Sample（S） 2L
and prognosis of the disease.It can also be used for Reagent 1（R1） 200L
differential diagnosis of metabolic acidosis. Mix well and incubate at 37 ℃ for 10 minutes, and
ASSAY PRINCIPLE measure the absorbance A1.
Lactic acid oxidase oxidizes lactic acid to produce
Note: Parameters above are only introduced with
pyruvate and hydrogen peroxide, and hydrogen
Hitachi 917 as an example. The parameters of different
peroxide reacts with 4-aminoantipyrine and TOOS to
biochemistry analyzers are slightly different. Please
produce purple product, which has the maximum
read the manual carefully before setting parameters.
absorption peak at 546nm, and the absorption intensity
CALIBRATION
is proportional to the content of lactic acid in the
Recommend using Gcell LAC calibrator,trace to internal
specimen.
calibration product. The value of the calibrated product
LOX
is assigned by weighing the pure product.
Lactate+ O2 pyruvate + H2O2
1. According to the requirements of the calibration
POD
procedure in the operation manual of biochemistry
H2O2 + 4 -ALDEHYDOANTIPYRINE+ TOOS
analyzer, each laboratory establishes its own calibration
purple product + H2O
procedure according to the specific conditions.
2. Requirements for calibration and frequency: It is
REAGENT COMPOSITION
recommended to calibrate at least once every two
Contents Concentration weeks. When the following situations occur, it is
Reagent 1 (R1) recommended to re-calibrate: change the reagent batch
number, the indoor quality control runs out of control,
Buffer 100 mmol/L the biochemistry analyzer carries out major
Aldehydiantipyrine-4 0.4 mmol/L maintenance or replaces the main parts such as light
source or cuvette.
Ascorbic Acid Oxidase ≥10000U/L QUALITY CONTROL
Peroxidase ≥1000U/L It is recommended to use Gcell LAC control. The
absorbance of quality control should be within the
Lactate oxidase ≥600U/L labeled value range. If the results deviate from the
Toos 2.1 mmol/L scope, please find out the reason by following steps:
1. Check the parameter setting and light source.
Preservative 2.Check the cleanliness of the cuvette and sampling
needle.
STABILITY AND PREPARATION OF REAGENTS 3.Check whether water is contaminated or not. Bacterial
1. Stable up to the expiry date when the reagent is growth can lead to incorrect results.
sealed and stored in dark at 2-8 ℃. 4. Check the reaction temperature.
2. Reagents should not be frozen. 5. Check the validity of the kit.

Beijing Strong Biotechnologies, Inc.

Add: 5/F,KuangYi Building,No.15,Hua Yuan Dong Lu,Haidian District,Beijing 100191,P.R.China
Tel: +86 10 8201 2486 Fax: +86 10 8201 2812

Web: https://en.bsbe.com.cn/ Email: overseas@bsbe.com.cn V.4.0

 CE-P097-04
CALCULATIONS OF RESULTS virus (HCV). All of them are negative. Although the
According to the specific calibration mode of the project, detection method is highly accurate, it can not be
the calibration curve is automatically generated by the guaranteed that all infected donors are found, so the
instrument, and the content of the measured object is control should also be treated as infectious specimens.
calculated from the absorbance change value of the References
measured object in the sample. Liu Junjie, Zhao Junjie. Modern anesthesiology [M]. 3
Unit conversion: mmol/L×9 = mg/dl. edition. Beijing: people's Health Publishing House, 2004
REFERENCE RANGE
/ 55.
0.5-2.22mmol/L or 4.5-20mg/dl.
Laboratories are suggested to establish its own
reference interval according to age, sex, diet and region. INDEX OF SYMBOLS
INTERFERENCE
The effect of ascorbic acid ≤ 10mg/dL, hemoglobin ≤ Manufacture
400mg/dl, Bilirubin ≤ 10 mg/dl, heparin sodium ≤
Catalogue Number
500u/ml is less than 10%.
ACCURACY Lot number
Compared with competitors, in the range of [0.5, 15] Date of manufacture
mmol/L, the correlation coefficient r≥0.975; in the range
of [0.5, 2] mmol/L, the absolute deviation should ≤±0.2 Use by(Expiration date)
mmol/L; in the range of (2, 15] mmol/L, the relative
deviation should ≤ ±10%. For In-Vitro Diagnostic use only
SENSITIVITY Stored at 2-8℃
When the sample concentration is 4.5mmol/L, the
absorbance change should between 0.4000～0.8000. Attention:See instruction for use
LINEARITY
In the range of [0.5, 15] mmol/L, the linear correlation EC REP
Authorized Representative in the
coefficient r≥0.99; in the range of [0.5, 2] mmol/L, the European Company
absolute deviation should ≤±0.2 mmol/L; in the range of
(2, 15] mmol/L, the relative deviation should ≤ ±10%.
PRECISION
Repeatability precision was obtained by testing control
or sample for 20 times of repeated measurement.
Intermediate precision was obtained by testing human
samples or control for 2 batches per day, and each
batch was measured for 2 times separately in morning
and afternoon, for total 20 days. The results are as
follows:
a)Repeatability(N=20)
Mean(mg/dl) CV（%）
Level1 13.56 0.71
Level 2 51.93 0.63
b)Intermediate precision(N=80)
Mean(mg/dl) CV（%）
Level1 13.47 1.07
Level 2 50.94 1.01
SAFETY PRECAUTIONS AND WARNINGS
1. The reagent contains preservatives. If it enters the
eyes, mouth or contact on the skin, please rinse it
thoroughly with clean water immediately and go to the
hospital if necessary.
2. The reagent contains preservatives, which can react
strongly with copper, lead and other metals to form
azide metal. Therefore, please dilute the waste liquid
and flush the drain pipe to avoid residual when disposal.
3. Do not mix or exchange reagents with different
batches in the process of detection.
4. Opened reagents should be sealed and stored
according to the specified method. Expired product
should not be used.
5. Please dispose test tubes and other instruments that
have touched the test sample according to the relevant
medical waste disposal regulations.
6. Calibrator and control use human matrix serum,
passed the detection of HIV (HIV 1, HIV 2) antibodies,
hepatitis B surface antigen (HbsAg) and hepatitis C

Beijing Strong Biotechnologies, Inc.

Add: 5/F,KuangYi Building,No.15,Hua Yuan Dong Lu,Haidian District,Beijing 100191,P.R.China
Tel: +86 10 8201 2486 Fax: +86 10 8201 2812

Web: https://en.bsbe.com.cn/ Email: overseas@bsbe.com.cn V.4.0