CE-P146-04

Ammonia Assay Kit This kit is theoretically suitable for all biochemistry
analyzers and spectrophotometers covering the
(AMM) wavelength range of 340/570nm..
It is recommended to use this kit on a biochemistry
Method: Glutamate Dehydrogenase Method analyzer for testing according to laboratory conditions.
SAMPLE COLLECTION AND PREPARATION
Cat.NO. Package Size Analyzer
EDTA Anticoagulated Plasma; Heparin Anticoagulated
EGSAMM R1: 1×60 ml For Hitachi917& Plasma.
R2: 1×20 ml OlympusAU640/400/600 Specimens must be placed in an ice bath immediately after
EGBAMM R1: 1×60 ml For Hitachi 717 collected. Plasma should be separated by centrifugation as
R2: 1×20 ml &ShimadzuCL7200/8000 soon as possible and measured in time [1]. After separation
R1: 1×45 ml from blood cells, plasma samples are stable for 4 hours at
EGHAMM For Hitachi 902 4 ℃ and 24 hours at -20 ℃.
R2: 1×15 ml
ASSAY PROCEDURE
For Siemens
R1: 12×3.8 ml Test Condition (Hitachi 917)
EGDAMM Dupont/Siemens Behring
R2: 6×2.6 ml Main wavelength Sample (S)
Series 340nm 17 μL
For Mindray Secondary Reagent
EGAMM460 R1: 1×18 ml 570nm 150 μL
BS120/180/190/200/220/2 wavelength (R1)
BS R2: 1×6 ml
30/240/430/460/830 Reaction Reagent
R1: 1×18ml temperature 37℃ (R2) 50 μL
EGGAMM For Semi Auto Analyzer
R2: 1×6 ml
Cuvette 1cm Reaction End
INTENDED USE diameter type
For in vitro quantitative determination of ammonia in point
plasma. Operation Procedure:
CLINICAL SIGNIFICANCE[1] Add into cuvette:
Under normal circumstances, ammonia converts to urea
in the liver. With severe liver disease, ammonia cannot Sample(S) 17 μL
be converted and eliminated from the circulation, which Reagent 1(R1)
in turn causes blood ammonia increase. High blood 150 μL
ammonia is neurotoxic, and will lead hepatic Mix well and incubate for 5 minutes at 37 ℃ , read
encephalopathy (hepatic coma). Adult plasma ammonia initial absorbance A1, add
determination mainly use for monitoring and treatment
of hepatic coma.In addition, plasma ammonia Reagent 2（R2） 50 μL
determination can be used in pediatric diagnosis of
Reye's syndrome. Mix well and incubate for another 5 minutes, read
ASSAY PRINCIPLE absorbance A2, calculate ΔA = A2 - A1.
Together with NADPH and α-ketoglutarate, the Note: Parameters above are only introduced with
ammonia in plasma can produce NADP+, glutamic acid Hitachi 917 as an example. The parameters of different
and water under the action of glutamate dehydrogenase. biochemistry analyzers are slightly different. Please
At 340nm, the changing rate of NADPH absorbance can read the manual carefully before setting parameters.
be measured and calculated to the concentration of CALIBRATION
blood ammonia. It is recommended to use Gcell AMM calibrator.
GLDH Calibrator traces to ammonium chloride pure material
NH4+ + α-Ketoglutaric Acid +NADPH 1.According to the requirements of the calibration
procedure in the operation manual of biochemistry
Glutamic Acid + NADP+ + H2O analyzer, each laboratory establishes its own calibration
procedure according to the specific conditions.
REAGENT COMPOSITION 2 Requirements for calibration and frequency: It is
recommended to calibrate the reagent blank every day
Contents Concentration
and reagents every 3 days. When the following
Reagent 1 (R1) situations occur, it is recommended to re-calibrate:
NADPH >0.1 mmol/L change the reagent batch number, the indoor quality
control runs out of control, the biochemistry analyzer
α-Ketoglutaric Acid >5 mmol/L
carries out major maintenance or replaces the main
Reagent 2 (R2) parts such as light source or cuvette.
GLDH >0.5 KU/L QUALITY CONTROL
STABILITY AND PREPARATION OF REAGENTS It is recommended to use Gcell AMM control. The
1. Stable up to the expiry date when the reagent is control measured value should be within the labeled
sealed and stored in dark at 2-8 ℃. value range.If the results deviate from the scope, please
2. Reagents should not be frozen. find out the reason by following steps:
3. Do not mix reagents of different batches. 1 Check the parameter setting and light source.
4.The production date and expiry date are shown on the 2 Check the cleanliness of the cuvette and sampling
label. needle.
APPLICABLE INSTRUMENT 3 Check whether water is contaminated or not. Bacterial
growth can lead to incorrect results.
4 Check the reaction temperature.
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: http://en.bsbe.com.cn/ Email: [email protected] V.4.0

 CE-P146-04
CALCULATION OF RESULT
According to the specific calibration mode of the project, INDEX OF SYMBOLS
the instrument will automatically generate calibration
curve and calculate the content of the measured object Manufacture
from the change value of absorbance in the sample.
REFERENCE RANGE Catalogue Number
Normal human plasma: < 47 μmol/L. Lot number
Laboratories are suggested to establish its own
Date of manufacture
reference interval according to age, sex, diet and region.
INTERFERENCE Use by(Expiration date)
The effect of Bilirubin < 50 mg/dL, Intralipid < 100mg/dL,
ascorbic acid <50 mg/dL, is less than 10%. For In-Vitro Diagnostic use only
ACCURACY
Recovery test: Add a certain volume pure solution to the Stored at 2-8℃
human EDTA anticoagulated plasma sample, the
measured recovery rate should be within the range of Attention:See instruction for use
(100 ± 20) %.
LINEARITY EC REP Authorized Representative in the
In the range of [20,1000] μmol/L,the linearity correlation European Company
coefficient r ≥ 0.990. In the range of [20,150]μmol/L, the
absolute deviation should ≤±15μmol/L; in the range of
(150,1000)μmol/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(μmol/L) CV(%)
Level1 122.5 1.8
Level 2 439.5 0.5
b)Intermediate precision(N=80)
Mean(μmol/L) CV(%)
Level1 120.3 1.66
Level 2 435.5 1.16
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.
REFERENCES
1.Department of Medical Administration, Ministry of
Health of the People's Republic of China. National
Clinical Laboratory Procedures [M]. 3rd Edition, Nanjing:
Southeast University Press, 2006, 460-462

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: http://en.bsbe.com.cn/ Email: [email protected] V.4.0