CE-P064-04

Complement 4 Assay Kit 3.The production date and expiry date are shown on the
label .
(C4) APPLICABLE INSTRUMENT
This kit is theoretically suitable for all biochemistry
Method: Immunoturbidimetric Method analyzers and spectrophotometers covering the
wavelength range of 340 nm.
Cat . No. Packing Size Analyzer It is recommended to use this kit on a biochemistry
analyzer for testing according to laboratory conditions.
R1: 2×50 ml For Hitachi917&
EGS681M SAMPLE COLLECTION AND PREPARATION
R2: 2×10 ml OlympusAU640/400/600 Serum .
R1: 2×50 ml For Hitachi 717 Samples can be kept stable at 2-8℃ for 7 days.
EGB680M R2: 2×10 ml &ShimadzuCL7200/8000 ASSAY PROCEDURE
R1:30×4.3ml For Siemens Test Condition（Hitachi 917）
EGD681M R2: 6×4.3 ml Dupont/Siemens Behring Main
340nm Sample（S） 2.4 l
Series wavelength
For Mindray Secondary Reagent 1
EG15AG4 R1:1×25ml 200l
BS120/180/190/200/220/ wavelength （R1）
60BS R2: 1×5 ml
230/240/430/460/830 Reaction Reagent 2
37℃ 40l
R1:1×25ml temperature （R2）
EGG15AG For Semi Auto Analyser
R2: 1×5ml Two
Cuvette
INTENDED USE diameter
1cm Reaction type point
For in vitro the quantitative determination of end
complement 4 in human serum. Operate procedure
CLINICAL SIGNIFICANCE Add into Cuvette：
Complement is mainly synthesized in the liver, and Sample（S） 2.4l
complement C3 and C4 are the most frequently Reagent 1（R1） 200l
detected. C4 is an important component of the classical Mix well and incubate for 5 minutes at 37℃, read initial
activation pathway of complement, and its determination absorbance A1;
is helpful for the diagnosis and treatment of autoimmune
Reagent 2（R2） 40l
diseases such as SLE. Lower levels of C4 are seen in
autoimmune chronic active hepatitis, SLE, multiple Mix well and incubate for 5 minutes at 37℃, read final
sclerosis, rheumatoid arthritis, and LgA kidney disease. absorbance A2;
In SLE, the reduction of C4 is often earlier than that of Calculate △A=A2-A1
other complement components, and the recovery is later Note: Parameters above are only introduced with
in remission than that of other components. C4 values Hitachi 917 as an example. The parameters of different
were significantly lower in lupus nephritis than in non- biochemistry analyzers are slightly different. Please
lupus nephritis. Elevated levels of C4 are common in the read the manual carefully before setting parameters.
acute phase of rheumatic fever, perituberous arteritis, CALCULATION
dermatomyositis, myocardial infarction, Rditer's It is recommended to use Gcell C4 calibrator.
syndrome, and various types of polyarthritis. Calibrator traces to the international reference materials
ASSAY PRINCIPLES ERM-DA470k/IFCC.
Based on the reaction between C4 antibodies and C4 1. According to the requirements of the calibration
antigens, the test forms an immune complex and procedure in the operation manual of biochemistry
detects changes in turbidity at the wavelength of 340nm, analyzer, each laboratory establishes its own calibration
which is proportional to the content of C4 in the sample. procedure according to the specific conditions.
REAGENT COMPOSITION 2. The calibrated liquid shall be diluted proportionally.
The zero-point calibrated liquid shall be ultra-pure water
Contents Concentration 3. Five-point nonlinear calibration.
Reagent1 (R1) 4. Requirements for calibration and frequency: It is
recommended to calibrate at least once every two
Tris Buffer (pH=7.50) ≥10mmol/L
weeks. When the following situations occur, it is
Sodium Chloride ≥150mmol/L recommended to re-calibrate: change the reagent batch
Preservatives number, the indoor quality control runs out of control,
Polyethylene glycol (peg) the biochemistry analyzer carries out major
Reagent2 (R2) maintenance or replaces the main parts such as light
source or cuvette.
Tris Buffer (pH=7.50) ≥10mmol/L
QUALITY CONTROL
Anti C4 antibody -- It is recommended to use Gcell C4 control. The
Preservatives -- absorbance of quality control should be within the
STABILITY AND PREPARATION OF REAGENTS labeled value range. If the results deviate from the
1.Stable up to the expiry date when the reagent is scope, please find out the reason by following steps:
sealed and stored in dark at 2-8 ℃. 1. Check the parameter setting and light source.
2.Once opened, the reagents are stable for 28 days 2. Check the cleanliness of the cuvette and sampling
when refrigerated on the analyzer or refrigerator. needle.

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-P064-04
3. Check whether water is contaminated or not. 6. The calibration, quality product adopts the serum
Bacterial growth can lead to incorrect results. matrix, has made (HIV1, HIV2) antibodies to HIV,
4 .Check the reaction temperature. hepatitis B surface antigen (HbsAg) and hepatitis C
5. Check the validity of the kit. virus (HCV) antibody detection, found were negative,
CALCULATION OF RESULTS while testing method is highly accurate, there is no
According to the specific calibration mode of the project, guarantee that can find all the infected donors, should
the instrument will automatically generate calibration also will therefore calibration, quality product according
curve and calculate the content of the measured object to treat infectious specimens.
from the change value of absorbance in the sample. REFERENCES
REFERENCE RANGE 1.Karl J, Engel WD. Determination of Apolipoprotein A1
Adult :0.1-0.4 g/L(10-40 mg/dl). and B without sample dilution. Poster presented at the
Unit conversion: mg/dl x 0.01 = g/L. 57th meeting of the European Atherosclerosis Society,
Laboratories are suggested to establish its own Lisbon and the IX European Congress of Clinical
reference interval according to age, sex, diet and region. Chemistry, Cracow 1991.
INTERFERENCE 2.Burtis CA, Ashwood ER. Tietz Fund. Of Clin. Chem.
The effect of Intralipid≤ 167 mg/dl, bilirubin ≤ 600umol/L, 5th ed. 30-54, 335-336, 462-494 and 972-973.
hemoglobin ≤ 500 mg/dl is less than 10% . 3.Consensus values of the Deutsche Gesellschaft fur
ACCURACY Laboratoriums-medizin, the Deutsche Gesellschaft fur
The kit is tested with ERM-DA470k/IFCC international Klinische Chemie and the Verband der Diagnostica-
reference material. The deviation of the results should Industrie.V. (VDGH). DG Klinische Chemie Mitteilungen
≤±10%. 1995; 26:119-122.
SENSITIVITY INDEX OF SYMBOLS
When the sample concentration is 30.0mg/dL, the
absorbance change should ≥ 0.1000. Manufacturer
LINEARITY
Catalogue Number
In the range of [10.0, 130.0] mg/dL, the linearity
correlation coefficient r ≥ 0.990. In the range of [10.0, Lot number
30.0] mg/dL, the absolute deviation should ≤±10.0 Date of manufacture
mg/dL ;In the range of （30.0, 130.0] mg/dL, the relative
deviation should ≤±10%. Use by(Expiration date)
PRECISION For In-Vitro Diagnostic use only
Repeatability precision was obtained by testing control
or sample for 20 times of repeated measurement. Stored at 2-8℃
Intermediate precision was obtained by testing human
samples or control for 2 batches 5 days, and each batch Attention:See instruction for use
was measured for 5 times.The results are as follows:
a）Repeatability Precision（N=20） EC REP
Authorized Representative in the
European Company
Mean （ mg/dL） CV(%)
Level 1 19.215 2.12
Level 2 38.670 2.49
b) Intermediate precision(N=50)

Mean （ mg/dL） CV(%)

Level 1 25.85 1.6

Level 2 40.85 1.9
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. During the test, please do not mix or exchange
reagents with different batch Numbers.
4. Unsealed reagents shall be stored in an airtight
manner as specified, and shall not be used after
expiration.
5. Please dispose of test tubes and other instruments
that have come in contact with the tested specimens
according to relevant medical waste treatment
regulations.
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