HIGHTOP Control S3 (20ng/mL) 1 vial 0.5 mL 5 vials 0.

5 mL
Carcinoembryonic Antigen (CEA) Control S4 (60ng/mL) 1 vial 0.5 mL 5 vials 0.5 mL
ELISA Test Kit Control S5 (200ng/mL) 1 vial 0.5 mL 5 vials 0.5 mL
(Serum/Plasma) Closure plate membrane 2 sheets 10 sheets
Note: different batches of reagent kit, and different component cannot be exchanged for use.
Package Insert
Once open, stable for 3 months at 2-8°C.
(Catalog Number: H322)
SAMPLE REQUIREMENT
For in vitro diagnostic and professional use only.
1. Specimen Collection: No special patient’s preparation required. Collect the specimen in
PRODUCT NAME
accordance with the normal laboratory practice. Either fresh serum specimens can be used with this
CEA ELISA Test Kit (Serum/Plasma)
assay. Blood collected by venipuncture should be allowed to clot naturally and completely – the
INTENDED USE
serum must be separated from the clot as early as possible as to avoid hemolysis of the RBC. Care
This kit is a quantitative detection of human serum/plasma of carcinoembryonic antigen (CEA). The
should be taken to ensure that the serum/plasma specimens are clear and not contaminated by
reagent is mainly used for dynamic monitoring of patients with malignant tumors to assist in judging
microorganisms.
disease progression or treatment effect.
2. Highly lipaemic, icteric, or hemolytic specimens should not be used as they can give false results
PRINCIPLE OF THE TEST
in the assay. Do not heat inactivate specimens. This can cause deterioration of the target analyte.
Carcinoembryonic antigen (CEA) is an acidic protein that belongs to non-organ-specific
Samples with visible microbial contamination should never be used.
tumor-associated antigens. CEA is firstly a tumor-associated antigen extracted from colon cancer and
3. CEA ELISA is intended ONLY for testing of individual serum/plasma samples. Do not use the assay
embryonic tissues. The CEA test was first used for the diagnosis of colorectal cancer. It was
for testing of cadaver samples, saliva, urine or other body fluids, or pooled (mixed) blood.
subsequently found that all endoderm-derived tumors showed elevated CEA, and gastric cancer
4. Transportation and Storage: Store specimens at 2-8°C. Specimens not required for assaying within
patients were positive. Rate can be as high as 50% or more. CEA testing is of great value in monitoring
3 days should be stored frozen (-20°C or lower). Multiple freeze-thaw cycles should be avoided. For
patients with persistently elevated CEA in the blood circulation. High concentrations of CEA predict
shipment, samples should be packaged and labeled in accordance with the existing local and
latent cancer metastasis or residual, and persistently elevated CEA levels may be associated with
international regulations for transportation of clinical samples and ethological agents.
developmental cancer and adverse treatment response, CEA decrease in concentration usually
TEST PROCEDURE
indicates a good prognosis and treatment response. There are various methods for detecting
1. All reagents should be allowed to reach room temperature for 15 minutes before use.
carcinoembryonic antigen in serum, such as fluorescence immunoassay, radioimmunoassay,
2. Dilute the wash buffer at the rate of 1:40 dilution with distilled water before use.
enzyme-linked immunosorbent assay, and colloidal gold assay. It is mainly used for dynamic
3. The sample should be corresponding to the number of micro plate, each plate should be provided
monitoring of patients with malignant tumors to assist in judging disease progression or treatment
with control wells(The number of well is determined by controls and sample) and blank control 1
effect, and cannot be used as a basis for early diagnosis or diagnosis of malignant tumors.
well.
The system of the CEA ELISA test is founded on the solid phase, double antibodies sandwich principle.
Note: Use a separate disposal pipette tip for each specimen, each control as to avoid cross
When CEA is present, it combine with the solid phase monoclonal antibody of CEA and monoclonal
contamination.
anti-CEA conjugated to horseradish peroxidase (HRP-Conjugate). In the course of washing, any
4. Add 50μL sample in the corresponding well, add 50μL each control S1, S2, S3, S4, S5 respectively
unbound HRP-Conjugate is removed. After chromogen solutions A and B are added into the wells and
to corresponding well.
incubation, the result will be calculated with enzyme microplate reader after stop solution is added.
5. Respectively adding Conjugate 50µL(Do not add in the blank well). Shake gently to mix. Incubate at
MAIN COMPONENTS
37°C for 60 minutes with the sealing plate membrane sealing the plate.
Materials provided with the kit:
6. At the end of the incubation, remove and discard the plate cover. Take out, add wash buffer to
Components 96T 480T
each well for 20 seconds. Repeat 5 times. After the final washing cycle, turn the plate over onto
Coated Microtiter plate 1 bag 96 wells 5 bags 96 wells blotting paper or clean towel, and tap it to remove any remainders.
Conjugate 1 vial 6.5 mL 5 vials 6.5 mL 7. Add Substrate A (50µL) and Substrate B (50µL). Shake gently to mix. Incubate at 37°C for 10
Wash Buffer (40X) 1 vial 20 mL 5 vials 20 mL minutes with the sealing plate membrane sealing the plate.
Substrate A 1 vial 7 mL 5 vials 7 mL 8. Add 50μL Stop Solution to each well. Mix gently by shaking, read the absorbance within 10
Substrate B 1 vial 7 mL 5 vials 7 mL minutes after stopping the reaction. Then read the absorbance value at 450nm/ 630nm with the
Stop Solution 1 vial 6 mL 5 vials 6 mL microplate reader. Calculate the concentration and evaluate the results.
Control S1 (5ng/mL) 1 vial 0.5 mL 5 vials 0.5 mL DATA HANDING
Control S2 (10ng/mL) 1 vial 0.5 mL 5 vials 0.5 mL Fit Type: 4 parameters Logistic
Coordinate Choice: X-Y
IFUE-CEA, A/2 1
REFERENCE VALUE (OR RANGE) before use.
Normal concentration (Just for reference): 4. Concentrated washing buffer will produce crystal at room temperature, should be dissolved
Non-smoking normal population ≤ 5ng/mL completely before use.
5. Please put the unused plate back into the bag, and store at 2～8°C.
Smoking population ≤ 10ng/mL 6. Operate strictly according to the instruction, control of reaction time and temperature strictly.
This normal concentration should be build by themselves during the long time practice for each test 7. Never reuse microplate sealing membrane. If the external of the microplate contact with water
room. when warm bath, results will be better.
INTERPRETATION OF RESULTS 8. Use sufficient volume of washing b in the washing steps. Fail to do so may cause color deepening.
1. Chromometry: Read the sample's optical density (OD) at 450nm/630mm with a microplate reader. 9. All reagents were treated by inactivation, but still should be regarded as potentially infectious. All
The detection range is 0.5～ 200ng/mL . If the determination value is higher or lower than normal specimens from human origin should be considered as potentially infectious. Strict adherence to GLP
range, it means there is an inaccurate result, The final result should be diagnosed with clinical (Good Laboratory Practice) regulations can ensure the personal safety.
symptom and other diagnose method. STORAGE AND EXPIRY
2. If the test result is in ±10% Cut-Off value, it should be retest in double wells. The final result should 1. Store at 2-8°C.DO NOT FREEZE. Valid for 12 months.
be diagnosed with clinical symptom and other diagnose method. 2. Once open, stable for 3 months at 2-8°C. Other liquid components have the same validity period
3. Some result out of this detect range calculated through reference curve extension can not be used with the reagent box.
as accurate quantitative result. The result of high concentration sample out of detection range should BIBLIOGRAPHY
be detected after diluted. [1] Pharmacopoeia of the People's Republic of China.
LIMITATIONS [2] Requirements for Biologics of the People's Republic of China.
1. It is no insignificance for positive results must be confirmed with another available method, and it MANUFACTURER
should be interpreted in conjunction with the patient clinical information. Qingdao Hightop Biotech Co., Ltd.
2. This reagent is only used for the detection of human serum/plasma samples. Address: No.369 Hedong Road, Hi-tech Industrial Development Zone, Qingdao, Shandong, China.
PERFORMANCE CHARACTERISTICS Web: www.hightopbio.com Email: sales@hightopbio.com
1. Dosage reflected the curve linear INSTRUCTIONS OF SYMBOL
Correlation coefficient of the standard curve (r) should be ≥ 0.9900.
Consult instruction
2. Limit of detection Keep dry
It should not be higher than 0.5ng/mL for this test kit. for use
3. Precision
Intra-assay: CV%≤15%; Inter-assay: CV% ≤ 20%; Precision between batches: CV%≤20% Store between Batch number
4.Accuracy
Bias% ≤10%
5. Test value for quality control material: Test value for 12ng/mL quality control material should be at Do not re-use IVD product
the range of 9ng/mL~15ng/mL; Test value for 120ng/mL quality control material should be at the
range of 90ng/mL~150ng/mL;
Manufacturer Date of manufacture
6. HOOK Effect: It will not be HOOK effect on the test sample which CEA concentration reached to
200000ng/mL.
7. There is not impact on the result for which sample added into 120IU/mL RF, 1400µmol/LBIL or Expire date Contains sufficient for <n> tests
34mmol/L TG. However, the sample with 20g/L hemoglobin will cause false positive result. So the
sample with hemolysis should be aviod.
8. Sample with AFP, CA125, CA72-4, CA19-9 or CA24-2 has no impact on result.
ATTENTIONS
1. Do not exchange reagents from different lots or use reagents from other commercially available kits.
The components of the kit are precisely matched for optimal performance of the tests.
2. Make sure that all reagents are within the validity indicated on the kit box and of the same lot.
Never use reagents beyond their expiry date stated on labels or boxes.
3. Allow the reagents and specimens to reach room temperature before use. Shake reagent gently

IFUE-CEA, A/2 2