CEA Rapid Test Uncut Sheet

INTENDED USE

The CEA Gold Rapid Screen Test (RST) is a chromatographic immunoassay for the detection of cancer embryo antigen (CEA) in human serum or plasma or whold blood.

PRINCIPLE

A correlative antigen to intestinal cancer, it can be used to assay the curative effect and prognosis of colon cancer. To some malignant cancer or pulmonary carcinoma outside of the intestine, the concentration of CEA in serum is a high. In clinical, CEA is taken as an early index to colon cancer, carcinoma of stomach, rectal cancer, cancer of esophagus and relapse of cancer after the operation.

The CEA RST is a chromatographic immunoassay (CIA) for the detection of CEA in human serum or plasma. Specific antibody against CEA re-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with other specific antibodies. If CEA present, a pink colored band will develop on the membrane in proportion to the amount of CEA presented in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of CEA.

This RST is convenient, easy to read, sensitive, rapid and credible diagnostic kit that suitable to all levels of hospitals and medical and hygienical institutions.

REAGENTS AND MATERIALS PROVIDED

1.   One pouched cassette with desiccant.

2.   One piece of operating instruction.

WARNING AND PRECAUTIONS

1.  For in vitro diagnostic use only.

2.  Do not use after expiration date.

3.  Test device should remain sealed until use.

4.  The device stored at 4℃ should be balanced to room temperature prior to use.

5.  Desiccant in the sealed pouch, don’t eat it.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).

SAMPLE COLLECTION AND PREPARATION

Fingerstick Specimens (Whole Blood)

1. Clean the area to be lanced with an alcohol swab.
2. Squeeze the end of the fingertip and pierce it with a sterile lancet.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Use micropipet to obtain about 100 ul fresh blood .

Plasma

1. Have a certified phlebotomies collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.

2. Separate the plasma by centrifugation.

3. Carefully withdraw the plasma for testing or label and store it at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up to one year.

Serum

1. Have a certified phlebotomies collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum for testing or label and store it at 2-8°C for up to two weeks. Serum may be frozen at -20°C for up to one year.

ASSAY PROCEDURE

Serum or Plasma Sample

Add 70-100 ul or 2-3 drops of serum or plasma into sample well.

Whole Blood Sample

Add 1 drop of whole blood into sample well, after all blood completely absorbed. Add 1 drop of whole blood diluent. Observe the result in 15-20 minutes.

INTERPRETATION OF RESULTS

1. Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).
2. Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).
3. Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.

PRODUCT DISCLAIMER

This product has been manufactured under strict GMP regulation so to ensure the diagnostic accuracy of the test. It is out of control of the manufacture when the test is performed in diverse environment and by diverse group of individuals which may affect the result to a certain degree.

NOTE

The manufacture, the Distributor or its associates will not be liable for any losses, claims, liability, costs or damages, whether direct or indirect or consequential arising out of or related to an incorrect diagnosis, whether a positive or negative by use of this product.

 

Contact  Rebecca Yan 

Skype: span.biotech

Email: rebecca@spanbio.com

Tel:  +86(755)89589611

Fax: +86(755)89580096

Web:

www.spanbiotech.com

Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Efficiently structured to provide lasting and economic health care solutions with export ready goods, our main products cover the following immunodiagnostic rapid test kits:
Rapid Tests for Human Use :
1) Fertility: Pregnancy HCG, ovulation LH, menopause FSH
2) Infectious diseases: Hepatitis B, HCV, HIV
3) Drug abuse: AMP, BAR, BZO, COC, mAMP, MOP, MTD, OPI, PCP, TCA, THC
4) Tumor markers: CEA, PSA, AFP, FOB
5) STDs(Sexually Transmitted Diseases): Gonorrhea, syphilis, chlamydia
6) New products: Malaria, H. Pylori, Multi-Hepatis B Panel (HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc), Blood Glucose Test, Multi-drug of Abuse Panel, Avian (Bird) Flu Rapid Test, etc.
Rapid Tests for Veterinary :
1) Bovine: Cow Pregnancy , Cow Ovulation, Bovine Brucella, Bovine Tuberculosis ,Food and Mouth Disease NSP Ab Test
2) Canine: Canine Distemper, Canine Parvovirus, Canine Coronavirus
3) Feline : Feline Leukemia Virus Ag Rapid Test ,Feline Panleucopenia Virus Ag Test,Feline Immunodeficiency Virus Ab Test
Rapid Tests for Food Safety :
1)For Antibiotics Residue : Nitrofurans (AOZ,AMOZ, AHD, SEM), Streptomycin , Sulfonamides , Chloramphenicol , Quinolone , Beta-Lactam&Tetracycline Combo (2 in 1), β-Lactams & Streptomycin & Chloramphenicol & Tetracyclines Combo (4 in 1), Beta-Lactam, Tetracycline test
2) For Beta-Agonist Residue : Ractopamine, Clenbuterol ,Salbutamol