Colloidal Gold Home Cancer Testing Kit

Carcino-embryonic Antigen quantitative rapid test kit (colloidal gold)

For the quantitative detection of CEA in serum/plasma /whole blood

Intended Use

Diagnostic Kit for Carcino-embryonic Antigen (CEA) is a chromatographic immunoassay (CIA) for the quantitative detection of Carcino-embryonic Antigen in serum/plasma and whole blood with the use of NEWSCEN Immuno Assay Reader.

Principle

Diagnostic Kit for Carcino-embryonic Antigen (CEA) is a double antibody sandwich immunoassay kit for the quantitative testing of Carcino-embryonic Antigen in blood. The membrane was precoated with CEA specific antibodies on the test band region and goat anti mouse IgG on the control band region.

During the test, the specimen is allowed to react with CEA specific antibodies-colloidal gold particles conjugate, which was predried on the test strip.The conjugate binds to the CEA forming an antibody-antigen complex.

The complex moves forward on the membrane by the capillary action, then the complex is captured by CEA specific antibody on the test region to produce a visual pink color band. The color band is positive correlated with the concentration of CEA of the specimen.

Regardless of the presence of CEA, as the mixture continues to move across the membrane to the control band region, the complex is captured by immobilized goat anti mouse antibodies to form a distinct pink colored control band.

Composition

The test kit contains CEA Specific antibodies on a colloid gold particles and a combination of CEA Specific antibodies on the membrane.

Specimen Collection

Fingertip Specimens (Whole Blood)

☀ Clean the area to be lanced with an alcohol swab.

☀ Squeeze the end of the fingertip and pierce it with a sterile lancet.

☀ Wipe away the first drop of blood with sterile gauze or cotton.

☀ Use micropipet to obtain a moderate amount of fresh blood .

Plasma

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

☀ Separate the plasma by centrifugation.

☀ Carefully withdraw the plasma for testing, or label and store sample in 5 days at 4℃. Plasma may be frozen at -20℃ for up to 3 months.

Serum

☀ Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.

☀ Allow the blood to clot.

☀ Separate the serum by centrifugation.

☀ Carefully withdraw the serum for testing or label and store sample in 5 days at 4°C. Serum may be frozen at -20℃ for up to 3 months.

Assay Procedure

☀ Bring the test to room temperature; Remove the test card from the foil pouch and place on a clean dry surface.

☀ Take the fresh whole blood/serum/plasma without pretreatment; bring 2~8℃stored specimen to room temperature for test.

☀ Remove the sample diluent, blending and set aside.

☀ Add 10μL of serum or plasma or 20L of whole blood into S well, add 80μL of buffer into B well. Read the result with Immuno Assay Reader within 15~20 minutes. Results after 20 minutes may be invalid.

☀ Calibration: before read the result, need to confirm that the Reader is in normal state. And the Reader passes the daily photometric calibration. Moreover, before read the cassette, import the standard curve.

Interpretation of Results

☀ Test results in the reference value, indicates that the body did not occur related diseases of CEA abnormal expression.

☀ The test result is higher than the reference value, indicates that the body has abnormal expression of CEA . There may be some pathological changes, colon polyps, ulcerative colitis, pancreatitis, liver cirrhosis, benign or malignant tumor ,can cause CEA elevation. CEA elevation could not determine the specific cause. In general the results were positively associated with the degree of abnormity.

☀ The results > 150ng/mL, indicates that CEA content of sample is higher than the upper limit test range. Recommend repeat testing after appropriate dilution, until you can get the specific concentration values, multiplied by the dilution factor is the sample concentration.

☀ Invalid result, no control line observed, retest required.

Quality Control

Diagnostic Kit for Carcino-embryonic Antigen has included a procedural control in the test. If a test kit is valid and assay was performed properly a pink colored band will always appear in the membrane regardless the test result.

Materials Required But Not Provided

☀ Clock or Timer

☀ Centrifuge tube

Reagents and Materials Provided

☀ One pouched cassette with desiccant.

☀ One instruction.

☀ One bottle of buffer.

Newscen Biopharm Co., Limited is a professional manufacturer of in vitro diagnostic products and related supporting apparatuses, which is jointly founded by Tianjin Pharmaceutical Group, Tianjin Zhongxin Pharmaceuticals Co., Ltd and oversea Chinese entrepreneurs.

Founded in 2003, the company is one national high tech corporation and Tianjin Grade A medical device manufacturer. Over the years, the company has been committed to the research, development, production and sales of in vitro diagnostic products and related supporting apparatuses, and also has provided OEM and ODM and technology transfer and cooperation as well as some other customer market based diversified services to customers at home and abroad.

NewScen is based on independent innovation and relies on the talent sharing at home and abroad, information interaction advantage, antibody preparation and new product R & D technology platform to develop and produce nine series about one hundred kinds of products including tests and instruments and put on the market in succession.

HIV (1 + 2) antibody rapid test Kit and other IVD (In Vitro Diagnostic) devices obtained National Patent and National Class of New Drug Certificate; HCV Antibody Rapid Test is the first double antigen sandwich test HCV patented product; NewScen’s quantitative test broke through the technical difficulty of the colloid gold quantitative detection, opening up a new situation for clinical application of Colloidal Gold test. Rapid immuno assay reader provides an open and common platform for qualitative and quantitative detection of the Colloidal Gold test.

The company has received CFDA medical device certificates of 32 products, 49 independent Intellectual Property Rights, FDA certificates of series of products and European CE certificates of 16 products. Production management is in strict accordance with the regulations of in vitro diagnostic product production as well as international quality management system (ISO 9001, ISO 13485) so as to ensure high product quality. Products are sold throughout the country and in North America, South America, Southeast Asia, Europe, the Middle East, Africa and other international markets.

Currently, the company integrated Colloidal Gold test, immunochromatographic interpretoscope and cloud technology and other technical advantages, and created management integrated POCT system, so as to achieve convenient, accurate and efficient onsite data collection and remote guidance or data sharing of the monitoring center and promote the development of modern testing technique and the improvement of diagnosis and treatment level.

NewScen has obtained the project support from Tianjin or the country for nine times in succession, has been identified as one Hightech Enterprise in Tianjin, has obtained the title of “Top 100 Enterprise in Tianjin” among Tianjin SMEs, and is the rapid diagnostic Hightech demonstration project base and National 863 Project undertaker awarded by the NDRC (National Development and Reform Commission).

Fecal Occult Blood, Serum Ferritin and Hepatitis C rapid test products were named Tianjin independent innovation products; brand “YBT”products have been awarded the title of “Chinese Women and Children Favorite Brand Product” by Chinese Women and Children Development Center; “YBT” trademark was named “Tianjin Famous Trademark”.

“Honesty, Verity, Authenticity, and Innovation", is our persistent commitment.

“Encouraging Our Employees Growing With Company” is the driving force beneath our surging growth.