Tumor Mark CEA Home Testing kits, 4mm cassette set, detecting Carcinoembryonic Antigen, home use

Product Name: CEA Rapid Diagnostic Test

Intended Use:

The CEA Home Testing kit is a rapid chromatographic immunoassay for the qualitative detection of CEA in whole blood, serum or plasma to aid in monitoring of cancer patients at home.

Summary:

Carcinoembryonic Antigen (CEA) is a tumor-associated antigen characterized as an oncofetal glycoprotein. CEA is expressed in a variety of malignancies, particularly pulmonary or gastrointestinal tumors (e.g. colon cancer, liver cancer and lung cancer). CEA normally occurs in fetal gut tissue with detectable serum levels essentially disappearing after birth.Therefore, elevated levels of CEA can be of significant value in the diagnosis of primary carcinomas. In addition to qualitative assessment, CEA testing plays an important role in the monitoring of cancer patients. Clinical evidence indicates that CEA levels can serve as predictive markers in both pre- and post-treatment cancer. Progressive elevation of CEA may signal tumor recurrence 3-36 months before clinical evidence of metastasis. Persistent elevation of circulating CEA following treatment is strongly indicative of occult metastatic and residual diseases and deficient therapeutic response. The CEA Rapid Test Cassette (Whole Blood/Serum/Plasma) utilizes a combination of anti-CEA antibody coated particles and anti-CEA antibodies to detect elevated levels of CEA in whole blood, serum or plasma. The minimum detection level is 5ng/ml.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to begin testing.

2. Remove the device from the sealed pouch and lay it on a flat and dry surface.

3. Using the provided pipette, add one drop of fresh specimen to the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Read the result between 15-20minutes. Do not read results after 20 minutes.

PERFORMANCE CHARACTERS:

Sensitivity and Specificity

Clinical Performance For One Step CEA Test

A total of 223 patients was selected as participants in this study, the samples collected from these patients were tested by the RDTs and by a commercial Elisa Test. Comparison for all subjects is showed in the following table.

Table 2　

Sensitivity＝[90/(90+4)]×100%=95.74%

Specialty＝[126/(3+126) ]×100%=97.67%

Total＝[(90+126)/(90+4+3+126)]×100%=96.86%

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.