4mm Cassette Home Testing Kits CE , Home Aids Test Kit For Carcinoembryonic Antigen

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%