CITEST DIAGNOSTICS INC.
CITEST DIAGNOSTICS INC.
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Convenient Carcinoembryonic Antigen (CEA) Test Easy Use By CItest GO fluorescence Immunoassay Analyzer Serum /Plasma
| Product features | Parameters |
| Principle | Fluorescence Immunoassay |
| Format | Cassette |
| Specimen | S/P |
| Certificate | CE |
| Reading Time | 15 minutes |
| Pack | 10T/25T |
| Storage Temperature | 4-30℃ |
| Shelf Life | 2 Years |
| Cut-Off | 4 ng/mL |
A test for measuring Carcinoembryonic Antigen (CEA) in serum or plasma with the use of CitestTM GO fluorescence Immunoassay
Analyzer. For professional in vitro diagnostic use only.
| 【PERFORMANCE CHARACTERISTICS】 1. Accuracy The deviation is ≤ ±15%. 2. Analytical sensitivity The CEA Test Cassette can detect levels of CEA as low as 1 ng/ml in serum, plasma. 3. Linearity range 1 – 500 ng/ml , R≥0.990 4. Precision C.V. ≤15% |
Fast Result (15 minutes) Simple Operation (Less Training Required) Objective (Results Read by Analyzer) Stringent Quality Control Insure High Accuracy User-friendly (Simple Plug & Play Operation) High Efficiency (Both STAT Testing and Batch Testing) |
Application:
The CEA Test Cassette (Serum/Plasma) is based on Fluorescence immunoassay for the quantitative detection of CEA in serum or plasma to aid in monitoring of cancer patients.
Description:
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 quantitative 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 of 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.
How to use?
Refer to CitestTM GO Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions on use of the Test. The test should be in room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “standard test” or “Quick test” mode.
2. Remove the ID card and insert it into the Analyzer ID Card Slot.
3. Pipette 50 μLof serum or plasma into the buffer tube, mix the specimen and the buffer well.
4. Pipette 75 μL diluted sample into the sample well of the cassette. Start the timer at the same time.
5. There are two test modes for CitestTM GO Fluorescence Immunoassay Analyzer, Standard Test mode and Quick Test mode.
Please refer to the user manual of CitestTM GO Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: After 15 minutes of adding sample,Insert the test cassette into the Analyzer click “QUICK TEST”, fill the test information and click "NEW TEST" immediately. The Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after adding specimen, click “STANDARD TEST”, fill the test information and click "NEW TEST" at the same time. The Analyzer will automatically countdown 15 minutes. After the countdown, the Analyzer will give the result at once.
INTERPRETATION OF RESULTS
Results read by CitestTM GO Fluorescence Immunoassay Analyzer.
The result of tests for CEA is calculated by Citest TM Fluorescence Immunoassay Analyzer and display the result on the screen. For additional information, please refer to the user manual of CitestTM GO.
Fluorescence Immunoassay Analyzer.
Linearity range of Citest TM CEA is 1-500 ng/mL.
Reference range:＜4ng/ml.
| Catalogue Number | Item Name | Sample | Test Range | KIT size |
| FI-CEA-302 | CEA Test Cassette | S/P | 1~500 ng/mL | 10T/25T |