【Product name】

Carbohydrate Antigen 153(CA153)Rapid Quantitative Test(Fluorescence immunoassay)

【Package specification】

25 Tests/kit

【Intended use】

This kit is used for quantitative determination of CA153 in human whole blood, plasma and serum.

CA153 is a glycoprotein secreted by breast cancer cells that can be measured. While the level of CA153 is rarely elevated in patients with early stage or localized cancer, the majority of patients with metastatic breast carcinoma (MBC) have elevated serum level of CA153. An Italian group has reported that serum CA153 could be an independent prognostic factor for survival and recurrence in addition to visceral metastases. CA 27-29, the other type of assay measuring MUC1 gene-derived glycoprotein, may have clinical utility in assessing the response to treatment. Indeed, some reports show comparable results between CA27-29 and CA153. It is also known that CA153 in combination with CA 27-29 has improved sensitivity, especially in patients with metastatic bone lesions. CEA is also associated with various malignancies, including cancer of the breast, colon, and lung. The low sensitivity of the CEA assay when compared with the CA15-3 measurement, however, reduces the value of CEA in breast cancer management.

【Components】

The components in different batches of kits cannot be used interchangeably.

【Reference interval】

Healthy female are expected to have assay values below 25U/mL. However,it is strongly recommended that each laboratory should determine its own normal and abnormal values.

【Interpretation of results】

1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
2. For samples with CA153 concentration lower than 10U/ml and higher than 400U/ml, the detection results are reported as "< 10U/ml" and "> 400U/ml", respectively.

【Performance】

1. Limits of detection

No more than 10U/ml.

2. Accuracy

The relative deviation from the target value is within ±15%.

3. Precision

The within and between assay coefficient of variations are within 15%.

4. Linear range

Within the linear range (10-400U/ml), the linear correlation coefficient R≥0.990.

【Note】

1. This kit is only used for in vitro diagnosis.

2. The test card and sample diluent are disposable and cannot be reused.

3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃ ~ 30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.

4. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.

5. The used kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.