CBIC issued Clarification on Electro-Chemiluminescence Immunoassay kits

The Central Board of Indirect Taxes & Customs(CBIC) has issued Clarification on Electro-Chemiluminescence Immunoassay kits by releasing Circular.

In relation to the benefit of exemption of duties accorded to Chemiluminescence Immuno Assay (CLIA) kits, the Board is in receipt of representations seeking a clarification on whether Electro chemiluminescence Immuno Assay (ECLIA) kits are covered under the ambit of CLIA diagnostic kits.

Clarification Given By CBIC:

1. Chemiluminescence immunoassay (CLIA) is la widely used detection method which combines the highly-sensitive chemiluminescence assay with highly-specific Immune response and affinity of antibodies. In CLIA diagnostic kits, chemiluminescence technique is combined with immunochemical reactions. CLIA Kits are designed to detect the chemiluminescence reactions. In CLIA the label, i.e. the true “indicator” of the analytic reaction, is a luminescent molecule.

2. CLIA have different label systems according to the difference of physical chemistry mechanism of the light emission which are mention below :-

i. Label Chemical Directly Involved in the Light Emission Reaction

i. Enzyme Catalyzed Light Emission Reaction

iii. Redox Reaction Mediated Light Emission Reaction (ECLIA).

3. CLIA and ECLIA (Electrochemiluminescence immunoassay) both, are advanced methods of Immuno diagnostics based on the concept of antibody- antigen binding. CLIA uses a chemical reaction to generate chemiluminescence following antibody-antigen binding while ECLIA uses an electrochemical reaction to generate chemiluminescence signals in the immunoassay technique. Both techniques are rapid, specific and similar in following points;-

• Both use the concept of chemiluminescence for detection.
• Both techniques rely on the concept of antigen-antibody binding.
• Both are mainly used for disease diagnostics based on analyte detection.

4. Chemiluminescence Immuno assay (CLIA) is a self sufficient kit which provides a sensitive, high throughput alternative to conventional colorimetrie methodologies. In Chemiluminescence Immuno assay (CLIA), the luminescence is produced as a result of chemical reaction where as in Electro Chemiluninescence Immuno assay (ECLIA), the luminescenee is produced as a result of electrochemical reaction. The CLIA and ECLIA can accommodate many immunoasay principles while providing superior performance and the applications, uses of both the techniques are same. Hence both CLIA and ECLIA are one and the same.

To Read Full Circular Download PDF Given Below: