Our ECLIA system is an integrated (closed) chemiluminescence immunoassay in-vitro diagnostics ("IVD") system comprised of an analyzer and reagents that are used to detect and quantify particular antibodies or antigens for the diagnosis and analysis of various diseases and disorders. Our first generation ECLIA system was approved by the State Food and Drug Administration (the "SFDA") of the People’s Republic of China ("PRC") in 2004.
Our ECLIA analyzer is a sensitive, accurate, cost-effective and simple-to-use IVD device capable of detecting minute levels of light triggered by combining reagents with body fluid samples to produce a diagnostic result. The key component of our ECLIA analyzer is the photon counter. We have developed several technologies that make our photon counter more sensitive and accurate. Embedded in our ECLIA analyzer is a data analysis system.
We provide Bright GeniusTM software which is designed specially for hospitals. Its friendly panel and counting system makes operation and analysis easy for customers. Furthermore, the data analysis system also uses our proprietary integrated circuit card ("IC Card") input technology to analyze and organize the information produced. The IC Card contains encryption codes that prevent users from conducting tests with reagents produced by other manufacturers.
We currently offer both our first and second generation semi-automatic analyzers. The second generation, which we launched in October 2006, is equipped with automated substrate access. We are currently developing our new fully-automatic analyzer. All of our ECLIA offerings are closed systems and are only compatible with our own reagents.
MPC-1: Our first generation semi-automatic analyzer
Reagents are chemically active substances that are formulated to create different reactions with blood or other bodily fluid samples depending on the extent to which a disease or condition is present or absent.
Tests should be conducted strictly in accordance with relevant procedures and requirements, as well as laboratory safety principles. A brief description of the steps is illustrated as follows:
1. Sample Preparation
The blood sample is placed in a clean and disposable tube and the serum is separated by centrifugation. Tests should be carried out on the sample immediately after centrifugation. If the sample is to be tested within one working day, it may be stored at room temperature. If not, it should be stored below -20°C. Repeated freezing and melting should be avoided.
2. Reagent Kit Preparation
The reagent kit should be stored at a temperature between 2°C-8°C and freezing storage is prohibited. Prior to testing, the reagent kit should be taken out of the refrigerator and balanced at room temperature for at least 30 minutes. For the same test, reagents of different lot numbers should not be used. The reagent kit should be stored back in the refrigerator after each application.
3. Sampling
Samples and other reagents are added to a microplate coated with antibodies or antigens. The number of samples to be used should strictly follow the directions stated on the reagent kits. It is recommended to add enzyme-labeled materials (enzyme conjugate) or captured antibodies into the wells first, followed by the samples, calibration materials and quality control ("QC") reagents. The microplate should be sealed properly with the cover membrane to prevent samples from evaporating, overflowing or mixing with impurities and cross-contamination in the process of incubation.
4. Incubation
Incubation is performed in a compatible shatter machine or water bath. Microplates should be placed horizontally and timing must strictly follow the directions stated on the reagent kits. If an antibody to the antigen (or vice versa) is present in the sample, an antigen-antibody complex will form. The antigen-antibody complex is present only in the wells that contain the specific antibody or antigen.
5. Washing
A washing device is used for rinsing the microplates to remove excess antigens, antibodies or other solutions. Specific washing methods and the number of washes required are stated on the reagent kits. Either manual wash solutions or automatic plate washing machines can be used.
6. Adding Chemiluminescence Solutions (Enhancer and Substrate)
An equal volume of enhancer and substrate are mixed thoroughly and added to each well of the microplate immediately following the mixing. The substrate will react with the antibody-antigen complex to produce a luminescent (light) signal. The enhancer is used to magnify the signal and to extend the signaling period for better measurement.
We provide two different methods for adding the chemiluminescence solution:
Manual adding – MPC-1
Automatic adding – JETLIA-96/2
7. Luminescence Measurement and Results
Immediately after adding the chemiluminescence solution, photons are counted and the intensity of the luminescent signal is measured by placing the microplate in a Microplate Single Photon Counting System (MPC-1 or JETLIA-96/2). The counting results and control reference may be printed together after self-calibration and calculation.
ECLIA Brochure
top
Disclaimer