ABBOTT PRISM Intended Use
The ABBOTT PRISM System is an automated immunoassay analyzer designed to perform Chemiluminescent immunoassay (ChLIA) technology. The ABBOTT PRISM performs batch/continuous access and STAT processing of specimens. The ABBOTT PRISM system is intended for in vitro diagnostic use only.
A high throughput, highly automated test system for blood screening
The ABBOTT PRISM is a fully automated, high-volume blood screening instrument designed to enhance the safety of the blood supply. Before a blood donation can enter the blood supply, it is tested for evidence of exposure to viruses that might cause disease. This screening process involves numerous assays, multiple test instruments and many manual steps. The ABBOTT PRISM instrument consolidates much of this testing into a single system, reducing errors and tampering by automating the manual testing procedures and steps currently used to screen blood.
The ABBOTT PRISM instrument is a completely closed system so once samples are loaded into the instrument, the inner-workings of the analyzer take-over and process samples similar to how an assembly line operates. Samples are transported through each station of the instrument while it detects antigens or antibodies which may be present in the samples. When the screening process is complete, the samples are removed.
Numerous safety features built into the system help track and monitor each sample providing documentation and quality control for testing facilities. Additionally, ABBOTT PRISM testing methodology, Chemiluminescent Immunoassay (ChLIA), allows the system to better detect infectious agents or antibodies which may be present in a sample.
As a donated blood sample is tested, manual documentation of lot numbers, expiration dates, incubation times, temperature and identification numbers must all be checked, recorded and verified multiple times during the screening process. ABBOTT PRISM technology significantly reduces the number of times a donated blood sample is handled by a technician and provides detailed audit trails that track each step of the testing process, eliminating the need for manual documentation and entries during processing. A mistake made during the screening process may produce a false result that might unnecessarily defer a donor or allow an infected unit of blood to be made available for transfusion.
The ABBOTT PRISM system can run 160 samples per hour making it possible to test more than 1,200 samples per eight-hour shift.
Chemiluminescence is the emission of light or photons as a result of a chemical reaction. In chemiluminescence, an excited electron state is created by a chemical treatment of the luminescing compound. When the electrons move from this "excited" or more energetic state back to their more natural "relaxed" state, they release energy in the form of light.
In the ABBOTT PRISM system, a chemiluminescent marker is activated, causing luminescence to immediately occur. This "flash" of light produced by the reaction is measured and quantified, becoming the basis of the test result.
The ABBOTT PRISM system is used in more than 30 countries. Nearly half of these countries rely on ABBOTT PRISM to screen 100 percent of their blood donations.
Features & Benefits
ABBOTT PRISM is an instrument designed with, and for the transfusion industry. It is a high throughput, highly automated test system for blood screening. It has revolutionized the industry due to the following features and benefits:
By automating, the ABBOTT PRISM instrument reduces the risk of accidents, errors or tampering of results. In fact, it reduces the opportunity for human intervention. Something that you, your customers, and your recipients will all appreciate.
ABBOTT PRISM was specifically designed to improve and automate cGMP monitoring and reporting throughout the testing process.
Manual checks and procedures are necessary yet tedious. ABBOTT PRISM was specifically designed to automatically take care of the routine details: processing, monitoring, and documenting for every run.
ABBOTT PRISM is designed to increase lab efficiency. It reduces manual steps and checks so you can reallocate workers and resources to more labor intensive procedures. ABBOTT PRISM increases throughput by running up to 160 samples per hour with STAT test capability in under one hour. ABBOTT PRISM increases throughput while reducing the number of failed runs due to human error. Simply put, this instrument can save you time and money.
ABBOTT PRISM is a flexible and highly efficient system, using microparticles as the solid phase, with chemiluminescence as the detection chemistry. Fifteen years of proven technology is now being used in most major hospitals and reference laboratories and is now available in the transfusion market. It provides accuracy, precision, speed, and automation.
Usage and Safety Information ABBOTT PRISM
System operators must be aware of both biohazardous risks and risks inherent in operating electromechanical equipment and are responsible for using the system only as designed. Failure to follow safe use instructions could cause injury to the operator, damage to the system, or adversely affect assay results.