The US Food and Drug Administration (FDA) approved Roche's AMPLICOR HIV-1 MONITOR? Test, has been chosen by our Virology and Molecular Micorbiology Unit, since it is the first commercial test to accurately and precisely measure quantities of HIV-1 RNA in the blood (viral "load”). The test uses polymerase chain reaction (PCR) technology, a process that allows the amplification and identification of specific DNA or RNA sequences. It is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis. Research suggests that viral load may be predictive of the clinical progression of HIV disease. The test has also been used as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV RNA levels. Roche Diagnostics received FDA approval for the first PCR-based HIV test - Amplicor HIV-1 Monitor? test - in June 1996. This test measures the amount of active HIV in a person’s bloodstream across a dynamic range of 400 to 750,000 copies of HIV-1 RNA per millilitre of plasma.
The AMPLICOR HIV-1 MONITOR? test quantitates viral loads over a broad dynamic range and to levels as low as 400 HIV RNA copies/mL. The test measures the amount of virus in a sample by comparison to a reference standard containing a known quantity of synthetic RNA that is added to each specimen. The test requires fewer steps and is less time-consuming than alternative methods, with results available in less than six hours. As the first standardized system that includes all reagents needed for quantitative PCR, the AMPLICOR HIV-1 MONITOR? Test provides reliable results quickly, permitting its use on a large scale by many laboratories.
Amplicor HIV-1 Monitor UltraSensitive Method has recently received approval from the US Food and Drug Administration (FDA). This test is the most sensitive means of measuring the amount of HIV circulating in an infected person’s blood (viral load). It can measure levels previously considered undetectable - to as few as 50 copies per mililitre of plasma. This approval represents a significant advance in the battle against HIV. Published studies indicate that lowering plasma HIV RNA (ribonucleic acid) to below 50 copies per millilitre is associated with more complete and durable viral suppression. Physicians will now have a clearer picture of the effectiveness of anti- HIV therapy. The Amplicor HIV-1 Monitor UltraSensitive Method is based on the Nobel Prize-winning polymerase chain reaction (PCR) technology. PCR enables amplification and identification of specific DNA (deoxyribonucleic acid) or RNA sequences in blood samples. Because PCR can directly detect the presence of viral material in a person’s blood, it has become the diagnostic "gold standard" in the management of infectious diseases such as HIV/AIDS and hepatitis.
COBAS AMPLICOR system has been set up in our laboratory. The COBAS AMPLICOR is the first system to automate both the amplification and detection steps of the PCR testing process by combining five instruments into one (thermal cycler, automatic pipettor, incubator, washer and reader). The system is a benchtop system that makes PCR testing a routine diagnostic, especially for the MONITOR (quantitative) tests. The COBAS AMPLICOR (tm) automation maximises walkaway time, improves laboratory productivity and assures result integrity. The software allows MultiPlex (multiple detections from an amplified sample) and ReFlex (automated pre-selected next test detection) testing. The COBAS AMPLICOR (tm) amplifies and detects up to 24 samples simultaneously with parallel amplification and detection of up to 48 samples. Up to six detections can be performed on each amplified ample, the system delivers 50 detection results per hour. For the MONITOR (tm) (quantitative) tests dilutions are performed automatically onboard.
HIV-AIDS
AMPLICOR HIV-1 MONITOR (tm) is the first test to accurately and precisely measure quantities of HIV-1 RNA in blood and is now considered to be the most sensitive quantitative test commercially available. It is used for disease prognosis, therapeutic monitoring of antiretroviral therapy and for the overall care of HIV/AIDS patients.
Hepatitis
b DNA (Chiron) and AMPLICOR HCV/HBV MONITOR (Roche)are selected for diagnostic useSexually transmitted diseases
The AMPLICOR (tm) Chlamydia trachomatis test is currently used to detect this sexually transmitted disease, from endocervical and urethral swabs, and male urine samples.