HIV Real-Time PCR Viral Load Test

An HIV-1 real-time polymerase chain reaction (PCR) test for monitoring viral load, one of the most sensitive viral load tests available, has received the CE Mark.

The test is capable of detecting HIV-1 in plasma down to as few as 40 RNA molecules per milliliter and as high as 10 million RNA molecules per milliliter, thereby reducing the need for sample dilutions and additional testing. The method is called real-time PCR because the amplified DNA can be detected during the PCR process, in real-time rather than at the end of the process. This ensures more accurate and precise quantification of nucleic acid. The test was developed by a joint venture formed by Abbott (Abbott Park, IL, USA) and Celera Diagnostics (Alameda, CA, USA) to develop a broad range of in vitro molecular diagnostic tests.

The Abbott RealTime HIV-1 assay was developed for use on the Abbott m2000 instrument system, which purifies the nucleic acid from the specimen and automatically combines this with the assay reagents. The system's software has been specifically designed to be user-friendly, and results are automatically calculated to provide highly reliable results for HIV viral load testing.

"With the dramatic improvements in antiretroviral therapy for patients infected with HIV, the ability to accurately and quickly measure virus levels in the blood is essential in providing optimal treatment for patients and improving the quality of their lives,” noted Anna Maria Geretti, M.D., Ph.D., head of the retroviral laboratory, Royal Free Hospital (London, UK), whose laboratory was one of more than 20 clinical sites throughout Europe to participate in the evaluation of the Abbott RealTime HIV-1 assay and the m2000 system. "Our experience with this test has demonstrated its effectiveness in quantifying the diverse subtypes of this virus across a range of plasma RNA levels.”

Quantitative measurements of HIV levels in blood are an essential part of the prognosis and management of HIV infection. The Abbott-Celera joint venture is developing additional tests for the Abbott m2000, including methods for detecting hepatitis C, hepatitis B, chlamydia, and gonorrhea.





Related Links:
Abbott
Celera Diagnostics