Keeping tabs on AIDS virus changes
Great progress has been made in battling HIV AIDS since the deadly virus emerged more than two decades ago. But there's a new cause to worry.
"Just as clinicians were gaining a high degree of confidence that most patients with HIV infection could be treated and monitored successfully with drug therapies, they now face the troubling emergence of variant subtypes," said John Robinson, senior director, research and development with Abbott Laboratories Molecular division. "According to some studies, these infections may represent up to 10 percent of HIV infections in certain areas of the United States and have important implications for HIV-1 diagnostics and patient management."
But thanks to Abbott's new RealTime HIV-1 viral load test, those new strains can be detected and monitored, and the test and Abbott's automated diagnostic technology are being used to help physicians determine the prognosis for the disease in individual patients, and the best course of treatment.
The innovative new molecular diagnostic test is the only one currently available that can detect the common strains of HIV as well as all known variants of the virus.
It's an innovation in medical care that earned Abbott its third Chicago Innovation Award.
The test targets a specific region of the virus' genome, enabling doctors to detect all known forms of the virus.
Being able to measure the viral loads of all strains of the virus in the blood is critical to treatment because it helps determine if the infection is under control.
HIV viral load levels influence when patients will progress to full-blown AIDS. So measuring viral load levels has been shown to be essential in understanding the prognosis in individual patients and in helping to monitor if the drug treatment is working. The goal of HIV therapy is to reduce the virus in blood to undetectable levels, thereby preventing progression to AIDS.
The reliability and precision of the test on Abbott's m2000 Instrument system should raise physicians' confidence in assessing viral levels in their patients, enabling them to provide optimal treatment, Robinson said.
The m2000 system automatically detects very small levels of viruses in patient samples, said Scott Safar, senior director, systems development and engineering, Abbott Molecular.
"What we were trying to achieve was something for laboratories that would be easy to use, and that would be faster in terms of processing results than current methods," he said.
Lab technicians can automatically load tubes with blood samples onto the system. It detects the bar code with the patient's identification, eliminating the need for technicians to type in the code numbers, and then tracks the patient's sample all the way through the generation of final test results, reducing the risk of errors. The system also automatically purifies the nucleic acid from the patient samples, and software automatically produces quantitative results.
Many tests can be generated in a short period of time, allowing hospital laboratories to get those results to the physicians quickly, Safar said. The system can produce 96 results per shift, compared with 24 when such tests are done manually and 72 by other automated methods, Safar said.
The test was approved by the U.S. Food and Dug Administration in May, and today is in 300 labs worldwide.
Abbott projects revenues of more than $10 million this year.
With increased global travel and immigration, the variant strains of HIV are expected to become more prevalent in the United States, creating greater demand for the test.