Roche: New Test Elevates HIV Diagnostics

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Roche says the Elecsys can detect HIV two weeks earlier, because it analyzes antibodies and antigens in the blood. Roche says the Elecsys can detect HIV two weeks earlier, because it analyzes antibodies and antigens in the blood.

Indianapolis was the nerve center for clinical trials that have now led to Roche Diagnostics launching its newest HIV test in the U.S. Roche says the Elecsys HIV combi PT assay is a significant step forward in infectious disease diagnostics; it can detect the virus about two weeks earlier than previous generations and diagnose multiple infectious diseases using a single sample—rather than running multiple tests on different pieces of equipment.

Efficiency is critical when one considers Roche equipment and its assays are responsible for analyzing millions of samples annually inside large reference laboratories. An important feature of the Elecsys assay, or test, is that it’s automated.

“That means less hands-on time required by the medical technologist. It’s our job to streamline their workflow as much as possible by providing efficient testing means,” says Roche Diagnostics Marketing Manager of Infectious Disease Jamie Flanagan. “We’re trying to provide a consolidated approach to the lab; [the Elecsys] has only one touch point on the patient sample. In that patient’s one tube [of blood], it can run all of their infectious disease testing and not have to go back to touch the tube again.”

Unlike earlier generations, the Elecsys can simultaneously test for hepatitis C and syphilis, which are common co-infections. Roche says this reduces the need to obtain multiple samples and use additional analyzers.

“Because HIV, hepatitis c and syphilis are often co-infections in the same patient, it’s important to utilize that one tube to get patient results,” says Flanagan. “It’s a factor in patient satisfaction and patient management from the clinician’s perspective—to have all of the answers from those three assays in one setting and one report.”

The Elecsys, which is a fourth-generation test, can also detect HIV two weeks earlier, because it analyzes antibodies and antigens in the blood; the third-generation assay focuses on only antibodies. The company says another unique factor of the Elecsys is its versatility; the assay can be run in large reference labs or hospital and clinic settings in smaller communities using Roche equipment.

A similar diagnostic tool is helping manage the HIV outbreak in Scott County, caused by the injection drug use of prescription opioids. In the field, the Indiana State Department of Health (ISDH) uses a rapid oral swab for initial detection of the disease, then sends blood samples to the ISDH lab to confirm the diagnosis.

While the state uses a fourth-generation antigen-antibody assay in its lab to detect HIV, the Elecsys—just launched in June of 2017—hasn’t been involved in managing the Scott County outbreak, which surfaced in early 2015. IUPUI Richard M. Fairbanks School of Public Health Associate Professor and Associate Dean of Public Health Practice Dr. Joan Duwve applauds any advances that could expand the public health leaders’ toolbox.

“I recognize the value of scientific achievement, and I’m always excited when science shows us a better way to do things,” says Duwve. “In situations with emerging pathogens, like Ebola or Zika, public health labs actually are first to have access to the latest and greatest diagnostic tests, before they’re even available to commercial labs. Public health labs also work closely with partners at the Centers for Disease Control, other state public health labs or private labs to expand their capacity. With limited public health resources, you have to make sure you’re getting the biggest bang for your buck.”

Roche says its fourth-generation test has been available in other countries for many years and will bring a new level of sensitivity to HIV diagnostics in the U.S.

“The sooner patients are diagnosed in conjunction with the aid of our assay,” says Flanagan, “the sooner they can be treated and receive therapies.” 

Flanagan says a fourth-generation test has been available outside of the U.S. for about 10 years.
Flanagan says Roche’s portfolio of infectious disease assays covers the entire spectrum of volume requirements.
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