Chicago Tribune (CT) - THURSDAY February 25, 1988 Edition: NATIONAL Section: BUSINESS Page: 3 Word Count: 483
Pamela Sherrod

The test, which is called HIVAGEN, is intended for use in confirming specimens that are positive in the AIDS screening test. The company said the new test virtually eliminates false positives, in which specimens without the AIDS virus appear to have it, and dramatically reduces indeterminate results.

"This test is a quantum leap forward in AIDS testing," said Dr. John Mills, chief of the division of Infectious Diseases at San Francisco General Hospital and professor of Medicine at the University of California's School of Medicine in San Francisco.

"Imagine the advantage of ruling out the anxiety that patients suffer from a false or indeterminate test result," said Mills, who performed the clinical trials. "In addition, retesting following an indeterminate result is costly."

In clinical trials of more than 2,500 individual samples, the HIVAGEN test had no false positives. It reduced indeterminate results by 84 percent in patients with AIDs antibodies, called true positives, and reduced the number by 77 percent in patients without the antibodies, called true negatives.

The HIVAGEN test is based on recombinant DNA technology and highly purified antigens developed by SmithKline & French Laboratories. The SmithKline division introducing the new test, SmithKline Bioscience Laboratories, said the HIVAGEN test will replace the supplemental testing procedure, Western blot assay.

In the controlled clinical trials the new test demonstrated 100 percent accuracy among 225 healthy-true negative-volunteers and was positive in 135 of 136 asymptomatic HIV-infected patients-true positives. Only one infected patient (seven-tenths of one percent) gave an indeterminate result, contrasted with an estimated 12 percent indeterminate rate for the Western blot in infected patients.

Mills said the accuracy of the Western blot depends on the training and ability of the individual performing the test because its technology is manual and requires subjective interpretation of results.

In another advancement related to the AIDs fight, Baxter Travenol Laboratories' Hyland Division said it has received approval from the Food and Drug Administration for its process of manufacturing HEMOFIL Antihemophilic Factor, used in the treatment of hemophilia.

"Risk of viral transmission is the single most important concern voiced by physicians treating people with hemophilia," said Carl Brooks, president of Hyland Division. "Finding a way to reduce the risk of hepatitis transmission, in particular, has long been a Baxter goal."

The process uses monoclonal antibodies to extract Factor VIII:C from plasma.

Factor VIII:C is the clotting protein missing from the blood of people with hemophilia. Baxter said the process significantly reduces the amounts of the viruses that cause hepatitis and AIDS.

For improved viral safety, the company said it has also licensed a solvent-detergent viral inactivation process from the New York Blood Center and added this step to the purifaction process.

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