MEDICAL

Disease Detection International Inc. said it has received U.S. Food and Drug Administration approval to market blood tests that can measure the presence of antibodies to viruses that cause rubella, herpes, cytomegalvirus or toxoplasma within 7 minutes in a doctor’s office.

Current tests, which typically are conducted in clinical laboratories, require blood samples to be diluted and take several hours to complete, the Irvine diagnostics company said.

The tests, called SeroCard tests, use plastic cards embedded with membranes on which doctors place a drop of blood from a patient’s finger. DDI President H. Thad Morris said the appearance of a blue spot on the card indicates a positive test.

A positive test means that antibodies to the viruses are present in the bloodstream and that the patient has developed an immunity to further infection.

The company said the tests are most often conducted to determine if pregnant women are susceptible to the viral infections, which can cause birth defects.

Rubella, also known as German measles, causes enlargement of lymph nodes in the neck and a rash. Herpes is a skin inflammation characterized by small blisters. Cytomegalvirus is a disease involving abnormal cell enlargement. Toxoplasma is a parasitic organism sometimes found in uncooked pork products.

DDI said it has developed a similar 7-minute physician-conducted test to detect the presence of antibodies to the human immunodeficiency virus, or HIV, which causes AIDS. A positive HIV test indicates the presence of antibodies, however the antibodies have not successfully fought the virus.

The company said that later this year it will seek FDA formal clinical approval for the HIV test.

The HIV test was developed jointly with Ferring Pharmaceuticals in Sweden. DDI said that, so far, it has tested more than 2,000 clinical specimens using the SeroCard. And it is selling the test for research and investigative use by physicians.

Morris said the company expects to receive Swedish regulatory approval to market the product later this spring. If U.S. approval is not received, he said, Ferring will begin production in Sweden, and DDI will seek marketing approval in other European countries and in Japan.

Morris said the FDA has told him there are “many questions that must be answered” before approval will be granted.