WASHINGTON, D.C. -- The Centers for Disease Control and Prevention (CDC) is offering a new experimental laboratory test for patients suspected of being infected with the SARS virus to about 100 specialized laboratories around the country.
The experimental diagnostic test was rapidly developed by the CDC during the past few months in an urgent effort to address this pressing public health need. The Food and Drug Administration (FDA) has worked closely with the CDC to develop appropriate information for patients and health professionals in order to make the test available on an investigational basis. Because information about the test's performance is still being collected, patients will be asked for written consent before the test is used.
"Because of the special efforts of the dedicated professionals at these two agencies to respond effectively to SARS, we now have a needed SARS diagnostic test for use at a growing number of laboratories," Health and Human Services Secretary Tommy G. Thompson said. "This experimental test marks a significant step forward in our ability to confront and ultimately overcome this new disease, and its development embodies the commitment of our department to protecting public health."
The new test uses polymerase chain reaction technology to detect evidence of the presence of the coronavirus. Polymerase chain reaction is a way to detect the genetic material of an organism in a couple of hours. The standard method of growing the organism in cell culture takes several days or up to several weeks.
As part of the wider distribution of the new test, patients and practitioners will receive clear information about how the test may assist in diagnosing SARS. The CDC and FDA are also cooperating on further scientific evaluation of the new test's accuracy and reliability.
In addition, through the evaluation of the test in more patients and settings, more will be learned about the accuracy and reliability of the test, and how it can be improved. This information will support the development of approved diagnostic tests as quickly as possible.