Standards for Anthrax Tests Developed

WASHINGTON (AP) — Scientists working for the government have developed standards to measure the accuracy of anthrax detection tests, hoping to steer first responders away from tests that have delivered too many false readings.

In 2002, the White House warned that not one of the anthrax field tests then commercially available was reliable. Since the 2001 anthrax attacks, these field tests have been commonly used whenever police or firefighters are asked to determine whether a bit of white powder may be a bioterror agent.

The new standards, announced Wednesday, are meant to help sort out which of the detectors actually work. The organization of scientists who developed the standards, AOAC International, said Wednesday that one test, meant for lab use only, has met the standards. A second test, a handheld device for use in the field, has proven effective in the lab but must still be tested in field conditions.

"There’s still uncertainties on the part of emergency responders as to whether or not the equipment that’s been marketed meets any consensus standards," said Bert Coursey, a standards executive in the science and technology arm of the Homeland Security Department, which contracted with AOAC to do the work.

"The emergency responders have to rely on the marketers’ claims," Coursey said. "There’s no way to see how good or bad they are against real agents."

Under a $2.6 million, 18-month contract with the Homeland Security and Defense departments, AOAC developed the standards and tested a first round of anthrax detectors.

Next, the nonprofit company will work with federal officials to develop standards to detect another biological, chemical or radiological agent. The agent or agents have not yet been picked, but candidates include other top biological threats, such as smallpox or botulinum toxin, and chemical threats, such as ricin.

Having reliable anthrax tests was deemed particularly important. After the 2001 attacks-by-mail, there was a large number of false anthrax alarms. Emergency responders would come to the scene and if their initial – often unreliable – devices suggested a powder was anthrax, officials might close buildings or even needlessly give employees antibiotic drugs.

The new standards are not officially endorsed by the government, but Coursey said the Homeland Security Department would recommend that first responders use those tests that have proven effective.

AOAC said Wednesday that it was awarding its "Officials Methods" designation to one laboratory test: MIDI Sherlock Microbial Identification System, manufactured by MIDI Inc. of Newark, Del.

This product, which was successful in detecting anthrax 96.3 percent of the time, has now set the standard for other laboratory tests, said James Bradford, AOAC’s executive director. If another company beats that record, the bar could go up, he said.

The company said a second test – this time, a handheld device used in the field – also met the standards for lab analysis but must be further tested in the field. It is the RAMP Anthrax Test Cartridge, made by Response Biomedical Corp. of Canada.

RAMP tests still must be tried out in real-life conditions to see if they will survive bumpy rides in fire trucks and whether workers, usually dressed in bulky, spacesuit-like hazardous materials outfits, will be able to use them.

"We know it’s good in the lab, but it might be a different thing to take it out," said Bradford.

This device was tested in 12 laboratories to see if it could detect anthrax when only 1 million of the tiny spores were present. Bradford said the Homeland Security Department would not let him to say how many times RAMP met this standard for fear of exposing vulnerabilities to potential terrorists.

Another four tests were also measured by AOAC and its network of laboratories, but none of them met the standard. Bradford said he was barred from naming them.

As a result of the testing, he said, manufacturers are working to improve their products.

"Many of the companies are going back to the drawing board and coming out with second generation" devices, he said.

—

On the Net:

AOAC International: http://www.aoac.org