As the avian flu virus gradually spreads worldwide, diagnostic firms are gearing up to meet the challenge.

Qiagen (Venlo, the Netherlands) this week reported the global launch of two test kits for the detection of the much-feared virus. And Tm Bioscience (Toronto) has reported that it has developed an upper respiratory viral panel that it said detects all of the major human respiratory viruses, including H5N1 (avian flu) and SARS Corona, or severe acute respiratory syndrome. Additionally, Quest Diagnostics (Lyndhurst, New Jersey) said it has developed a test to detect the avian flu virus.

Qiagen's molecular test for humans, called the artus Influenza/H5 kit, was being offered as of Tuesday by the company's sales team focused on molecular diagnostics testing, Dr. Solveigh Mahler, director of investor relations and public relations for Qiagen, told Diagnostics & Imaging Week.

As for the demand for such a test, Mahler said, "Look around – there's a lot of requests and a lot of need for this kind of testing."

She said that the company can handle the current demand, since the virus is still only at "threat" level in many areas of the world, but that the need could increase greatly as governments ramp up their emergency plans.

She specifically referred to the $6.5 billion budget amount President George Bush plans to allocate targeting avian flu testing.

"And I think one big point is if the avian flu virus really spreads over to the U.S. or European countries," she said. "These are the most important questions."

Qiagen's test for humans, which has been in development for some time, "combines a highly specific assay for the detection of characteristic nucleic acids [RNA] of avian flu [H5N1] virus strains," the company said. Qiagen also noted that the test "requires only small sample amounts of a patient's sputum, throat and nasal swabs" and "can detect an infection of influenza or avian flu in less than two hours."

The test is run on Qiagen's LightCycler instrument.

The company said that "contrary to the classical detection procedures for influenza viruses which require seven to 14 days time for results, the specific and highly sensitive Qiagen detection kit reduces the time to detection of the influenza or avian flu virus to less than two hours."

The much shorter analysis time, in combination with highest levels of sensitivity and reliability, allows detection of the influenza virus at a very early stage, it said.

The second kit added to the portfolio is for animals and was launched in China initially in 2004 by PG Biotech, a company that Qiagen agreed to acquire in September. A specific avian flu molecular detection kit, the test targets veterinary, import/export control and quarantine needs, according to Qiagen.

"This molecular test is worldwide the first product approved by a governmental authority specifically to detect avian flu in animals," the company said. "It is believed to be by far the most widely used test kit for this purpose in the world."

Tm Bioscience said its test was developed in collaboration with researchers in the lab of Dr. Jim Mahony at McMaster University (Hamilton, Ontario) as reported in May. Tm said that the prototype test is "currently undergoing optimization and will begin clinical evaluation in the coming weeks."

Richard Janeczko, chief scientific officer for Tm, told D&IW that the company's targeted time-frame for making the test commercially available in the U.S. is Jan. 15 of next year.

"Tm is in discussions with regulators, including the FDA, on preparing IVD submissions for expedited review," the company said in a prepared news release.

In the mid-January timeframe, the test would be made available not only to hospital laboratories, primarily in North America, but to "surveillance containment programs that have been established worldwide."

"We are currently in discussions with public health authorities in North America, throughout the Pan-American and Pan-Asian and European regions, and we're discussing with them the potential use of this product for their surveillance programs," Janeczko said, noting later that "the worldwide application of this is really much more focused on public health, rather than on hospital environments where they're looking at patients arriving on their doorstep with clinical symptoms that could be avian flu."

Currently, Tm has an annual capacity of 6 million to 6.5 million tests a year but is targeting, through improved manufacturing processes, capacity of 35 million to 40 million tests a year by next August, Janeczko told D&IW.

Mahony also said that this new test would make it possible to replace conventional lab tests, which are "laborious and often take several days or weeks to produce a definitive result."

"It provides physicians with a diagnosis much earlier than conventional tests, thereby improving patient management for infected individuals," Mahony said. "More importantly, however, this test could play a major role during an outbreak or epidemic by clearly identifying infected individuals early in the outbreak and limiting the spread of virus in the community."

Mahony said the test will assist public health authorities to avoid "false alarms" by determining which specific virus, if any, is present in a patient presenting with flu symptoms.

Tm Bioscience said it plans to launch successive versions of its Upper Respiratory Infectious Disease Panel. The first version of the panel, which detects and differentiates among various strains of respiratory syncitial virus, SARS Corona virus, parainfluenza and influenza virus A/B, including H5N1, will be available for evaluation by hospital-based laboratories and reference laboratories early next month.

The company said the subsequent versions will be expanded to include additional viruses and "may identify specific mutant variants of the H5N1 virus that are capable of human-to-human transmission or that develop Tamiflu resistance."

Quest Diagnostics this week reported development of a test to detect the avian flu virus and plans to participate in government preparedness efforts to provide rapid diagnosis and early surveillance of an outbreak, should need arise.

Quest said the test is a gene-based assay to identify the H5N1 strain of Influenza A virus. The test is intended to screen patients with a range of flu-like symptoms who may have been exposed to the virus. Testing is performed on respiratory samples, such as sputum, swabs and bronchial washes.

Positive results of the screening test would be considered a "presumptive identification" of avian flu until confirmed by the Centers for Disease Control and Prevention (Atlanta) or other public health laboratory, Quest said.

Sanuvox Technologies (Montreal) said this week that it has been receiving many inquiries regarding the use of its Sanuvox Ultraviolet Air Purification Systems on the Avian Flu.

It said its systems are designed to limit the spread of influenza in working and public environments such as ambulances.