For influenza testing as the H1N1 virus rises to pandemic levels, there is the first-to-market advantage and then there is, well, not much for all the rest.

Moving quickly since guidelines were released by the World Health Organization (WHO) in August, 2009, the Korean company Seegene (Bangyi-Dong, South Korea) was able to present at the Medica trade fair held here last week a real-time, high volume rapid test for the four pathogen assays required by guidelines.

And in December Seegene said it will launch a high-through put technology for the leading lines of polymerase-chain-reaction (PCR) instruments used in labs worldwide that will effectively cut in half the current turn-around time.

"When someone in your family develops a cough, you will want them to go to the hospital to find out if it is a serious flu," said Jee Hoon "James" Park with Seegene's Global Business Team.

"Tamiflu has been shown to be effective against the H1N1 virus during the first 48 hours, so people want results right away, and medically, faster results are critical," he said.

Korea is currently at a pandemic stage for the disease, he said, and the country's five largest commercial labs are running in excess of 10,000 tests per day.

"If you add the processing of tests at community hospitals and other centers, you begin to realize how tremendous the volumes will be for other nations as they approach a pandemic stage," he said.

Released the week ahead of Medica, the Seegene One-Step multiplex real-time PCR is being used by the Canadian state laboratories and Park said Seegene has seen a strong take up in Western Europe, "from north to south, including Sweden, Norway, the United Kingdom, France, Spain, and Portugal," adding that labs in Romania, Poland and Turkey have also bought into the Seegene tests.

WHO standards require testing of four pathogens including common influenza A, two seasonal influenzas H1 and H2, as well as the new influenza A, better known as H1N1 since the world agreed to stop calling it "swine flu."

Conventional testing of these four pathogens at labs requires a sequential process that covers 44 samples in five hours, where the Seegene rapid test combines all four tests in a concurrent multiplexing kit that covers 94 samples in the same time period.

In December Seegene will release the real-time READ (real amplification detection) technology that Park said is, "totally new, like comparing a family sedan with a BMW sports coupe."

"We have succeeded in combining the detection on a real-time platform with amplification of 35 pathogens in a single tube for mass screenings of Flu A, Flu B and 29 other viruses or bacteria."

From a single nasal swab sample the READ real-time amplification of the sample takes two hours and then another 30 minute for the detection.

Randox brings IVD lab closer to patient

Bringing the lab closer to the patient, Randox Laboratories (Crumlin, Northern Ireland) rolled out the Evidence Multistat at Medica 2009, a benchtop analyzer that was previewed at last year's trade show and has racked up a raft of pre-orders, according to Marketing Manager Chris Henry.

The new instrument provides results in 20 minutes for the two in vitro diagnostic (IVD) assays currently offered for emergency departments for cardiac screening and drugs-of-abuse.

"Any emergency department personnel can operate this analyzer with really minimal training," said product manager Bettina Karger who demonstrated the insertion of the "butterfly" biochip into the unit and the one-button launch for the automated process.

The Multistat does not require lab-like precision from trauma staff, tolerating a wide range of sample sizes, and features a touchscreen user interface for ease of use and onboard quality control.

The results can be sent directly to a lab info management system (LIMS) and the Multistat features four USB ports for data storage, transfer or print outs.

"The market is crying out for multiple assay capabilities, and the Multistat brings that technology out of the lab with proven bio-chip array technology," said Henry, who said the company was very pleased with advance orders for the Multistat.

Randox announced earlier this year it is licensing multiplex PCR technology from SeeGene to develop high-throughput biochip array technology screening panels to simultaneously detect a broad range of infectious pathogens.

The near-the-patient Multistat is one in a series of three Randox instruments able to process the biochips.

Mindray expands IVD portfolio with analyzers

Marking its 10th year of participating in Medica, Mindray Medical International (Shenzhen, China) introduced in Europe four new products for its growing portolfio of in vitro diagnostics.

Three five-part hematology analyzers were featured front-and-center at the company's stand in Hall 03 covering the range of laboratory needs from the manual BC-5300, to the mid-line automated BC-5380 to the top of the line BC 5800 that is currently in pre-launch evaluation.

With its low operational cost and small footprint, the BC-5300 has proved to be the most popular unit from Mindray among European clinics and hospitals, according to Product Manager Han Li.

"Running cost is a critical factor for low-volume labs who appreciate the savings realized from the BC-5300 that also provides a high quality read out," he said.

The ease of operation and the fast training curve are also winning features.

Where the BC-5300 is manually operated, the next step up in the Mindray line of hematology analyzers is the automated BC-5380 that processes 30 tubes per run and also provides five-part differentiation for 27 parameters.

The top-of-the-line BC-5800 auto hematology analyzer integrates a series of enhancements that, according to Han Li, "quite simply provides more test information in a shorter period of time."

Testing up to 90 samples per hour for 29 parameters, the flagship BC 5800 offers customizable features unique in its class, such as setting up preferred printing format or reconfiguring re-examination rules.

"Lab directors can use these features to filter out samples that are abnormal and improves processes," said Han Li, adding, "More than just spinning out the data, this model is designed to help with decision-making."

Also being previewed at Medica 2009 is the high-end, highly automated BS-800 chemistry analyzer that Regional Manager Rogun Luo said will undergo a six-month evaluation period at a reference hospital in Italy before becoming available in Europe toward the middle of 2010.