New QA program gives test results more certainty

A new program and online database developed in Victoria will offer laboratories all over the world a much better chance of avoiding false positives and false negatives when screening blood for viruses, particularly HIV and Hepatitis C.

Wayne Dimech -- project manager with the National Serology Reference Laboratory -- has managed the development of the program and database, called EDCNet, which also has application in the quality control of screening blood for other viruses.

Dimech is one of 16 finalists in the 2005 Fresh Innovators program who are presenting their work over the next three weeks in Sydney.

"We are mainly looking at HIV and Hepatitis C," said Dimech.

There are currently about seven or eight assays available to screen blood for HIV and hepatitis C. They all test for the same antibodies, for example the HIV assays all test for antibodies to HIV1 and HIV 2.

However, it is difficult to obtain standard measures for antibodies for a number of reasons: there are different classes of antibodies, different people produce different antibodies to different components of a virus, and the antibodies themselves have different avidities and affinities.

The EDCNet program helps to overcome this. For a laboratory to use EDCNet, an external quality assurance scheme is conducted which monitors the labs performance and the performance of the assay they are using. Then a quality control program is conducted, which involves the NRL sending out enough aliquots of the same sample for the lab to test for an entire year. These test results, along with other results, can then be entered into the ECDNet database, via the internet, and compared with everyone else's data. This gives the lab an idea of how their assays are performing and whether variation is occurring.

"It's a way of ensuring high quality in blood screening," said Dimech. "It means that when a test reading goes outside the predictable ranges then we can look at it; it's a warning sign and it's happening in real-time."

Dimech said that in the past this type of quality assurance was conducted manually and could take up to 18 months to finalise, by which time the outcome would no longer be relevant.

Quality assurance in blood screening is critical to intervention programs, such as HIV/AIDS prevention initiatives where billions is currently being spent. False positive or false negatives can be costly, both economically and socially, and can also lead to a build up of drug resistance.

ECDNet also provides the ability for labs to join a peer group and compare data, which Dimech said is particularly useful for countries like Ireland, Israel and Norway, where there is only one blood-screening laboratory. It also means that labs around the world, in Thailand or Angola for example, can access the same quality assurance facilities as labs in developed countries like Australia.

Dimech is about to head overseas to promote the EDCNet program in the US. EDCNet was developed by the National Serology Reference Laboratory in 2001 in collaboration with Victorian software house, Myretsu. Seventeen different countries are already using or trialing the program as part of their national quality assurance programs for blood screening.

"We have an agreement with AcroMetrix," said Dimech of the US-based company that manufactures the 10 litres per year of stable noninfectious blood the NRL needs to send out to laboratories around the world. "AcroMetrix acquired Viral Quality Control in the Netherlands, with whom we originally had this agreement, which therefore gives us good access to the US and the European blood screening community."

Part of Australian Innovation Week, the Fresh Innovators forum supports early career innovators from the fields of science, technology and engineering develop expertise in communicating their ideas clearly and the innovator who best meets the objectives of Fresh Innovators will receive $4,000 towards a study tour in the UK.