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BIA-Brukerstyrt innovasjonsarena

Whole process quality assurance by liposoma internal control particles customized to target organisms in gene technology-based assays

Tildelt: kr 1,3 mill.

Prosjektnummer:

188010

Prosjektperiode:

2008 - 2010

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Samarbeidsland:

The nucleic acid tests (NATs) have revolutionized the detection of viruses, bacteria, cancer cells etc. These gene technology-based analyses can give both qualitative and quantitative results that can be of crucial importance, e.g., for detection of patho gens or special cell types, and for monitoring the effect of a given therapy. The NAT results are normally being interpreted as being highly trustworthy due to the unique sensitivity of the nucleic acid amplification technology. However, without special i mplements for elimination of false results, the test results might be invalid. To detect false negative results internal controls might be used. The problem is that the naked internal controls commonly used in the NATs today can only offer incomplete qua lity assurance, and inefficient detection of any source of false negative results, which may strike randomly throughout the entire analysis procedure. A whole process approach is necessary to efficiently eliminate false negative results. Liposomes can be looked upon as synthetic particle resembles of an in vivo double-membrane. The flexibility of various liposome shells could enable customized particles enabling whole process quality assurance provided. It is feasible as the lipoomes may serve as the cell /virus imitating internal control vehicle in the early steps of NAT procedures, in general. One focus of the project is to design and customize different liposome/internal internal control particle with various physical and chemical properties. Through R& D collaboration with both national and international partners the project shall examine the technology's ability to enable whole process quality assurance of NATs, by focus on selected clinically significant typical target organisms.

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BIA-Brukerstyrt innovasjonsarena