Hepatitis B virus and dried blood spots
This project will determine the analytical sensitivity and estimate clinical sensitivity of screening using a new immunoassay for hepatitis B core antibody. The Elecsys Anti-HBsAg assay is an in-vitro diagnostic test for the qualitative detection of total antibodies to the core protein of hepatitis B virus in human serum or plasma it has FDA approval for this use and is available in Europe as a CE marked assay. It does not have approval for use in testing dried blood spots. The anti-HBsAg assay is an 18-minute test designed for use with Roche’s electrochemiluminescence (ECL) technology. This project aims to provide evidence for ‘self-validation’ of this assay for use with dried blood spots under the EU in vitro diagnostics evaluation rules (EU 2015).
The Introduction must cover all the aspect about this subject including:
1. Usefulness of dried blood spots in general as a diagnostic tool and for hepatitis B virus diagnosis/advantageseg cost effectiveness.
2. Why did they tend to use DBS rather than taking serum sample? Fear of blood/injection, Drug users/ damaged veins. What else?
3. Comparison and evaluation between use of DBS/ oral swabs/ serum samples
4. History about the discovery of this method
5. Application where DBS testing is used
6. Implications of using DBS samples compared with traditional methods/ disadvantages of DBS use – filter paper type/size & volume of drop, sample collection and storage condition/biosafety issues as blood could be infectious/contamination risks
7. How samples are collected and how they are stored
8. How samples then are used for diagnosis/ automation of DBS
9. Information about hepatitis B virus
10. Epidemiology
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