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A comparison between a "In house IVD" and a commercial platform for detecting HHVs
University of Skövde, School of Health Sciences.
2024 (English)Independent thesis Basic level (degree of Bachelor), 20 credits / 30 HE creditsStudent thesis
Abstract [en]

Herpes simplex virus type 1, Herpes simplex virus type 2, and Varicella zoster are three common types of human herpes viruses that cause skin lesions, blisters and ulcers. Billions of people suffer from one of the three human herpes viruses. Commonly quantitative polymerase chain reactions are used to detect the infections in patients. For the method to work certain kits are used that are specific for the pathogens. They work by binding to specific nucleotide sequences in the viral deoxyribonucleic acid. When bound it starts to amplify the sequence and increase the concentration of the viral deoxyribonucleic acid. The kits used in this process can either be developed in house or sourced from a manufacturer. In house development of diagnostic platforms has been questioned and regulations have been set on how an In vitro diagnostic should be manufactured. The idea of these regulations is to ensure that the specificity and quality of the kits is sufficient. One regulation that is relevant for clinical labs operating in the European Union is the in vitro diagnostic regulations. The goal of these regulations is to decrease inconsistencies between clinical laboratories. One of the ways to follow the regulations is to move away from in house in vitro diagnostics. In this study a comparison was conducted to compare an existing in house in vitro diagnostic with a commercial kit. The results showed that both kits performed equally even though there was a significant difference in cyclic thresholds.

Place, publisher, year, edition, pages
2024. , p. 18
National Category
Biomedical Laboratory Science/Technology
Identifiers
URN: urn:nbn:se:his:diva-23994OAI: oai:DiVA.org:his-23994DiVA, id: diva2:1873502
External cooperation
Unilabs
Subject / course
Biomedicine/Medical Science
Educational program
Biomedicine - Study Programme
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Examiners
Available from: 2024-06-19 Created: 2024-06-19 Last updated: 2024-06-19Bibliographically approved

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