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What about Genotypes?

What about Genotypes?. Matthias Gessner Baxter AG, Vienna. What‘s the matter with Genotypes?. “...not clear if these detection limits are valid for every known subtype of the different viruses or not…” “What is done regarding the two variants of Parvo B19 Virus (V9 and A6)?”

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What about Genotypes?

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  1. What about Genotypes? Matthias Gessner Baxter AG, Vienna

  2. What‘s the matter with Genotypes? • “...not clear if these detection limits are valid for every known subtype of the different viruses or not…” • “What is done regarding the two variants of Parvo B19 Virus (V9 and A6)?” • “How many samples of each HCV genotype were studied?” • “…provide evidence that […] genotype 6a can be detected.” • “…provide data for a minimum of 10 specimens of each [HIV] subtype.” • “...demonstrate the assay is able to detect all known human HAV genotypes…”

  3. Detection of Genotypes • Does every NAT assay need to detect all known genotypes? • From the moment of discovery? • Fishing assays used on blood will most likely increase the number of new genotypes detected in the future. • Example: Parvovirus 4 and 5**Fryer,J.F., Kapoor,A., Minor,P.D., Delwart,E., Baylis,S.A., 2006. Novel parvovirus and related variant in human plasma. Emerg. Infect. Dis. 12, 151-154.) • Newly detected and known genotypes need to be evaluated for relevance in testing in order to focus the efforts in assay development. • Who to define which genotypes/subtypes minimally need to be detected?

  4. Characterized Genotype Samples • Where to obtain well characterized samples to demonstrate detection of specific genotypes? • Genotype samples need to be characterized based on accepted standardized protocols • Quantity • Genotype • Genotype samples need to be • Available in sufficient quantity to everyone • At acceptable cost

  5. Another Mission for SoGAT • Establish criteria to evaluate relevance of known and newly detected viral genotypes for inclusion in a NAT portfolio. • Establish criteria for the standardized characterization of genotype samples and support implementation.

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