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Exploring Genotype Detection Limitations: A Comprehensive Analysis

Investigating the challenges in detecting various virus genotypes, sample sizes, and assay limitations to enhance genotype detection accuracy.

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Exploring Genotype Detection Limitations: A Comprehensive Analysis

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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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