Beskrivning
Land | Sverige |
---|---|
Lista | Nordic SME Sweden |
Sektor | Hälsovård |
Industri | Läkemedel & Handel |
Attana now enables self sampling through an updated CE IVD-marking for capillary blood samples using Capitainer[®]qDBS cards (quantitative dried blood spot), enabling laboratories improved opportunities to perform immune profiling and monitoring of vaccine efficacy in broad patient populations.
As presented together with Capitainer in February 2022, the goal of Attana Diagnostics is to offer broader and more patient-centric blood sampling solutions for the Attana AVA[TM] system. Since then, Attana has validated its AVA[TM] SARS-CoV-2 IgG Immunoassay kit for capillary blood samples, both qDBS and test tubes. The result of this work has today led to an updated CE IVD-marking.
Attanas CE IVD-marked products
The CE IVD-marked test is a serological immunoassay for the detection of IgG antibodies to SARS-CoV-2 used together with Attana's analytical instruments. In the summer of 2021, the product was initially registered solely for analysis of serum samples. The sample types have now been expanded to also include capillary blood samples (finger prick) both as whole blood in test tubes and via Capitainer[®]qDBS cards (quantitative dried blood spot). The CE IVD-marking still allows qualitative and semi-quantitative measurement of IgG antibodies, but laboratories using the Attana diagnostic platform also have access to unique data (for research use), such as antibody neutralization from the patient samples.
About the studies behind the CE IVD-marking
All technical studies have been performed in Kalmar in collaboration with Linnaeus University. The capillary patient samples were analyzed with Attana's CE IVD-marked kits and validated against serum samples taken at the same time, showing very good agreement. The studies are supplemented by technical studies previously published by Capitainer.
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The attached picture shows the blood sample types which Attana has CE IVD-marked and those which can be used for research purposes ("Research use").
Teodor Aastrup, CEO of Attana, comments:
"By expanding our product offering with self sampling together with the Capitainer[®]qDBS cards, Attana now enables distributed, simple, and quality-assured sampling for information-rich immunity profiling."