IVD

Antigen-test sensitivity depends on the population

Original source: Antigen-test sensitivity depends on the population

Original source publication date:

A large hospital study illustrates why intended users, symptoms and study setting belong beside every performance estimate.

What was studied

Wagenhäuser and colleagues compared rapid antigen tests with RT-qPCR at a single German tertiary-care hospital between November 2020 and June 2023. Across 78,798 paired results, overall sensitivity was 34.5% and specificity was 99.6%. Higher viral load and typical COVID-19 symptoms were associated with a positive antigen result among infected individuals.

What the estimate does not say

The findings describe the tests, population and screening use in this study. They are not a universal sensitivity estimate for every rapid antigen product, symptomatic setting or specimen workflow. The authors associated the decline over time primarily with a changing symptom profile.

Implication for study planning

Our editorial takeaway is to define the intended population before choosing a performance target. Record symptoms, timing, comparator, specimen procedures and subgroup analyses so that the result can be interpreted in the context of intended use.

Sources & further reading

Read the original company post on LinkedInOriginal study — eBioMedicine, 2024PubMed abstract and bibliographic record

Adapted from a public company post, with sources checked on 8 October 2026. Original post dates are preserved; the website summary is not attributed to an individual employee.

Back to all resources
CONTACT HMC

Discuss your study
or regulatory submission.

Tell us your product type, target market,
and the support you need.

Contact HMC
Hands using an office telephone, from the original HMC website

Ready to learn more about working with us?

CONTACT USCHAT WITH US