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Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection : A Prospective Cohort Study

Annals of internal medicine · 2023
Paper authors: Soni A, Herbert C, Lin H, Yan Y, Pretz C, Stamegna P, Wang B, Orwig T, Wright C, Tarrant S, Behar S, Suvarna T, Schrader S, Harman E, Nowak C, Kheterpal V, Rao LV, Cashman L, Orvek E, Ayturk D, Gibson L, Zai A, Wong S, Lazar P, Wang Z, Filippaios A, Barton B, Achenbach CJ, Murphy RL, Robinson ML, Manabe YC, Pandey S, Colubri A, O'Connor L, Lemon SC, Fahey N, Luzuriaga KL, Hafer N, Roth K, Lowe T, Stenzel T, Heetderks W, Broach J, McManus DD.
Research reading note · Based on the abstract · Editorial summary prepared by Hopkins MedTech Compliance
Original source: Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection : A Prospective Cohort Study

Original source publication date:

Why the timing and repetition of an antigen test matter as much as its single-test sensitivity.

What the paper explores

This prospective US cohort paired home antigen testing with molecular testing every 48 hours. Performance differed by symptom status, and repeat testing improved detection. The study treats a sequence of tests as an evaluation strategy, rather than assuming one negative result answers the clinical question.

How to interpret the evidence

The tested interval was 48 hours. The results do not establish performance for shorter intervals, other products or every later viral variant.

Questions for MedTech teams

For an IVD study, define the intended population, testing schedule and interpretation of repeated results before selecting performance endpoints.

Sources & further reading

Read original paper

DOI: 10.7326/M23-0385

Bibliographic record and abstract on PubMed

This is a short editorial reading note on external research. The original research is attributed to its authors and does not represent an HMC study, product validation or regulatory determination.

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