Diagnostic accuracy of thirteen COVID‐19 (SARS‐CoV‐2) rapid antigen self‐tests with very high sensitivity approved for home use in Australia

Shores, E. Arthur; Berry, Jamie

doi:10.1111/1753-6405.13285

Cited by 1 publication

(1 citation statement)

References 4 publications

(7 reference statements)

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“…10 , 26 , 27 However, knowledge of the poorer diagnostic accuracy of RATs when used by a self-test by consumers in real-world settings appears to low in the general community. 28 At the time of our study (and still the case now), published information on the accuracy of RATs on the Australian Government’s Therapeutic Goods Association Web site (provided by test manufacturers) indicated substantially higher sensitivity than actual performance when used as intended—as a self-test by community members. 10…”

Section: Discussionmentioning

confidence: 78%

Communicating the Imperfect Diagnostic Accuracy of COVID-19 Rapid Antigen Self-Tests: An Online Randomized Experiment

Li,

Kalra,

Zhu

et al. 2024

Med Decis Making

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Objective To investigate the potential impacts of optimizing coronavirus disease 2019 (COVID-19) rapid antigen test (RAT) self-testing diagnostic accuracy information. Design Online randomized experiment using hypothetical scenarios: in scenarios 1 to 3 (RAT result positive), the posttest probability was considered to be very high (likely true positives), and in scenarios 4 and 5 (RAT result negative), the posttest probability was considered to be moderately high (likely false negatives). Setting December 12 to 22, 2022, during the mixed-variant Omicron wave in Australia. Participants Australian adults. Intervention: diagnostic accuracy of a COVID-19 self-RAT presented in a health literacy-sensitive way; usual care: diagnostic accuracy information provided by the manufacturer; control: no diagnostic accuracy information. Main Outcome Measure Intention to self-isolate. Results A total of 226 participants were randomized (control n = 75, usual care n = 76, intervention n = 75). More participants in the intervention group correctly interpreted the meaning of the diagnostic accuracy information ( P = 0.08 for understanding sensitivity, P < 0.001 for understanding specificity). The proportion who would self-isolate was similar across scenarios 1 to 3 (likely true positives). The proportion was higher in the intervention group than in the control for scenarios 4 and 5 (likely false negatives). These differences were not statistically significant. The largest potential effect was seen in scenario 5 (dinner party with confirmed cases, the person has symptoms, negative self-RAT result), with 63% of the intervention group and 49% of the control group indicating they would self-isolate (absolute difference 13.3%, 95% confidence interval: −2% to 30%, P = 0.10). Conclusion Health literacy sensitive formatting supported participant understanding and recall of diagnostic accuracy information. This may increase community intentions to self-isolate when there is a likely false-negative self-RAT result. Trial registration: Australia New Zealand Clinical Trial Registry (ACTRN12622001517763) Highlights Community-based diagnostic accuracy studies of COVID-19 self-RATs indicate substantially lower sensitivity (and higher risk of false-negative results) than the manufacturer-supplied information on most government public Web sites. This online randomized study found that a health literacy–sensitive presentation of the imperfect diagnostic accuracy COVID-19 self-RATs supported participant understanding and recall of diagnostic accuracy information. Health literacy–sensitive presentation may increase community intentions to self-isolate after a negative test result where the posttest probability is still moderately high (i.e., likely false-negative result). To prevent the onward spread of infection, efforts to improve communication about the high risk of false-negative results from COVID-19 self-RATs are urgently needed.

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Section: Discussionmentioning

confidence: 78%