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Validity of at-home rapid antigen lateral flow assay and artificial intelligence read to detect SARS-CoV-2

ABSTRACT:

Background

The gold standard for COVID-19 diagnosis–reverse-transcriptase polymerase chain reaction (RT-PCR)– is expensive and often slow to yield results whereas lateral flow tests can lack sensitivity.

Methods

We tested a rapid, lateral flow antigen (LFA) assay with artificial intelligence read (LFAIR) in subjects from COVID-19 treatment trials (N=37; daily tests for five days) and from a population-based study (N=88; single test). LFAIR was compared to RT-PCR from same-day samples.

Results

Using each participant's first sample, LFAIR showed 86.2% sensitivity (95% CI 73.6% - 98.8) and 94.3% specificity (88.8% - 99.7%) compared to RT-PCR. Adjusting for days since symptom onset and repeat testing, sensitivity was 97.8% (89.9% - 99.5%) on the first symptomatic day and decreased with each additional day. Sensitivity improved with artificial intelligence (AI) read (86.2%) compared to the human eye (71.4%).

Conclusion

LFAIR showed improved accuracy compared to LFA alone. particularly early in infection.

SUBMITTER: Richardson S

PROVIDER: S-EPMC9259514 | biostudies-literature |

REPOSITORIES: biostudies-literature

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