Diagnostic accuracy of SARS-CoV-2 rapid antigen self-tests in asymptomatic individuals in the Omicron period: cross sectional study

Venekamp, Roderick P; Schuit, Ewoud; Hooft, Lotty; Veldhuijzen, Irene; Bijllaardt, Wouter van den; Pas, Suzan D.; Zwart, Vivian F.; Lodder, Esther B.; Hellwich, Marloes; Koppelman, Marco; Molenkamp, Richard; Wijers, Constantijn; Vroom, Irene H; Smeets, Leonard C.; Nagel-Imming, Carla R. S.; Han, Wanda G. H.; Hof, Susan van den; Kluytmans, Jan; Wijgert, Janneke van de; Moons, Karel G.M.

doi:10.1101/2022.07.07.22277366

Cited by 2 publications

(1 citation statement)

References 12 publications

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“…In the study of Schuit et al (n=620), ACON is more sensitive in the infection dominated by Delta than in the Omicron period. However, this difference was not reflected in the smaller sample size (n=60) in the study by Sanjat et al ACON achieved its lowest sensitivity in the study by Roderick et al (27.5%) [23]. Although their trial has a considerable sample size (n=1229), most of the samples were conducted by ordinary subjects who had not been trained for the correct RAT using methods.…”

Section: Resultsmentioning

confidence: 95%

Diagnostic Accuracy of Rapid Antigen Tests for SARS-CoV-2 Approved for Use in China

Li¹

2023

HSET

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Rapid antigen tests (RATs), a simple, inexpensive test that can be performed at home by residents, have been widely used in COVID-19 diagnosis around the world. Until 29th April 2022, the Chinese National Medical Products Administration (CNMPA) has approved a total of 31 items of RAT products. Review the existing research evaluating the diagnostic accuracy of CNMPA-approved RATs, then collect the raw data of included texts, calculate the sensitivity and specificity in each study, and compare them with these two aspects to provide optimal choice for RAT used in real-life practice. Using the Cochrane and WHO COVID-19 databases, studies with full texts published between 2020-2022 were included if they aimed detection for SARS-CoV-2 infection, had CNMPA-approved RAT for index testing and compared with RT-PCR results. Studies were excluded if they failed to provide primary data for accuracy testing or the data provided did not allow the calculation of sensitivity or specificity. No language restrictions were applied in this review, and all study designs that provided diagnostic accuracy data were accepted. Results: 22 studies were included in this review. All CNMPA-approved RATs included in the review performed well in diagnostic specificity except for four individual studies. However, the sensitivity of CNMPA-approved RATs varied widely among different RATs and different studies. The two worst sensitivity-performing RATs were Savant and LEPU, while the best was Wondfo.

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Section: Resultsmentioning

confidence: 95%

Diagnostic Accuracy of Rapid Antigen Tests for SARS-CoV-2 Approved for Use in China

Li¹

2023

HSET

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A population-based study of the trend in SARS-CoV-2 diagnostic modalities from the beginning of the pandemic to the Omicron surge in Kyoto City, Kyoto, Japan

Kyo,

Patel,

Yamamoto

et al. 2023

BMC Public Health

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Background The coronavirus disease 2019 (COVID-19) presents critical diagnostic challenges for managing the pandemic. We investigated the 30-month changes in COVID-19 testing modalities and functional testing sites from the early period of the pandemic to the most recent Omicron surge in 2022 in Kyoto City, Japan. Methods This is a retrospective-observational study using a local anonymized population database that included patients' demographic and clinical information, testing methods and facilities from January 2020 to June 2022, a total of 30 months. We computed the distribution of symptomatic presentation, testing methods, and testing facilities among cases. Differences over time were tested using chi-square tests of independence. Results During the study period, 133,115 confirmed COVID-19 cases were reported, of which 90.9% were symptomatic. Although nucleic acid amplification testing occupied 68.9% of all testing, the ratio of lateral flow devices (LFDs) rapidly increased in 2022. As the pandemic continued, the testing capability was shifted from COVID-19 designated facilities to general practitioners, who became the leading testing providers (57.3% of 99,945 tests in 2022). Conclusions There was a dynamic shift in testing modality during the first 30 months of the pandemic in Kyoto City. General practitioners increased their role substantially as the use of LFDs spread dramatically in 2022. By comprehending and documenting the evolution of testing methods and testing locations, it is anticipated that this will contribute to the establishment of an even more efficient testing infrastructure for the next pandemic.

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Diagnostic accuracy of SARS-CoV-2 rapid antigen self-tests in asymptomatic individuals in the Omicron period: cross sectional study

Cited by 2 publications

References 12 publications

Diagnostic Accuracy of Rapid Antigen Tests for SARS-CoV-2 Approved for Use in China

Diagnostic Accuracy of Rapid Antigen Tests for SARS-CoV-2 Approved for Use in China

A population-based study of the trend in SARS-CoV-2 diagnostic modalities from the beginning of the pandemic to the Omicron surge in Kyoto City, Kyoto, Japan

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