Performance Evaluation of Five Rapid At-Home COVID-19 Antigen Tests against the Omicron Variant

Sugiharto, Victor A.; Gatrell, Stephanie; Chen, Huawei; Blazek, Gabrielle R; Cherry, Amanda M; Schilling, Megan A.

doi:10.1128/spectrum.02286-22

Cited by 9 publications

(14 citation statements)

References 9 publications

(11 reference statements)

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“…We examined the incremental cost of screening per resident life-year gained at varying JAMA Health Forum | Original Investigation levels of booster uptake, antiviral uptake, and masking adherence. Given the variation in rapid antigen test sensitivity based on an individual's viral load at the time of testing and the brand of test used, 54 we lowered the estimate of test sensitivity to 0.65 in another sensitivity analysis. We also varied the number of resident and staff contacts in communal areas by one-third and examined the scenario in which only staff are screened.…”

Section: Sensitivity Analysismentioning

confidence: 99%

Screening Strategies to Reduce COVID-19 Mortality in Nursing Homes

Dong,

Jutkowitz,

Giardina

et al. 2024

JAMA Health Forum

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ImportanceNursing home residents continue to bear a disproportionate share of COVID-19 morbidity and mortality, accounting for 9% of all US COVID-19 deaths in 2023, despite comprising only 0.4% of the population.ObjectiveTo evaluate the cost-effectiveness of screening strategies in reducing COVID-19 mortality in nursing homes.Design and SettingAn agent-based model was developed to simulate SARS-CoV-2 transmission in the nursing home setting. Parameters were determined using SARS-CoV-2 virus data and COVID-19 data from the Centers for Medicare &amp; Medicaid Services and US Centers for Disease Control and Prevention that were published between 2020 and 2023, as well as data on nursing homes published between 2010 and 2023. The model used in this study simulated interactions and SARS-CoV-2 transmission between residents, staff, and visitors in a nursing home setting. The population used in the simulation model was based on the size of the average US nursing home and recommended staffing levels, with 90 residents, 90 visitors (1 per resident), and 83 nursing staff members.ExposureScreening frequency (none, weekly, and twice weekly) was varied over 30 days against varying levels of COVID-19 community incidence, booster uptake, and antiviral use.Main Outcomes and MeasuresThe main outcomes were SARS-CoV-2 infections, detected cases per 1000 tests, and incremental cost of screening per life-year gained.ResultsNursing home interactions were modeled between 90 residents, 90 visitors, and 83 nursing staff over 30 days, completing 4000 to 8000 simulations per parameter combination. The incremental cost-effectiveness ratios of weekly and twice-weekly screening were less than $150 000 per resident life-year with moderate (50 cases per 100 000) and high (100 cases per 100 000) COVID-19 community incidence across low–booster uptake and high–booster uptake levels. When COVID-19 antiviral use reached 100%, screening incremental cost-effectiveness ratios increased to more than $150 000 per life-year when booster uptake was low and community incidence was high.Conclusions and RelevanceThe results of this cost-effectiveness analysis suggest that screening may be effective for reducing COVID-19 mortality in nursing homes when COVID-19 community incidence is high and/or booster uptake is low. Nursing home administrators can use these findings to guide planning in the context of widely varying levels of SARS-CoV-2 transmission and intervention measures across the US.

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Section: Sensitivity Analysismentioning

confidence: 99%

Screening Strategies to Reduce COVID-19 Mortality in Nursing Homes

Dong,

Jutkowitz,

Giardina

et al. 2024

JAMA Health Forum

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“…4,5 It also has been shown that the sensitivity of LFTs is high for samples with low Ct values and low for samples with high Ct values due to low viral loads. 6 In addition, using heat inactivated wild type (USA-WA1/2020) and Delta variant B.1.617.2, Morinaga et al 7 demonstrated that measuring time-to-positive test results in six LFTs was shorter for a high viral concentration (2.5 × 10 5 TCID 50 /mL) than with a lower viral concentration (2.5 × 10 4 TCID 50 /mL). Additionally, two groups reported that the time-to-positive SARS-CoV-2 antigen result was inversely correlated with the Ct values.…”

Section: Introductionmentioning

confidence: 99%

“…It has been well‐established that patients with COVID‐19 who have high SARS‐CoV‐2 viral loads have short cycle threshold (Ct) values on reverse transcription‐polymerase chain reaction (RT‐PCR) tests, while those with low viral loads have high Ct values 4,5 . It also has been shown that the sensitivity of LFTs is high for samples with low Ct values and low for samples with high Ct values due to low viral loads 6 . In addition, using heat inactivated wild type (USA‐WA1/2020) and Delta variant B.1.617.2, Morinaga et al 7 .…”

Section: Introductionmentioning

confidence: 99%

Quantification of SARS‐CoV‐2 viral load in patients using time‐to‐results in antigen lateral flow tests

Braunstein,

Vail,

et al. 2024

Clinical Translational Sci

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Based upon clinical observations and recent reports, we anticipated there would be an inverse dose–response relationship between the severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2) viral load and the time‐to‐positivity after application of the nasal swab sample in two popular home coronavirus disease 2019 (COVID‐19) antigen tests, BinaxNOW COVID‐19 Antigen Self‐Test and Flowflex COVID‐19 Antigen Home Test, both of which are sensitive to the nucleocapsid protein (NP). The relationship among the concentration of NP, WA1, and Omicron XBB.1.5 viral strains and the time‐to‐positive result by visual assessment in the tests was examined. The correlation between reverse transcription‐polymerase chain reaction cycle threshold (Ct) values and time‐to‐positivity in clinical samples (training set) also was determined. Strong inverse correlations were obtained between the concentration of the NP, WA1, XBB.1.5, Ct values for dilutions of both WA1 and XBB.1.5, as well as Ct values from the clinical samples and time‐to‐positivity in both antigen tests. The correlation between the actual and predicted Ct values interpolated from the training set was high with both tests in a second set of clinical samples. These results, together with those of other investigations with similar tests, suggest that the time‐to‐positive visual result in most, if not all, lateral flow COVID‐19 antigen tests can be utilized to estimate SARS‐CoV‐2 viral concentrations.

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“…To this end, we and others previously compared the sensitivity of RATs and found that most RATs show similar sensitivity against ancestral SARS‐CoV‐2, SARS‐CoV‐2 possessing the D614G substitution in its S protein, and the delta variant (lineage B.1.617.2) 9–15 . RAT performance has also been evaluated for Omicron variant detection, including BA.1 and BA.2 16–22 . Several groups found that RATs maintained sensitivity to omicron variants, 18,21 but others reported that RATs performed poorly with these variants 16,20,23 .…”

Section: Introductionmentioning

confidence: 99%

“…9-15 RAT performance has also been evaluated for Omicron variant detection, including BA.1 and BA.2. [16][17][18][19][20][21][22] Several groups found that RATs maintained sensitivity to omicron variants, 18,21 but others reported that RATs performed poorly with these variants. 16,20,23 The decreased sensitivity could be associated with a lower viral load of Omicron than delta.…”

mentioning

confidence: 99%

Sensitivity of rapid antigen tests for Omicron subvariants of SARS‐CoV‐2

Sakai‐Tagawa

Yamayoshi

Halfmann

et al. 2023

Journal of Medical Virology

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Diagnosis by rapid antigen tests (RATs) is useful for early initiation of antiviral treatment.Because RATs are easy to use, they can be adapted for self-testing. Several kinds of RATs approved for such use by the Japanese regulatory authority are available from drug stores and websites. Most RATs for COVID-19 are based on antibody detection of the SARS-CoV-2 N protein. Since Omicron and its subvariants have accumulated several amino acid substitutions in the N protein, such amino acid changes might affect the sensitivity of RATs. Here, we investigated the sensitivity of seven RATs available in Japan, six of which are approved for public use and one of which is approved for clinical use, for the detection of BA.5, BA.2.75, BF.7, XBB.1, and BQ.1.1, as well as the delta variant (B.1.627.2). All tested RATs detected the delta variant with a detection level between 7500 and 75 000 pfu per test, and all tested RATs showed similar sensitivity to

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Performance Evaluation of Five Rapid At-Home COVID-19 Antigen Tests against the Omicron Variant

Abstract: The emergence of the Omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is due to mutations as part of the virus evolution process. These mutations might affect the sensitivity of diagnostic tests that are currently being used to detect the virus.

Cited by 9 publications

References 9 publications

Screening Strategies to Reduce COVID-19 Mortality in Nursing Homes

Screening Strategies to Reduce COVID-19 Mortality in Nursing Homes

Quantification of SARS‐CoV‐2 viral load in patients using time‐to‐results in antigen lateral flow tests

Sensitivity of rapid antigen tests for Omicron subvariants of SARS‐CoV‐2

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