Field Performance and Public Health Response Using the BinaxNOWTM Rapid Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Assay During Community-Based Testing

Pilarowski, Genay; Marquez, Carina; Rubio, Luis; Peng, James; Martinez, Jackie; Black, Douglas; Chamie, Gabriel; Jones, Diane; Jacobo, Jon; Tulier-Laiwa, Valerie; Rojas, Susana; Rojas, Susy; Cox, Chesa; Nakamura, Robert M.; Petersen, Maya; DeRisi, Joseph L.; Havlir, Diane V.

doi:10.1093/cid/ciaa1890

Cited by 98 publications

(128 citation statements)

References 12 publications

(15 reference statements)

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“…A key intervention to remove physical distancing in this study was screening SARS-CoV-2 infection with Ag-RDTs immediately before entering the event. Despite the lower overall sensitivity than RT-PCR, Ag-RDTs have proven the ability to detect SARS-CoV-2 infection in respiratory specimens with Ct in RT-PCR below 25 and 30 (sensitivity of 100% and 98.6%, respectively), irrespective of the presence of symptoms and age 9,20 . While the sensitivity of these tests decreases at Ct beyond this threshold, a growing body of evidence indicates that respiratory specimens with Ct >30 have limited infection capacity [21][22][23][24][25] .…”

Section: Discussionmentioning

confidence: 99%

SARS-CoV-2 transmission in an indoor mass-gathering live music event. A randomized clinical trial.

Llibre

Revollo

Blanco

et al. 2021

Preprint

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The banning of mass-gathering indoor events to prevent SARS-CoV-2 spread cause an important impact on local economies. We designed a randomized-controlled open-label trial to assess the effectiveness of a comprehensive preventive intervention for a mass-gathering indoor event (a live concert) based on systematic screening of attendees with antigen-detecting rapid diagnostic tests, use of facial mask, and adequate air ventilation. According to a RT-PCR test performed on day 8 after the event, none of the 465 assistants in the experimental arm (i.e., event attendants) became infected by SARS-CoV-2 (observed incidence 0%; Bayesian estimated incidence 0.14%; 95%CI: 0% to 0.61%) versus 2 out of 495 controls (not entering into the event) (0.31%; 95%CI: 0.04% to 0.73%). No significant differences were observed between the estimated incidence in the two study arms. Our study provides evidence on the safety of indoor mass-gathering events conducted during a COVID-19 outbreak under a comprehensive preventive intervention. (ClinicalTrials.gov number, NCT04668625)

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Section: Discussionmentioning

confidence: 99%

SARS-CoV-2 transmission in an indoor mass-gathering live music event. A randomized clinical trial.

Llibre

Revollo

Blanco

et al. 2021

Preprint

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“…We limit our consideration to differences in test sensitivity, considering specificity to encompass the related issue of non-etiologic SARS-CoV-2 detections; under field conditions, antigen and molecular tests have been found to have similar analytical specificity. 26,27 The limiting case of an assay which perfectly rules out SARS-CoV-2 detections that are not causing symptoms ( σ s = 0) yields the contingency table presented in Table 4 for case and control groups ( Table S1 extends this for non-zero values of σ s ).…”

Section: Outcome Misclassificationmentioning

confidence: 99%

“…Antigen detection tests, with lower analytic sensitivity, may in contrast yield negative results for individuals with low virus shedding that is detectable by molecular testing. 26 In comparison to mild illness, both assays may have lower sensitivity for severe disease which can be delayed in presentation, occurring often during the second week after infection onset when viral shedding is lower. 42…”

Section: Outcome Misclassificationmentioning

confidence: 99%

Theoretical framework for retrospective studies of the effectiveness of SARS-CoV-2 vaccines

Lewnard

Patel

Jewell

et al. 2021

Preprint

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Observational studies of the effectiveness of vaccines to prevent COVID-19 are needed to inform real-world use. These are now in planning amid the ongoing rollout of SARS-CoV-2 vaccines globally. While traditional case-control (TCC) and test-negative design (TND) studies feature prominently among strategies used to assess vaccine effectiveness, such studies may encounter important threats to validity. Here we review the theoretical basis for estimation of vaccine direct effects under TCC and TND frameworks, addressing specific natural history parameters of SARS-CoV-2 infection and COVID-19 relevant to these designs. Bias may be introduced by misclassification of cases and controls, particularly when clinical case criteria include common, non-specific indicators of COVID-19. When using diagnostic assays with high analytical sensitivity for SARS-CoV-2 detection, individuals testing positive may be counted as cases even if their symptoms are due to other causes. The TCC may be particularly prone to confounding due to associations of vaccination with healthcare-seeking behavior or risk of infection. The TND reduces but may not eliminate this confounding, for instance if individuals who receive vaccination seek care or testing for less-severe infection. These circumstances indicate the two study designs cannot be applied naively to datasets gathered through public health surveillance or administrative sources. We suggest practical strategies to reduce bias in vaccine effectiveness estimates at the study design and analysis stages.

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“…We reviewed the data on the performance of antigen testing and found sensitivity estimates ranging from a low of 41.2% to a high of 100% and specificities from 97% to 99.9%. 7,[21][22][23][24][25][26][27] We then focused our estimates on cases when testing was accompanied by either a low cycle threshold (high titers of virus) or the ability to isolate replicationcompetent virus, as these cases represented people in the most transmissible stage of COVID-19 and excluded those in the recovery phase who might still have positive PCRs. 13,[28][29] While some studies described antigen sensitivity as exceeding 90% under these circumstances, we deliberately lowered our base case sensitivity assumption to 80%…”

Section: Performance Of Testingmentioning

confidence: 99%

Clinical and Economic Impact of Widespread Rapid Testing to Decrease SARS-CoV-2 Transmission

Paltiel¹,

Zheng

Sax

2021

Preprint

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Background: The value of frequent, rapid testing to reduce community transmission of SARS-CoV-2 is poorly understood. Objective: To define performance standards and predict the clinical, epidemiological, and economic outcomes of nationwide, home-based, antigen testing. Design: A simple compartmental epidemic model estimated viral transmission, clinical history, and resource use, with and without testing. Data Sources: Parameter values and ranges informed by Centers for Disease Control guidance and published literature. Target Population: United States population. Time Horizon: 60 days. Perspective: Societal. Costs include: testing, inpatient care, and lost workdays. Intervention: Home-based SARS-CoV-2 antigen testing. Outcome Measures: Cumulative infections and deaths, numbers isolated and/or hospitalized, and total costs. Results of Base-Case Analysis: Without a testing intervention, the model anticipates 15 million infections, 125,000 deaths, and $10.4 billion in costs ($6.5 billion inpatient; $3.9 billion lost productivity) over a 60-day horizon. Weekly availability of testing may avert 4 million infections and 19,000 deaths, raising costs by $21.5 billion. Lower inpatient outlays ($5.9 billion) would partially offset additional testing expenditures ($12.0 billion) and workdays lost ($13.9 billion), yielding incremental costs per infection (death) averted of $5,400 ($1,100,000). Results of Sensitivity Analysis: Outcome estimates vary widely under different behavioral assumptions and testing frequencies. However, key findings persist across all scenarios: large reductions in infections, mortality, and hospitalizations; and costs per death averted roughly an order of magnitude lower than commonly accepted willingness-to-pay values per statistical life saved ($5-17 million). Limitations: Analysis restricted to at-home testing and limited by uncertainties about test performance. Conclusion: High-frequency home testing for SARS-CoV-2 using an inexpensive, imperfect test could contribute to pandemic control at justifiable cost and warrants consideration as part of a national containment strategy.

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Field Performance and Public Health Response Using the BinaxNOWTM Rapid Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Assay During Community-Based Testing

Cited by 98 publications

References 12 publications

SARS-CoV-2 transmission in an indoor mass-gathering live music event. A randomized clinical trial.

SARS-CoV-2 transmission in an indoor mass-gathering live music event. A randomized clinical trial.

Theoretical framework for retrospective studies of the effectiveness of SARS-CoV-2 vaccines

Clinical and Economic Impact of Widespread Rapid Testing to Decrease SARS-CoV-2 Transmission

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