Performance Characteristics of the Abbott BinaxNOW SARS-CoV-2 Antigen Test in Comparison to Real-Time Reverse Transcriptase PCR and Viral Culture in Community Testing Sites during November 2020.

Point-of-care antigen tests are an important tool for SARS-CoV-2 detection. Antigen tests are less sensitive than real-time reverse transcriptase PCR (rRT-PCR). Data on the performance of the BinaxNOW antigen test compared to rRT-PCR and viral culture by symptom and known exposure status, timing during disease, or exposure period and demographic variables are limited. During 3 to 17 November 2020, we collected paired upper respiratory swab specimens to test for SARS-CoV-2 by rRT-PCR and Abbott BinaxNOW antigen test at two community testing sites in Pima County, Arizona. We administered a questionnaire to capture symptoms, known exposure status, and previous SARS-CoV-2 test results. Specimens positive by either test were analyzed by viral culture. Previously we showed overall BinaxNOW sensitivity was 52.5%. Here, we showed BinaxNOW sensitivity increased to 65.7% among currently symptomatic individuals reporting a known exposure. BinaxNOW sensitivity was lower among participants with a known exposure and previously symptomatic (32.4%) or never symptomatic (47.1%) within 14 days of testing. Sensitivity was 71.1% in participants within a week of symptom onset. In participants with a known exposure, sensitivity was highest 8 to 10 days postexposure (75%). The positive predictive value for recovery of virus in cell culture was 56.7% for BinaxNOW-positive and 35.4% for rRT-PCR-positive specimens. Result reporting time was 2.5 h for BinaxNOW and 26 h for rRT-PCR. Point-of-care antigen tests have a shorter turnaround time than laboratory-based nucleic acid amplification tests, which allows for more rapid identification of infected individuals. Antigen test sensitivity limitations are important to consider when developing a testing program.

Investigation of a Severe Acute Respiratory Syndrome Coronavirus 2 Delta (B.1.617.2) Variant Outbreak Among Residents of a Skilled Nursing Facility and Vaccine Effectiveness Analysis: Maricopa County, Arizona, June-July 2021.

BACKGROUND: Short-term rehabilitation units present unique infection control challenges because of high turnover and medically complex residents. In June 2021, the Maricopa County Department of Public Health was notified of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta outbreak in a skilled nursing facility short-term rehabilitation unit. We describe the outbreak and assess vaccine effectiveness (VE). METHODS: Facility electronic medical records were reviewed for residents who spent > 1 night on the affected unit between June 10 and July 23, 2021, to collect demographics, SARS-CoV-2 test results, underlying medical conditions, vaccination status, and clinical outcomes. Coronavirus disease 2019 VE estimates using Cox proportional hazards models were calculated. RESULTS: Forty (37%) of 109 short-stay rehabilitation unit residents who met inclusion criteria tested positive for SARS-CoV-2. SARS-CoV-2-positive case-patients were mostly male (58%) and White (78%) with a median age of 65 (range, 27-92) years; 11 (27%) were immunocompromised. Of residents, 39% (10 cases, 32 noncases) received 2 doses and 9% (4 cases, 6 noncases) received 1 dose of messenger RNA (mRNA) vaccine. Among nonimmunocompromised residents, adjusted 2-dose primary-series mRNA VE against symptomatic infection was 80% (95% confidence interval, 15-95). More cases were hospitalized (33%) or died (38%) than noncases (10% hospitalized; 16% died). CONCLUSIONS: In this large SARS-CoV-2 Delta outbreak in a high-turnover short-term rehabilitation unit, a low vaccination rate and medically complex resident population were noted alongside severe outcomes. VE of 2-dose primary-series mRNA vaccine against symptomatic infection was the highest in nonimmunocompromised residents. Health departments can use vaccine coverage data to prioritize facilities for assistance in preventing outbreaks.

COVID-19 Outbreaks Associated With Youth Club Sports: Maricopa County, Arizona, September-November 2020.

The Maricopa County Department of Public Health in Arizona investigated three COVID-19 outbreaks associated with club sports, two in tournaments and one in a hockey league. During September through November 2020, 195 team-associated and 69 secondary household contact cases were identified among 2093 athletes, coaches, and staff members; the team attack rate ranged from 6% to 72%. Outbreaks occurred during high community transmission periods in Maricopa County. Identification of contacts and characterization of prevention strategies were challenging because of limited cooperation from athletes, families, and staff. (Am J Public Health. 2022;112(2):216-219. https://doi.org/10.2105/AJPH.2021.306579).

Clinical outcomes of monoclonal antibody therapy during a COVID-19 outbreak in a skilled nursing facility-Arizona, 2021.

BACKGROUND: Adult residents of skilled nursing facilities (SNF) have experienced high morbidity and mortality from SARS-CoV-2 infection and are at increased risk for severe COVID-19 disease. Use of monoclonal antibody (mAb) treatment improves clinical outcomes among high-risk outpatients with mild-to-moderate COVID-19, but information on mAb effectiveness in SNF residents with COVID-19 is limited. We assessed outcomes in SNF residents with mild-to-moderate COVID-19 associated with an outbreak in Arizona during January-February 2021 that did and did not receive a mAb. METHODS: Medical records were reviewed to describe the effect of bamlanivimab therapy on COVID-19 mortality. Secondary outcomes included referral to an acute care setting and escalation of medical therapies at the SNF (e.g., new oxygen requirements). Residents treated with bamlanivimab were compared to residents who were eligible for treatment under the FDA's Emergency Use Authorization (EUA) but were not treated. Multivariable logistic regression was used to determine association between outcomes and treatment status. RESULTS: Seventy-five residents identified with COVID-19 during this outbreak met eligibility for mAb treatment, of whom 56 received bamlanivimab. Treated and untreated groups were similar in age and comorbidities associated with increased risk of severe COVID-19 disease. Treatment with bamlanivimab was associated with reduced 21-day mortality (adjusted OR = 0.06; 95% CI: 0.01, 0.39) and lower odds of initiating oxygen therapy (adjusted OR = 0.07; 95% CI: 0.02, 0.34). Referrals to acute care were not significantly different between treated and untreated residents. CONCLUSIONS: mAb therapy was successfully administered to SNF residents with COVID-19 in a large outbreak setting. Treatment with bamlanivimab reduced 21-day mortality and reduced initiation of oxygen therapy. As the COVID-19 pandemic evolves and newer immunotherapies gain FDA authorization, more studies of the effectiveness of mAb therapies for treating emerging SARS-CoV-2 variants of concern in high-risk congregate settings are needed.

Accuracy of Case-Based Seroprevalence of SARS-CoV-2 Antibodies in Maricopa County, Arizona.

We conducted a community seroprevalence survey in Arizona, from September 12 to October 1, 2020, to determine the presence of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We used the seroprevalence estimate to predict SARS-CoV-2 infections in the jurisdiction by applying the adjusted seroprevalence to the county's population. The estimated community seroprevalence of SARS-CoV-2 infections was 4.3 times greater (95% confidence interval = 2.2, 7.5) than the number of reported cases. Field surveys with representative sampling provide data that may help fill in gaps in traditional public health reporting. (Am J Public Health. 2022;112(1):38-42. https://doi.org/10.2105/AJPH.2021.306568).

Association Between K-12 School Mask Policies and School-Associated COVID-19 Outbreaks - Maricopa and Pima Counties, Arizona, July-August 2021.

CDC recommends universal indoor masking by students, staff members, faculty, and visitors in kindergarten through grade 12 (K-12) schools, regardless of vaccination status, to reduce transmission of SARS-CoV-2, the virus that causes COVID-19 (1). Schools in Maricopa and Pima Counties, which account for >75% of Arizona's population (2), resumed in-person learning for the 2021-22 academic year during late July through early August 2021. In mid-July, county-wide 7-day case rates were 161 and 105 per 100,000 persons in Maricopa and Pima Counties, respectively, and 47.6% of Maricopa County residents and 59.2% of Pima County residents had received at least 1 dose of a COVID-19 vaccine. School districts in both counties implemented variable mask policies at the start of the 2021-22 academic year (Table). The association between school mask policies and school-associated COVID-19 outbreaks in K-12 public noncharter schools open for in-person learning in Maricopa and Pima Counties during July 15-August 31, 2021, was evaluated.

Evaluation of Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 Infection at Two Community-Based Testing Sites - Pima County, Arizona, November 3-17, 2020.

Rapid antigen tests, such as the Abbott BinaxNOW COVID-19 Ag Card (BinaxNOW), offer results more rapidly (approximately 15-30 minutes) and at a lower cost than do highly sensitive nucleic acid amplification tests (NAATs) (1). Rapid antigen tests have received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for use in symptomatic persons (2), but data are lacking on test performance in asymptomatic persons to inform expanded screening testing to rapidly identify and isolate infected persons (3). To evaluate the performance of the BinaxNOW rapid antigen test, it was used along with real-time reverse transcription-polymerase chain reaction (RT-PCR) testing to analyze 3,419 paired specimens collected from persons aged ≥10 years at two community testing sites in Pima County, Arizona, during November 3-17, 2020. Viral culture was performed on 274 of 303 residual real-time RT-PCR specimens with positive results by either test (29 were not available for culture). Compared with real-time RT-PCR testing, the BinaxNOW antigen test had a sensitivity of 64.2% for specimens from symptomatic persons and 35.8% for specimens from asymptomatic persons, with near 100% specificity in specimens from both groups. Virus was cultured from 96 of 274 (35.0%) specimens, including 85 (57.8%) of 147 with concordant antigen and real-time RT-PCR positive results, 11 (8.9%) of 124 with false-negative antigen test results, and none of three with false-positive antigen test results. Among specimens positive for viral culture, sensitivity was 92.6% for symptomatic and 78.6% for asymptomatic individuals. When the pretest probability for receiving positive test results for SARS-CoV-2 is elevated (e.g., in symptomatic persons or in persons with a known COVID-19 exposure), a negative antigen test result should be confirmed by NAAT (1). Despite a lower sensitivity to detect infection, rapid antigen tests can be an important tool for screening because of their quick turnaround time, lower costs and resource needs, high specificity, and high positive predictive value (PPV) in settings of high pretest probability. The faster turnaround time of the antigen test can help limit transmission by more rapidly identifying infectious persons for isolation, particularly when used as a component of serial testing strategies.