Evaluation of the Abbott BinaxNOW COVID-19 Test Ag Card for rapid detection of SARS-CoV-2 infection by a local public health district with a rural population.
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ABSTRACT:
SUBMITTER: Pollreis RE
PROVIDER: S-EPMC8638850 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundRapid antigen tests hold much promise for use in the school environment. However, the performance of these tests in non-clinical settings and among one of the main target populations in schools-asymptomatic children-is unclear. To address this gap, we examined the positive and negative concordance between the BinaxNOW™ rapid SARS-CoV-2 antigen assay and an RT-PCR test among children at a community-based Covid-19 testing site.MethodsWe conducted rapid antigen (BinaxNOW™) and oral fluid RT-PCR (Curative Labs) tests on children presenting at a walk-up testing site in Los Angeles County from November 25, 2020 to December 9, 2020. Positive concordance was determined as the fraction of RT-PCR positive participants that were also antigen positive. Negative concordance was determined as the fraction of RT-PCR negative participants that were also antigen negative. Multivariate logistic regression models were used to examine the association between positive or negative concordance and participant age, race-ethnicity, sex at birth, symptoms and Ct values.Results226 children tested positive on RT-PCR; 127 children or 56.2% (95% CI: 49.5% to 62.8%) of these also tested positive on the rapid antigen test. Positive concordance was higher among symptomatic children (64.4%; 95% CI: 53.4% to 74.4%) compared to asymptomatic children (51.1%; 95% CI: 42.5% to 59.7%). Positive concordance was negatively associated with Ct values and was 93.8% (95% CI: 69.8% to 99.8%) for children with Ct values less than or equal to 25. 548 children tested negative on RT-PCR; 539 or 98.4% (95% CI: 96.9% to 99.2%) of these also tested negative on the rapid antigen test. Negative concordance was higher among asymptomatic children.ConclusionsRapid antigen testing can successfully identify most COVID infections in children with viral load levels likely to be infectious. Serial rapid testing may help compensate for limited sensitivity in early infection.
| S-EPMC8021178 | biostudies-literature
Project description:Rapid diagnostic tests (RDTs) for SARS-CoV-2 antigens (Ag) that can be performed at point of care (POC) can supplement molecular testing and help mitigate the COVID-19 pandemic. Deployment of an Ag RDT requires an understanding of its operational and performance characteristics under real-world conditions and in relevant subpopulations. We evaluated the Abbott BinaxNOW COVID-19 Ag card in a high-throughput, drive-through, free community testing site in Massachusetts using anterior nasal (AN) swab reverse transcriptase PCR (RT-PCR) for clinical testing. Individuals presenting for molecular testing in two of seven lanes were offered the opportunity to also receive BinaxNOW testing. Dual AN swabs were collected from symptomatic and asymptomatic children (≤18 years of age) and adults. BinaxNOW testing was performed in a testing pod with temperature/humidity monitoring. One individual performed testing and official result reporting for each test, but most tests had a second independent reading to assess interoperator agreement. Positive BinaxNOW results were scored as faint, medium, or strong. Positive BinaxNOW results were reported to patients by phone, and they were instructed to isolate pending RT-PCR results. The paired RT-PCR result was the reference for sensitivity and specificity calculations. Of 2,482 participants, 1,380 adults and 928 children had paired RT-PCR/BinaxNOW results and complete symptom data. In this study, 974/1,380 (71%) adults and 829/928 (89%) children were asymptomatic. BinaxNOW had 96.5% (95% confidence interval [CI], 90.0 to 99.3) sensitivity and 100% (95% CI, 98.6 to 100.0) specificity in adults within 7 days of symptoms and 84.6% (95% CI, 65.1 to 95.6) sensitivity and 100% (95% CI, 94.5 to 100.0) specificity in children within 7 days of symptoms. Sensitivity and specificity in asymptomatic adults were 70.2% (95% CI, 56.6 to 81.6) and 99.6% (95% CI, 98.9 to 99.9), respectively, and in asymptomatic children, they were 65.4% (95% CI, 55.6 to 74.4) and 99.0% (95% CI, 98.0 to 99.6), respectively. By cycle threshold (CT ) value cutoff, sensitivity in all subgroups combined (n = 292 RT-PCR-positive individuals) was 99.3% with CT values of ≤25, 95.8% with CT values of ≤30, and 81.2% with CT values of ≤35. Twelve false-positive BinaxNOW results (out of 2,308 tests) were observed; in all 12, the test bands were faint but otherwise normal and were noted by both readers. One invalid BinaxNOW result was identified. Interoperator agreement (positive versus negative BinaxNOW result) was 100% (n = 2,230/2,230 double reads). Each operator was able to process 20 RDTs per hour. In a separate set of 30 specimens (from individuals with symptoms ≤7 days) run at temperatures below the manufacturer's recommended range (46 to 58.5°F), sensitivity was 66.7% and specificity 95.2%. BinaxNOW had very high specificity in both adults and children and very high sensitivity in newly symptomatic adults. Overall, 95.8% sensitivity was observed with CT values of ≤30. These data support public health recommendations for use of the BinaxNOW test in adults with symptoms for ≤7 days without RT-PCR confirmation. Excellent interoperator agreement indicates that an individual can perform and read the BinaxNOW test alone. A skilled laboratorian can perform and read 20 tests per hour. Careful attention to temperature is critical.
| S-EPMC8091851 | biostudies-literature
Project description:While there has been significant progress in the development of rapid COVID-19 diagnostics, as the pandemic unfolds, new challenges have emerged, including whether these technologies can reliably detect the more infectious variants of concern and be viably deployed in non-clinical settings as "self-tests". Multidisciplinary evaluation of the Abbott BinaxNOW COVID-19 Ag Card (BinaxNOW, a widely used rapid antigen test, included limit of detection, variant detection, test performance across different age-groups, and usability with self/caregiver-administration. While BinaxNOW detected the highly infectious variants, B.1.1.7 (Alpha) first identified in the UK, B.1.351 (Beta) first identified in South Africa, P.1 (Gamma) first identified in Brazil, B.1.617.2 (Delta) first identified in India and B.1.2, a non-VOC, test sensitivity decreased with decreasing viral loads. Moreover, BinaxNOW sensitivity trended lower when devices were performed by patients/caregivers themselves compared to trained clinical staff, despite universally high usability assessments following self/caregiver-administration among different age groups. Overall, these data indicate that while BinaxNOW accurately detects the new viral variants, as rapid COVID-19 tests enter the home, their already lower sensitivities compared to RT-PCR may decrease even more due to user error.
| S-EPMC8285474 | biostudies-literature
Project description:ObjectiveWe compared the automated non-treponemal reagin (rapid plasma reagin (RPR)) test with the conventional RPR card test for usefulness in clinical applications.SettingA comparative study of laboratory methods using clinical specimens in a single institute.ParticipantsA total of 112 serum samples including 59 Treponema pallidum particle agglutination (TPPA)-positive and 53 TPPA-negative specimens were evaluated.Outcome measuresHiSens Auto RPR LTIA (HBI, Anyang, Korea) was compared with Macro-Vue RPR Card Tests (Becton Dickinson BD Microbiology Systems, Sparks, Maryland, USA). Treponemal-specific tests were performed by Serodia TPPA assay (Fujirebio, Tokyo, Japan). The percentage agreement, ? value and overall sensitivity and specificity of the two RPR tests were compared. Seroconversion rates after treatment were also compared for each RPR test.ResultsThe percentage agreement between the two RPR tests was 78.6% (? 0.565; 95% CI 0.422 to 0.709). Sensitivity and specificity of the automated RPR test relative to the TPPA test was 52.5% (95% CI 39.1% to 65.7%) and 94.3% (95% CI 84.3% to 98.8%), respectively, while the same values for the conventional RPR card test were 86.4% (95% CI 75% to 93.9%) and 94.3% (95% CI 84.3% to 98.8%), respectively. The conventional RPR card test showed overall higher positivity than the automated RPR test, whereas the automated RPR test showed higher seroconversion (43.5%, 10/23) than the conventional RPR card test (4.3%, 1/23) in treated patients.ConclusionsThe automated RPR test showed overall lower sensitivity than the conventional RPR test based on the treponemal test, but higher seroconversion after treatment. The automated RPR test could be used to monitor treatment response, especially in the reverse screening algorithm in syphilis testing.
| S-EPMC4281540 | biostudies-literature
Project description:BackgroundDecisions to isolate patients at risk of having coronavirus disease 2019 (COVID-19) in the emergency department (ED) must be rapid and accurate to ensure prompt treatment and maintain patient flow whilst minimising nosocomial spread. Reverse transcription polymerase chain reaction (RT-PCR) assays are too slow to achieve this, and near-patient testing is being used increasingly to facilitate triage. The ID NOW severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) assay is an isothermal nucleic acid amplification near-patient test which targets the RNA-dependent RNA-polymerase gene.AimTo assess the diagnostic performance of ID NOW as a COVID-19 triage tool for medical admissions from the ED of a large acute hospital.MethodsAll adult acute medical admissions from the ED between 31st March and 31st July 2021 with valid ID NOW and RT-PCR results were included. The diagnostic accuracy of ID NOW [sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)] was calculated against the laboratory reference standard. Discrepant results were explored further using cycle threshold values and clinical data.FindingsTwo percent (124/6050) of medical admissions were SARS-CoV-2 positive on RT-PCR. Compared with PCR, ID NOW had sensitivity and specificity of 83.1% [95% confidence interval (CI) 75.4-88.7] and 99.5% (95% CI 99.3-99.6), respectively. PPV and NPV were 76.9% (95% CI 69.0-83.2) and 99.6% (95% CI 99.5-99.8), respectively. The median time from arrival in the ED to ID NOW result was 59 min.ConclusionID NOW provides a rapid and reliable adjunct for the safe triage of patients with COVID-19, and can work effectively when integrated into an ED triage algorithm.
| S-EPMC8863956 | biostudies-literature
Project description:ObjectiveData-informed decision making is valued among school districts, but challenges remain for local health departments to provide data, especially during a pandemic. We describe the rapid planning and deployment of a school-based COVID-19 surveillance system in a metropolitan US county.MethodsIn 2020, we used several data sources to construct disease- and school-based indicators for COVID-19 surveillance in Franklin County, an urban county in central Ohio. We collected, processed, analyzed, and visualized data in the COVID-19 Analytics and Targeted Surveillance System for Schools (CATS). CATS included web-based applications (public and secure versions), automated alerts, and weekly reports for the general public and decision makers, including school administrators, school boards, and local health departments.ResultsWe deployed a pilot version of CATS in less than 2 months (August-September 2020) and added 21 school districts in central Ohio (15 in Franklin County and 6 outside the county) into CATS during the subsequent months. Public-facing web-based applications provided parents and students with local information for data-informed decision making. We created an algorithm to enable local health departments to precisely identify school districts and school buildings at high risk of an outbreak and active SARS-CoV-2 transmission in school settings.Practice implicationsPiloting a surveillance system with diverse school districts helps scale up to other districts. Leveraging past relationships and identifying emerging partner needs were critical to rapid and sustainable collaboration. Valuing diverse skill sets is key to rapid deployment of proactive and innovative public health practices during a global pandemic.
| S-EPMC8203033 | biostudies-literature
Project description:Proper hand hygiene with soap and detergents prevents the transmission of many infectious diseases. However, commercial detergents are less likely to be accessible or affordable to poor people in remote rural areas. These people traditionally use some plant parts as a detergent even though their antibacterial activity has not been yet investigated. Therefore, this study aims to determine the antibacterial activities of some of the plants against bacteria isolated from humans.Plants selected for this study are Phytolacca dodecandra fruits, Rumex nepalensis leaves, Grewia ferruginea bark and leaves. The samples of these plants were collected from rural areas of Jimma town based on their ethno-botanical survey and information on their local use. Acetone was used as a solvent to extract the bioactive constituents of the plants. The antibacterial activities of the plants were evaluated against reference strains and bacteria isolated from humans using disc diffusion and macro dilution methods.The plant extracts have shown varying antimicrobial activities against the bacterial species tested. Susceptibility testing shows zones of inhibition ranging from 8.0 ± 1.0 mm to 20.7 ± 5.5 mm. The MIC and MBC of the plants against the bacterial species tested were 3.13 and 12.5 mg/ml respectively. These variations are attributed to different concentrations of the bioactive constituents of the extracts like saponins, tannins, flavonoids and terpenoids.The studied plants can contribute to achieve better personal hygiene since they are effective against different bacterial agents and are freely available in rural areas.
| S-EPMC5534096 | biostudies-other
Project description:IntroductionThis paper aimed at estimating the resources required to implement a community Score Card by a typical rural district health team in Uganda, as a mechanism for fostering accountability, utilization and quality of maternal and child healthcare service.MethodsThis costing analysis was done from the payer's perspective using the ingredients approach over five quarterly rounds of scoring between 2017 and 2018. Expenditure data was obtained from project records, entered and analyzed in Microsoft excel. Two scale-up scenarios, scenario one (considered cost inputs by the MakSPH research teams) and scenario two (considering cost inputs based on contextual knowledge from district implementing teams), were simulated to better understand the cost implications of integrating the Community Score Card (CSC) into a district health system.ResultsThe total and average cost of implementing CSC for five quarterly rounds over a period of 18?months were USD 59,962 and USD 11,992 per round of scoring, respectively. Considering the six sub-counties (including one Town Council) in Kibuku district that were included in this analysis, the average cost of implementating the CSC in each sub-county was USD 1998 per scoring round. Scaling-up of the intervention across the entire district (included 22 sub-counties) under the first scenario would cost a total of USD 19,003 per scoring round. Under the second scaleup scenario, the cost would be lower at USD 7116. The total annual cost of scaling CSC in the entire district would be USD 76,012 under scenario one compared to USD 28,465 under scenario two. The main cost drivers identified were transportation costs, coordination and supervision costs, and technical support to supplement local implementers.ConclusionOur analysis suggests that it is financially feasible to implement and scale-up the CSC initiative, as an accountability tool for enhancing service delivery. However, the CSC design and approach needs to be embedded within local systems and implemented in collaboration with existing stakeholders so as to optimise costs. A comprehensive economic analysis of the costs associated with transportation, involvement of the district teams in coordination, supervision as well as provision of technical support is necessary to determine the cost-effectiveness of the CSC approach.
| S-EPMC7777411 | biostudies-literature
Project description:Background:We investigated predictors of the rural clients' satisfaction level (CSL), and interlinks between perceived specific service quality (PSSQ), perceived utility value (PUV), CSL, and clients' reactions (CR) towards current and future utilization of providers and facilities in the public-private mixed health system of Bangladesh. Methods:A quantitative study using interviewer-administered questionnaire was conducted among 400 rural patients. CSL was measured both directly and indirectly. Clients' opinions of PSSQ relating to healthcare structure and process features were measured for indirectly assessing their satisfaction. PUV and CR were also measured indirectly. 5-point Likert scales were used to measure PSSQ, PUV, CSL and CR. Multiple regression and mediation were the models. Results:Clients' satisfaction was low in both health sectors with significantly lower in the public than private sector. Accessibility (financial) predicted commonly high variations in CSL both in the public (18.2%) and private sectors (25.0%). Availability predicted incomparably highest variations in CSL in the public sector (34.6%). Structural factors predicted higher variations in clients' satisfaction in the public sector, which in the private sector were service process-features. Clients' reaction was the ultimate outcome of PSSQ mediated through PUV and CSL. PUV mediated the effects of PSSQ on clients' reaction stronger than CSL. Conclusion:Financial accessibility is a crucial risk of impoverishment in both public and private sectors. Both structural and process features of healthcare are in ample needs for addressing existing low satisfaction in patients in rural Bangladesh.
| S-EPMC5683547 | biostudies-literature
Project description:ObjectivesThere is limited information on the performance of rapid antigen detection (RAD) tests to identify SARS-CoV-2-infected asymptomatic individuals. In this field study, we evaluated the Panbio™ COVID-19 Ag Rapid Test Device (Abbott Diagnostics, Jena, Germany) for this purpose.MethodsA total of 634 individuals (355 female; median age, 37 years; range, 9-87) were enrolled. Two nasopharyngeal swabs were collected from household (n = 338) and non-household contacts (n = 296) of COVID-19 cases. RAD testing was carried out at the point of care. The RT-PCR test used was the TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, MA, USA).ResultsHousehold contacts were tested at a median of 2 days (range, 1-7) after diagnosis of the index case, whereas non-household contacts (n = 296) were tested at a median of 6 days (range, 1-7) after exposure. In total, 79 individuals (12.4%) tested positive by RT-PCR, of whom 38 (48.1%) yielded positive RAD results. The overall sensitivity and specificity of the RAD test was 48.1% (95% CI 37.4-58.9) and 100% (95% CI 99.3-100), respectively. Sensitivity was higher in household (50.8%; 95% CI 38.9-62.5) than in non-household (35.7%; 95% CI 16.3-61.2%) contacts. Individuals testing positive by RAD test were more likely (p < 0.001) to become symptomatic than their negative counterparts.DiscussionThe Panbio test displays low sensitivity in asymptomatic close contacts of COVID-19 patients, particularly in non-household contacts. Nonetheless, establishing the optimal timing for upper respiratory tract collection in this group seems imperative to pinpoint test sensitivity.
| S-EPMC7833843 | biostudies-literature