Point-of-Care Antigen Test for SARS-CoV-2 in Asymptomatic College Students

Tinker, Sarah C.; Szablewski, Christine M.; Litvintseva, Anastasia P.; Drenzek, Cherie; Voccio, Gary E.; Hunter, Melissa A.; Briggs, Stephen L.; Heida, Debbie E.; Folster, Jennifer; Shewmaker, Patricia L.; Medrzycki, Magdalena; Bowen, Michael D.; Bohannon, Caitlin; Bagarozzi, Dennis A.; Petway, Marla; Rota, Paul A.; Kuhnert-Tallman, Wendi; Thornburg, Natalie J.; Prince-Guerra, Jessica L.; Barrios, Lisa C.; Tamin, Azaibi; Harcourt, Jennifer L.; Honein, Margaret A.

doi:10.3201/eid2710.210080

Cited by 17 publications

(25 citation statements)

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“…Across other studies, BinaxNOW sensitivity varied between 64.4% and 96.5% among symptomatic persons ( 6 , 8 , 10 – 13 ) and between 20.0% and 70.2% among asymptomatic participants ( 9 , 14 ). Several factors may contribute to variability in test performance, including differences in population characteristics, the timing during disease course, test operator training ( 7 ), and methodological differences, such as the comparator rRT-PCR assay, specimen type, and collection method.…”

Section: Discussionmentioning

confidence: 75%

“…Prior studies ( 6 – 14 ) have examined BinaxNOW antigen test performance; however, detailed data on the association of antigen test performance compared to rRT-PCR and viral culture by key epidemiologic characteristics, such as symptom and known exposure status, timing during infection, and demographic variables, are limited. An earlier brief report ( 15 ) analyzing these data showed high specificity for BinaxNOW but low sensitivity in specimens from either symptomatic (64.2%) or asymptomatic persons (35.8%) and showed improved sensitivity compared to rRT-PCR when limiting the analysis to culture-positive specimens.…”

Section: Introductionmentioning

confidence: 99%

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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

et al. 2022

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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 November 3 rd -17 th , 2020, we collected paired upper respiratory swab specimens to test for SARS-CoV-2 by rRT-PCR and Abbott BinaxNOW (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 8-10 days post-exposure (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 hours for BinaxNOW and 26 hours for rRT-PCR. Point-of-care antigen tests have a shorter turn-around time compared to 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.

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Section: Discussionmentioning

confidence: 75%

Section: Introductionmentioning

confidence: 99%

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

et al. 2022

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“…However, 2 studies with IFU-conforming testing procedure on NP or AN/MT sample, still showed a low sensitivity. This quite likely results from the on average low viral load in 1 study [49], and the asymptomatic study population in the other [175]. On the contrary, compared to the other studies unusual high sensitivity was found in studies where average viral load was high [45, 84, 144, 145] or participants were mainly within the first week of symptom onset [42, 54, 135].…”

Section: Discussionmentioning

confidence: 98%

Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: an updated systematic review and meta-analysis with meta regression analyzing influencing factors

Brümmer

Katzenschlager

McGrath

et al. 2022

Preprint

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Background Comprehensive information about the accuracy of antigen rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 is essential to guide public health decision makers in choosing the best tests and testing policies. In August 2021, we published a systematic review and meta-analysis about the accuracy of Ag-RDTs. We now update this work and analyze the factors influencing test sensitivity in further detail. Methods and findings We registered the review on PROSPERO (registration number: CRD42020225140). We systematically searched multiple databases (PubMed, Web of Science Core Collection, medRvix, bioRvix, and FIND) for publications evaluating the accuracy of Ag-RDTs for SARS-CoV-2 until August 31, 2021. Descriptive analyses of all studies were performed, and when more than 4 studies were available, a random-effects meta-analysis was used to estimate pooled sensitivity and specificity with reverse transcription polymerase chain reaction (RT-PCR) testing as a reference. To evaluate factors influencing test sensitivity, we performed 3 different analyses using multivariate mixed-effects meta-regression models. We included 194 studies with 221,878 Ag-RDTs performed. Overall, the pooled estimates of Ag-RDT sensitivity and specificity were 72.0% (95% confidence interval [CI] 69.8 to 74.2) and 98.9% (95% CI 98.6 to 99.1), respectively. When manufacturer instructions were followed, sensitivity increased to 76.4% (95%CI 73.8 to 78.8). Sensitivity was markedly better on samples with lower RT-PCR cycle threshold (Ct) values (sensitivity of 97.9% [95% CI 96.9 to 98.9] and 90.6% [95% CI 88.3 to 93.0] for Ct-values <20 and <25, compared to 54.4% [95% CI 47.3 to 61.5] and 18.7% [95% CI 13.9 to 23.4] for Ct-values ≥25 and ≥30) and was estimated to increase by 2.9 percentage points (95% CI 1.7 to 4.0) for every unit decrease in mean Ct-value when adjusting for testing procedure and patients symptom status. Concordantly, we found the mean Ct-value to be lower for true positive (22.2 [95% CI 21.5 to 22.8]) compared to false negative (30.4 [95% CI 29.7 to 31.1]) results. Testing in the first week from symptom onset resulted in substantially higher sensitivity (81.9% [95% CI 77.7 to 85.5]) compared to testing after 1 week (51.8%, 95% CI 41.5 to 61.9). Similarly, sensitivity was higher in symptomatic (76.2% [95% CI 73.3 to 78.9]) compared to asymptomatic (56.8% [95% CI 50.9 to 62.4]) persons. However, both effects were mainly driven by the Ct-value of the sample. With regards to sample type, highest sensitivity was found for nasopharyngeal (NP) and combined NP/oropharyngeal samples (70.8% [95% CI 68.3 to 73.2]), as well as in anterior nasal/mid-turbinate samples (77.3% [95% CI 73.0 to 81.0]). Conclusion Ag-RDTs detect most of the individuals infected with SARS-CoV-2, and almost all when high viral loads are present (>90%). With viral load, as estimated by Ct-value, being the most influential factor on their sensitivity, they are especially useful to detect persons with high viral load who are most likely to transmit the virus. To further quantify the effects of other factors influencing test sensitivity, standardization of clinical accuracy studies and access to patient level Ct-values and duration of symptoms are needed.

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“…The European Centers for Disease Control and Prevention recommend that antigen tests should not be used for the screening of asymptomatic patients if the prevalence is <10% [ 60 ]. The sensitivity of antigen tests using self-collected specimens, such as saliva or ANS, is even lower [ 63 - 67 ].…”

Section: Antigen Testmentioning

confidence: 99%

Update of Guidelines for Laboratory Diagnosis of COVID-19 in Korea

et al. 2022

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Korean Society for Laboratory Medicine and the Korea Disease Prevention and Control Agency have announced guidelines for diagnosing coronavirus disease (COVID-19) in clinical laboratories in Korea. With the ongoing pandemic, we propose an update of the previous guidelines based on new scientific data. This update includes recommendations for tests that were not included in the previous guidelines, including the rapid molecular test, antigen test, antibody test, and self-collected specimens, and a revision of the previous recommendations. This update will aid clinical laboratories in performing laboratory tests for diagnosing COVID-19.

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Point-of-Care Antigen Test for SARS-CoV-2 in Asymptomatic College Students

Cited by 17 publications

References 4 publications

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

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

Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: an updated systematic review and meta-analysis with meta regression analyzing influencing factors

Update of Guidelines for Laboratory Diagnosis of COVID-19 in Korea

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