Validation of an At-Home Direct Antigen Rapid Test for COVID-19

Harmon, Alexander; Chang, Celina; Salcedo, Nol; Sena, Brena F; Herrera, Bobby Brooke; Bosch, Irene; Holberger, Laura E

doi:10.1001/jamanetworkopen.2021.26931

Cited by 38 publications

(39 citation statements)

References 5 publications

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“…Although there is reduced sensitivity compared to using NP swabs in our evaluation, the NA swab offers several advantages. It is less invasive, which is more acceptable by people compared to NP swabs ( 26 , 27 ), and the ease of use facilitates volunteer training and self-testing at home or workplace ( 28 , 29 ). These factors, combined with rapid turnaround time, low cost, and ease of use afforded by Ag-RDTs ( 30 – 32 ), can help facilitate repeat testing over time and may compensate for reduced sensitivity ( 5 , 9 , 33 ).…”

Section: Discussionmentioning

confidence: 99%

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

et al. 2022

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Section: Discussionmentioning

confidence: 99%

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

et al. 2022

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“…The need for larger test capacity and rapid case identification lead to the adoption of a point-of-care (POC) rapid antigen test in some screening programs ( 4 ). The test is cheap, rapid, easy to use, and does not require a laboratory setting ( 5 ). These factors allow the rapid antigen testing to overcome several logistical hurdles with mass SARS-CoV-2 testing.…”

Section: Introductionmentioning

confidence: 99%

The Performance of Two Rapid Antigen Tests During Population-Level Screening for SARS-CoV-2 Infection

et al. 2021

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Background: SARS-CoV-2 antigen assays offer a rapid mean to diagnose and isolate infected individuals. However, their utility in population-level screening is unknown.Objectives: The performance of two antigen tests in detecting SARS-CoV-2 was assessed among individuals randomly selected in the community.Study Design: A prospective study that performed head-to-head comparison of two SARS-CoV-2 antigen assays. Individuals were recruited during community SARS-CoV-2 screening over 10 working days. Demographic and clinical data were collected. Standard Q COVID-19 Ag test, a point-of-care chromatographic assay, was conducted immediately, and then the sample was transported to the virology laboratory to perform PCR and the LIAISON SARS-CoV-2 Ag chemiluminesence immunoassay.Results: respiratory samples from 991 individuals were collected, and 62 were positive by PCR. Inconclusive PCR results were observed in 19 samples and were excluded. The median age of participants was 40.2 years (IQR 32.3–47.8), and 932 (94%) were males. Most (77.4%) of infections were asymptomatic. The sensitivity and the specificity of the LIAISON assay were 43.3% (95%CI 30.6–56.8) and 99.9% (95%CI 99.3–100). The Standard Q assay had lower sensitivity (30.6%, 95%CI 19.6–43.7) but similar specificity (98.8%, 95%CI, 97.8–99.4). Similarly, the LIAISON assay had higher positive predictive value (96.3%, 95%CI 81–99.9% vs. 63.3%, 95%CI, 43.9–80.1%). Both assays performed better in symptomatic patients and among samples with a low-cycle threshold (Ct < 25).Conclusion: In our setting of random community surveillance, rapid antigen testing of nasopharyngeal swabs by either LIAISON SARS-CoV-2 Ag (DiaSorin) or Standard Q COVID-19 Ag (SD Biosensor) was less sensitive to detecting SARS-CoV-2 than the TaqPath COVID-19 RT-PCR.

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“…Most of these tests show lower sensitivity as compared to our previous published RT-LAMP assay (100% sensitivity) [ 16 ]. Meanwhile, Harmon et al [ 17 ] reported 78.9% sensitivity using an at-home direct antigen rapid test kit. Another study reported by Shrestha et al (2020) also revealed that low sensitivity of lateral flow antigen test kits for COVID-19 testing with 85% sensitivity [ 18 ].…”

Section: Resultsmentioning

confidence: 99%

RNA purification-free detection of SARS-CoV-2 using reverse transcription loop-mediated isothermal amplification (RT-LAMP)

Lai¹,

Suppiah

Thayan

et al. 2022

Trop Med Health

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Background Current diagnosis of SARS-CoV-2 infection relies on RNA purification prior to amplification. Typical extraction methods limit the processing speed and turnaround time for SARS-CoV-2 diagnostic testing. Methods Here, we applied reverse transcription loop-mediated isothermal amplification directly onto human clinical swabs samples to amplify the RNA from SARS-CoV-2 swab samples after processing with chelating resin. Results By testing our method on 64 samples, we managed to develop an RT-LAMP assay with 95.9% sensitivity (95% CI 86 to 99.5%) and 100% specificity (95% CI 78.2–100%). Conclusion The entire process including sample processing can be completed in approximately 50 min. This method has promising potential to be applied as a fast, simple and inexpensive diagnostic tool for the detection of SARS-CoV-2.

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Validation of an At-Home Direct Antigen Rapid Test for COVID-19

Abstract: Open Access. This is an open access article distributed under the terms of the CC-BY-NC-ND License.

Cited by 38 publications

References 5 publications

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

Comparison between Nasal and Nasopharyngeal Swabs for SARS-CoV-2 Rapid Antigen Detection in an Asymptomatic Population, and Direct Confirmation by RT-PCR from the Residual Buffer

The Performance of Two Rapid Antigen Tests During Population-Level Screening for SARS-CoV-2 Infection

RNA purification-free detection of SARS-CoV-2 using reverse transcription loop-mediated isothermal amplification (RT-LAMP)

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