Limit of detection in different matrices of nineteen commercially available rapid antigen tests for the detection of SARS-CoV-2

Atienzar, Ana I Cubas; Kontogianni, Konstantina; Edwards, Thomas; Wooding, Dominic; Buist, Kate; Thompson, Caitlin R.; Williams, Christopher T; Patterson, Edward I; Hughes, Grant L; Baldwin, Lisa; Escadafal, Camille; Sacks, Jilian A.; Adams, Emily

doi:10.1101/2021.03.19.21253950

Cited by 11 publications

(19 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Similar results were found in another study, where Standard Q showed the lowest LOD (detecting virus up to what is an equivalent Ct value of 26.3 to 28.7), compared to that of Rapigen and Coris (detecting virus up to what is an equivalent Ct value of only 18.4 for both) [208,274,275]. However, another study found Panbio, Standard Q, Coris, and BinaxNOW to have a similar LOD values of 5.0 × 10 3 plaque forming units (PFU)/mL, but the ESPLINE SARS-CoV-2 by Fujirebio (Japan), the COVID-19 Rapid Antigen Test by Mologic (UK), and the Sure Status COVID-19 Antigen Card Test by Premier Medical Corporation (India) performed markedly better (LOD 2.5 × 10 2 to 5.0 × 10 2 PFU/mLAU : IchangedLOD ) [173]. An overview of all LOD values reported in the studies can be found in S3 Table.…”

Section: Comparison With Analytical Studiesmentioning

confidence: 98%

“…At the end of the data extraction process, 37 studies were still in preprint form [4,171,173,174,177,180,190,192,201,204,205,207,211,[214][215][216]218,220,222,223,225,227,231,233,234,238,240,244,247,253,257,265,267,284,287,290,293]. All studies were written in English, except for 2 in Spanish [175,280].…”

Section: Summary Of Studiesmentioning

confidence: 99%

“…All studies were written in English, except for 2 in Spanish [175,280]. Out of the 133 studies, 9 reported analytical accuracy [173,191,198,208,227,256,274,275,282], and the remaining 124 reported clinical accuracy.…”

Section: Summary Of Studiesmentioning

confidence: 99%

“…Only 7 studies reported a sample size, for which 833 (90.6%) samples originated from NP swabs, while for 86 (9.4%) the sample type was unclear. One of the 2 studies not reporting sample size used saliva samples [198], while the other used the sample type specified in the respective Ag-RDT's IFU [173].…”

Section: Comparison With Analytical Studiesmentioning

confidence: 99%

See 3 more Smart Citations

Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis

et al. 2021

Self Cite

View full text Add to dashboard Cite

Background SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) are increasingly being integrated in testing strategies around the world. Studies of the Ag-RDTs have shown variable performance. In this systematic review and meta-analysis, we assessed the clinical accuracy (sensitivity and specificity) of commercially available Ag-RDTs. 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 up until 30 April 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 in comparison to reverse transcription polymerase chain reaction (RT-PCR) testing. We assessed heterogeneity by subgroup analyses, and rated study quality and risk of bias using the QUADAS-2 assessment tool. From a total of 14,254 articles, we included 133 analytical and clinical studies resulting in 214 clinical accuracy datasets with 112,323 samples. Across all meta-analyzed samples, the pooled Ag-RDT sensitivity and specificity were 71.2% (95% CI 68.2% to 74.0%) and 98.9% (95% CI 98.6% to 99.1%), respectively. Sensitivity increased to 76.3% (95% CI 73.1% to 79.2%) if analysis was restricted to studies that followed the Ag-RDT manufacturers’ instructions. LumiraDx showed the highest sensitivity, with 88.2% (95% CI 59.0% to 97.5%). Of instrument-free Ag-RDTs, Standard Q nasal performed best, with 80.2% sensitivity (95% CI 70.3% to 87.4%). Across all Ag-RDTs, sensitivity was markedly better on samples with lower RT-PCR cycle threshold (Ct) values, i.e., <20 (96.5%, 95% CI 92.6% to 98.4%) and <25 (95.8%, 95% CI 92.3% to 97.8%), in comparison to those with Ct ≥ 25 (50.7%, 95% CI 35.6% to 65.8%) and ≥30 (20.9%, 95% CI 12.5% to 32.8%). Testing in the first week from symptom onset resulted in substantially higher sensitivity (83.8%, 95% CI 76.3% to 89.2%) compared to testing after 1 week (61.5%, 95% CI 52.2% to 70.0%). The best Ag-RDT sensitivity was found with anterior nasal sampling (75.5%, 95% CI 70.4% to 79.9%), in comparison to other sample types (e.g., nasopharyngeal, 71.6%, 95% CI 68.1% to 74.9%), although CIs were overlapping. Concerns of bias were raised across all datasets, and financial support from the manufacturer was reported in 24.1% of datasets. Our analysis was limited by the included studies’ heterogeneity in design and reporting. Conclusions In this study we found that Ag-RDTs detect the vast majority of SARS-CoV-2-infected persons within the first week of symptom onset and those with high viral load. Thus, they can have high utility for diagnostic purposes in the early phase of disease, making them a valuable tool to fight the spread of SARS-CoV-2. Standardization in conduct and reporting of clinical accuracy studies would improve comparability and use of data.

show abstract

Section: Comparison With Analytical Studiesmentioning

confidence: 98%

Section: Summary Of Studiesmentioning

confidence: 99%

Section: Summary Of Studiesmentioning

confidence: 99%

Section: Comparison With Analytical Studiesmentioning

confidence: 99%

See 2 more Smart Citations

Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis

et al. 2021

Self Cite

View full text Add to dashboard Cite

show abstract

“…At the end of the data extraction process, 37 studies were still in preprint form [4,171,173,174,177,180,190,192,201,204,205,207,211,214–216,218,220,222,223,225,227,231,233,234,238,240,244,247,253,257,265,267,284,287,290,293]. All studies were written in English, except for two in Spanish [175, 280].…”

Section: Resultsmentioning

confidence: 99%

The accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis

Brümmer

Katzenschlager

Gaeddert

et al. 2021

Preprint

Self Cite

102

View full text Add to dashboard Cite

Background: SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) are increasingly being inte-grated in testing strategies around the world. Studies of the Ag-RDTs have shown variable performance. In this systematic review and meta-analysis, we assessed the clinical accuracy (sensi-tivity and specificity) of commercially available Ag-RDTs. Methods: We registered the review on PROSPERO (Registration number: CRD42020225140). We systematically searched multiple databases (PubMed, Web of Science Core Collection, medRvix and bioRvix, FINDdx) for publications up until December 11th, 2020. Descriptive analyses of all studies were performed and when more than four studies were avail-able, a random-effects meta-analysis was used to estimate pooled sensitivity and specificity in comparison to reverse transcriptase polymerase chain reaction testing. We assessed heterogeneity by subgroup analyses ((1) performed conform with manufacturers instructions for use (IFU) or not, (2) symptomatic vs. asymptomatic, (3) duration of symptoms less than seven days vs. more than seven days, (4) Ct-value <25 vs. <30 vs. >30, (5) by sample type)) and with meta-regression. We assessed study quality and risk of bias using the QUADAS 2 assessment tool. Results: From a total of 11,715 articles, we extracted 98 analytical and clinical data sets. 74 clinical accuracy data sets were evaluated that included 31,202 samples. Across all meta-analyzed samples, the pooled Ag-RDT sensitivity was 73.8% (CI 68.6 to 78.5). If analysis was re-stricted to studies that followed the Ag-RDT manufacturers instructions using fresh upper res-piratory swab samples, the sensitivity increased to 79.1% (95%CI 75.0 to 82.8). The SD Biosensor Standard Q and Abbott Panbio showed the highest sensitivity with 81.7% and 72.7%, respectively. The best Ag-RDT performance was found with nasopharyngeal sampling (77.3%, CI 72.0 to 81.9) in comparison to other sample types (e.g., anterior nasal or mid turbinate 63.5%, CI 49.5 to 75.5). Testing in the first week from symptom onset resulted in higher sensitivity (87.5%, CI 86.0 to 89.1) compared to testing after one week (64.1%, CI 54.4 to 73.8). The tests performed markedly better on samples with lower Ct-values, i.e., <30 (87.9%, CI 86.7 to 88.8), in comparison to those with Ct >30 (47.8%, CI 41.1 to 54.5). Bias concerns were raised across all data sets, and financial support from the manufacturer was reported in 28.2% of data sets. Conclusion: As Ag-RDTs detect most cases within the first week of symptom onset and those with high viral load, they can have high utility for screening purposes in the early phase of disease, and thus can be a valuable tool to fight the spread of SARS-CoV-2. Standardization of con-duct and reporting of clinical accuracy studies would improve comparability and use of data.

show abstract

A Versatile Biomimic Nanotemplating Fluidic Assay for Multiplex Quantitative Monitoring of Viral Respiratory Infections and Immune Responses in Saliva and Blood

et al. 2022

View full text Add to dashboard Cite

The last pandemic exposed critical gaps in monitoring and mitigating the spread of viral respiratory infections at the point‐of‐need. A cost‐effective multiplexed fluidic device (NFluidEX), as a home‐test kit analogous to a glucometer, that uses saliva and blood for parallel quantitative detection of viral infection and body's immune response in an automated manner within 11 min is proposed. The technology integrates a versatile biomimetic receptor based on molecularly imprinted polymers in a core–shell structure with nano gold electrodes, a multiplexed fluidic‐impedimetric readout, built‐in saliva collection/preparation, and smartphone‐enabled data acquisition and interpretation. NFluidEX is validated with Influenza A H1N1 and SARS‐CoV‐2 (original strain and variants of concern), and achieves low detection limit in saliva and blood for the viral proteins and the anti‐receptor binding domain (RBD) Immunoglobulin G (IgG) and Immunoglobulin M (IgM), respectively. It is demonstrated that nanoprotrusions of gold electrodes are essential for the fine templating of antibodies and spike proteins during molecular imprinting, and differentiation of IgG and IgM in whole blood. In the clinical setting, NFluidEX achieves 100% sensitivity and 100% specificity by testing 44 COVID‐positive and 25 COVID‐negative saliva and blood samples on par with the real‐time quantitative polymerase chain reaction (p < 0.001, 95% confidence) and the enzyme‐linked immunosorbent assay.

show abstract

Limit of detection in different matrices of nineteen commercially available rapid antigen tests for the detection of SARS-CoV-2

Cited by 11 publications

References 29 publications

Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis

Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis

The accuracy of novel antigen rapid diagnostics for SARS-CoV-2: a living systematic review and meta-analysis

A Versatile Biomimic Nanotemplating Fluidic Assay for Multiplex Quantitative Monitoring of Viral Respiratory Infections and Immune Responses in Saliva and Blood

Contact Info

Product

Resources

About