Evaluation of a Rapid Diagnostic Assay for Detection of SARS-CoV-2 Antigen in Nasopharyngeal Swabs

Lambert-Niclot, Sidonie; Cuffel, Alexis; Pape, Samuel Le; Vauloup‐Fellous, Christelle; Morand‐Joubert, Laurence; Roque–Afonso, Anne–Marie; Goff, Jérôme Le; Delaugerre, Constance

doi:10.1128/jcm.00977-20

Cited by 220 publications

(229 citation statements)

References 3 publications

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“…Another assay with visual bands (Respi-Strip CORIS) was recently evaluated in two European studies. Overall sensitivity ranged from 50% to 57.6%; however, detection rates improved for samples with high viral loads (Ct <25) reaching sensitivities of 73.9% to 82.2% (16, 17). The other two assays evaluated by us showed an insufficient performance.…”

Section: Discussionmentioning

confidence: 99%

“…Antigen-based testing is still in its infancy and evaluations are scarce (12). Up to now, we only found four publications available (three peer-reviewed), evaluating two assays (15–17, 24), while comparative studies are lacking.…”

Section: Discussionmentioning

confidence: 99%

“…Importantly, our evaluation protocol included a deviation from the manufacturer’s instructions. Instead of using the provided test solution, we used the equivalent volume of UTM, as described in other studies (15–17). This method allowed us to compare all four assays using the same specimens and to rapidly evaluate a large number of samples previously characterized by RT-PCR.…”

Section: Methodsmentioning

confidence: 99%

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Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples

Weitzel

Legarraga²,

Iruretagoyena³

et al. 2020

Preprint

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21In the context of the Covid-19 pandemic, the development and validation of rapid and easy-to-22 perform diagnostic methods are of high priority. We compared the performance of four rapid 23 antigen detection tests for SARS-CoV-2 in respiratory samples. Immunochromatographic SARS-24CoV-2 assays from RapiGEN, Liming bio, Savant, and Bioeasy were evaluated using universal 25 transport medium containing naso-oropharyngeal swabs from suspected Covid-19 cases. The 26 diagnostic accuracy was determined in comparison to SARS-CoV-2 RT-PCR. A total of 111 27 samples were included; 80 were RT-PCR positive. Median patients' age was 40 years, 55% were 28 female, and 88% presented within the first week after symptom onset. The evaluation of the 29Liming bio assay was discontinued due to insufficient performance. The overall sensitivity 30 values of RapiGEN, Liming bio, and Bioeasy tests were 62.0% (CI95% 51.0-71.9), 16.7% 31 (CI95% 10.0-26.5), and 85.0% (CI95% 75.6-91.2), respectively, with specificities of 100%. 32Sensitivity was significantly higher in samples with high viral loads (RapiGEN, 84.9%; Bioeasy, 33 100%). The study highlighted the significant heterogeneity of test performance among evaluated 34 assays, which might have been influenced by the use of a non-validated sample material. The 35 high sensitivity of some tests demonstrated that rapid antigen detection has the potential to serve 36 as an alternative diagnostic method, especially in patients presenting with high viral loads in 37 early phases of infection. This is particularly important in situations with limited access to PCR or prolonged turnaround time. Further comparative evaluations are necessary to select 39 products with high performance among the growing market of diagnostic tests for SARS-CoV-2. 40 41

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples

Weitzel

Legarraga²,

Iruretagoyena³

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

“…Users of these antigen tests should be aware that the sensitivity varies significantly with different assays. The average sensitivity was 56% with a range from 0% to 95% [ [48] , [49] , [50] , [51] ], False positive occurs infrequently. The specificity are reported to be high (>97%) [ 47 ] and are most commonly due to cross-reaction with proteins in other human coronaviruses.…”

Section: Laboratory Testing Techniquementioning

confidence: 99%

Laboratory testing for the diagnosis of COVID-19

Lai

Lam

2021

Biochemical and Biophysical Research Communications

108

104

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Rapid and accurate laboratory diagnosis of active COVID-19 infection is one of the cornerstones of pandemic control. With the myriad of tests available in the market, the use of correct specimen type and laboratory-testing technique in the right clinical scenario could be challenging for non-specialists. In this mini-review, we will discuss the difference in diagnostic performance for different upper and lower respiratory tract specimens, and the role of blood and fecal specimens. We will analyze the performance characteristics of laboratory testing techniques of nucleic acid amplification tests, antigen detection tests, antibody detection tests, and point-of-care tests. Finally, the dynamics of viral replication and antibody production, and laboratory results interpretation in conjunction with clinical scenarios will be discussed.

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“…Since then, many new RAD kits are commercially available. Data on the performance of RAD kits varied between different studies and different brands [ [4] , [5] , [6] , [7] , [8] , [9] ]. The purpose of this evaluation is to assess analytical sensitivity of the three SARS-CoV-2 RAD kits by means of limit of detection (LOD) using a set of serial tenfold dilution samples; and clinical sensitivity in detecting SARS-CoV-2 virus in different types of respiratory specimens.…”

Section: Introductionmentioning

confidence: 99%

Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus

Mak

Lau

Wong

et al. 2020

Journal of Clinical Virology

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Highlights We compared analytical sensitivity and clinical sensitivity for the three commercially available rapid antigen detection (RAD) kits for detection of SARS-CoV-2 virus. The three RAD kits varied 102 to 105 fold less sensitive than RT-PCR. Clinical sensitivity of RAD kits ranged from 22.9% to 71.4% for detecting respiratory specimens from COVID-19 patients. Understanding the clinical characteristics of different RAD kits can increase the likelihood of positive results.

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Evaluation of a Rapid Diagnostic Assay for Detection of SARS-CoV-2 Antigen in Nasopharyngeal Swabs

Abstract: Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), the virus causing causing Coronavirus disease 2019 (COVID-19) was reported for the first time in Wuhan (Hubei, China) in December 2019 (1, 2) and has become a major public health concern all over the world.…

Cited by 220 publications

References 3 publications

Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples

Head-to-head comparison of four antigen-based rapid detection tests for the diagnosis of SARS-CoV-2 in respiratory samples

Laboratory testing for the diagnosis of COVID-19

Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus

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