Performance evaluation of a lateral flow assay for nasopharyngeal antigen detection for SARS‐CoV‐2 diagnosis

Peña-Rodríguez, Marcela; Viera-Segura, Oliver; García‐Chagollán, Mariel; Zepeda-Nuño, José Sergio; Muñoz‐Valle, José Francisco; Mora-Mora, Jesús C.; León, Gabriela; Bustillo-Armendáriz, Gustavo; García-Cedillo, Fernanda; Vega-Magaña, Natali

doi:10.1002/jcla.23745

Cited by 23 publications

(18 citation statements)

References 14 publications

(16 reference statements)

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“…As a consequence, we were able to conduct 2,028 paired RT-qPCR and RADT tests directly on site and cultivate virus on the same day without prior sample freezing. While the sensitivities of other RADT vary between 24 and 93% in different studies ( 33 – 35 ), the reported Standard Q RADT sensitivities are mostly in the range from 68 to 90% ( 14 – 24 ). The overall diagnostic sensitivity observed in our study was 42.86%.…”

Section: Discussionmentioning

confidence: 98%

Evaluation of a Rapid Antigen Test To Detect SARS-CoV-2 Infection and Identify Potentially Infectious Individuals

et al. 2021

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The identification and isolation of highly infectious SARS-CoV-2-infected individuals is an important public health strategy. Rapid antigen detection tests (RADT) are promising candidates for large-scale screenings due to timely results and feasibility for on-site testing. Nonetheless, the diagnostic performance of RADT in detecting infectious individuals is yet to be fully determined. In this study, RT-qPCR and virus culture of RT-qPCR positive samples were used to evaluate and compare the performance of the Standard Q COVID-19 Ag Test in detecting SARS-CoV-2 infected and possibly infectious individuals. To this end, two combined oro- and nasopharyngeal swabs were collected at a routine SARS-CoV-2 diagnostic center. A total of 2,028 samples were tested and 118 virus cultures inoculated. SARS-CoV-2 infection was detected in 210 samples by RT-qPCR, representing a positive rate of 10.36%. The Standard Q COVID-19 Ag Test yielded a positive result in 92 (4.54%) samples resulting in an overall sensitivity and specificity of 42.86% and 99.89%. For adjusted Ct values <20 (n=14), <25 (n=57), and <30 (n=88) the RADT reached sensitivities of 100%, 98.25%, and 88.64%, respectively. All 29 culture positive samples were detected by RADT. While overall sensitivity was low, Standard Q COVID-19 RADT reliably detected patients with high RNA loads. Additionally, negative RADT results fully corresponded with the lack of viral cultivability in Vero E6 cells. These results indicate that RADT can be a valuable tool for the detection of individuals that are likely to transmit SARS-CoV-2. RADT testing could therefore guide public health testing strategies to combat the COVID-19 pandemic.

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Section: Discussionmentioning

confidence: 98%

Evaluation of a Rapid Antigen Test To Detect SARS-CoV-2 Infection and Identify Potentially Infectious Individuals

et al. 2021

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“…The specificity and sensitivity of antigen detection have been demonstrated to be highly dependent on Ct values and decreases when viral load is low. 25 , 26 Indeed, the proposed LFA was further divided according to Ct values into high, intermediate, and low subgroups. Here, the high viral load group showed a 94% sensitivity and this sensitivity decreases with low Ct values ( Figure 3 B).…”

Section: Resultsmentioning

confidence: 99%

Dye-Loaded Polymersome-Based Lateral Flow Assay: Rational Design of a COVID-19 Testing Platform by Repurposing SARS-CoV-2 Antibody Cocktail and Antigens Obtained from Positive Human Samples

et al. 2021

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The global pandemic of COVID-19 continues to be an important threat, especially with the fast transmission rate observed after the discovery of novel mutations. In this perspective, prompt diagnosis requires massive economical and human resources to mitigate the disease. The current study proposes a rational design of a colorimetric lateral flow immunoassay (LFA) based on the repurposing of human samples to produce COVID-19-specific antigens and antibodies in combination with a novel dye-loaded polymersome for naked-eye detection. A group of 121 human samples (61 serums and 60 nasal swabs) were obtained and analyzed by RT-PCR and ELISA. Pooled samples were used to purify antibodies using affinity chromatography, while antigens were purified via magnetic nanoparticles-based affinity. The purified proteins were confirmed for their specificity to COVID-19 via commercial LFA, ELISA, and electrochemical tests in addition to sodium dodecyl sulfate-polyacrylamide gel electrophoresis analysis. Polymersomes were prepared using methoxy polyethylene glycol- b -polycaprolactone (mPEG- b -PCL) diblock copolymers and loaded with a Coomassie Blue dye. The polymersomes were then functionalized with the purified antibodies and applied for the preparation of two types of LFA (antigen test and antibody test). Overall, the proposed diagnostic tests demonstrated 93 and 92.2% sensitivity for antigen and antibody tests, respectively. The repeatability (92–94%) and reproducibility (96–98%) of the tests highlight the potential of the proposed LFA. The LFA test was also analyzed for stability, and after 4 weeks, 91–97% correct diagnosis was observed. The current LFA platform is a valuable assay that has great economical and analytical potential for widespread applications.

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“…A diverse range of rapid point‐of‐care antigen tests for the detection of SARS‐CoV‐2 from nasopharyngeal swabs and oropharyngeal swabs are currently available in the market. Some excellent publications have described the evaluation results for these rapid point‐of‐care assays, 17 , 18 , 19 , 20 , 21 , 22 , 23 and meta‐analyses on this topic have also been published. 15 , 16 A summary of the published data suggests that the sensitivity of these rapid point‐of‐care antigen assays is generally low, ranging from 20% to 95% depending on the assay and the virus load.…”

Section: Discussionmentioning

confidence: 99%

Diagnostic performance of the Elecsys SARS‐CoV‐2 antigen assay in the clinical routine of a tertiary care hospital: Preliminary results from a single‐center evaluation

Mueller

Kompatscher

Guardia

2021

Clinical Laboratory Analysis

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Background This report describes a manufacturer‐independent evaluation of the diagnostic accuracy of the Elecsys SARS‐CoV‐2 antigen assay from Roche Diagnostics in a tertiary care setting. Methods In this single‐center study, we used nasopharyngeal swabs from 403 cases from the emergency department and intensive care unit of our hospital. The reference standard for detecting SARS‐CoV‐2 was the reverse‐transcription polymerase chain reaction (RT‐PCR) assay. Cycle threshold (Ct) values were recorded for positive RT‐PCR assays. The index test was the Elecsys SARS‐CoV‐2 antigen assay. This electrochemiluminescence immunoassay produces results as cutoff index (COI) values, with values ≥1.00 being reported as positive. Results Of the 403 cases, 47 showed positive results in RT‐PCR assays. Of the 47 RT‐PCR‐positive cases, 12 showed positive results in the antigen assay. Of the 356 RT‐PCR‐negative cases, all showed negative results in the antigen assay. Thus, the antigen assay showed a sensitivity of 26% (95% CI, 14%‐40%) and specificity of 100% (95% CI, 99%‐100%). Analysis of the relationship between Ct values and COI values in the 47 RT‐PCR‐positive cases showed a correlation coefficient of −0.704 (95% CI, −0.824 to −0.522). The true‐positive rate of the antigen assay for Ct values of 15–24.9, 25–29.9, 30–34.9, and 35–39.9 was 100%, 44%, 8%, and 6%, respectively. Conclusions The Elecsys SARS‐CoV‐2 antigen assay has a low sensitivity for detecting SARS‐CoV‐2 from nasopharyngeal swabs. Hence, we decided to not use this assay in the clinical routine of our hospital.

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Performance evaluation of a lateral flow assay for nasopharyngeal antigen detection for SARS‐CoV‐2 diagnosis

Cited by 23 publications

References 14 publications

Evaluation of a Rapid Antigen Test To Detect SARS-CoV-2 Infection and Identify Potentially Infectious Individuals

Evaluation of a Rapid Antigen Test To Detect SARS-CoV-2 Infection and Identify Potentially Infectious Individuals

Dye-Loaded Polymersome-Based Lateral Flow Assay: Rational Design of a COVID-19 Testing Platform by Repurposing SARS-CoV-2 Antibody Cocktail and Antigens Obtained from Positive Human Samples

Diagnostic performance of the Elecsys SARS‐CoV‐2 antigen assay in the clinical routine of a tertiary care hospital: Preliminary results from a single‐center evaluation

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