Rapid antigen detection alone may not be sufficient for early diagnosis and/or mass screening of COVID‐19

Wan, Zhenzhou; Zhao, Yufei; Lu, Renfei; Dong, Yajuan; Zhang, Chiyu

doi:10.1002/jmv.27236

Cited by 7 publications

(6 citation statements)

References 13 publications

(26 reference statements)

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“…Given that the viral load of SARS-CoV-2 in nasopharyngeal swab samples of COVID-19 patients is in the range of 10 3 to 10 9 copies per mL, 29 − 31 the multiplex RT-LAMP assay was sufficiently sensitive to detect SARS-CoV-2 RNA in clinical situations. 32 To test whether the HFman-based pipeline improved the specificity of the multiplex RT-LAMP, we performed SYTO-9-based (non-specific DNA binding fluorescent dye) and HFman probe-based multiplex RT-LAMP reactions using RNase-free H 2 O (non-template control, NTC). Non-specific amplification (Tt values: 21.8–38.0) occurred in the RT-LAMP reaction with SYTO-9, but no amplification signal was observed in the reactions with HFman probes ( Figure 3 b).…”

Section: Resultsmentioning

confidence: 99%

“…As diagnosis of COVID-19 requires a positive test for two different SARS-CoV-2 genes, the overall assay LOD was 115 copies per reaction. Given that the viral load of SARS-CoV-2 in nasopharyngeal swab samples of COVID-19 patients is in the range of 10 3 to 10 9 copies per mL, − the multiplex RT-LAMP assay was sufficiently sensitive to detect SARS-CoV-2 RNA in clinical situations . To test whether the HFman-based pipeline improved the specificity of the multiplex RT-LAMP, we performed SYTO-9-based (non-specific DNA binding fluorescent dye) and HFman probe-based multiplex RT-LAMP reactions using RNase-free H 2 O (non-template control, NTC).…”

Section: Resultsmentioning

confidence: 99%

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Multiplex, Real-Time, Point-of-care RT-LAMP for SARS-CoV-2 Detection Using the HFman Probe

Dong

Zhao

et al. 2022

ACS Sens.

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Viral evolution impacts diagnostic test performance through the emergence of variants with sequences affecting the efficiency of primer binding. Such variants that evade detection by nucleic acid-based tests are subject to selective pressure, enabling them to spread more efficiently. Here, we report a variant-tolerant diagnostic test for SARS-CoV-2 using a loop-mediated isothermal nucleic acid-based amplification (LAMP) assay containing high-fidelity DNA polymerase and a high-fidelity DNA polymerase-medicated probe (HFman probe). In addition to demonstrating a high tolerance to variable SARS-CoV-2 viral sequences, the mechanism also overcomes frequently observed limitations of LAMP assays arising from non-specific amplification within multiplexed reactions performed in a single “pot”. Results showed excellent clinical performance (sensitivity 94.5%, specificity 100%, n = 190) when compared directly to a commercial gold standard reverse transcription quantitative polymerase chain reaction assay for the extracted RNA from nasopharyngeal samples and the capability of detecting a wide range of sequences containing at least alpha and delta variants. To further validate the test with no sample processing, directly from nasopharyngeal swabs, we also detected SARS-CoV-2 in positive clinical samples ( n = 49), opening up the possibility for the assay’s use in decentralized testing.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Multiplex, Real-Time, Point-of-care RT-LAMP for SARS-CoV-2 Detection Using the HFman Probe

Dong

Zhao

et al. 2022

ACS Sens.

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“…An effective mass screening based on antigen test detection of SARS-CoV-2 has been described 21 . But a recent review of several antigen tests on the market states that two-thirds had overall sensitivities (30.8%-68.9%) below the World Health Organization recommended standard of ≥ 80% raising concerns whether the antigen detection alone is sufficient for COVID-19 mass screening 22 . Combining our predictive model with an antigen test could be a promising mass screening strategy.…”

Section: Discussionmentioning

confidence: 99%

A machine learning COVID-19 mass screening based on symptoms and a simple olfactory test

Azeli

Fernández

Capriles

et al. 2022

Sci Rep

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The early detection of symptoms and rapid testing are the basis of an efficient screening strategy to control COVID-19 transmission. The olfactory dysfunction is one of the most prevalent symptom and in many cases is the first symptom. This study aims to develop a machine learning COVID-19 predictive tool based on symptoms and a simple olfactory test, which consists of identifying the smell of an aromatized hydroalcoholic gel. A multi-centre population-based prospective study was carried out in the city of Reus (Catalonia, Spain). The study included consecutive patients undergoing a reverse transcriptase polymerase chain reaction test for presenting symptoms suggestive of COVID-19 or for being close contacts of a confirmed COVID-19 case. A total of 519 patients were included, 386 (74.4%) had at least one symptom and 133 (25.6%) were asymptomatic. A classification tree model including sex, age, relevant symptoms and the olfactory test results obtained a sensitivity of 0.97 (95% CI 0.91–0.99), a specificity of 0.39 (95% CI 0.34–0.44) and an AUC of 0.87 (95% CI 0.83–0.92). This shows that this machine learning predictive model is a promising mass screening for COVID-19.

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“…Concerning the rapid antigen tests, these are also being widely adopted for preliminary screening, but they have substantially lower sensitivity than the WHO-recommended standard, especially for pre-symptomatic and asymptomatic cases [15].…”

Section: Introductionmentioning

confidence: 99%

MALDI MS-Based Investigations for SARS-CoV-2 Detection

Preianò

Correnti

Pelaia

et al. 2021

BioChem

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The urgent need to fight the COVID-19 pandemic has impressively stimulated the efforts of the international scientific community, providing an extraordinary wealth of studies. After the sequence of the virus became available in early January 2020, safe and effective vaccines were developed in a time frame much shorter than everybody expected. However, additional studies are required since viral mutations have the potential of facilitating viral transmission, thus reducing the efficacy of developed vaccines. Therefore, improving the current laboratory testing methods and developing new rapid and reliable diagnostic approaches might be useful in managing contact tracing in the fight against both the original SARS-CoV-2 strain and the new, potentially fast-spreading CoV-2 variants. Mass Spectrometry (MS)-based testing methods are being explored, with the challenging promise to overcome the many limitations arising from currently used laboratory testing assays. More specifically, MALDI-MS, since its advent in the mid 1980s, has demonstrated without any doubt the great potential to overcome many unresolved analytical challenges, becoming an effective proteomic tool in several applications, including pathogen identification. With the aim of highlighting the challenges and opportunities that derive from MALDI-based approaches for the detection of SARS-CoV-2 and its variants, we extensively examined the most promising proofs of concept for MALDI studies related to the COVID-19 outbreak.

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Rapid antigen detection alone may not be sufficient for early diagnosis and/or mass screening of COVID‐19

Cited by 7 publications

References 13 publications

Multiplex, Real-Time, Point-of-care RT-LAMP for SARS-CoV-2 Detection Using the HFman Probe

Multiplex, Real-Time, Point-of-care RT-LAMP for SARS-CoV-2 Detection Using the HFman Probe

A machine learning COVID-19 mass screening based on symptoms and a simple olfactory test

MALDI MS-Based Investigations for SARS-CoV-2 Detection

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