Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection

BMC Infectious Diseases, Journal Year: 2022, Volume and Issue: 22(1)

Published: March 22, 2022

Abstract Background SARS-CoV-2 rapid antigen (Ag) detection kits are widely used in addition to quantitative reverse transcription PCR (RT-qPCR), as they cheaper with a turnaround time. As there many concerns regarding their sensitivity and specificity, different settings, we evaluated two WHO approved Ag large cohort of Sri Lankan individuals. Methods Paired nasopharangeal swabs were obtained from 4786 participants for validation the SD-Biosensor assay 3325 Abbott assay, comparison RT-qPCR. A short questionnaire was record symptoms at time testing, blood samples 2721 them specific antibodies. Results The overall kit 36.5% test 50.76%. showed specificity 99.4% 97.5%. At Ct values < 25, 71.3% 76.6% 77.3% 88.9% test. all genes (RdRP, S, E N) tested RT-qPCR significantly lower positive results compared 209 (48.04%) individuals who had antibodies gave result, antibody positivity rates higher > 30 (46.1 82.9%). 32.1% those result 26.3% detection. Conclusions Both tests appeared be highly sensitive detecting values, community setting Lanka, but it will important further establish relationship infectivity.

Language: Английский

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The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis

Life, Journal Year: 2023, Volume and Issue: 13(2), P. 281 - 281

Published: Jan. 19, 2023

Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of disease 2019 (COVID-19), a that quickly spread into pandemic. As such, management COVID-19 pandemic deemed necessary, and it can be achieved by using reliable diagnostic tests for SARS-CoV-2. The gold standard diagnosis SARS-CoV-2 molecular detection test reverse transcription polymerase chain reaction technique (rt-PCR), which characterized various disadvantages in contrast with self-taken nasal rapid antigen produce results faster, have lower costs do not require specialized personnel. Therefore, usefulness indisputable management, facilitating both health system examinees. Our systematic review aims to access accuracy tests. Methods: This was conducted following Preferred Reporting Items Systematic Reviews Meta-Analyses (PRISMA) guidelines, Quality Assessment Diagnostic Accuracy Studies (QUADAS-2) tool used assess risk bias included studies. All studies this were found after searching two databases, Scopus PubΜed. but original articles excluded from review, while all concerning sample rt-PCR as reference included. Meta-analysis plots obtained RevMan software MetaDTA website. Results: 22 meta-analysis demonstrated specificity greater than 98%, exceeds minimum required yield SARS-CoV-2, according WHO. Notwithstanding, sensitivity varies (from 40% 98.7%), makes them some cases unsuitable positive cases. In majority studies, performance set WHO achieved, 80% compared pooled calculated 91.1% 99.5%. Conclusions: conclusion, many advantages over tests, such those related reading their low cost. They also considerable kits remarkable sensitivity. Consequently, wide range utility are able completely replace

Language: Английский

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Practical aspects of SAM-based electrochemical DNA biosensors on miniaturized planar gold transducers: A case study with SARS-CoV-2

Measurement, Journal Year: 2025, Volume and Issue: unknown, P. 117212 - 117212

Published: March 1, 2025

Language: Английский

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Real-world accuracy of SARS-CoV-2 antigen detection compared with qPCR: A cross-sectional study in Toledo - PR, Brazil

The Brazilian Journal of Infectious Diseases, Journal Year: 2025, Volume and Issue: 29(3), P. 104520 - 104520

Published: April 17, 2025

Language: Английский

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Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom

Emerging infectious diseases, Journal Year: 2025, Volume and Issue: 31(6)

Published: May 6, 2025

The ongoing outbreaks of mpox highlight the urgent need for a rapid and low-cost diagnostic test to accurately detect control this emerging disease. We estimated analytical sensitivity using viral culture monkeypox virus clade IIb lineage clinical performance 3 antigen detection tests (Ag-RDT) by skin swab samples upper-respiratory from patients in Democratic Republic Congo United Kingdom. limit was 1.0 × 104 plaque-forming units/mL, fulfilling World Health Organization recommendations. Specificity Ag-RDTs 100%, but at 0.00%-15.79% 0.00% respiratory samples. None reached Organization's target sensitivity, we do not recommend them as or screening tools suspected cases. Accurate diagnosis remain urgently needed.

Language: Английский

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Applicability of a colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay for SARS-CoV-2 detection in high exposure risk setting

International Journal of Infectious Diseases, Journal Year: 2023, Volume and Issue: 128, P. 285 - 289

Published: Jan. 13, 2023

During the third wave, growing number of COVID-19 case clusters reported countrywide in Thailand demonstrated rapidly evolving characteristics SARS-CoV-2, causative agent pandemic. The rapid spread infections had been extensively public areas and construction camps, as well congested communities with poor sanitation. High demand for SARS-CoV-2 genome testing quick reporting by an hour identification isolation characterizes crisis Thailand. This situation leads to urgent need alternative molecular tests which are reliable, rapid, cost-effective.In this study, we assessed colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP), using real-time transcription-polymerase chain reaction (RT-PCR) a reference standard, active finding suspected (mostly asymptomatic) cases living high-risk Bangkok.The diagnostic performance RT-LAMP compared RT-PCR specimens from 549 Thais were computed real-world field study setting. Our that achieved robust infection, sensitivity specificity 91.67% 100%, respectively.RT-LAMP is reliable assay detection scalable use emergency response nationwide pandemic, despite resource limitations. data derived validate its potential laboratory practice. good choice laboratory-based test when not available.

Language: Английский

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Performance evaluation of STANDARD Q COVID‐19 Ag home test for the diagnosis of COVID‐19 during early symptom onset

Journal of Clinical Laboratory Analysis, Journal Year: 2022, Volume and Issue: 36(6)

Published: April 20, 2022

Surveillance and control of SARS-CoV-2 outbreak through gold standard detection, that is, real-time polymerase chain reaction (RT-PCR), become a great obstacle, especially in overwhelming outbreaks. In this study, we aimed to analyze the performance rapid antigen home test (RAHT) as an alternative detection method compared with RT-PCR.In total, 79 COVID-19-positive 217 COVID-19-negative patients confirmed by RT-PCR were enrolled study. A duration from symptom onset COVID-19 confirmation <5 days was considered recruiting criterion for cases. nasal cavity specimen collected RAHT, nasopharyngeal swab RT-PCR.Sensitivity STANDARD Q Ag Home Test (SD Biosensor, Korea), RT-PCR, 94.94% (75/79) (95% [confidence interval] CI, 87.54%-98.60%), specificity 100%. Sensitivity significantly higher symptomatic (98.00%) than asymptomatic (89.66%) (p-value = 0.03). There no difference sensitivity according (100% 0-2 96.97% 3-5 days, respectively) 1.00). The RAHT detected all 51 whose Ct values ≤25 (100%), whereas 73.33% (11/15) among >25 0.01).The showed excellent COVID-19-confirmed cases, those symptoms. decrease when value is over 25, indicating screening may be useful during early phase onset, viral numbers are it more transmissible.

Language: Английский

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Analytical sensitivity of COVID-19 rapid antigen tests: A case for a robust reference standard

Talanta Open, Journal Year: 2023, Volume and Issue: 7, P. 100187 - 100187

Published: Jan. 21, 2023

Aggressive diagnostic testing remains an indispensable strategy for health and aged care facilities to prevent the transmission of SARS-CoV-2 in vulnerable populations. The preferred platform has shifted towards COVID-19 rapid antigen tests (RATs) identify most infectious individuals. As such, RATs are being manufactured faster than at any other time our history yet lack relevant quantitative analytics required inform on absolute analytical sensitivity enabling manufacturers maintain high batch-to-batch reproducibility, end-users accurately compare brands decision making. Here, we describe a novel reference standard measure using recombinant GFP-tagged nucleocapsid protein (NP-GFP). Importantly, show that GFP tag does not interfere with NP detection provides several advantages affording streamlined expression purification yields as well faster, cheaper more sensitive quality control measures post-production assessment solubility stability. Ten commercial were evaluated ranked NP-GFP standard. Analytical data selected devices determined did correlate those reported by median tissue culture dose (TCID50) assay. Of note, TCID50 discordance been previously reported. Taken together, results highlight urgent need reliable evaluation benchmarking RAT devices. is promising candidate will ensure performance communicated healthcare providers public.

Language: Английский

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Comparative Characterization of Diverse DNA Aptamers for Recognition of Spike Proteins of Multiple SARS‐CoV‐2 Variants

Analysis & Sensing, Journal Year: 2023, Volume and Issue: 3(5)

Published: Feb. 2, 2023

Abstract Many DNA aptamers have been reported to target the spike protein (S‐protein) of SARS‐CoV‐2. These display different affinities or recognize epitopes S‐protein. We conducted a comparative study 9 for binding several variants S‐protein and pseudoviruses using same testing methods, including dot‐blot assays enzyme‐linked aptamer assays, evaluate their affinity ranking analytical utility. Moreover, sites these on were examined competition understand effect mutations degree overlapping by aptamers.

Language: Английский

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Antibody- and aptamer-free SERS substrate for ultrasensitive and anti-interference detection of SARS-CoV-2 spike protein in untreated saliva

Biosensors and Bioelectronics, Journal Year: 2023, Volume and Issue: 237, P. 115457 - 115457

Published: June 8, 2023

Language: Английский

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