Performance of antigen lateral flow devices in the UK during the alpha, delta, and omicron waves of the SARS-CoV-2 pandemic: a diagnostic and observational study

The Lancet Infectious Diseases, Journal Year: 2023, Volume and Issue: 23(8), P. 922 - 932

Published: March 28, 2023

BackgroundAntigen lateral flow devices (LFDs) have been widely used to control SARS-CoV-2. We aimed improve understanding of LFD performance with changes in variant infections, vaccination, viral load, and use, the detection infectious individuals.MethodsIn this diagnostic study, paired RT-PCR test results were prospectively collected from asymptomatic symptomatic participants UK between Nov 4, 2020, March 21, 2022, support National Health Service (NHS) England's Test Trace programme. The LFDs evaluated Innova SARS-CoV-2 Antigen Rapid Qualitative Test, Orient Gene Covid-19 (Antigen) Self-Test, Acon Flowflex (Self-Testing). across various community testing settings, including predeployment sites, routine centres, homes, schools, universities, workplaces, targeted testing, health-care workers. multivariable logistic regression analyse sensitivity specificity using as a reference standard, adjusting for manufacturer, setting, age, sex, assistance, symptom status, vaccination variant. contact tracing data NHS (Jan 1, 2021, Jan 11, 2022) estimate proportion transmitting index patients (with ≥1 RT-PCR-positive or LFD-positive contact) potentially detectable by (specifically Innova, most LFD) time, accounting variant, status.FindingsWe assessed 75 382 pairs tests. Of these, 4131 (5·5%) RT-PCR-positive. versus was 63·2% (95% CI 61·7–64·6) 99·71% 99·66–99·74). Increased load independently associated being positive (adjusted odds ratio [aOR] 2·85 [95% 2·66–3·06] per 1 log10 copies mL increase; p<0·0001). There no evidence that differed delta (B.1.617.2) infections alpha (B.1.1.7) pre-alpha (B.1.177) (aOR 1·00 [0·69–1·45]; p=0·99), whereas omicron (BA.1 BA.2) appeared more likely be 1·63 [1·02–2·59]; p=0·042). Sensitivity higher (68·7% 66·9–70·4]) than (52·8% [50·1–55·4]). Among 347 374 unique probable onward transmission, 78·3% 75·3–81·2) estimated (Innova), mostly stable time successive variants. Overall, lower (57·6% [53·6–61·9]) (79·7% [76·7–82·5]).InterpretationLFDs remained able detect throughout vaccine roll-out different can transmit others reduce risk transmission. However, is individuals individuals.FundingUK Security Agency, Government Department Social Care, Institute Research (NIHR) Protection Unit Healthcare Associated Infections Antimicrobial Resistance, University Oxford NIHR Biomedical Centre.

Language: Английский

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A Universal DNA Aptamer that Recognizes Spike Proteins of Diverse SARS‐CoV‐2 Variants of Concern

Chemistry - A European Journal, Journal Year: 2022, Volume and Issue: 28(15)

Published: Jan. 27, 2022

We report on a unique DNA aptamer, denoted MSA52, that displays universally high affinity for the spike proteins of wildtype SARS-CoV-2 as well Alpha, Beta, Gamma, Epsilon, Kappa, Delta and Omicron variants. Using an aptamer pool produced from round 13 selection against S1 domain protein, we carried out one-round SELEX experiments using five different trimeric variants, followed by high-throughput sequencing sequence alignment analysis aptamers formed complexes with all proteins. A previously unidentified showed K

Language: Английский

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Aptamers for SARS‐CoV‐2: Isolation, Characterization, and Diagnostic and Therapeutic Developments

Analysis & Sensing, Journal Year: 2022, Volume and Issue: 2(5)

Published: April 21, 2022

The SARS-CoV-2 virus and COVID-19 pandemic continue to demand effective diagnostic therapeutic solutions. Finding these solutions requires highly functional molecular recognition elements. Nucleic acid aptamers represent a possible solution. Characterized by their high affinity specificity, can be rapidly identified from random-sequence nucleic libraries. Over the past two years, many labs around world have rushed create diverse that target important structural proteins of SARS-CoV-2: spike (S) protein nucleocapsid (N) protein. These led identification show real promise for development tests agents SARS-CoV-2. Herein we review all developments, with special focus on aptasensors detecting include electrochemical optical sensors, lateral flow devices, aptamer-linked immobilized sorbent assays.

Language: Английский

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High Rates of Rapid Antigen Test Positivity After 5 days of Isolation for COVID-19

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2022, Volume and Issue: unknown

Published: Feb. 2, 2022

Abstract Background The emergence of the highly transmissible COVID-19 variant, omicron, has resulted in high numbers breakthrough infections, including among healthcare workers (HCW). Recent CDC recommendations now allow to return work after day 5 if symptoms have improved, without a requirement for negative rapid antigen test (RAT). Methods Fully vaccinated and non-immunocompromised HCW at large, urban, academic medical center who tested positive starting late December, 2021 (when omicron was predominant circulating strain) were allowed early all had resolved excepting mild, intermittent cough and/or lingering loss taste/smell, provided upon return. Those with tests stipulations that they wear an N95 times take breaks eat meals apart from others. on first attempt could 24-48 hours later again as many days needed achieve result or until completed 10 restriction work. Results Between January 2, 2022 12, there 309 total RAT done 260 separate 5-10 illness. Overall, 43% (134 309) between 5-10. greatest percent noted returning their 6 (58%). rate positivity (58%) 6. 8 9 less likely (26%, 19/74). In (and which line intensity recorded) 49% (25/51) recorded having darkest RAT. most often remained second test, 56% tests, aggregated across 6-10, remaining positive. Over performed 5-10, boosted nearly twice positive: 53% (75 out 141) Discussion More than 40% felt well enough still when presenting 10. Boosted individuals 3x 5, eligible return, ∼2x overall. New guidance provides clearance exit isolation symptom onset, need exit, long are beginning resolve. Per CDC, driven by prior studies, mostly collected before Omicron people infected, reported onset one more peak virus loads. such instance, where based did not begin load already attained, then release would be appropriate. However, reports showing much earlier symptoms, coupled our own results here demonstrate relationship changed, may no longer appropriate window end support safe exit. Conclusion These indicate substantial proportion contagious illness regardless status. Early liberation should undertaken only understanding inclusion 6-10 community settings increase risk spread others which, turn, undermine intended benefits staffing resulting sick workers.

Language: Английский

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Clinical performance of rapid antigen tests in comparison to RT‐PCR for SARS‐COV‐2 diagnosis in Omicron variant: A systematic review and meta‐analysis

Reviews in Medical Virology, Journal Year: 2023, Volume and Issue: 33(2)

Published: Feb. 15, 2023

Abstract The Omicron variant of concern has a high level mutations in different genes that raised awareness about the performance immunological products such as vaccines and antigen detection kits. In this systematic review meta‐analysis, we investigated whether had significant influence on rapid test (RAT) comparison to PCR. We registered meta‐analysis PROSPERO with registration number CRD42022355510. searched PubMed, Scopus, Embase, Web Science databases systematically 1 August 2022. After article screening, assessed quality included studies based JBI checklist. Following data extraction, performed using R software. 18 qualified articles presenting sufficient RATs RT‐PCR infections. pooled specificity sensitivity were 1.000 (0.997–1.000) 0.671 (0.595–0.721), respectively. FDA‐approved kits showed better than WHO‐approved ones 0.728 (0.620–0.815). use nasal swabs higher compared nasopharyngeal swabs. for samples CT‐value >25 was 0.108 (0.048–0.227). Rapid tests show impaired COVID‐19 diagnosis when is circulating, particularly low viral loads.

Language: Английский

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Rapid antigen testing for SARS-CoV-2 by lateral flow assay: A field evaluation of self- and professional testing at UK community testing sites

Journal of Clinical Virology, Journal Year: 2024, Volume and Issue: 171, P. 105654 - 105654

Published: Feb. 15, 2024

The advent of lateral flow devices (LFDs) for SARS-CoV-2 detection enabled widespread use rapid self-tests during the pandemic. While self-testing using LFDs is now common, whether provides comparable performance to professional testing was a key question that remained important pandemic planning.

Language: Английский

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Evaluation of the Diagnostic Performance of a SARS-CoV-2 and Influenza A/B Combo Rapid Antigen Test in Respiratory Samples

Diagnostics, Journal Year: 2023, Volume and Issue: 13(5), P. 972 - 972

Published: March 3, 2023

This study aimed to evaluate the performance characteristics of a rapid antigen test developed detect SARS-CoV-2 (COVID-19), influenza A virus (IAV), and B (IBV) (flu) compared with those real-time reverse transcription-polymerase chain reaction (rRT-PCR) method. One hundred SARS-CoV-2, one IAV, twenty-four IBV patients whose diagnoses were confirmed by clinical laboratory methods included in patient group. Seventy-six patients, who negative for all respiratory tract viruses, as control The Panbio™ COVID-19/Flu A&B Rapid Panel kit was used assays. sensitivity values 97.5%, 97.9%, 33.33% IBV, respectively, samples viral load below 20 Ct values. 16.7%, 36.5%, 11.11% above Ct. kit's specificity 100%. In conclusion, this demonstrated high IAV loads values, but not compatible PCR positivity lower over tests may be preferred routine screening tool communal environments, especially symptomatic individuals, when diagnosing caution.

Language: Английский

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Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis

Virology Journal, Journal Year: 2024, Volume and Issue: 21(1)

Published: April 29, 2024

During the COVID-19 pandemic, antigen diagnostic tests were frequently used for screening, triage, and diagnosis. Novel instrument-based (iAg tests) hold promise of outperforming their instrument-free, visually-read counterparts. Here, we provide a systematic review meta-analysis SARS-CoV-2 iAg tests' clinical accuracy.

Language: Английский

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Comparative analyses of eighteen rapid antigen tests and RT-PCR for COVID-19 quarantine and surveillance-based isolation

Communications Medicine, Journal Year: 2022, Volume and Issue: 2(1)

Published: July 9, 2022

Abstract Background Rapid antigen (RA) tests are being increasingly employed to detect SARS-CoV-2 infections in quarantine and surveillance. Prior research has focused on RT-PCR testing, a single RA test, or generic diagnostic characteristics of assessing testing strategies. Methods We have conducted comparative analysis the post-quarantine transmission, effective reproduction number during serial false-positive rates for 18 with emergency use authorization from The United States Food Drug Administration an test. To quantify extent we developed analytical mathematical framework informed by COVID-19 infectiousness, test specificity, temporal sensitivity data. Results demonstrate that relative effectiveness reducing transmission depends duration turnaround time results. For quarantines two days shorter, conducting exit reduces onward more than (with 24-h delay) upon exit. Applied complementary approach performing at specified frequency paired isolation positives, shown outperform delay. results our modeling consistent data collected remote industry setting. Conclusions These test-specific important component tool set policy decision-making, judicious selection appropriate can supply viable alternative efforts control spread disease.

Language: Английский

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Evaluation of the Diagnostic Accuracy of Nasal Cavity and Nasopharyngeal Swab Specimens for SARS-CoV-2 Detection via Rapid Antigen Test According to Specimen Collection Timing and Viral Load

Diagnostics, Journal Year: 2022, Volume and Issue: 12(3), P. 710 - 710

Published: March 14, 2022

The rapid diagnosis of SARS-CoV-2 is an essential aspect in the detection and control spread COVID-19. We evaluated accuracy antigen test (RAT) using samples from nasal cavity nasopharynx based on sample collection timing viral load. enrolled 175 patients, which 71 patients 104 had tested positive negative, respectively, real time-PCR. Nasal nasopharyngeal swab were STANDARD Q COVID-19 Ag tests (Q Ag, SD Biosensor, Korea). sensitivity was 77.5% (95% confidence interval [CI], 67.8−87.2%) for 81.7% [CI, 72.7−90.7%) specimens. RAT results showed a substantial agreement between specimens (Cohen’s kappa index = 0.78). exceeded 89% <5 days after symptom onset (DSO) 86% Ct E RdRp < 25. performed fairly well, especially early DSO when high load present, can be considered alternative site

Language: Английский

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