Evaluation of the diagnostic accuracy of two point-of-care tests for COVID-19 when used in symptomatic patients in community settings in the UK primary care COVID diagnostic accuracy platform trial (RAPTOR-C19) DOI Creative Commons
Brian D Nicholson, Philip J. Turner, Thomas Fanshawe

и другие.

PLoS ONE, Год журнала: 2023, Номер 18(7), С. e0288612 - e0288612

Опубликована: Июль 21, 2023

Background and objective Point-of-care lateral flow device antigen testing has been used extensively to identify individuals with active SARS-CoV-2 infection in the community. This study aimed evaluate diagnostic accuracy of two point-of-care tests (POCTs) for routine community care. Methods Adults children symptoms consistent suspected current COVID-19 were prospectively recruited from 19 UK general practices centres between October 2020 2021. Participants tested by trained healthcare workers using at least one index POCTs (Roche-branded SD Biosensor Standard™ Q Rapid Antigen Test and/or BD Veritor™ System Detection SARS-CoV-2). The reference standard was laboratory triplex reverse transcription quantitative PCR (RT-PCR) a combined nasal/oropharyngeal swab. Diagnostic parameters estimated, 95% confidence intervals (CIs), overall, relation RT-PCR cycle threshold pre-specified subgroups. Results Of 663 participants included primary analysis, 39.2% (260/663, CI 35.5% 43.0%) had positive result. POCT sensitivity 84.0% (178/212, 78.3% 88.6%) specificity 98.5% (328/333, 96.5% 99.5%), Veritor 76.5% (127/166, 69.3% 82.7%) 98.8% (249/252, 96.6% 99.8%) compared RT-PCR. Sensitivity both devices dropped substantially thresholds ≥30 more than 7 days after onset symptoms. Conclusions Both assessed exceed Medicines Healthcare products Regulatory Agency target product profile’s minimum acceptable 95%. Confidence include 80%. In symptomatic patients, negative results on these do not preclude possibility infection. Tests should be expected reliably detect disease week symptom onset, when viral load may reduced. Registration ISRCTN142269 .

Язык: Английский

The role of SARS-CoV-2 N protein in diagnosis and vaccination in the context of emerging variants: present status and prospects DOI Creative Commons

Wanchen Song,

Zhongbiao Fang, Feike Ma

и другие.

Frontiers in Microbiology, Год журнала: 2023, Номер 14

Опубликована: Авг. 14, 2023

Despite many countries rapidly revising their strategies to prevent contagions, the number of people infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues surge. The emergent variants that can evade immune response significantly affect effectiveness mainstream vaccines and diagnostic products based on original spike protein. Therefore, it is essential focus highly conserved nature nucleocapsid protein as a potential target in field diagnostics. In this regard, our review initially discusses structure, function, mechanism action N Based discussion, we summarize relevant research in-depth development application methods protein, such serology nucleic acid detection. Such valuable information aid designing more efficient vaccine tools could help end SARS-CoV-2 pandemic.

Язык: Английский

Процитировано

18
Sequencing directly from antigen-detection rapid diagnostic tests in Belgium, 2022: a gamechanger in genomic surveillance? DOI Creative Commons
Annabel Rector, Mandy Bloemen, Gilberte Schiettekatte

и другие.

Eurosurveillance, Год журнала: 2023, Номер 28(9)

Опубликована: Март 2, 2023

Background Lateral flow antigen-detection rapid diagnostic tests (Ag-RDTs) for viral infections constitute a fast, cheap and reliable alternative to nucleic acid amplification (NAATs). Whereas leftover material from NAATs can be employed genomic analysis of positive samples, there is paucity information on whether genetic characterisation achieved archived Ag-RDTs. Aim To evaluate the possibility retrieving several viruses range Ag-RDTs, molecular analysis. Methods Archived Ag-RDTs which had been stored up 3 months at room temperature were used extract acids subsequent RT-qPCR, Sanger sequencing Nanopore whole genome sequencing. The effects brands Ag-RDT various ways prepare evaluated. Results SARS-CoV-2 successfully extracted sequenced nine different SARS-CoV-2, five these, after storage temperature. approach also worked influenza virus (n = brands), as well rotavirus adenovirus 40/41 1 brand). buffer an important influence RNA yield test strip efficiency Conclusion Our finding that in suited preserve material, even temperature, therefore serve source could help improve global coverage surveillance other viruses.

Язык: Английский

Процитировано

12
Revolutionizing SARS-CoV-2 omicron variant detection: Towards faster and more reliable methods DOI
Dan Li, Cai Sun,

Pengfei Zhuang

и другие.

Talanta, Год журнала: 2023, Номер 266, С. 124937 - 124937

Опубликована: Июль 12, 2023

Язык: Английский

Процитировано

11
Design of external quality assessment schemes and definition of the roles of their providers in future epidemics DOI Creative Commons
Christoph Buchta, Heinz Zeichhardt,

Stephan W. Aberle

и другие.

The Lancet Microbe, Год журнала: 2023, Номер 4(7), С. e552 - e562

Опубликована: Май 5, 2023

During an epidemic, individual test results form the basis of epidemiological indicators such as case numbers or incidence. Therefore, accuracy measures derived from these depends on reliability results. In COVID-19 pandemic, monitoring and evaluating performance unprecedented number testing facilities in operation, novel systems use, was urgently needed. External quality assessment (EQA) schemes are unique sources data reporting performance, their providers recognised contacts support for (for technical–analytical topics) health authorities planning infection diagnostics). To identify information provided by SARS-CoV-2 genome detection EQA that is relevant public microbiology, we reviewed current literature published PubMed between January, 2020, July, 2022. We recommendations best practices to monitor pathogen-detection future epidemics. also showed laboratories, facilities, benefits they can derive data, non-EQA services providers.

Язык: Английский

Процитировано

7
Ten rapid antigen tests for SARS-CoV-2 widely differ in their ability to detect Omicron-BA.4 and -BA.5 DOI Creative Commons

Franziska Krenn,

Christopher Dächert, Irina Badell

и другие.

Medical Microbiology and Immunology, Год журнала: 2023, Номер 212(5), С. 323 - 337

Опубликована: Авг. 10, 2023

Abstract Since late 2021, the variant landscape of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been dominated by concern (VoC) Omicron and its sublineages. We others have shown that detection Omicron-BA.1 -BA.2-positive specimens rapid antigen tests (RATs) is impaired compared to Delta VoC-containing samples. Here, in a single-center retrospective laboratory study, we evaluated performance ten most commonly used RATs for Omicron-BA.4 -BA.5 infections. 171 swab from SARS-CoV-2 RNA-positive patients, which 71 were classified as BA.4 100 BA.5. All swabs collected between July September 2022. 50 PCR-negative samples healthy individuals, October 2022, showed high specificity 9 out 10 RATs. When assessing analytical sensitivity using clinical specimens, 50% limit (LoD50) ranged 7.6 × 4 3.3 6 RNA copies subjected 6.8 3.0 Overall, intra-assay differences these two subvariants not significant both tissue culture-expanded virus isolates. In contrast, marked heterogeneity was observed among RATs: be positive point-of-care tests, up 443-fold (BA.4) 56-fold (BA.5) higher viral loads required worst performing RAT best RAT. True-positive rates Omicron-BA.4- or -BA.5-containing highest load category ( C t values < 25) 94.3 34.3%, dropping 25.6 0% with intermediate (25–30). conclude remains challenge general public obtain reliable results evolving subvariant-driven pandemic.

Язык: Английский

Процитировано

7
Sensitivity of rapid antigen tests for Omicron subvariants of SARS‐CoV‐2 DOI Creative Commons
Yuko Sakai‐Tagawa, Seiya Yamayoshi, Peter Halfmann

и другие.

Journal of Medical Virology, Год журнала: 2023, Номер 95(5)

Опубликована: Май 1, 2023

Abstract Diagnosis by rapid antigen tests (RATs) is useful for early initiation of antiviral treatment. Because RATs are easy to use, they can be adapted self‐testing. Several kinds approved such use the Japanese regulatory authority available from drug stores and websites. Most COVID‐19 based on antibody detection SARS‐CoV‐2 N protein. Since Omicron its subvariants have accumulated several amino acid substitutions in protein, changes might affect sensitivity RATs. Here, we investigated seven Japan, six which public one clinical BA.5, BA.2.75, BF.7, XBB.1, BQ.1.1, as well delta variant (B.1.627.2). All tested detected with a level between 7500 75 000 pfu per test, all showed similar (BA.5, BQ.1.1). Human saliva did not reduce tested. Espline highest followed Inspecter KOWA V Trust Ag. failed detect low levels infectious virus, individuals whose specimens contained less virus than limit would considered negative. Therefore, it important note that may miss shedding virus.

Язык: Английский

Процитировано

6
Automated antigen assays display a high heterogeneity for the detection of SARS-CoV-2 variants of concern, including several Omicron sublineages DOI Creative Commons
Andreas Osterman,

Franziska Krenn,

Maximilian Iglhaut

и другие.

Medical Microbiology and Immunology, Год журнала: 2023, Номер 212(5), С. 307 - 322

Опубликована: Авг. 10, 2023

Diagnostic tests for direct pathogen detection have been instrumental to contain the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic. Automated, quantitative, laboratory-based nucleocapsid antigen (Ag) SARS-CoV-2 launched alongside nucleic acid-based test systems and point-of-care (POC) lateral-flow Ag tests. Here, we evaluated four commercial on automated platforms of different sublineages Omicron variant concern (VoC) (B.1.1.529) in comparison with "non-Omicron" VoCs. A total 203 PCR-positive swabs (53 BA.1, 48 BA.2, 23 BQ.1, 39 XBB.1.5 40 other subvariants) from period February March 2022 2023 were examined. In addition, tissue culture-expanded clinical isolates Delta (B.1.617.2), Omicron-BA.1, -BF.7, -BN.1 -BQ.1 studied. These results compared previously reported data 107 samples end second pandemic wave (February 2021) as well cell culture-derived wildtype (wt) EU-1 (B.1.177), Alpha VoC (B.1.1.7) Beta (B.1.351)). All able detect at least 90.9% Omicron-containing high viral loads (Ct < 25). The rates true-positive BA.1/BA.2-positive intermediate 25-30) ranged between 6.7% 100.0%, while they dropped 0 15.4% low Ct values (> 30). This heterogeneity was reflected also by tests' 50%-limit (LoD50) ranging 44,444 1,866,900 Geq/ml. Respiratory containing Omicron-BQ.1/XBB.1.5 or subvariants that emerged detected enormous (0 100%) load ranges LoD50 23,019 1,152,048 contrast, more sensitive, scoring positive 35 100% 1.3 32.9% cases loads, respectively, corresponding 6181 749,792 assays VoCs Alpha, Beta, carrying up six amino acid mutations protein sensitivities comparable non-VoC EU-1. Overall, quantitative are not sensitive than standard rapid used POC settings show a performance recognition. best these may potential complement diagnostics primarily focused protection vulnerable groups. light constant emergence new recombinants, most recently XBB lineage, must be regularly re-evaluated, especially when carry immunological parameters change.

Язык: Английский

Процитировано

3
Efficacy of novel SARS-CoV-2 rapid antigen tests in the era of omicron outbreak DOI Creative Commons
Kristin Widyasari, Sun‐Joo Kim

PLoS ONE, Год журнала: 2023, Номер 18(8), С. e0289990 - e0289990

Опубликована: Авг. 10, 2023

Following the outbreak of Omicron and its subvariants, many currently available rapid Ag tests (RATs) showed a decrease in clinical performance. In this study, we evaluated sensitivity SARS-CoV-2 Rapid Antigen Test 2.0 for nasopharyngeal swabs Nasal nasal 56 symptomatic individuals by comparing results between RATs, RT-PCR, whole-genome sequencing (WGS). Furthermore, sequences subvariants’ spike proteins were subjected to phylogenetic analysis. Both novel RATs demonstrated high up 92.86%, (95% CI 82.71%– 98.02%), 94.23%, 83.07%– 98.49%), 97.95% 87.76%– 99.89%) compared WGS, respectively. The was at highest when Ct value restricted 15≤Ct<25, with 97.05% RdRp genes. RT-PCR analysis revealed subvariants BA.4 or BA.5 (76.8%) BA.2.75 (16.1%). Subsequently, WGS identified (65.5%) as dominant subvariant. Phylogenetic protein Omicron’s close relationship BA.4, BA.5, BA.2.75. These that are considered useful efficient detection SARS-CoV-2, particularly during current wave.

Язык: Английский

Процитировано

2
Evaluation of the diagnostic accuracy of two point-of-care tests for COVID-19 when used in symptomatic patients in community settings in the UK primary care COVID diagnostic accuracy platform trial (RAPTOR-C19) DOI Creative Commons
Brian D Nicholson, Philip J. Turner, Thomas Fanshawe

и другие.

PLoS ONE, Год журнала: 2023, Номер 18(7), С. e0288612 - e0288612

Опубликована: Июль 21, 2023

Background and objective Point-of-care lateral flow device antigen testing has been used extensively to identify individuals with active SARS-CoV-2 infection in the community. This study aimed evaluate diagnostic accuracy of two point-of-care tests (POCTs) for routine community care. Methods Adults children symptoms consistent suspected current COVID-19 were prospectively recruited from 19 UK general practices centres between October 2020 2021. Participants tested by trained healthcare workers using at least one index POCTs (Roche-branded SD Biosensor Standard™ Q Rapid Antigen Test and/or BD Veritor™ System Detection SARS-CoV-2). The reference standard was laboratory triplex reverse transcription quantitative PCR (RT-PCR) a combined nasal/oropharyngeal swab. Diagnostic parameters estimated, 95% confidence intervals (CIs), overall, relation RT-PCR cycle threshold pre-specified subgroups. Results Of 663 participants included primary analysis, 39.2% (260/663, CI 35.5% 43.0%) had positive result. POCT sensitivity 84.0% (178/212, 78.3% 88.6%) specificity 98.5% (328/333, 96.5% 99.5%), Veritor 76.5% (127/166, 69.3% 82.7%) 98.8% (249/252, 96.6% 99.8%) compared RT-PCR. Sensitivity both devices dropped substantially thresholds ≥30 more than 7 days after onset symptoms. Conclusions Both assessed exceed Medicines Healthcare products Regulatory Agency target product profile’s minimum acceptable 95%. Confidence include 80%. In symptomatic patients, negative results on these do not preclude possibility infection. Tests should be expected reliably detect disease week symptom onset, when viral load may reduced. Registration ISRCTN142269 .

Язык: Английский

Процитировано

1