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  1. Article ; Online: Learning From Agility, Partnership and Innovation During the Covid-19 Pandemic: A Perspective From Industry.

    Cárdenas, Ana María / Roger-Dalbert, Celine

    Frontiers in cellular and infection microbiology

    2022  Volume 12, Page(s) 838565

    Abstract: Two years after the COVID-19 pandemic started, the world continues to adapt to the profound effects that Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has had on our lives. As the global crisis took hold, many looked to the medical ... ...

    Abstract Two years after the COVID-19 pandemic started, the world continues to adapt to the profound effects that Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has had on our lives. As the global crisis took hold, many looked to the medical technology/device industry for guidance and solutions. All while the industry itself, was disrupting its own processes and activities. In order to evolve and deliver accelerated innovation the industry had to be agile, resilient and collaborative with the broader healthcare community and technology partners. Now comes a time when we will start to see what changes were temporary and which ones will become part of the new process, but one thing is certain, we will not be going back to where we were pre-pandemic.
    MeSH term(s) COVID-19 ; Delivery of Health Care ; Humans ; Pandemics ; SARS-CoV-2/genetics
    Language English
    Publishing date 2022-02-17
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2619676-1
    ISSN 2235-2988 ; 2235-2988
    ISSN (online) 2235-2988
    ISSN 2235-2988
    DOI 10.3389/fcimb.2022.838565
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  2. Article ; Online: Chromogenic enzyme substrates based on [2-(nitroaryl)ethenyl]pyridinium and quinolinium derivatives for the detection of nitroreductase activity in clinically important microorganisms.

    Cellier-Rastit, Marie / Chalansonnet, Valérie / James, Arthur L / Johnston, Annette / Orenga, Sylvain / Perry, John D / Roger-Dalbert, Celine / Salwatura, Vindhya L / Stanforth, Stephen P / Sykes, Hannah E / Truong, Viet T / Turnbull, Graeme

    Journal of materials chemistry. B

    2023  Volume 11, Issue 26, Page(s) 6106–6113

    Abstract: A series of [2-(nitroaryl)ethenyl]pyridinium and quinolinium derivatives have been synthesised as potential indicators of microbial nitroreductase activity. When assessed against a selection of 20 clinically important pathogenic microorganisms, microbial ...

    Abstract A series of [2-(nitroaryl)ethenyl]pyridinium and quinolinium derivatives have been synthesised as potential indicators of microbial nitroreductase activity. When assessed against a selection of 20 clinically important pathogenic microorganisms, microbial colonies of various colours (yellow, green, red, brown, black) were produced and attributed to nitroreductase activity. Most substrates elicited colour responses with Gram-negative microorganisms. In contrast, the growth of several species of Gram-positive microorganisms and yeasts was often inhibited by the substrates and hence coloured responses were not seen.
    MeSH term(s) Chromogenic Compounds/chemistry ; Substrate Specificity ; Nitroreductases/metabolism
    Chemical Substances Chromogenic Compounds ; Nitroreductases (EC 1.7.-)
    Language English
    Publishing date 2023-07-05
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2702241-9
    ISSN 2050-7518 ; 2050-750X
    ISSN (online) 2050-7518
    ISSN 2050-750X
    DOI 10.1039/d3tb00715d
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  3. Article ; Online: Antigen-Based Testing but Not Real-Time Polymerase Chain Reaction Correlates With Severe Acute Respiratory Syndrome Coronavirus 2 Viral Culture.

    Pekosz, Andrew / Parvu, Valentin / Li, Maggie / Andrews, Jeffrey C / Manabe, Yukari C / Kodsi, Salma / Gary, Devin S / Roger-Dalbert, Celine / Leitch, Jeffry / Cooper, Charles K

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2021  Volume 73, Issue 9, Page(s) e2861–e2866

    Abstract: Background: Individuals can test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by molecular assays following the resolution of their clinical disease. Recent studies indicate that SARS-CoV-2 antigen-based tests are likely to ... ...

    Abstract Background: Individuals can test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by molecular assays following the resolution of their clinical disease. Recent studies indicate that SARS-CoV-2 antigen-based tests are likely to be positive early in the disease course, when there is an increased likelihood of high levels of infectious virus.
    Methods: Upper respiratory specimens from 251 participants with coronavirus disease 2019 symptoms (≤7 days from symptom onset) were prospectively collected and tested with a lateral flow antigen test and a real-time polymerase chain reaction (rt-PCR) assay for detection of SARS-CoV-2. Specimens from a subset of the study specimens were utilized to determine the presence of infectious virus in the VeroE6TMPRSS2 cell culture model.
    Results: The antigen test demonstrated a higher positive predictive value (90%) than rt-PCR (70%) when compared to culture-positive results. The positive percentage agreement for detection of infectious virus for the antigen test was similar to rt-PCR when compared to culture results.
    Conclusions: The correlation between SARS-CoV-2 antigen and SARS-CoV-2 culture positivity represents a significant advancement in determining the risk for potential transmissibility beyond that which can be achieved by detection of SARS-CoV-2 genomic RNA. SARS-CoV-2 antigen testing can facilitate low-cost, scalable, and rapid time-to-result, while providing good risk determination of those who are likely harboring infectious virus, compared to rt-PCR.
    MeSH term(s) Antigens, Viral ; COVID-19 ; Humans ; Real-Time Polymerase Chain Reaction ; SARS-CoV-2 ; Sensitivity and Specificity
    Chemical Substances Antigens, Viral
    Language English
    Publishing date 2021-01-21
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciaa1706
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  4. Article ; Online: Clinical Evaluation of BD Veritor SARS-CoV-2 Point-of-Care Test Performance Compared to PCR-Based Testing and versus the Sofia 2 SARS Antigen Point-of-Care Test.

    Young, Stephen / Taylor, Stephanie N / Cammarata, Catherine L / Varnado, Katey G / Roger-Dalbert, Celine / Montano, Amanda / Griego-Fullbright, Christen / Burgard, Cameron / Fernandez, Catherine / Eckert, Karen / Andrews, Jeffrey C / Ren, Huimiao / Allen, Joseph / Ackerman, Ronald / Cooper, Charles K

    Journal of clinical microbiology

    2020  Volume 59, Issue 1

    Abstract: The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID- ... ...

    Abstract The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO], ≥18 years of age) were utilized to compare Veritor with the Lyra SARS-CoV-2 PCR assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (≤5 DSO, ≥18 years of age) were utilized to compare performance of Veritor to that of the Sofia 2 SARS Antigen FIA test (Sofia 2). The positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. In study 1, the PPA for Veritor, compared to Lyra, ranged from 81.8 to 87.5% across the 0 to 1 and 0 to 6 DSO ranges. In study 2, Veritor had PPA, NPA, and OPA values of 97.4, 98.1, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. Veritor met FDA emergency use authorization (EUA) acceptance criteria for SARS-CoV-2 antigen testing for the 0 to 5 and 0 to 6 DSO ranges (PPA values of 83.9% and 82.4%, respectively). Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test allows for more rapid COVID-19 testing utilizing easy-to-collect nasal swabs but demonstrated <100% PPA compared to PCR.
    MeSH term(s) Adult ; Antigens, Viral/analysis ; COVID-19/diagnosis ; COVID-19 Testing/methods ; Coronavirus Nucleocapsid Proteins/analysis ; Female ; Humans ; Immunoassay/methods ; Male ; Middle Aged ; Nasopharynx/virology ; Oropharynx/virology ; Point-of-Care Testing ; Polymerase Chain Reaction/methods ; SARS-CoV-2/genetics ; SARS-CoV-2/immunology ; Sensitivity and Specificity ; Spike Glycoprotein, Coronavirus/analysis
    Chemical Substances Antigens, Viral ; Coronavirus Nucleocapsid Proteins ; N protein, SARS-CoV ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-12-17
    Publishing country United States
    Document type Comparative Study ; Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    DOI 10.1128/JCM.02338-20
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  5. Article ; Online: Antigen-based testing but not real-time PCR correlates with SARS-CoV-2 virus culture

    Pekosz, Andrew / Cooper, Charles / Parvu, Valentin / Li, Maggie / Andrews, Jeffrey / Manabe, Yukari C C / Kodsi, Salma / Leitch, Jeffry / Gary, Devin / Roger-Dalbert, Celine

    Abstract: Individuals can test positive for SARS-CoV-2 by real-time polymerase chain reaction (RT-PCR) after no longer being infectious.1-8 Positive SARS-CoV-2 antigen-based testing exhibits a temporal pattern that corresponds with active, replicating virus and ... ...

    Abstract Individuals can test positive for SARS-CoV-2 by real-time polymerase chain reaction (RT-PCR) after no longer being infectious.1-8 Positive SARS-CoV-2 antigen-based testing exhibits a temporal pattern that corresponds with active, replicating virus and could therefore be a more accurate predictor of an individuals potential to transmit SARS-CoV-2.2,3,9 Using the BD Veritor System for Rapid Detection of SARS-CoV-2 later flow antigen detection test, we demonstrate a higher concordance of antigen-positive test results with the presence of cultured, infectious virus when compared to RT-PCR. When compared to infectious virus isolation, the sensitivity of antigen-based testing is similar to RT-PCR. The correlation between SARS-CoV-2 antigen and SARS-CoV-2 culture represents a significant advancement in determining the risk for potential transmissibility beyond that which can be achieved by detection of SARS-CoV-2 genomic RNA. Coupled with a rapid time-to-result, low cost, and scalability, antigen-based testing should facilitate effective implementation of testing and public health interventions that will better contain COVID-19.
    Keywords covid19
    Publisher MedRxiv; WHO
    Document type Article ; Online
    Note WHO #Covidence: #20205708
    DOI 10.1101/2020.10.02.20205708
    Database COVID19

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  6. Article ; Online: Antigen-based testing but not real-time PCR correlates with SARS-CoV-2 virus culture.

    Pekosz, Andrew / Cooper, Charles / Parvu, Valentin / Li, Maggie / Andrews, Jeffrey / Manabe, Yukari C C / Kodsi, Salma / Leitch, Jeffry / Gary, Devin / Roger-Dalbert, Celine

    medRxiv

    Abstract: Individuals can test positive for SARS-CoV-2 by real-time polymerase chain reaction (RT-PCR) after no longer being infectious.1-8 Positive SARS-CoV-2 antigen-based testing exhibits a temporal pattern that corresponds with active, replicating virus and ... ...

    Abstract Individuals can test positive for SARS-CoV-2 by real-time polymerase chain reaction (RT-PCR) after no longer being infectious.1-8 Positive SARS-CoV-2 antigen-based testing exhibits a temporal pattern that corresponds with active, replicating virus and could therefore be a more accurate predictor of an individuals potential to transmit SARS-CoV-2.2,3,9 Using the BD Veritor System for Rapid Detection of SARS-CoV-2 later flow antigen detection test, we demonstrate a higher concordance of antigen-positive test results with the presence of cultured, infectious virus when compared to RT-PCR. When compared to infectious virus isolation, the sensitivity of antigen-based testing is similar to RT-PCR. The correlation between SARS-CoV-2 antigen and SARS-CoV-2 culture represents a significant advancement in determining the risk for potential transmissibility beyond that which can be achieved by detection of SARS-CoV-2 genomic RNA. Coupled with a rapid time-to-result, low cost, and scalability, antigen-based testing should facilitate effective implementation of testing and public health interventions that will better contain COVID-19.
    Keywords covid19
    Language English
    Publishing date 2020-10-05
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2020.10.02.20205708
    Database COVID19

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  7. Article ; Online: Clinical evaluation of BD Veritor SARS-CoV-2 point-of-care test performance compared to PCR-based testing and versus the Sofia 2 SARS Antigen point-of-care test.

    Young, Stephen / Taylor, Stephanie / Cammarata, Catherine / Roger-Dalbert, Celine / Montano, Amanda / Griego-Fullbright, Christen / Burgard, Cameron / Fernandez, Catherine / Eckert, Karen / Andrews, Jeffrey C / Ren, Huimiao / Allen, Joseph / Ackerman, Ronald / Gary, Devin / Cooper, Charles

    medRxiv

    Abstract: Objectives The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 antigen (Veritor), a chromatographic immunoassay that detects the SARS-CoV-2 nucleocapsid antigen as a point-of-care test, was evaluated on nasal specimens ... ...

    Abstract Objectives The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 antigen (Veritor), a chromatographic immunoassay that detects the SARS-CoV-2 nucleocapsid antigen as a point-of-care test, was evaluated on nasal specimens from individuals with COVID-19 symptoms. Methods and Materials Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (<=7 days from symptom onset [DSO]), >=18 years of age, were utilized to compare Veritor with the Lyra SARS-CoV-2 PCR Assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (<=5 DSO), >=18 years of age, were utilized to compare performance of Veritor to that of the Sofia 2 SARS Antigen FIA test (Sofia 2). Positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. Results In study 1, PPA for Veritor, compared to Lyra, ranged from 81.8%-87.5% for 0-1 through 0-6 DSO ranges. In study 2, Veritor had a PPA, NPA, and OPA of 97.4%, 98.1%, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. Conclusions Veritor met FDA-EUA acceptance criteria for SARS-CoV-2 antigen testing (>=80% PPA point estimate) for the 0-5 and 0-6 DSO ranges. Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test should facilitate rapid and reliable results for COVID-19 diagnosis utilizing easy-to-collect nasal swabs.
    Keywords covid19
    Language English
    Publishing date 2020-09-04
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2020.09.01.20185777
    Database COVID19

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  8. Article ; Online: Clinical evaluation of BD Veritor SARS-CoV-2 point-of-care test performance compared to PCR-based testing and versus the Sofia 2 SARS Antigen point-of-care test.

    Young, Stephen / Taylor, Stephanie N. / Cammarata, Catherine L. / Varnado, Katey G. / Roger-Dalbert, Celine / Montano, Amanda / Griego-Fullbright, Christen / Burgard, Cameron / Fernandez, Catherine / Eckert, Karen / Andrews, Jeffrey C. / Ren, Huimiao / Allen, Joseph / Ackerman, Ronald / Cooper, Charles K.

    Journal of Clinical Microbiology ; ISSN 0095-1137 1098-660X

    2020  

    Abstract: Objectives The clinical performance of the BD Veritor™ System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals ... ...

    Abstract Objectives The clinical performance of the BD Veritor™ System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Methods: Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO]), ≥18 years of age, were utilized to compare Veritor with the Lyra® SARS-CoV-2 PCR Assay (Lyra). In the second study, nasal specimens from 361 participants with COVID-19 symptoms (≤5 DSO), ≥18 years of age, were utilized to compare performance of Veritor to that of the Sofia® 2 SARS Antigen FIA test (Sofia 2). Positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) were the primary outcomes. Results: In study 1, PPA for Veritor, compared to Lyra, ranged from 81.8%-87.5% for 0-1 through 0-6 DSO ranges. In study 2, Veritor had a PPA, NPA, and OPA of 97.4%, 98.1%, and 98.1%, respectively, with Sofia 2. Discordant analysis showed one Lyra positive missed by Veritor and five Lyra positives missed by Sofia 2; one Veritor positive result was negative by Lyra. Conclusions: Veritor met FDA-EUA acceptance criteria for SARS-CoV-2 antigen testing (≥80% PPA point estimate) for the 0-5 and 0-6 DSO ranges. Veritor and Sofia 2 showed a high degree of agreement for SARS-CoV-2 detection. The Veritor test allows for more rapid COVID-19 testing utilizing easy-to-collect nasal swabs, but demonstrated less than 100% PPA compared to PCR..
    Keywords Microbiology (medical) ; covid19
    Language English
    Publisher American Society for Microbiology
    Publishing country us
    Document type Article ; Online
    DOI 10.1128/jcm.02338-20
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article: Evaluation of a Novel Chromogenic Agar Medium for Isolation and Differentiation of Vancomycin-Resistant Enterococcus faecium and Enterococcus faecalis Isolates

    Ledeboer, Nathan A / Das, Kingshuk / Eveland, Michael / Roger-Dalbert, Céline / Mailler, Sandrine / Chatellier, Sonia / Dunne, William Michael

    Journal of clinical microbiology JCM. 2007 May, v. 45, no. 5

    2007  

    Abstract: The development of reliable and rapid methods for the identification of patients colonized with vancomycin-resistant enterococci (VRE) is central to the containment of this agent within a hospital environment. To this end, we evaluated a prototype ... ...

    Abstract The development of reliable and rapid methods for the identification of patients colonized with vancomycin-resistant enterococci (VRE) is central to the containment of this agent within a hospital environment. To this end, we evaluated a prototype chromogenic agar medium (VRE-BMX; bioMérieux, Marcy l'Etoile, France) used to recover VRE from clinical specimens. This medium can also identify isolated colonies as either vancomycin-resistant Enterococcus faecium or Enterococcus faecalis, based on distinct colony colors. We compared the performance of VRE-BMX with bile esculin azide agar supplemented with vancomycin (BEAV). For this study, 147 stool samples were plated on each test medium and examined after 24 and 48 h of incubation. At 24 h, the sensitivity and specificity of each medium were as follows: BEAV, 90.9% and 89.9%, respectively; VRE-BMX, 96.4% and 96.6%, respectively. The positive predictive values (PPV) of VRE-BMX and BEAV at 24 h were 89.8% and 80.7%, respectively. VRE-BMX provided the identification of 10 isolates of vancomycin-resistant E. faecalis and 4 isolates of vancomycin-resistant E. faecium that were not recovered by BEAV. Further, VRE-BMX was capable of identifying patients colonized with both E. faecium and E. faecalis, a feature useful for infection control purposes that is not a function of BEAV. In terms of the recovery of vancomycin-resistant E. faecium and E. faecalis, the sensitivity and PPV were as follows: BEAV, 75.7% and 74.6%, respectively; VRE-BMX, 95.5% and 91.3%, respectively. In this initial evaluation, we found that VRE-BMX provided improved recovery of VRE from stool specimens, with the added advantage of being able to differentiate between vancomycin-resistant E. faecalis and E. faecium. Extending the incubation period beyond 24 h did not significantly improve the recovery of VRE and resulted in decreased specificity.
    Language English
    Dates of publication 2007-05
    Size p. 1556-1560.
    Publishing place American Society for Microbiology
    Document type Article
    ZDB-ID 390499-4
    ISSN 1098-660X ; 0095-1137
    ISSN (online) 1098-660X
    ISSN 0095-1137
    Database NAL-Catalogue (AGRICOLA)

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  10. Article ; Online: Synthesis and evaluation of novel chromogenic peptidase substrates based on 9-(4'-aminophenyl)-10-methylacridinium salts as diagnostic tools in clinical bacteriology.

    Anderson, Rosaleen J / Groundwater, Paul W / Huang, Yongxue / James, Arthur L / Orenga, Sylvain / Rigby, Annette / Roger-Dalbert, Céline / Perry, John D

    Bioorganic & medicinal chemistry letters

    2008  Volume 18, Issue 2, Page(s) 832–835

    Abstract: The synthesis and initial evaluation of novel chromogenic substrates with potential in the detection and differentiation of cultured bacterial colonies are described. The substrates were readily hydrolysed by specific aminopeptidase activity to release ... ...

    Abstract The synthesis and initial evaluation of novel chromogenic substrates with potential in the detection and differentiation of cultured bacterial colonies are described. The substrates were readily hydrolysed by specific aminopeptidase activity to release the chromogen, 9-(4'-aminophenyl)-10-methylacridinium salt, which provided a clear visual indication of the presence of the corresponding bacteria.
    MeSH term(s) Acridines/chemical synthesis ; Acridines/chemistry ; Bacterial Infections/diagnosis ; Peptide Hydrolases/metabolism ; Substrate Specificity
    Chemical Substances Acridines ; Peptide Hydrolases (EC 3.4.-)
    Language English
    Publishing date 2008-01-15
    Publishing country England
    Document type Journal Article
    ZDB-ID 1063195-1
    ISSN 1464-3405 ; 0960-894X
    ISSN (online) 1464-3405
    ISSN 0960-894X
    DOI 10.1016/j.bmcl.2007.11.018
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