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  1. Article ; Online: Performance Evaluation of the SAMBA II SARS-CoV-2 Test for Point-of-Care Detection of SARS-CoV-2.

    Assennato, Sonny M / Ritchie, Allyson V / Nadala, Cesar / Goel, Neha / Tie, Cuijuan / Nadala, Lourdes M / Zhang, Hongyi / Datir, Rawlings / Gupta, Ravindra K / Curran, Martin D / Lee, Helen H

    Journal of clinical microbiology

    2020  Volume 59, Issue 1

    Abstract: ... Based Assay (SAMBA) II SARS-CoV-2 test were determined by both ... SARS-CoV-2) RNA in respiratory samples is the standard method for diagnosis. The majority ... of this testing is centralized and therefore has turnaround times of several days. Point-of-care (POC) testing ...

    Abstract Nucleic acid amplification for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in respiratory samples is the standard method for diagnosis. The majority of this testing is centralized and therefore has turnaround times of several days. Point-of-care (POC) testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly. The inclusivity and specificity of the Simple AMplification-Based Assay (SAMBA) II SARS-CoV-2 test were determined by both
    MeSH term(s) COVID-19/diagnosis ; COVID-19 Testing/methods ; Coronavirus Nucleocapsid Proteins/genetics ; Humans ; Molecular Diagnostic Techniques/methods ; Nucleic Acid Amplification Techniques/methods ; Point-of-Care Testing ; Polyproteins/genetics ; RNA, Viral/genetics ; SARS-CoV-2/genetics ; Sensitivity and Specificity ; Viral Proteins/genetics
    Chemical Substances Coronavirus Nucleocapsid Proteins ; N protein, SARS-CoV ; ORF1ab polyprotein, SARS-CoV-2 ; Polyproteins ; RNA, Viral ; Viral Proteins
    Keywords covid19
    Language English
    Publishing date 2020-12-17
    Publishing country United States
    Document type 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.01262-20
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Performance evaluation of the point-of-care SAMBA II SARS-CoV-2 Test for detection of SARS-CoV-2

    Assennato, Sonny M / Ritchie, Allyson V / Nadala, Cesar / Zhang, Hongyi / Datir, Rawlings / Gupta, Ravindra K / Curran, Martin D / Lee, Helen H / Goel, Neha

    medRxiv

    Abstract: ... reference tests. Results: The limit of detection of the SAMBA II SARS-CoV-2 Test is 250 cp/mL and is ... Analytical and clinical sensitivity and specificity of the SAMBA II SARS-CoV-2 Test was evaluated on panels ... negative by PHE. Discussion: The data shows that the SAMBA II SARS-CoV-2 Test performs equivalently ...

    Abstract Background: Nucleic acid amplification for the detection of SARS-CoV-2 RNA in respiratory samples is the standard method for diagnosis. These tests are centralised and therefore turnaround times can be 2-5 days. Point-of-care testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly. Methods: Analytical and clinical sensitivity and specificity of the SAMBA II SARS-CoV-2 Test was evaluated on panels and residual clinical samples. The clinical performance was compared to the Public Health England reference tests. Results: The limit of detection of the SAMBA II SARS-CoV-2 Test is 250 cp/mL and is specific for detection of 2 regions of the SARS-CoV-2 genome. The clinical sensitivity was evaluated in 172 clinical samples provided by Public Health England, Cambridge, which showed a sensitivity of 98.9% (95% CI 94.03-99.97%), specificity of 100% (95% CI 95.55-100%), PPV of 100% and NPV of 98.78% (92.02-99.82%) compared to testing by Public Health England (PHE). SAMBA detected 3 positive samples that were initially negative by PHE. Discussion: The data shows that the SAMBA II SARS-CoV-2 Test performs equivalently to the centralised testing methods with a much quicker turnaround time. Point of care testing, such as SAMBA, should enable rapid patient management and effective implementation of infection control measures.
    Keywords covid19
    Language English
    Publishing date 2020-05-26
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2020.05.24.20100990
    Database COVID19

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  3. Article ; Online: Performance evaluation of the point-of-care SAMBA II SARS-CoV-2 Test for detection of SARS-CoV-2

    Assennato, S. M. / Ritchie, A. V. / Nadala, C. / Zhang, H. / Datir, R. / Gupta, R. K. / Curran, M. D. / Lee, H. H. / Goel, N.

    Abstract: ... reference tests. Results: The limit of detection of the SAMBA II SARS-CoV-2 Test is 250 cp/mL and is ... Analytical and clinical sensitivity and specificity of the SAMBA II SARS-CoV-2 Test was evaluated on panels ... negative by PHE. Discussion: The data shows that the SAMBA II SARS-CoV-2 Test performs equivalently ...

    Abstract Background: Nucleic acid amplification for the detection of SARS-CoV-2 RNA in respiratory samples is the standard method for diagnosis. These tests are centralised and therefore turnaround times can be 2-5 days. Point-of-care testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly. Methods: Analytical and clinical sensitivity and specificity of the SAMBA II SARS-CoV-2 Test was evaluated on panels and residual clinical samples. The clinical performance was compared to the Public Health England reference tests. Results: The limit of detection of the SAMBA II SARS-CoV-2 Test is 250 cp/mL and is specific for detection of 2 regions of the SARS-CoV-2 genome. The clinical sensitivity was evaluated in 172 clinical samples provided by Public Health England, Cambridge, which showed a sensitivity of 98.9% (95% CI 94.03-99.97%), specificity of 100% (95% CI 95.55-100%), PPV of 100% and NPV of 98.78% (92.02-99.82%) compared to testing by Public Health England (PHE). SAMBA detected 3 positive samples that were initially negative by PHE. Discussion: The data shows that the SAMBA II SARS-CoV-2 Test performs equivalently to the centralised testing methods with a much quicker turnaround time. Point of care testing, such as SAMBA, should enable rapid patient management and effective implementation of infection control measures.
    Keywords covid19
    Publisher MedRxiv; WHO
    Document type Article ; Online
    DOI 10.1101/2020.05.24.20100990
    Database COVID19

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  4. Article: Performance evaluation of the SAMBA II SARS-CoV-2 Test for point-of-care detection of SARS-CoV-2

    Assennato, Sonny M / Ritchie, Allyson V / Nadala, Cesar / Goel, Neha / Tie, Cuijuan / Nadala, Lourdes M / Zhang, Hongyi / Datir, Rawlings / Gupta, Ravindra K / Curran, Martin D / Lee, Helen H

    J. clin. microbiol

    Abstract: ... testing. The SAMBA II SARS-CoV-2 Test was evaluated for performance characteristics. Clinical performance ... to testing by CMPHL.The data shows that the SAMBA II SARS-CoV-2 Test performs equivalently to the centralised ... of the SAMBA II SARS-CoV-2 Test was determined by both in silico analyses of the primers and probes and wet ...

    Abstract Nucleic acid amplification for the detection of SARS-CoV-2 RNA in respiratory samples is the standard method for diagnosis. The majority of this testing is centralised and therefore turnaround times of several days. Point-of-care testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly.Inclusivity and specificity of the SAMBA II SARS-CoV-2 Test was determined by both in silico analyses of the primers and probes and wet testing. The SAMBA II SARS-CoV-2 Test was evaluated for performance characteristics. Clinical performance was evaluated in residual combined throat/nose swabs and compared to the Public Health England real-time PCR assay targeting the RdRp gene.The SAMBA II SARS-CoV-2 Test has an analytical sensitivity of 250 cp/mL detecting two regions of the genome (Orf1ab and N). The clinical performance was evaluated in 172 residual combined nose/throat swabs provided by the Clinical Microbiology and Public Health Laboratory, Addenbrooke's Hospital, Cambridge (CMPHL), which showed an estimated positive percent agreement of 98.9% (95% CI: 93.83-99.97) negative percent agreement of 96.4% (95%CI: 89.92-99.26) compared to testing by CMPHL.The data shows that the SAMBA II SARS-CoV-2 Test performs equivalently to the centralised testing methods with shorter turnaround time of 86-101 minutes). Point of care testing, such as SAMBA, should enable rapid patient management and effective implementation of infection control measures.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #868272
    Database COVID19

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  5. Article ; Online: Performance evaluation of the SAMBA II SARS-CoV-2 Test for point-of-care detection of SARS-CoV-2

    Assennato, Sonny M / Ritchie, Allyson V / Nadala, Cesar / Goel, Neha / Tie, Cuijuan / Nadala, Lourdes M / Zhang, Hongyi / Datir, Rawlings / Gupta, Ravindra K / Curran, Martin D / Lee, Helen H

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

    2020  

    Abstract: ... testing. The SAMBA II SARS-CoV-2 Test was evaluated for performance characteristics. Clinical performance ... to testing by CMPHL. The data shows that the SAMBA II SARS-CoV-2 Test performs equivalently ... of the SAMBA II SARS-CoV-2 Test was determined by both in silico analyses of the primers and probes and wet ...

    Abstract Nucleic acid amplification for the detection of SARS-CoV-2 RNA in respiratory samples is the standard method for diagnosis. The majority of this testing is centralised and therefore turnaround times of several days. Point-of-care testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly. Inclusivity and specificity of the SAMBA II SARS-CoV-2 Test was determined by both in silico analyses of the primers and probes and wet testing. The SAMBA II SARS-CoV-2 Test was evaluated for performance characteristics. Clinical performance was evaluated in residual combined throat/nose swabs and compared to the Public Health England real-time PCR assay targeting the RdRp gene. The SAMBA II SARS-CoV-2 Test has an analytical sensitivity of 250 cp/mL detecting two regions of the genome (Orf1ab and N). The clinical performance was evaluated in 172 residual combined nose/throat swabs provided by the Clinical Microbiology and Public Health Laboratory, Addenbrooke's Hospital, Cambridge (CMPHL), which showed an estimated positive percent agreement of 98.9% (95% CI: 93.83-99.97) negative percent agreement of 96.4% (95%CI: 89.92-99.26) compared to testing by CMPHL. The data shows that the SAMBA II SARS-CoV-2 Test performs equivalently to the centralised testing methods with shorter turnaround time of 86-101 minutes). Point of care testing, such as SAMBA, should enable rapid patient management and effective implementation of infection control measures.
    Keywords Microbiology (medical) ; covid19
    Language English
    Publisher American Society for Microbiology
    Publishing country us
    Document type Article ; Online
    DOI 10.1128/jcm.01262-20
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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