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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: 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 ... ...

    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: Evaluation of SAMBA II: A Qualitative and Semiquantitative HIV Point-of-Care Nucleic Acid Test.

    Violette, Lauren R / Cornelius-Hudson, Andy / Snidarich, Madison / Niemann, Lisa A / Assennato, Sonny Michael / Ritchie, Allyson / Goel, Neha / Chavez, Pollyanna R / Ethridge, Steven F / Katz, David A / Lee, Helen / Delaney, Kevin P / Stekler, Joanne D

    Journal of acquired immune deficiency syndromes (1999)

    2022  Volume 89, Issue 5, Page(s) 537–545

    Abstract: Background: Point-of-care (POC) nucleic acid tests (NATs) have potential to diagnose acute HIV infection and monitor persons taking pre-exposure prophylaxis or antiretroviral therapy (ART). POC NATs have not yet been evaluated in the US.: Methods: ... ...

    Abstract Background: Point-of-care (POC) nucleic acid tests (NATs) have potential to diagnose acute HIV infection and monitor persons taking pre-exposure prophylaxis or antiretroviral therapy (ART). POC NATs have not yet been evaluated in the US.
    Methods: From June 2018-March 2019, we conducted a cross-sectional evaluation of the Simple Amplification-Based Assay version II (SAMBA II) POC NAT. People with HIV (PWH) and persons testing for HIV were tested with the SAMBA II qualitative (Qual) whole blood (WB) test. From April-September 2019, the Qual test was used on persons who were ART-naive, and SAMBA II Semi-quantitative (Semi-Q) WB was used with ART-experienced PWH. Both were performed on unprocessed venipuncture (VP) and, when indicated by protocol, fingerstick (FS) WB and plasma. SAMBA results were compared with Abbott RealTime HIV-1 polymerase chain reaction results on plasma. We calculated sensitivity, specificity, and concordance between tests.
    Results: SAMBA was used in 330 visits among 280 participants: 202 (61.2%) visits from PWH, and 128 (38.8%) from HIV-negative persons. Qual test sensitivity with ART-naive participants was 91.4% [32/35, 95% confidence interval (CI): 77.6% to 97.0%] using VP WB and 100% (27/27, 95% CI: 87.5% to 100%) using FS WB. Specificity was 100% using both specimen types. Concordance between the gold standard and Semi-Q at 1000 copies/mL among PWH on ART was 97.7% (86/88, 95% CI: 92.1% to 99.4%) and 100% (30/30, 95% CI: 88.7% to 100%) using VP and FS WB, respectively.
    Conclusions: The SAMBA II POC NATs showed high sensitivity, specificity, and concordance with the gold standard assay, indicating its potential use in diagnostics and monitoring. Future work will evaluate POC NAT implementation in the US.
    MeSH term(s) Cross-Sectional Studies ; HIV Infections/diagnosis ; HIV Infections/drug therapy ; Humans ; Nucleic Acids/therapeutic use ; Point-of-Care Systems ; Point-of-Care Testing ; Sensitivity and Specificity ; Viral Load/methods
    Chemical Substances Nucleic Acids
    Language English
    Publishing date 2022-01-06
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 645053-2
    ISSN 1944-7884 ; 1077-9450 ; 0897-5965 ; 0894-9255 ; 1525-4135
    ISSN (online) 1944-7884 ; 1077-9450
    ISSN 0897-5965 ; 0894-9255 ; 1525-4135
    DOI 10.1097/QAI.0000000000002902
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. 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: 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 ... ...

    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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  4. 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: 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 ... ...

    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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  5. 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: 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 ... ...

    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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  6. Article ; Online: Evaluation of an easy and affordable flow cytometer for volumetric haematopoietic stem cell counting.

    Mariani, Mariagabriella / Colombo, Federico / Assennato, Sonny M / Frugoni, Cecilia / Cattaneo, Alessandra / Trombetta, Elena / Rebulla, Paolo / Porretti, Laura

    Blood transfusion = Trasfusione del sangue

    2014  Volume 12, Issue 3, Page(s) 416–420

    Abstract: Background: Accurate estimation of haematopoietic stem cell (HSC) counts by flow cytometry may be difficult in laboratories in which sophisticated equipment and staff with specific expertise are not available. Affordable flow cytometers that can perform ...

    Abstract Background: Accurate estimation of haematopoietic stem cell (HSC) counts by flow cytometry may be difficult in laboratories in which sophisticated equipment and staff with specific expertise are not available. Affordable flow cytometers that can perform basic functions may help to overcome these difficulties. In this study we compared HSC and leucocyte counts determined by volumetric and bead-based protocols performed with the small, low-cost Accuri(®) C6, with those obtained with two gold-standard instruments, the four-colour FACSCalibur(®) and the eight-colour FACSCantoII(®), our reference flow cytometers.
    Materials and methods: With the three cytometers we tested, in parallel, 111 consecutive samples from cord blood, peripheral blood from patients with myelofibrosis and myeloproliferative syndromes, fresh and thawed HSC collected by apheresis and bone marrow products. The findings were compared with one-way ANOVA, Bland-Altman analysis and linear regression.
    Results: The results of HSC and leucocyte enumeration by the three devices were strongly correlated (r(2)>0.99; p<0.0001). ANOVA performed on different subgroups of samples did not reveal significant differences between HSC count determined by the C6 bead-based and reference flow cytometers in any of the subgroups. Regarding the C6 volumetric protocol, a statistically significant difference was observed only in the cord blood subgroup. Time for instrument set-up, calibration and analysis was slightly longer with Accuri(®) C6 (40 min) than with FACSCantoII(®) (30 min).
    Discussion: Accuri(®) C6 is a reliable instrument for HSC enumeration in fresh samples, using both volumetric and bead-based approaches, although the volumetric protocol on cord blood samples needs to be improved. The Accuri(®) C6 is easy to use, does not require profound knowledge of flow cytometry and could be employed in an urgent setting. Its performance may be improved by more efficient calibration and shorter analysis time.
    MeSH term(s) Female ; Flow Cytometry/instrumentation ; Flow Cytometry/methods ; Hematopoietic Stem Cells/cytology ; Humans ; Leukocyte Count/instrumentation ; Leukocyte Count/methods ; Male
    Language English
    Publishing date 2014-03-19
    Publishing country Italy
    Document type Journal Article
    ZDB-ID 2135732-8
    ISSN 2385-2070 ; 0041-1787 ; 1723-2007
    ISSN (online) 2385-2070
    ISSN 0041-1787 ; 1723-2007
    DOI 10.2450/2014.0198-13
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study.

    Collier, Dami A / Assennato, Sonny M / Warne, Ben / Sithole, Nyarie / Sharrocks, Katherine / Ritchie, Allyson / Ravji, Pooja / Routledge, Matthew / Sparkes, Dominic / Skittrall, Jordan / Smielewska, Anna / Ramsey, Isobel / Goel, Neha / Curran, Martin / Enoch, David / Tassell, Rhys / Lineham, Michelle / Vaghela, Devan / Leong, Clare /
    Mok, Hoi Ping / Bradley, John / Smith, Kenneth G C / Mendoza, Vivienne / Demiris, Nikos / Besser, Martin / Dougan, Gordon / Lehner, Paul J / Siedner, Mark J / Zhang, Hongyi / Waddington, Claire S / Lee, Helen / Gupta, Ravindra K

    Cell reports. Medicine

    2020  Volume 1, Issue 5, Page(s) 100062

    Abstract: There is an urgent need for rapid SARS-CoV-2 testing in hospitals to limit nosocomial spread. We report an evaluation of point of care (POC) nucleic acid amplification testing (NAAT) in 149 participants with parallel combined nasal and throat swabbing ... ...

    Abstract There is an urgent need for rapid SARS-CoV-2 testing in hospitals to limit nosocomial spread. We report an evaluation of point of care (POC) nucleic acid amplification testing (NAAT) in 149 participants with parallel combined nasal and throat swabbing for POC versus standard lab RT-PCR testing. Median time to result is 2.6 (IQR 2.3-4.8) versus 26.4 h (IQR 21.4-31.4, p < 0.001), with 32 (21.5%) positive and 117 (78.5%) negative. Cohen's κ correlation between tests is 0.96 (95% CI 0.91-1.00). When comparing nearly 1,000 tests pre- and post-implementation, the median time to definitive bed placement from admission is 23.4 (8.6-41.9) versus 17.1 h (9.0-28.8), p = 0.02. Mean length of stay on COVID-19 "holding" wards is 58.5 versus 29.9 h (p < 0.001). POC testing increases isolation room availability, avoids bed closures, allows discharge to care homes, and expedites access to hospital procedures. POC testing could mitigate the impact of COVID-19 on hospital systems.
    MeSH term(s) Adult ; Aged ; COVID-19/diagnosis ; COVID-19 Nucleic Acid Testing/standards ; Cross Infection/prevention & control ; Female ; Hospitalization ; Humans ; Infection Control/methods ; Male ; Middle Aged ; Point-of-Care Testing/standards ; SARS-CoV-2/genetics ; SARS-CoV-2/isolation & purification
    Keywords covid19
    Language English
    Publishing date 2020-07-15
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't ; Validation Study
    ISSN 2666-3791
    ISSN (online) 2666-3791
    DOI 10.1016/j.xcrm.2020.100062
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Combined Point-of-Care Nucleic Acid and Antibody Testing for SARS-CoV-2 following Emergence of D614G Spike Variant.

    Mlcochova, Petra / Collier, Dami / Ritchie, Allyson / Assennato, Sonny M / Hosmillo, Myra / Goel, Neha / Meng, Bo / Chatterjee, Krishna / Mendoza, Vivien / Temperton, Nigel / Kiss, Leo / James, Leo C / Ciazynska, Katarzyna A / Xiong, Xiaoli / Briggs, John A G / Nathan, James A / Mescia, Federica / Bergamaschi, Laura / Zhang, Hongyi /
    Barmpounakis, Petros / Demeris, Nikos / Skells, Richard / Lyons, Paul A / Bradley, John / Baker, Steven / Allain, Jean Pierre / Smith, Kenneth G C / Bousfield, Rachel / Wilson, Michael / Sparkes, Dominic / Amoroso, Glenn / Gkrania-Klotsas, Effrosyni / Hardwick, Susie / Boyle, Adrian / Goodfellow, Ian / Gupta, Ravindra K

    Cell reports. Medicine

    2020  Volume 1, Issue 6, Page(s) 100099

    Abstract: Rapid COVID-19 diagnosis in the hospital is essential, although this is complicated by 30%-50% of nose/throat swabs being negative by SARS-CoV-2 nucleic acid amplification testing (NAAT). Furthermore, the D614G spike mutant dominates the pandemic and it ... ...

    Abstract Rapid COVID-19 diagnosis in the hospital is essential, although this is complicated by 30%-50% of nose/throat swabs being negative by SARS-CoV-2 nucleic acid amplification testing (NAAT). Furthermore, the D614G spike mutant dominates the pandemic and it is unclear how serological tests designed to detect anti-spike antibodies perform against this variant. We assess the diagnostic accuracy of combined rapid antibody point of care (POC) and nucleic acid assays for suspected COVID-19 disease due to either wild-type or the D614G spike mutant SARS-CoV-2. The overall detection rate for COVID-19 is 79.2% (95% CI 57.8-92.9) by rapid NAAT alone. The combined point of care antibody test and rapid NAAT is not affected by D614G and results in very high sensitivity for COVID-19 diagnosis with very high specificity.
    MeSH term(s) Aged ; Aged, 80 and over ; Antibodies, Viral/blood ; COVID-19/diagnosis ; COVID-19 Testing/methods ; COVID-19 Testing/standards ; Female ; Humans ; Immunoassay ; Male ; Middle Aged ; Neutralization Tests ; Nucleic Acid Amplification Techniques ; Point-of-Care Testing ; SARS-CoV-2/genetics ; SARS-CoV-2/immunology ; SARS-CoV-2/isolation & purification ; Sensitivity and Specificity ; Spike Glycoprotein, Coronavirus/genetics ; Spike Glycoprotein, Coronavirus/immunology
    Chemical Substances Antibodies, Viral ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-09-01
    Publishing country United States
    Document type Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2666-3791
    ISSN (online) 2666-3791
    DOI 10.1016/j.xcrm.2020.100099
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Plasmodium genome in blood donors at risk for malaria after several years of residence in Italy.

    Assennato, Sonny Michael / Berzuini, Alessandra / Foglieni, Barbara / Spreafico, Marta / Allain, Jean-Pierre / Prati, Daniele

    Transfusion

    2014  Volume 54, Issue 10, Page(s) 2419–2424

    Abstract: Background: At present, the main risk of transfusion-transmitted malaria (TTM) in nonendemic countries is chronic, asymptomatic immigrants from malaria-endemic areas. Semi-immune donors may carry undetected parasitemia. This study examines Plasmodium ... ...

    Abstract Background: At present, the main risk of transfusion-transmitted malaria (TTM) in nonendemic countries is chronic, asymptomatic immigrants from malaria-endemic areas. Semi-immune donors may carry undetected parasitemia. This study examines Plasmodium infection in at-risk blood donors in Northern Italy.
    Study design and methods: Plasma samples from 97 candidate donors and 80 controls were tested for malarial antibodies using a commercial enzyme immunoassay. The conserved 18S rRNA and the mitochondrial genes of Plasmodium were amplified to detect and quantify parasite genomes (copies/mL). Plasmodium species were identified with a species-specific nested polymerase chain reaction. Parasitemic samples were further tested by amplification of polymorphic repetitive regions in MSP-1 Block 2, MSP-2 Block 3, and glutamate-rich protein (GLURP) confirmed by sequencing.
    Results: Three of 83 seropositive (3.6%) and one of 14 seronegative at-risk candidate donors carried Plasmodium genome (4 × 10(3) -8.5 × 10(4) copies/mL): two P. falciparum, one P. malariae (seronegative sample), and one coinfection with P. malariae and P. ovale. Alleles of MSP-1 (MAD20 and K1), MSP-2 (3D7 and FC27), and GLURP were amplified from Sample 261. In Sample 282 only one allele in MSP-2 (FC27) and GLURP was amplified. No alleles were detected in Samples 283 and 331.
    Conclusions: Immigrants from endemic countries might carry infectious Plasmodium after 2 to 5 years of continuous residence in Italy. Serologic screening may miss donors carrying P. malariae. Permanent exclusion or screening for both antibodies and genome are needed to prevent TTM.
    MeSH term(s) Adult ; Aged ; Antibodies, Protozoan/blood ; Blood Donors/statistics & numerical data ; Blood Transfusion, Autologous/statistics & numerical data ; Emigrants and Immigrants/statistics & numerical data ; Female ; Genetic Variation ; Genome, Protozoan ; Humans ; Italy/epidemiology ; Malaria/blood ; Malaria/genetics ; Malaria/parasitology ; Malaria/transmission ; Male ; Middle Aged ; Plasmodium/genetics ; Plasmodium/isolation & purification ; Polymerase Chain Reaction ; Risk Factors ; Sequence Analysis, DNA ; Young Adult
    Chemical Substances Antibodies, Protozoan
    Language English
    Publishing date 2014-10
    Publishing country United States
    Document type Journal Article
    ZDB-ID 208417-x
    ISSN 1537-2995 ; 0041-1132
    ISSN (online) 1537-2995
    ISSN 0041-1132
    DOI 10.1111/trf.12650
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article: Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study

    Collier, Dami A / Assennato, Sonny M / Warne, Ben / Sithole, Nyarie / Sharrocks, Katherine / Ritchie, Allyson / Ravji, Pooja / Routledge, Matthew / Sparkes, Dominic / Skittrall, Jordan / Smielewska, Anna / Ramsey, Isobel / Goel, Neha / Curran, Martin / Enoch, David / Tassell, Rhys / Lineham, Michelle / Vaghela, Devan / Leong, Clare /
    Mok, Hoi Ping / Bradley, John / Smith, Kenneth G C / Mendoza, Vivienne / Demiris, Nikos / Besser, Martin / Dougan, Gordon / Lehner, Paul J / Siedner, Mark J / Zhang, Hongyi / Waddington, Claire S / Lee, Helen / Gupta, Ravindra K

    Cell Rep Med

    Abstract: There is an urgent need for rapid SARS-CoV-2 testing in hospitals to limit nosocomial spread. We report an evaluation of point of care (POC) nucleic acid amplification testing (NAAT) in 149 participants with parallel combined nasal and throat swabbing ... ...

    Abstract There is an urgent need for rapid SARS-CoV-2 testing in hospitals to limit nosocomial spread. We report an evaluation of point of care (POC) nucleic acid amplification testing (NAAT) in 149 participants with parallel combined nasal and throat swabbing for POC versus standard lab RT-PCR testing. Median time to result is 2.6 (IQR 2.3-4.8) versus 26.4 h (IQR 21.4-31.4, p < 0.001), with 32 (21.5%) positive and 117 (78.5%) negative. Cohen's κ correlation between tests is 0.96 (95% CI 0.91-1.00). When comparing nearly 1,000 tests pre- and post-implementation, the median time to definitive bed placement from admission is 23.4 (8.6-41.9) versus 17.1 h (9.0-28.8), p = 0.02. Mean length of stay on COVID-19 "holding" wards is 58.5 versus 29.9 h (p < 0.001). POC testing increases isolation room availability, avoids bed closures, allows discharge to care homes, and expedites access to hospital procedures. POC testing could mitigate the impact of COVID-19 on hospital systems.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #653595
    Database COVID19

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