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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.
  • Assennato SM; Diagnostics for the Real World EU, Ltd., Chesterford Research Park, Great Chesterford, United Kingdom.
  • Ritchie AV; Diagnostics for the Real World EU, Ltd., Chesterford Research Park, Great Chesterford, United Kingdom.
  • Nadala C; Diagnostics for the Real World, Ltd., San Jose, California, USA.
  • Goel N; Diagnostics for the Real World EU, Ltd., Chesterford Research Park, Great Chesterford, United Kingdom.
  • Tie C; Diagnostics for the Real World, Ltd., San Jose, California, USA.
  • Nadala LM; Diagnostics for the Real World, Ltd., San Jose, California, USA.
  • Zhang H; Clinical Microbiology and Public Health Laboratory, PHE Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom.
  • Datir R; Division of Infection and Immunity, University College London, London, United Kingdom.
  • Gupta RK; Department of Medicine, University of Cambridge, Cambridge, United Kingdom.
  • Curran MD; Africa Health Research Institute, Durban, South Africa.
  • Lee HH; Clinical Microbiology and Public Health Laboratory, PHE Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom.
J Clin Microbiol ; 59(1)2020 12 17.
Article in English | MEDLINE | ID: covidwho-991745
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 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 that of 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 copies/ml for detecting two regions of the genome (open reading frame 1ab [ORF1ab] and nucleocapsid protein [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% confidence interval [CI], 93.83 to 99.97) and negative percent agreement of 96.4% (95% CI, 89.92 to 99.26) compared to testing by the CMPHL. The data show that the SAMBA II SARS-CoV-2 test performs equivalently to the centralized testing methods, but with a shorter turnaround time of 86 to 101 min. Point-of-care tests such as SAMBA should enable rapid patient management and effective implementation of infection control measures.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Viral Proteins / Nucleic Acid Amplification Techniques / Coronavirus Nucleocapsid Proteins / COVID-19 Testing / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Year: 2020 Document Type: Article Affiliation country: JCM.01262-20

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Viral Proteins / Nucleic Acid Amplification Techniques / Coronavirus Nucleocapsid Proteins / COVID-19 Testing / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Year: 2020 Document Type: Article Affiliation country: JCM.01262-20