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SARS-CoV-2 sample-to-answer nucleic acid testing in a tertiary care emergency department: evaluation and utility
Preprint
in En
| PREPRINT-MEDRXIV
| ID: ppmedrxiv-20145383
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A scientific journal published article is available and is probably based on this preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
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ABSTRACT
Rapid sample-to-answer tests for detection of SARS-CoV-2 are emerging and data on their relative performance is urgently needed. We evaluated the analytical performance of two rapid nucleic acid tests, Cepheid Xpert(R) Xpress SARS-CoV-2 and Mobidiag Novodiag(R) Covid-19, in comparison to a combination reference of three large-scale PCR tests. Moreover, utility of the Novodiag(R) test in tertiary care emergency departments was assessed. In the preliminary evaluation, analysis of 90 respiratory samples resulted in 100% specificity and sensitivity for Xpert(R), whereas analysis of 107 samples resulted in 93.4% sensitivity and 100% specificity for Novodiag(R). Rapid SARS-CoV-2 testing with Novodiag(R) was made available for four tertiary care emergency departments in Helsinki, Finland between 18 and 31 May, coinciding with a rapidly declining epidemic phase. Altogether 361 respiratory specimens, together with relevant clinical data, were analyzed with Novodiag(R) and reference tests 355/361 of the specimens were negative with both methods, and 1/361 was positive in Novodiag(R) and negative by the reference method. Of the 5 remaining specimens, two were negative with Novodiag(R), but positive with the reference method with late Ct values. On average, a test result using Novodiag(R) was available nearly 8 hours earlier than that obtained with the large-scale PCR tests. While the performance of novel sample-to-answer PCR tests need to be carefully evaluated, they may provide timely and reliable results in detection of SARS-CoV-2 and thus facilitate patient management including effective cohorting.
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Full text:
1
Collection:
09-preprints
Database:
PREPRINT-MEDRXIV
Type of study:
Cohort_studies
/
Diagnostic_studies
/
Experimental_studies
/
Observational_studies
/
Prognostic_studies
Language:
En
Year:
2020
Document type:
Preprint