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Clinical evaluation of a RT-LAMP SARS-CoV-2 test for the Point-Of-Care, rapid, low-cost, integrating sample solid phase extraction and on which reagents are lyophilized.
Preprint
in English
| medRxiv
| ID: ppmedrxiv-21264480
ABSTRACT
ObjectivesDetermine the sensitivity and specificity of a Point-Of-Care test ( COVIDISC) for SARS-COV2. The novelty of the test is to integrate, on the same (low-cost) compact plastic/paper device, solid phase RNA extraction and RT-LAMP amplification, all reagents being freeze-dried on it. MethodRetrospective study with a cohort of 99 patients characterized by real-time RT-PCR. The 37 positive naso-pharyngeal samples cover a broad range of viral loads (from 5 gc /{micro}L to 2 106 gc/ {micro}L of sample). ResultsThe COVIDISC found 36 positives (out of 37 by IP4 RT-PCR protocols) and 63 negatives (out of 62 by RT-PCR). ConclusionThe sensitivity of the COVIDISC, found in this 99-patient retrospective study, is 97% and the specificity 100%.
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Full text:
Available
Collection:
Preprints
Database:
medRxiv
Type of study:
Cohort_studies
/
Diagnostic study
/
Experimental_studies
/
Observational study
/
Prognostic study
Language:
English
Year:
2021
Document type:
Preprint
