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)

ABSTRACT

Objectives: Determine 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. Method: Retrospective 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 /microL to 2 10^6 gc/ microL of sample) . Results: The COVIDISC found 36 positives (out of 37 by IP4 RT-PCR protocols) and 63 negatives (out of 62 by RT-PCR). Conclusion: The sensitivity of the COVIDISC, found in this 99-patient retrospective study, is 97% and the specificity 100%.