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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)
medrxiv; 2021.
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在 英语
| medRxiv | ID: ppzbmed-10.1101.2021.10.03.21264480
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%.相关文档
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