Abstract:
Untilvaccinesandeffectivetherapeuticsbecomeavailable,thepracticalsolutiontotransit safelyoutofthecurrentcoronavirusdisease19(CoVID-19)lockdownmayincludetheimplementation ofaneffectivetesting,tracingandtrackingsystem.However,thisrequiresareliableandclinically validateddiagnosticplatformforthesensitiveandspecificidentificationofSARS-CoV-2.Here, wereportonthedevelopmentofadenovo,high-resolutionandcomparativegenomicsguided reverse-transcribedloop-mediatedisothermalamplification(LAMP)assay.Tofurtherenhancethe assayperformanceandtoremoveanysubjectivityassociatedwithoperatorinterpretationofresults, weengineeredanovelhand-heldsmartdiagnosticdevice.Therobustdiagnosticdevicewasfurther furnishedwithautomatedimageacquisitionandprocessingalgorithmsandthecollateddatawas processedthroughartificialintelligence(AI)pipelinestofurtherreducetheassayruntimeandthe subjectivityofthecolorimetricLAMPdetection.ThisadvancedAIalgorithm-implementedLAMP (ai-LAMP)assay,targetingtheRNA-dependentRNApolymerasegene,showedhighanalytical sensitivityandspecificityforSARS-CoV-2.Atotalof~200coronavirusdisease(CoVID-19)-suspected NHSpatientsamplesweretestedusingtheplatformanditwasshowntobereliable,highlyspecific andsignificantlymoresensitivethanthecurrentgoldstandardqRT-PCR.Therefore,thissystemcould provideanefficientandcost-effectiveplatformtodetectSARS-CoV-2inresource-limitedlaboratories.