Evaluating Operational Specifications of Point-of-Care Diagnostic Tests A Standardized Scorecard 英文参考文献.docVIP

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Evaluating Operational Specifications of Point-of-Care Diagnostic Tests A Standardized Scorecard 英文参考文献.doc

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Evaluating Operational Specifications of Point-of-Care Diagnostic Tests A Standardized Scorecard 英文参考文献

EvaluatingOperationalSpecificationsofPoint-of-Care DiagnosticTests:AStandardizedScorecard JonathanD.Lehe1,Na′diaE.Sitoe2,OceanTobaiwa1,OsvaldoLoquiha3,JorgeI.Quevedo1, TrevorF.Peter1,IleshV.Jani2* 1Clinton Health Access Initiative, Maputo, Mozambique, 2Instituto Nacional de Sau′de, Maputo, Mozambique, 3Department of Mathematics and Informatics, UniversidadeEduardoMondlane,Maputo,Mozambique Abstract TheexpansionofHIVantiretroviral therapyintodecentralizedruralsettingswillincreasinglyrequiresimplepoint-of-care (POC) diagnostic tests that can be used without laboratory infrastructure and technical skills. New POC test devices are becomingavailablebutdecisionsaroundwhichtechnologiestodeploymaybebiasedwithoutsystematicassessmentof theirsuitabilityfordecentralizedhealthcaresettings.Toaddressthis,wedevelopedastandardized,quantitativescorecard tooltoobjectivelyevaluatetheoperationalcharacteristicsofPOCdiagnosticdevices.Thetoolscoresdevicesonascaleof 1–5across30weightedcharacteristicssuchaseaseofuse,qualitycontrol,electricalrequirements,shelflife,portability,cost andservice,andprovidesacumulativescorethatranksproductsagainstasetofidealPOCcharacteristics.Thescorecard was tested on 19 devices for POC CD4 T-lymphocyte cell counting, clinical chemistry or hematology testing. Single and multi-parameterdeviceswereassessedineachoftestcategories.Thescoresacrossalldevicesrangedfrom2.78to4.40out of5.Thetooleffectivelyrankeddeviceswithineachcategory(p,0.01)excepttheCD4andmulti-parameterhematology products. The tool also enabled comparison of different characteristics between products. Agreement across the four scorersforeachproductwashigh(intra-classcorrelation.0.80;p,0.001).Useofthistoolenablesthesystematicevaluation ofdiagnostic tests tofacilitateproduct selectionandinvestmentin appropriate technology. Itis particularly relevantfor countriesandtestingprogramsconsideringtheadoptionofnewPOCdiagnostictests. Citation: Lehe JD, Sitoe NE, Tobaiwa O, Loquiha O, Quevedo JI, et al. (201