Evaluation of Portable Point-of-Care CD4 Counter with High Sensitivity for Detecting Patients Eligible for Antiretroviral Therapy 英文参考文献.docVIP

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Evaluation of Portable Point-of-Care CD4 Counter with High Sensitivity for Detecting Patients Eligible for Antiretroviral Therapy 英文参考文献.doc

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Evaluation of Portable Point-of-Care CD4 Counter with High Sensitivity for Detecting Patients Eligible for Antiretroviral Therapy 英文参考文献

EvaluationofPortablePoint-of-CareCD4Counterwith HighSensitivityforDetectingPatientsEligiblefor AntiretroviralTherapy YukariC.Manabe1,2,3*,YapingWang2,AliElbireer3,4,BrandonAuerbach1,BarbaraCastelnuovo1 1InfectiousDiseasesInstitute,MakerereCollegeofHealthSciences,Kampala,Uganda,2DivisionofInfectiousDiseases,DepartmentofMedicine,JohnsHopkinsUniversity SchoolofMedicine,Baltimore,Maryland,UnitedStatesofAmerica,3MakerereUniversity-JohnsHopkinsUniversityClinicalCoreLaboratory,DepartmentofPathology, JohnsHopkinsUniversitySchoolofMedicine,Baltimore,Maryland,UnitedStatesofAmerica,4DivisionofPathology,DepartmentofMedicine,JohnsHopkinsUniversity SchoolofMedicine,Baltimore,Maryland,UnitedStatesofAmerica Abstract Background:Accurate,inexpensivepoint-of-careCD4+TcelltestingtechnologiesareneededthatcandeliverCD4+Tcell results at lower level health centers or community outreach voluntary counseling and testing. We sought to evaluate apoint-of-careCD4+Tcellcounter,thePimaCD4TestSystem,aportable,battery-operatedbench-topinstrumentthatis designedtousefingerstickbloodsamplessuitableforfielduseinconjunctionwithrapidHIVtesting. Methods: Duplicate measurements were performed on both capillary and venous samples using Pima CD4 analyzers, comparedtotheBDFACSCalibur(referencemethod).ThemeanbiaswasestimatedbypairedStudent’st-test.BlandAltman plotswereusedtoassessagreement. Results:206participantswereenrolledwithamedianCD4countof396(range;18–1500).ThefingerstickPIMAhadamean bias of 266.3cells/mL (95%CI 283.4249.2, P,0.001) compared to the FACSCalibur; the bias was smaller at lower CD4 counts (0–250cells/mL) with a mean bias of 210.8 (95%CI 227.32+5.6, P=0.198), and much greater at higher CD4 cell counts(.500cells/mL)withameanbiasof2120.6(95%CI2162.8,278.4,P,0.001).Thesensitivity(95%CI)ofthePimaCD4 analyzerwas96.3%(79.1–99.8%)fora,250cells/ulcut-offwithanegativepredictivevalueof99.2%(95.1–99.9%). Conclusions:ThePimaCD4fingersticktestisaneasy-to-use,portable,relativelyfastdevicetotestCD4+Tcell