Watkins, Nicholas NHassan, UmerDamhorst, GregoryNi, HengkanVaid, AwaisRodriguez, WilliamBashir, Rashid2020-02-062020-02-062013-12-05http://dx.doi.org/10.1126/scitranslmed.3006870https://lib.digitalsquare.io/xmlui/handle/123456789/6596Roughly 33 million people worldwide are infected with HIV disease burden is highest in resource limited settings One important diagnostic in HIV disease management is the absolute count of lymphocytes expressing the CD4 and CD8 receptors The current diagnostic instruments and procedures require expensive equipment and trained technicians In response we have developed microfluidic biochips that count CD4 and CD8 lymphocytes in whole blood samples without the need for off chip sample preparation The device is based on differential electrical counting and relies on five on chip modules that in sequence chemically lyses erythrocytes quenches lysis to preserve leukocytes enumerates cells electrically depletes the target cells CD4 or CD8 with antibodies and enumerates the remaining cells electrically We demonstrate application of this chip using blood from healthy and HIV infected subjects Erythrocyte lysis and quenching durations were optimized to create pure leukocyte populations in less than 1 min Target cell depletion was accomplished through shear stress based immunocapture using antibody coated microposts to increase the contact surface area and enhance depletion efficiency With the differential electrical counting method device based CD4 and CD8 T cell counts closely matched control counts obtained from flow cytometry over a dynamic range of 40 to 1000 cells l By providing accurate cell counts in less than 20 min from samples obtained from one drop of whole blood this approach has the potential to be realized as a handheld battery powered instrument that would deliver simple HIV diagnostics to patients anywhere in the world regardless of geography or socioeconomic statusBeneficiary age rangeNewbornInfantChildYoung people (10-24 years)AdultSeniorSpecial populationAt risk for a particular disease or infectionChildren Under 5 yearsIncarceratedDisabledDrug usersFamily as a unitImmigrant and refugeeLesbian, gay, bisexual, and transgenderMen (only)Vulnerable childrenParentsRacial and ethnic minoritiesRural populationsStudent populationsUrban populationsWorkforceWomen (only)Target userClientSocial support networkFacility-based health workerCommunity-based health workerManagerHealth system constraintInformationLack of population enumerationDelayed reporting of eventsQuality/unreliability of dataCommunication roadblocksAccess to information or dataAvailabilitySupply of commoditiesSupply of servicesSupply of equipmentDiversity of treatment optionsQualityQuality of careHealth worker competenceQuality of commoditiesHealth worker motivationContinuity of careSupportive supervisionAcceptabilityAlignment with local normsAddressing individual beliefs and practicesStigmaUtilizationDemand for servicesGeographic inaccessibilityLow adherence to treatmentsLoss to follow upEfficiencyWorkflow managementEffective resource allocationUnnecessary referrals and transportationPlanning and coordinationTimeliness of careCostExpenses related to commodity productionExpenses related to commodity supplyExpenses related to commodity disbursementExpenses related to service deliveryClient-side expensesStage of development of the strategyPre-prototypePrototypePilotLimited demonstrationScaled programEvaluationEvaluation intentFeasibilityFunctionalityUsabilityEfficacyEffectivenessOptimizationEvaluation designNon ExperimentalPopulation basedIndividual basedExperimentalRandomizedNon-randomizedHealth domainFamily planning and reproductive healthSafe sexContraceptionSafe abortion careBirth spacingInfertilityFemale genital mutilationMaternal healthPregnancyAntenatal carePregnancy complicationsDanger signsEmergency preparednessLaborBirth planningPostpartum careBreastfeedingChild HealthGrowth and developmentChild abuseInfant nutritionVaccinesNewborn carePMTCTMalformations/birth defectsInfectious, parasitic and vector-borne diseaseTuberculosisSTIs, excluding HIVHIV/AIDSDiarrheal diseaseHepatitisMalariaParastic InfectionsVector-BorneRespiratory tract infections (URI, LRI, OM)Non-communicable diseasesCancerDiabetesCardiovascular diseaseAsthmaTobacco UseAlcohol useOral healthNutritionMalnutritionProtein energy malnutritionMicronutrient deficiencyObesityMental healthViolenceViolence against women (inc. Rape)Intimate partner violence (IPV)Familial violence (non-IPV)Community violenceUnintentional injuryRoad traffic injuriesPoisoningsFallsBurnsDrowningInjuriesCare modelPreventiveShort-termAcute or emergencyChronic careLong term institutionalized caremHealth applicationSocial and behavior change communicationHealth education or promotionHotlines and information servicesAppointment remindersTreatment adherenceMass messaging campaignsWorkforce development and performance supportProvider training and educationProvider work planning and schedulingHuman resource managementConstituent feedback on service qualityService deliveryElectronic decision supportProvider-to-provider communicationRemote client-to-provider consultations (Telemedicine)Disease preventionDisease diagnosis / Point-of-care diagnosticsDisease managementReferralsInformation systemsData collection and reportingService delivery statisticsHousehold surveysSurveillanceElectronic health recordsRegistries/vital events trackingFinancial transactions and incentivesPayment for servicesConditional cash transfersSavings accountsInsurancePerformance-based incentivesSupply managementCold chain managementStock out preventionCounterfeit preventionMaintenance of equipmentCommodity tracking / replenishmentTechnologyTechnology ChannelVoiceSMSMMSUSSDInternetBluetoothRF/NFCTechnology Content formatTextImageAudioVideoRaw dataTechnology HardwareCameraGPSAccelerometers / Motion sensorsPhysiologic BiosensorsBiometric identifiersSIMMemory Card (eg. MicroSD)Technology FunctionsDigital formDigital protocolDecision support algorithmElectronic checklistsElectronic case listsMobile phone calendarChat / Discussion CommunityInstalled applicationClosed User GroupIVR