Complete blood counts and a basic metabolic panel are the most ordered blood tests in nearly all clinical settings. These tests are predominantly conducted on expensive high-throughput instrumentation in centralized or well- equipped satellite laboratories. Currently, there is no cost-effective and efficient instrumentation that can conduct these tests at the point-of-need or in clinics that do not have access to centralized testing facilities. The development of clinical instruments that can increase access to testing and provide clinicians with earlier, actionable diagnostic tests results have significant potential to improve healthcare management in a variety of clinical settings including rural and low resource settings, pediatric and neonate testing, and urgent and primary care settings. Critically, in many of these settings, healthcare personnel can be limited. In these settings phlebotomists or other trained personnel required for blood draws and clinical testing are not typically present. Consequently, there is a need for diagnostic testing instrumentation that can improve the accessibility of testing in various healthcare settings. Critically, this instrumentation requires ease of use, including CLIA waiver status, while providing performance that is comparable to standard testing in centralized laboratory settings. However, there are no solutions available that meet this need. To address this need, General Fluidics has developed the Axess System, which is a unique, rapid, cost-effective, and high-performance point-of-need solution that combines comprehensive clinical chemistry and hematology testing into a single modular platform delivering results in 15 to 20 minutes. The Axess system has been validated with venous whole blood for hematology and plasma derived from venous blood for clinical chemistry testing. In this proposal, the Axess system will be validated using fingerstick (i.e., capillary blood), where performance equivalence with venous blood would support use of the Axess systems in clinical settings where phlebotomists are not present. This would support further optimization and commercialization of the Axess system with a FDA CLIA waiver, which would deliver the first comprehensive instrument with central laboratory performance that could be used at the point-of-need. General Fluidics has previously validated a basic metabolic panel and a complete blood count through clinical performance evaluation studies at Massachusetts General Hospital and in-house evaluations. The goal of this Phase I project will be to demonstrate equivalence for hematology and clinical chemistry testing that is performed on the Axess System with de-identified matched capillary and venous blood specimens.
Public Health Relevance Statement: PROJECT NARRATIVE The development of comprehensive point-of-need analytical instrumentation that is easy to use (CLIA waiver), cost-effective, and high performance has significant potential to improve the access to diagnostic testing in a variety of underserved healthcare settings including rural and low-resource settings, pediatric and neonate clinics, and many urgent and primary care facilities. General Fluidics has developed the Axess System which uses venous blood and delivers performance comparable to centralized testing capabilities in a rapid, modular, point-of-need instrument. The goal of this proposal will be to demonstrate performance equivalence in venous and capillary blood specimens to support future CLIA waiver and to improve the accessibility of diagnostic testing.
Project Terms: advanced age; elders; geriatric; late life; later life; older adult; older person; senior citizen; Elderly; Biological Assay; Assay; Bioassay; Biologic Assays; Blood; Blood Reticuloendothelial System; Blood Platelets; Marrow platelet; Platelets; Thrombocytes; Blood capillaries; capillary; Clinical Chemistry; Child; 0-11 years old; Child Youth; Children (0-21); kids; youngster; Complete Blood Count; Edetic Acid; EDTA; Edathamil; Ethylenediaminetetraacetic Acid; Ethylenedinitrilotetraacetic Acid; Evaluation Studies; Fingers; Future; Goals; Health care facility; Health Facilities; Healthcare Facility; care facilities; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Blood Tests; Hematologic Tests; Hematological Tests; Hematology Testing; Hematology; Heparin; Heparinic Acid; General Hospitals; Immunochemistry; instrumentation; Laboratories; Leukocytes; Blood leukocyte; Leukocytes Reticuloendothelial System; Marrow leukocyte; White Blood Cells; White Cell; white blood cell; white blood corpuscle; Lithium; Li+ element; Massachusetts; Plasma; Blood Plasma; Plasma Serum; Reticuloendothelial System, Serum, Plasma; Primary Care Physician; medical specialties; Specialty; Testing; Time; Diagnostic tests; Managed Care; Data Set; Guidelines; Tube; Blood Sample; Blood specimen; Label; Vial; Vial device; improved; Procedures; Clinical; Phase; Ensure; Evaluation; Training; pediatric; Childhood; Individual; Rural; Collaborations; Metabolic; instrument; Venous; Specimen; Research Specimen; Whole Blood; Clinic; Protocols documentation; Protocol; System; Test Result; Clinical Chemistry Tests; Performance; success; Participant; Human Resources; Manpower; personnel; Sampling; Address; Improve Access; Reproducibility; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Collection; Validation; validations; Process; Development; developmental; neonate; cost effective; healthy volunteer; commercialization; primary care setting; clinical practice; waiver; urgent care; rural health care; rural healthcare; clinical development; healthcare settings; health care settings; health care management; healthcare management; health management; health care outcomes; healthcare outcomes; care outcomes; rapid assay; rapid tests; rapid test; Resource-limited setting; Low-resource area; Low-resource community; Low-resource environment; Low-resource region; Low-resource setting; Resource-constrained area; Resource-constrained community; Resource-constrained environment; Resource-constrained region; Resource-constrained setting; Resource-limited area; Resource-limited community; Resource-limited environment; Resource-limited region; Resource-poor area; Resource-poor community; Resource-poor environment; Resource-poor region; Resource-poor setting; Primary Care
