Blood collection tubes as medical devices: The potential to affect assays and proposed verification and validation processes for the clinical laboratory

Clinical Biochemistry

Volumn 49, Issue 18, 2016, Pages 1321-1330

  Bowen, Raffick A R ^a   Adcock, Dorothy M ^b  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b LABORATORY CORPORATION OF AMERICA   (United States)

Author keywords

Blood; Collection; Preanalytical; Tube; Validation; Verification

Indexed keywords

ANALYTIC METHOD; BLOOD COLLECTION TUBE; CANADA; CLINICAL EVALUATION; CLINICAL LABORATORY; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST; ECONOMIC ASPECT; EMERGING TECHNOLOGY; EQUIPMENT DESIGN; EUROPEAN UNION; GOOD LABORATORY PRACTICE; HEALTH CARE COST; HUMAN; IN VITRO STUDY; MEDICAL DEVICE REGULATION; MEDICAL TECHNOLOGY; NONHUMAN; PATIENT CARE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; UNITED STATES; VALIDATION PROCESS; BLOOD SAMPLING; DEVICES; VALIDATION STUDY;

BLOOD SPECIMEN COLLECTION; EQUIPMENT AND SUPPLIES; HUMANS; QUALITY CONTROL;

EID: 84999885226     PISSN: 00099120     EISSN: 18732933     Source Type: Journal    
DOI: 10.1016/j.clinbiochem.2016.10.004     Document Type: Review

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