A Multicenter Study Conducted to Evaluate the Agreement between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to Results on the Reference Analyzer
The purpose of the study is to gather data to determine agreement between sample types, which together with performance evaluation data will be used to support CE marking under Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices 3, using ISO 13612:2002 - Performance Evaluation of In Vitro Diagnostic Medical Devices as the standard. The investigative devices are the LumiraDx Platform D Dimer Test and the LumiraDx Platform CRP Test. The LumiraDx Platform employs a portable diagnostic instrument used with single use D Dimer or CRP Assay Test Strips. Agreement of the different sample types to the reference method will be demonstrated across a patient population representative of the indication for use of the products. Operators will be trained clinical site staff who are representative of the intended users of the product, i.e. health care professionals at the point of care such as nurses, technicians, doctors, etc. A panel of whole blood and plasma samples will be obtained from each patient in order to assess the accuracy of the investigative device across all sample types.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Blood tube will be collected from standard venepuncture
Capillary blood will be collected by fingerstick
Rancho Paseo Medical Group
Banning, California, United States
Centura Health Physician Group
Northglenn, Colorado, United States
New Medical Healthcare
Wichita, Kansas, United States
Diagnostic Clinic of Longview
Longview, Texas, United States
Assessment of sample matrix comparison
Verification that all sample types give an equivalent result when tested in the LumiraDx assays. Results generated from capillary blood and venous whole blood will be compared to those generated from plasma to ensure that all 3 sample types give equivalent values. Results will be compared by standard statisitical techniques which may include Regression analysis (e.g. Passing Bablok) or Bias analysis (e.g. Altman Bland)
Time frame: 2 months
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