System Accuracy Evaluation LUX Chol HDL test

Transcription

1 System Accuracy Evaluation LUX Chol HDL test 1. Minimum Acceptable System Accuracy 1.1 System Accuracy Requirement The minimum acceptable accuracy for results produced by a Lipidmonitoring systemshall be as follows. Ninety-five percent (95%) of the individual HDL cholesterol results shall fall within ±15% at HDL cholesterol concentrations mmol/l ( 10mg/dL). 1.2 Data presentation For HDL cholesterol concentrations mmol/l ( 10mg/dL), results shall be expressed asthe percentage of values falling within the following intervals: ±5%, ±10% 2. Strip & Meter 1) Lots of HDL cholesterol teststrips; 1 strip lot per site Site # Strip lot number Quantity 1 L12BN1Z 150 strips from 15 vials 2 L12BN1S 150 strips from 15 vials 3 L12BD1H 150 strips from 15 vials 2) LUX Meters; 1 meter per site Site #1 Site #2 Site #3 meter # serial number meter # serial number meter # serial number 1 L L L )Cobas C111 The calibration accuracy of the Cobas C111was validated with Quality control solution calibration. 4)Instructions for use Lay users were provided with LUX METER-1 includinguser manual as draft labeled and packaged as it would for the US market in English. Lay users, who were able to read the user manual in English, were given sufficient time to read and understand the instructions and the contents of LUX METER 1. They did not receive additional training, other instruction, assistance or training material other than those. 5)Questionnaire Lay users were given the questionnaires to evaluate their understanding of the LUX METER andinstructions, and satisfaction of them. System Accuracy Evaluation report LUX Chol HDL test Page 1 of 10

2 3. Test date & environmental condition a)test Period: 14th February to 24th March 2014 b)temperature Range: 23.0 to Evaluation Protocol User performance study was performed using 150 participants from 3 sites - 50 participants at each site. Lay user performed his own fingerstick and tested him using LUX METER by himself. And then, healthcare gathered lay user s capillary whole blood by lay user s skin puncture and measured the HDL cholesterol using the same LUX METER. By additional skin puncture within 5 min, healthcare gathered capillary whole blood in the capillary anticoagulant tube. This capillary whole blood was measured by Cobas c111 After test, lay users filled the questionnaires. The questionnaires contained lay user information (sex, age, level of education), evaluation of their understanding of the system and instructions, and satisfaction of them. 4.1 Exclusion criteria a) Pregnancy or lactation period b) Severe acute disease c) Severe chronic disease with potential risk during the study d) Hematocrit value outside the range of 30~50% (based on manufacturer s instructions for use) System Accuracy Evaluation report LUX Chol HDL test Page 2 of 10

3 5.Test results System Accuracy Evaluation report LUX Chol HDL test Page 3 of 10

4 System Accuracy Evaluation report LUX Chol HDL test Page 4 of 10

5 System Accuracy Evaluation report LUX Chol HDL test Page 5 of 10

6 Lay user Lay user System Accuracy Evaluation report LUX Chol HDL test Page 6 of 10

7 Professional Professional System Accuracy Evaluation report LUX Chol HDL test Page 7 of 10

8 Human Factors and Questionnaire System Accuracy Evaluation report LUX Chol HDL test Page 8 of 10

9 System Accuracy Evaluation report LUX Chol HDL test Page 9 of 10

10 6.Conclusion [Acceptance criteria] Ninety-five percent (95%) of the individual HDLuser performance results shall fall within ±10% at HDL concentrations mmol/l ( 10mg/dL). [Result] A fine and direct correlation between Cobas c111 and LUX METER HDL strip for lay user vs professional were confirmed in the 150 blood samples with the correlation coefficient Lay User R2=0.977 and Professional R2= The results indicate that the use of the LUX METER HDL strip generate similar results as the Cobas c111, a laboratory instrument used in hospitals to test for HDL concentration. The data shown indicates that the results are within acceptance criteria. RESULT: Passed User Performance Evaluation Regression analysis results are summarized below: Arezzo, 24 th March 2014 BIOCHEMICAL SYSTEMS INTERNATIONAL SRL Dr.ssa Annalisa Imbriani QC Manager System Accuracy Evaluation report LUX Chol HDL test Page 10 of 10