3. System Accuracy Evaluation LUX Hgb test 1. Samples

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1 3. System Accuracy Evaluation LUX Hgb test 1. Samples - Type of sample: Capillary Blood System accuracy evaluation was performed with 200 fresh capillary blood samples, each with sufficient volume to be measured by two different meters and by Hemocue. Exclusion criteria, such as packed cell volume (hematocrit), were based on the manufacturer s instructions for use. Capillary blood samples were collected by auto-disabling lancing devices prepared and processed according to the instructions for use, including sample pretreatment if required. Sample containers designed for the collection of capillary blood was used. It is difficult to obtain a sufficient number of fresh capillary blood samples with very low and very high Hemoglobin concentrations. In these cases, modified capillary blood samples in which the Hemoglobin concentration is elevated or lowered was substituted (see below Table 2.) The Hemoglobin concentrations were distributed as specified in Table 1. Once a concentration category is filled, no more samples were added to that category. Table.1 Hemoglobin concentrations of samples for system accuracy evaluation Percentage of samples (%) Hemoglobin concentration g/dl (mmol/l) to 10.9 (0.78 to 1.69) to 14.0 (1.71 to 2.17) to 18.0 (2.19 to 2.79) to 21.0 (2.81 to 3.26) to 25.0 (3.27 to 3.88) Only unaltered capillary blood samples were used for Hemoglobin concentrations of 5 g/dl to 25 g/dl (0.78 mmol/l to 3.88 mmol/l). In order to obtain sufficient samples in the lowest and highest concentration intervals, Hemoglobin concentrations were adjusted as follows. - To obtain additional samples with Hemoglobin < 5 g/dl (< 0.78 mmol/l), capillary blood samples was collected with K 2EDTA anti-coagulant tube and incubated to allow Hemoglobin to hydrolyse. The incubation conditions (Temperature: 23~24, Humidity: 40~50 RH%) to produce sample compatible System Accuracy Evaluation report LUX Hemoglobin Test Page 1 of 9

2 with the system without hemolytic was determined by the manufacturer. - To obtain additional samples with Hemoglobin > 25 g/dl (> 3.88 mmol/dl), capillary blood samples was collected with K 2EDTA anti-coagulant tube and then supplemented with Hemoglobin. Table.2 Number of samples Hemoglobin concentration Number of samples Percentage of samples (%) g/dl (mmol/l) 5.0 to 10.9 (0.78 to 1.69) to 14.0 (1.71 to 2.17) to 18.0 (2.19 to 2.79) to 21.0 (2.81 to 3.26) to 25.0 (3.27 to 3.88) 0 0 Total Strip & Meter 1) Lots of hemoglobin test strips Site # Strip lot number Quantity 1 H strips from 40 vials 2 H strips from 40 vials 2) LUX METER Site #1 Site #2 meter # serial number meter # serial number 1 L L L L ) Instructions for use Two healthcare professionals were given instructions for use of LUX METER for the subject s skin puncture. 3. Test Date and Environmental condition 1) Test period: from 14 th February 2014 to 24 th March ) Temperature Range: 23.0 C to 23.9 C System Accuracy Evaluation report LUX Hemoglobin Test Page 2 of 9

3 4. Evaluation Protocol The following procedure is the minimum experimental design to evaluate system accuracy. It requires at least 100 subjects with Hemoglobin concentrations that span the measuring interval as specified in Table 1. The procedure may be modified to accommodate multiple reagent lots. The reagent system units shall be taken from the same vial/package for each sample. Steps a) to f) shall be performed for each sample. a) Assign numbers to the vials or packages (e.g. 1 to 10). b) Obtain a sample of fresh capillary blood b skin puncture. c) Remove an aliquot of the sample for at least duplicate hemoglobin measurements by the manufacturer s measurement procedure. If the measurement s procedure is designed for plasma samples, the plasma preparation procedure (e.g. centrifugation at 1000g for 10 min to remove cells) shall be performed for each sample. d) Take two reagent system units out of vial/package number one and measure the hemoglobin concentration in the sample using two different meters. Change vials or packages every ten subjects and ensure that reagent system units from all vials are used in the evaluation. Record the results. e) Repeat step c) to obtain a second from the manufacturer s measurement procedure. f) Evaluate the results from the manufacturer s measurement procedure to verify sample stability. If these results demonstrate the effect of drift based on predetermined stability criteria [e.g. change between the first and last results > 4% at hemoglobin > 0.78 mmol/l (5 g/dl), then the results for that subject shall not be included. The rejected sample shall be replaced with another sample in the same concentration interval. g) Obtain a sample from the next subject and repeat steps b) to f). 5. Minimum Acceptable System Accuracy 5.1 System accuracy requirement The minimum acceptable accuracy for results produced by a Hemoglobin monitoring system shall be as follows. Ninety-five percent (95%) of the individual hemoglobin results shall fall within ±10% at hemoglobin concentrations 0.78 mmol/l ( 5 g/dl). System Accuracy Evaluation report LUX Hemoglobin Test Page 3 of 9

4 5.2 Data presentation Results are presented hemoglobin concentration 0.78 mmol/l ( 5 g/dl), results shall be expressed as the percentage of values falling within the following intervals: ±10% 6. Test results System Accuracy Evaluation report LUX Hemoglobin Test Page 4 of 9

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9 7. Conclusion Ninety-five percent (95%) of the individual hemoglobin results shall fall within ±10% at hemoglobin concentrations 0.78 mmol/l ( 5 g/dl). [Result] A fine and direct correlation between Cobas c111 and LUX hemoglobin strips was confirmed in the 200 blood samples with the correlation coefficient R 2 = The results indicate that the use of the LUX hemoglobin strip generate similar results as the Cobas c111, a laboratory instrument used in hospitals to test for hemoglobin concentration. The data shown indicates that the results are within acceptance criteria. RESULT: Passed System Accuracy Evaluation Regression analysis results for hemoglobin concentration: Linear regression R2 N Sample range [mg/dl] Y=0.9845X to 19.3 System accuracy results hemoglobin concentration Within ± 5% Within ± 10% 200/200 (100%) 200/200 (100%) Arezzo, 24 th March 2014 BIOCHEMICAL SYSTEMS INTERNATIONAL SRL Dr.ssa Annalisa Imbriani QC Manager System Accuracy Evaluation report LUX Hemoglobin Test Page 9 of 9