Equivalent Accuracy Evaluation of FORA Premium V10 Blood Glucose Monitoring System as Compared to Fora V30 Blood Glucose Monitoring System

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1 Equivalent Accuracy Evaluation of FORA Premium V10 Blood Glucose Monitoring System as Compared to Fora V30 Blood Glucose Monitoring System

2 Abstract Objective: Both Fora Premium V10 and V30 blood glucose monitoring systems (BGMS) have very similar functions and share the same test strips. Since a full accuracy study was completed with Fora V30 according to the international standard ISO 15197: 2003 and more recent ISO 15197: 2013 guidelines, the goal of this study was to evaluate the accuracy equivalence between Fora Premium V10 and Fora V30. Methods: The study was conducted on 29 subjects comprised of 16 patients with type1 diabetes and 11 patients with type 2 diabetes and 2 with diabetes undefined. The capillary blood specimens were collected via fingertip stick from participants at AMCRI Institute (700 West El Norte Parkway, Suite 201, Escondido, CA 92026). The samples were tested with Fora V30 and Fora Premium V10 BGMS at the same time on 3 different lots of strips. The accuracy of Fora Premium V10 was determined as compared to the Fora V30 as the reference standard a. Results: The accuracy trend for Fora Premium V10 is very similar to Fora V30, therefore this BGMS is compliant with the requirements of DIN EN ISO 15197:2003 with all 3 reagent system lot(s). & ± 5 % (Within ± 0.28 mmol/l & ± 5 %) & ± 10 % & ± 10 %) & ± 15 % & ± 15 %) & ± 20 % (Within ± 0.83 mmol/l & ± 20 %) 40 / 58 (69.0 %) 53 / 58 (91.4 %) 56 / 58 (96.6 %) 58 / 58 (100 %) 39 / 58 (67.2 %) 52 / 58 (89.7 %) 55 / 58 (94.8 %) 58 / 58 (100 %) 34 / 58 (58.6 %) 49 / 58 (84.5 %) 53 / 58 (91.4 %) 58 / 58 (100 %) The Fora Premium V10 BGMS also showed trends similar to Fora V30 based on the requirements of ISO 15197:2013 from all three lots of test strips tested. & ± 5 % (Within ± 0.28 mmol/l & ± 5 %) & ± 10 % & ± 10 %) & ± 15 % (Within ± 0.83 mmol/l & ± 15 %) 42 / 58 (72.4 %) 54 / 58 (93.1 %) 58 / 58 (100 %) 40 / 58 (69.0 %) 54 / 58 (93.1 %) 57 / 58 (98.3 %) 35 / 58 (60.3 %) 51 / 58 (87.9 %) 56 / 58 (96.6 %) Conclusion: The study suggested that the Fora Premium V10 blood glucose monitoring system showed a very similar trend to Fora V30 BGMS. Since Fora V30 met both ISO15197:2003 and the newer 2013 guideline (ISO15197:2013), our results demonstrated that Fora Premium V10 also met both ISO15197:2003 and ISO15197:2013 guidelines. 2

3 1. Introduction This study was to evaluate the system accuracy following ISO 15197:2003 c protocol and, the newly published ISO 19197:2013 d guideline. EN ISO 15197:2003 is an international standard published by International Standard Origination (ISO) specifying requirements for in vitro glucose monitoring systems on self-testing in managing diabetes mellitus. The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: Ninety-five percent (95 %) of the individual glucose results shall fall within ± 15 mg/dl (± 0.83 mmol/l) of the results of the reference measurement at glucose concentrations < 75 mg/dl (< 4.2 mmol/l) and within ± 20 % at glucose concentrations 75 mg/dl ( 4.2 mmol/l). In 2013, ISO published a newer standard ISO 15197:2013 (E) which tighten the accuracy acceptance criteria. The minimum acceptable accuracy for results produced by a glucose monitoring system changed to the followings: Ninety-five percent (95 %) of the individual glucose results shall fall within ± 15 mg/dl (± 0.83 mmol/l) of the results of the reference measurement at glucose concentrations < 100 mg/dl (< 5.55 mmol/l) and within ± 15 % at glucose concentrations 100 mg/dl ( 5.55 mmol/l). Comparison between 2 ISO standards: EN ISO 15197: 2003 ISO 15197: 2013 (E) Maximum deviation from glucose reference value At glucose levels < 75 mg/dl (< 4.2 mmol/l) At glucose levels 75 mg/dl ( 4.2 mmol/l) ± 15mg/dl (0.83 mmol/l) ± 20% At glucose levels < 100 mg/dl (< 5.5 mmol/l) At glucose levels 100 mg/dl ( 4.2 mmol/l) ± 15mg/dl (0.83 mmol/l) ± 15% 2. Material and Methods 2.1 Reference standard The reference used in this study was to compare to Fora V30 BGMS. 2.2 Preparation of Samples Samples were assigned to the respective glucose concentration category following the Fora V30 measurements. Concentration category Glucose concentration [mg/dl (mmol/l)] Number of test subjects 1 > (> ) 6 2 > (> ) 4 3 > (> ) 6 4 > (> ) 6 5 > (> ) 4 6 > 400 (> 22.20) 3 3

4 2.3 Test of Blood Glucose Sample capillary blood was obtained by a finger stick using a 25G safety lancet. The blood sample was immediately collected onto a Lithium-Heparin Microvette (~ 200 µl) The capillary blood was then placed on a parafilm and tested on Fora Premium V10 blood glucose monitoring systems and Fora V30 blood glucose monitoring systems (2 devices per station with test strip lot 1, 2, and 3). Each test strip lot was tested twice (duplicates) from the same capillary sample. 2.4 Statistical analysis In this study, the following statistical analyses were performed: Bias analysis according to Bland and Altman 5. Regression analysis according to Passing and Bablok Results 3.1 Test subjects Total of 38 test subjects were enrolled in the study. Among them, only 29 test subjects were included in this study. Nine test subjects were excluded because of the following reasons. FORA Premium V10 Reagent system lot total test subjects Number of subjects rejected Based on ISO 15197: 2013 (E) criteria The change between first (before the measurement procedure) and second (after the measurement procedure) comparison measurement result is > 4 % at glucose concentrations > 100 mg/dl or > 4 mg/dl at glucose concentrations 100 mg/dl (acceptance criterion for sample stability) Additional exclusion criteria based on Fora protocol HCT is high than 50% or below 35% Others Sample 85, 95, 96, 100 was removed because it only had enough blood be tested on Fora V30 or could not complete the duplicated testing on Premium V

5 The detail test log FORA Premium V10 Reagent system lot Number of included samples Test results Glucose concentration range (YSI 2300 STAT Plus TM glucose analyzer) minimum maximum [mg/dl] Hematocrit range [%] Age [years] Type 1 / Type 2 / NA 16 / 11 / 2 16 / 11 / 2 16 / 11 / 2 Gender [male / female / unknown] 9 / 14 / 6 9 / 14 / 6 9 / 14 / 6 Temperature [ ] (during the test) Humidity [%] (during the test) Accuracy results following ISO 15197:2003 Summary: Within Consensus Error Grid zones A and B 174 / 174 (100 %) Conclusion: Fora Premium V10 BGMS is in compliance with the requirements of DIN EN ISO 15197:2003 for all 3 reagent system lot(s). Detail results: n System accuracy results for glucose concentrations < 75 mg/dl (4.2 mmol/l) (Within ± 0.28 mmol/l) ) (Within ± 0.83 mmol/l) 7 / 11 (63.6 %) 9 / 11 (81.8 %) 11 / 11 (100 %) 6 / 11 (54.6 %) 9 / 11 (81.8 %) 11 / 11 (100 %) 5 / 10 (50.0 %) 7 / 10 (70.0 %) 10 / 10 (100 %) 5

6 n System accuracy results for glucose concentrations 75 mg/dl (4.2 mmol/l) Within ± 5 % Within ± 10 % Within ± 15 % Within ± 20 % 33 / 47 (70.2 %) 44 / 47 (93.6 %) 47 / 47 (100 %) 47 / 47 (100 %) 33 / 47 (70.2 %) 43 / 47 (91.5 %) 46 / 47 (97.9 %) 47 / 47 (100 %) 29 / 48 (60.4 %) 42 / 48 (87.5 %) 46 / 48 (95.8 %) 47 / 47 (100 %) n System accuracy results for glucose concentrations between 37 mg/dl (2.06 mmol/l) and 547 mg/dl (30.4 mmol/l) & ± 5 % (Within ± 0.28 mmol/l & ± 5 %) & ± 10 % & ± 10 %) & ± 15 % & ± 15 %) & ± 20 % (Within ± 0.83 mmol/l & ± 20 %) 40 / 58 (69.0 %) 53 / 58 (91.4 %) 56 / 58 (96.6 %) 58 / 58 (100 %) 39 / 58 (67.2 %) 52 / 58 (89.7 %) 55 / 58 (94.8 %) 58 / 58 (100 %) 34 / 58 (58.6 %) 49 / 58 (84.5 %) 53 / 58 (91.4 %) 58 / 58 (100 %) Accuracy results following ISO 15197:2013 (E) Summary: Within Consensus Error Grid zones A and B 172 / 174 (98.9 %) Conclusion: The Fora Premium V10 BGMS met the requirements of new ISO standard (ISO 15197:2013)Detail results: n System accuracy results for glucose concentrations < 100 mg/dl (5.55 mmol/l) (Within ± 0.28 mmol/l) ) (Within ± 0.83 mmol/l) 12 / 17 (70.6 %) 16 / 17 (94.1 %) 17 / 17 (100 %) 10 / 16 (62.5 %) 15 / 16 (93.8 %) 16 / 16 (100 %) 10 / 18 (55.6 %) 17 / 18 (94.4 %) 18 / 18 (100 %) 6

7 n System accuracy results for glucose concentrations 100 mg/dl (5.55 mmol/l) Within ± 5 % Within ± 10 % Within ± 15 % 30 / 41 (73.2 %) 38 / 41 (92.7 %) 41 / 41 (100 %) 30 / 42 (71.4 %) 39 / 42 (92.9 %) 41 / 42 (97.6 %) 25 / 40 (62.5 %) 34 / 40 (85.0 %) 38 / 40 (95.0 %) n System accuracy results for glucose concentrations between 37 mg/dl (2.06 mmol/l) and 547 mg/dl (30.4 mmol/l) Reagent system lot & ± 5 % (Within ± 0.28 mmol/l & ± 5 %) & ± 10 % & ± 10 %) & ± 15 % (Within ± 0.83 mmol/l & ± 15 %) TD14E123-C0G 42 / 58 (72.4 %) 54 / 58 (93.1 %) 58 / 58 (100 %) TD14E823-C0G 40 / 58 (69.0 %) 54 / 58 (93.1 %) 57 / 58 (98.3 %) TD14E923-C0G 35 / 58 (60.3 %) 51 / 58 (87.9 %) 56 / 58 (96.6 %) 7

8 Consensus Error Grid for FORA Premium V10 with three reagent system lots as compared to Fora V30 Region Number Percent A % B % C % D % E

9 Summary of regression analysis (Passing and Bablok) n=58 Regression Reagent system lot 1: TD14D228-C0E Reagent system lot 2: TD14 D828-C0E Reagent system lot 3: TD14 D928-C0E Y= X Y= X Y= X 9

10 3.2.3 Absolute differences between FORA Premium V10 and FORA V30

11 4. Conclusion and discussion: This study showed that the Fora Premium V10 blood glucose monitoring system values correlated with the values measured by the Fora V30 with minimal bias. In addition, 99% of the data points fall within Zone A & B of Consensus Error Grid, which means that when a user obtains a value using a Fora Premium V10 monitor, it should not result in a clinical decision that could be deemed differently from using a Fora V30. Although only a small number of patients were tested, the glucose concentration categories had given, a sample representation of the full ISO protocol. The results also demonstrated that the Fora Premium V10 not only met the current accuracy standard (ISO15197:2003), but also exceeded the minimum acceptable accuracy standard published in the newer 2013 guideline (ISO15197:2013). Reference a. System Accuracy Evaluation System accuracy evaluation of FORA V30 Blood Glucose Monitoring System versus YSI 2300 STAT Plus glucose analyzer following ISO 15197:2003 and Report#Fora R-V30. b International Diabetes Federation, the global burden. c. In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. EN ISO 15197:2003. d. In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2013. e. Parkes JL, Slatin SL, Pardo S, Ginsberg BH: A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care 2000; 23: f. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 1: g. Passing H, Bablok. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983; 21: