Перевод с русского языка на английский Translated from Russian into English <Seal of Biopromin Limited Liability Company> Approved by Director of BIOPROMIN LTD <Signature> Sydora Volodymyr L. Report on clinical studies of the medical device “Automatic Noninvasive Express Screening Analyzer ANESA” Technical Specifications of Ukraine ТУ У 33.1-22716816-001:2006 Code of Standard Industrial Classification of Economic Activities (HS code) 9018 19 90 00 manufactured by “Biopromin” Ltd. Title of the clinical studies: “Monitoring of the device ANESA and software USPIH functioning. Improving of working protocol.” Clinical study was carried out according to National Standards of Ukraine DSTU 4659-2:2006 (ISO 14155-2:2003) Carried out in cooperation with: The Institute of neurology, Psychiatry and Narcology of AMS of Ukraine (Kharkiv, Ukraine) Regional Clinical Psychiatry Hospital No.3, Section 8 (Kharkiv, Ukraine) “Alfa Labservice” LTD (Kharkiv, Ukraine) Description of model: “Automatic Noninvasive Express Screening Analyzer ANESA” Technical Specifications of Ukraine ТУ У 33.1-22716816-001:2006 HS code 9018 19 90 00 Serial number of medical device: 38001515 Software version: USPIH 10.0 Kharkiv, 21-05-2013
Transcript
Перевод с русского языка на английский Translated from Russian into English
Technical Specifications of Ukraine ТУ У 33.1-22716816-001:2006
HS code 9018 19 90 00
Serial number of medical device: 38001515
Software version: USPIH 10.0
Kharkiv, 21-05-2013
LIST OF EXECUTORS
Executor
Name and Surname
Head of clinical tests
Malykhin Anatolii V., PhD
Academician of Russian Academy of
Natural Sciences
Leading scientist of the Institute of neurology, Psychiatry and Narcology
of AMS of Ukraine
Responsible executor Malykhin Anatolii, PhD
Researcher
Kucherenko Petro A., MD “Biopromin” LTD
Researcher
Kryvenko Sergii, PhD Leading engineer of “Biopromin”
LTD
TABLES OF CONTENTS
SUMMARY ................................................................................................................................... 4 INTRODUCTION ......................................................................................................................... 5 PURPOSE OF STUDY ................................................................................................................ 6 OBJECTIVES OF STUDY ........................................................................................................... 6 MATERIALS AND METHODS OF STUDY ............................................................................. 6 RESULTS OF STUDY .............................................................................................................. 10 CONCLUSIONS ......................................................................................................................... 19 REFERENCES ............................................................................................................................ 20
SUMMARY Materials on clinical study of the medical device “Automatic Noninvasive Express Screening Analyzer ANESA”, manufactured by “Biopromin” Ltd. (Ukraine) are provided. It is designed to collect data of a patient's clinical blood analysis values (hemoglobin, glucose, aspartate aminotransferase (AST), alanine aminotransferase (ALT), amylase, total protein, total bilirubin, direct bilirubin, ceruloplasmin, hematocrit, creatinine, leucocytes, lymphocyte, urea, monocytes, erythrocyte sedimentation rate (ESR), differential count – band neutrophils) without invasive blood drawing followed by data processing with “USPIH 10” software. Clinical study of volunteers was carried out by comparative analysis with using certified hematology analyzers and commonly accepted methods of laboratory examinations. Study results were processed by statistical methods. This study allowed determining that the test medical device ensures the necessary reproducibility with 95% of confidence interval. Parallel control by the standard (common) laboratory methods is recommended. The report contains 32 pages, 3 tables. Bibliography: 10 sources. Purposes of clinical studies
1. Comparative assessment of clinical blood analysis accuracy determined by the medical device by reference to the results obtained from laboratories.
2. Statistical processing of received data for objective comparative assessment of the device “Automatic Noninvasive Express Screening Analyzer ANESA”.
3. Detection of unexpected adverse reactions, risks and undesirable effect on a human. 4. Assessment of safety of the device “Automatic Noninvasive Express Screening Analyzer
ANESA” during usage, based on the subjective sensations of volunteers.
Inclusion criteria for study subjects:
Inclusion criteria: 1) Age: 18-80. 2) Body weight: 40-110 kg. 3) State of health: patients with alcohol abuse, neurological pathology, without allergic diseases 4) Ethnic status: irrelevant. 5) Gender: both. 6) Patient’s mental status: within normal. 7) Organ to be contacted: 5 areas on a body: cervical, axillary and abdominal artery bifurcation.
Commencement date of study: January 10, 2013 Completion date of study: May 20, 2013
INTRODUCTION
In 2008, the main concept of activity of the World Health Organization (WHO) was primary care patients. The objective methods of patient examination, first of all blood analysis, are the base for diagnosing of diseases. Inflammatory and allergic processes, hematologic diseases, are the initial things for the subsequent comprehensive patient examination and identification of a disease without clinical manifestations. Blood analysis plays a leading role among the various comprehensive diagnostic methods. Correct and early diagnosing, reasonable treatment, true prognosis of a disease development are often impossible without morphological and biochemical blood analysis data. Blood picture analysis in the course of a disease allows judging of the process severity, patient status improvement or deterioration. Clinical blood analysis is of extremely great importance. General clinical blood analysis contains the results of examination of different parameters (including hemoglobin and glucose), influencing to a human life. “Automatic Noninvasive Express Screening Analyzer ANESA” Technical Specifications of Ukraine ТУ У 33.1-22716816-001:2006, HS code 9018 19 90 00 manufactured by “Biopromin” Ltd. is a device that allows measuring temperature on the “reference” biologically active points on a human body, and then determining (calculating) the values of the clinical and biochemical blood analysis, which is used for diagnostics of diseases in medical practice.
MAIN PURPOSE OF STUDY The purpose of post-clinical study is to test capability of the medical device “Automatic Noninvasive Express Screening Analyzer ANESA”, manufactured by “Biopromin” Ltd. (Ukraine) to determine the values of clinical and biochemical blood analysis automatically by results of temperature measurement on the “reference” points on a human body, without blood drawing and skin damage, as well as to assess safety of this device and detect the unforeseen side effects while in operation.
OBJECTIVES OF STUDY Clinical examination of the peripheral blood values using the “Automatic Noninvasive Express Screening Analyzer ANESA”, are carried out with the assistance of the Institute of neurology, Psychiatry and Narcology of AMS of Ukraine (Kharkiv, Ukraine), Regional Clinical Psychiatry Hospital No.3, Section 8 (Kharkiv, Ukraine) and “Alfa Labservice” LTD on 116 volunteers with the following diseases: Konovalov-Wilson’s disease, drug addiction, alcoholism and endogenous depression, for the following:
• Comparative analysis of the peripheral blood values examination data using certified analyzers and commonly accepted methods of laboratory examinations.
• Detection of unexpected adverse reactions, risks and undesirable effect • Assessment of compliance of the clinical studies with the program developed
MATERIALS AND METHODS OF STUDY 1. Measurement conditions:
a. – room air temperature is not more than +27ºС or not less than +20°С; b. – room air humidity is not more than 80%, when the temperature is 25ºС; c. – no aggressive agents are kept in a room; d. – no excessive dust in a room; e. – no long-term exposure of direct sunlight and conditioned air flow; f. – no exposure of strong electric and magnetic fields; g. – atmosphere pressure should be in the bonds of 82 - 101.38 kPa.
2. Requirements to the study subjects.
Before measurement procedure the following shall be observed:
– ordinary dietary regime for at least three days (carbohydrates content > 125-150 g a day) and habitual physical exercises for the patients shall be followed; – fasting test upon restraint from food during one night for 10-14 hours (smoking and alcohol use is prohibited); – lying position or stepped-lying position for a patient while drawing blood, no smoking, low temperature and physical exercises; – test is recommended upon or under stressed conditions; – no treatment procedures and drug administration (adrenaline, glucocorticoids, contraceptives, caffeine, thiazide diuretics, psychotropics and antidepressants, and other medical agents affecting hematic picture) before test;
3. Measurement procedure. Microprocessor sensors of the medical device “Automatic Noninvasive Express Screening Analyzer ANESA”, were applied on certain “reference” biologically active points on a human body surface (after pre-treatment of skin and sensors with 96% ethyl alcohol for degreasing):
- blue sensor – on bifurcation of the left carotid artery in the annular cartilage region; - green sensor – on bifurcation of the right carotid artery in the annular cartilage region; - yellow sensor – on the left axillary crease (thermometer position); - violet sensor – on the right axillary crease (thermometer position); - red sensor – on the abdominal area (inside the umbilical crease, if no umbilicus, on the area
where it was positioned before surgery). The measurement procedure, depending on the rate of human body temperature stabilization, took 180-720 seconds.
Values to be measured
While testing the medical device “Automatic Noninvasive Express Screening Analyzer ANESA”, the following parameters were determined:
The results were analyzed with reference to the data obtained within measurement of the same venous blood parameters using the certified hematology analyzer and commonly accepted methods of laboratory tests in the above-mentioned laboratories. Venous blood was examined using the certified hematology analyzer, by venipuncture of the median cubital vein into the test tubes of Venosafe VF-053 SDK with EDTA. The composition of peripheral blood was determined using the certified analyzers according to the operating manual. Study results were delivered next day after blood drawing and measurement using a noninvasive hemogram analyzer.
The criteria for inclusion of volunteers into the study were: 1. Absence of allergic diseases. 2. Consent of a volunteer to take part in the study. Volunteers were excluded from the study in case of: 1. Existence of allergic diseases. 2. Volunteers take medications, which may affect to the blood parameters. 3. A volunteer refuses to take part in the research.
Variables to be measured In accordance with the National Standards of Ukraine, GOST ISO 5725 it is required to determine that the test medical device “Automatic Noninvasive Express Screening Analyzer ANESA”, ensures necessary repeatability with the confidence interval of 95%. In this regard the study results were compared and analyzed as well as statistically processed.
Study subjects This study was carried out during the period from January 01, 2013 till May 20, 2013. The number of results is different fir different parameters. Thus the studied amount of people was 91 patients for examination of ALT, 88 patients – amylase, 94 patients – AST, 103 patients – total protein, 99 patients – total bilirubin and direct bilirubin, 6 patients – ceruloplasmin, 116 patients – hemoglobin, 36 patients – glucose, 9 patients – hematocrit, 113 patients – leukocytes, lymphocytes, monocytes, band neutrophils and ESR, 101 patients – urea. The patients were not grouped for the research by their pathology. The results of tests, made on certified hematology analyzer were considered as standard, with satisfied accuracy, certified and acceptable by the WHO (hereinafter standard method). The results of test, made on “Automatic Noninvasive Express Screening Analyzer ANESA”, were considered as the method, which should be approved (hereinafter new method).
Analytical procedures
These results were statistically processed in accordance with the relevant standards:
• National Standards of Ukraine 3514-97. Statistical methods of control and regulation. Terms and definitions. K.: Gosstandart of Ukraine. 1997. p. 52. • National Standards of Ukraine, GOST ISO 5725-1:2005 Validity (accuracy and precision) of measurement methods and results. Part 1. General principles and definitions (GOST ISO 5725-1-2003, IDT). • National Standards of Ukraine, GOST ISO 5725-2:2005 Validity (accuracy and precision) of measurement methods and results. Part 2. Basic method to determine repeatability and reproducibility of the standard measurement method (GOST ISO 5725-2-2003, IDT) • National Standards of Ukraine, GOST ISO 5725-3:2005 Validity (accuracy and precision) of measurement methods and results. Part 3. Intermediate values of the standard measurement method precision (GOST ISO 5725-3-2003, IDT) • National Standards of Ukraine, GOST ISO 5725-4:2005 Validity (accuracy and precision) of measurement methods and results. Part 4. Basic method to determine standard measurement method accuracy (GOST ISO 5725-4-2003, IDT) • National Standards of Ukraine, GOST ISO 5725-5:2005 Validity (accuracy and precision) of measurement methods and results. Part 5. Alternative methods to determine standard measurement method precision (GOST ISO 5725-5-2003, IDT) • National Standards of Ukraine, GOST ISO 5725-6:2005 Validity (accuracy and precision) of measurement methods and results. Part 6. Use of accuracy values in practice (GOST ISO 5725-6-2003, IDT)
Statistical analysis methods
Statistical processing of results:
1) Determination of average value of each parameter and standard deviation (SD).
2) Calculation of correlation factor between values of each hematologic parameter measured by the standard method and new method. Determination of statistical significance of correlation factor: hypothesis formulation of parameter measurement independence by the standard and new methods (НО: р = 0) and validation of this hypothesis. In the event that it is accepted, these results were deemed to be independent of one another and correlation between them was deemed to be statistically insignificant. In the event that it is rejected, these results were deemed to be dependent of one another and correlation between them was deemed to be statistically significant.
3) Interval estimate for each hematologic parameter and determination of parameter interval
overlap percent measured by the new and standard methods.
4) Hypothesis formulation of the same accuracy of the standard and new methods (НО: σ12 = σ2
2) and validation of this hypothesis. Further, hypothesis is formed with regard to possibility of correlation between measurements results obtained by the standard and new methods (НО: µ1
2 = µ2
2). At that, the standard method was deemed to be satisfactory and results obtained by this method were deemed to be accepted in medical practice, i.e., reference ones for new method. As a result of this analysis, decisions with regard to compliance of new method with the requirements of medical practice.
PATIENT EXAMINATION DESIGN
FUNCTIONAL AND ANTHROPOMETRIC MEASUREMENTS
Test Age Weight Heart rate, bpm Respiration rate, rpm
DATA OF AN EXAMINATION
Comparison between ANESA and laboratory results (units)
Patient’s ID
ANESA Lab Difference
List of detection of unexpected adverse reactions, risks and undesirable effect on a human
Date Type of unexpected reactions
Degree of severity Measures
RESULTS OF STUDY
Tables 1 and 2 provide anthropometric and physiological characteristics of volunteers as well as results of examination by each parameter, obtained by the different methods: standard and new.
Table 1
Anthropometric and physiological characteristics of volunteers
The study included males and females, normosthenic type, respiratory rate was within
physiological normal.
Comparative analysis of study results
The results of examination for each tested parameter, received from “Automatic Noninvasive Express Screening Analyzer ANESA” and from laboratory (using certified hematology analyzers and commonly accepted methods of laboratory examinations), as well as the differences between the data, which were received by two different methods, were generated by the template of the table 2:
Table 2. Comparative analysis of results by a parameter
(made on 16 pages)
Comparative analysis of results by a parameter (units) ID of a patient ANESA Lab Differences between the
results
Comparative analysis of results by the
parameter ceruloplasmin (g/l)
Comparative analysis of results by the
parameter haematocrit (%)
Parameter Number of subjects/patients
Average age, years
Average body weight, kg,
Average heart rate, bm
ALT 91 37,92±0,51 79,29±0,71 93,52±0,58 AST 94 37,77±0,49 79,01±0,68 92,74±0,58 Amylase 88 35,72±0,47 79,75±0,74 92,64±0,58 Total protein 103 37,07±0,46 77,64±0,62 92,27±0,56 Total bilirubin, Direct bilirubin
Comparative analysis of results by the parameter haemoglobin (g/l):
Comparative analysis of results by the parameter glucose (mmol/l)
Comparative analysis of results by the parameter AST (mmol/l)
Comparative analysis of results by the parameter ALT (mmol/l)
Comparative analysis of results by the parameter amylase (g/l*h)
Comparative analysis of results by the parameter amylase (g/l)
Comparative analysis of results by the parameter total bilirubin (mkmol/l)
Comparative analysis of results by the parameter direct bilirubin (mkmol/l)
Comparative analysis of results by the parameter creatinine (mkmol/l)
Comparative analysis of results by the parameter leukocytes (x10E9/l)
Comparative analysis of results by the parameter lymphocytes (%)
Comparative analysis of results by the parameter urea (mmol/l)
Comparative analysis of results by the parameter monocytes (%)
Comparative analysis of results by the parameter ESR (mm/h)
Statistical Analysis The received results were processed statistically in order to make the objective comparative assessment of the new method and standard one, using in medical practice (Table 3).
Table 3. Results of statistical processing of each parameter
Parameter
ANESA (n=91)
Lab (n=91)
ALT, MMOL/L Average value
SD Confidence interval
1,51 0,88 1,32÷1,69
1,61 1,04 1,39÷1,83
Zкр Zβ
1,996 0,716
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for ALT count measurement – accepted Parameter
ANESA (n=88)
Lab (n=88)
AMYLASE, g/l*h Average value
SD Confidence interval
25,00 15,51 21,71÷28,28
24,67 16,21 21,23÷28,10
Zкр Zβ
1,996 0,137
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for AMYLASE count measurement – accepted
Parameter
ANESA (n=94)
Lab (n=94)
AST, MMOL/L Average value
SD Confidence interval
0,92 0,48 0,82÷1,02
0,90 0,49 0,80÷1,00
Zкр Zβ
1,996 0,268
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for AST count measurement – accepted Parameter
ANESA (n=103)
Lab (n=103)
TOTAL PROTEIN, MMOL/L Average value
SD Confidence interval
69,84 10,51 67,79÷71,88
68,49 11,99 66,15÷70,82
Zкр Zβ
1,973 0,861
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for TOTAL PROTEIN count measurement – accepted
Table 3 (continued)
Parameter
ANESA (n=99)
Lab (n=99)
TOTAL BILIRUBIN, MMOL/L Average value
SD Confidence interval
20,83 10,25 18,79÷22,87
20,67 10,36 18,60÷22,74
Zкр Zβ
1,996 0,107
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for TOTAL BILIRUBIN count measurement – accepted
Parameter
ANESA (n=99)
Lab (n=99)
DIRECT BILIRUBIN, MMOL/L Average value
SD Confidence interval
5,50 3,16 4,87÷6,13
5,13 3,49 4,44÷5,83
Zкр Zβ
1,996 0,787
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for DIRECT BILIRUBIN count measurement – accepted
Parameter
ANESA (n=6)
Lab (n=6)
CERULOPLASMIN, G/L Average value
SD Confidence interval
41,40 2,75 38,65÷44,15
32,90 16,47 16,45÷49,35
Zкр Zβ
2,447 1,247
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for CERULOPLASMIN count measurement – accepted
Parameter
ANESA (n=116)
Lab (n=116)
HAEMOGLOBIN, G/L Average value
SD Confidence interval
136,84 18,25 133,49÷140,19
136,54 18,08 133,22÷139,86
Zкр Zβ
1,973 0,125
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for HAEMOGLOBIN count measurement – accepted
Table 3 (continued) Parameter
ANESA (n=36)
Lab (n=36)
GLUCOSE, MMOL/L Average value
SD Confidence interval
4,82 0,98 4,49÷5,16
5,06 1,05 4,71÷5,42
Zкр Zβ
2,028 0,986
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for GLUCOSE count measurement – accepted
Parameter
ANESA (n=9)
Lab (n=9)
HAEMATOCRIT, % Average value
SD Confidence interval
40,44 2,75 38,36÷42,52
41,01 3,53 38,35÷43,68
Zкр Zβ
2,262 0,383
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for HAEMATOCRIT count measurement – accepted
Parameter
ANESA (n=91)
Lab (n=91)
CREATININE, MKMOL/L Average value
SD Confidence interval
68,63 11,53 66,23÷71,03
69,23 12,63 66,61÷71,86
Zкр Zβ
1,996 0,338
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for CREATININE count measurement – accepted
Parameter
ANESA (n=113)
Lab (n=113)
LEUKOCYTES, x10E9/L Average value
SD Confidence interval
10,26 6,40 9,07÷11,45
10,26 6,45 9,06÷11,46
Zкр Zβ
1,973 0,009
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for LEUKOCYTES count measurement – accepted
Table 3 (continued) Parameter
ANESA (n=113)
Lab (n=113)
LYMPHOCYTES, % Average value
SD Confidence interval
18,95 8,25 17,42÷20,49
18,47 8,07 16,97÷19,97
Zкр Zβ
1,973 0,444
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for LYMPHOCYTES count measurement – accepted
Parameter
ANESA (n=101)
Lab (n=101)
UREA, MMOL/L Average value
SD Confidence interval
5,38 1,21 5,14÷5,62
5,18 1,37 4,91÷5,44
Zкр Zβ
1,973 1,111
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for UREA count measurement – accepted
Parameter
ANESA (n=113)
Lab (n=113)
MONOCYTES, % Average value
SD Confidence interval
7,84 2,69 7,34÷8,34
6,87 2,35 6,43÷7,31
Zкр Zβ
1,973 2,886
Zβ> Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for MONOCYTES count measurement – not accepted
Parameter
ANESA (n=113)
Lab (n=113)
BAND NEUTROPHILS, % Average value
SD Confidence interval
6,46 4,92 5,55÷7,38
5,76 5,71 4,70÷6,82
Zкр Zβ
1,973 0,991
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for BAND NEUTROPHILS count measurement – accepted
Table 3 (continued) Parameter
ANESA (n=113)
Lab (n=113)
ESR, mm/h Average value
SD Confidence interval
20,74 17,69 17,45÷24,04
19,41 19,63 15,75÷23,06
Zкр Zβ
1,973 0,538
Zβ< Zкр accepted
Hypothesis of the same accuracy of the standard and new methods for ESR count measurement – accepted
Average level of ALT in volunteers measuring by the standard method totaled 1.61 ± 1.04 mmol/l, and by a new method totaled 1.51 ± 0.88 mmol/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of ALT is accepted”. Hypothesis acceptance level Zβ (0.716) < Zкp (1.996) is deemed to be sufficient. Average level of amylase in volunteers measuring by the standard method totaled 24.67 ± 16.21 g/l*h, and by a new method totaled 25.00 ± 15.51 mmol/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of amylase is accepted”. Hypothesis acceptance level Zβ (0.137) < Zкp (1.996) is deemed to be sufficient. Average level of AST in volunteers measuring by the standard method totaled 0.90 ± 0.49 mmol/l, and by a new method totaled 0.92± 0.48 mmol/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of AST is accepted”. Hypothesis acceptance level Zβ (0.268) < Zкp (1.996) is deemed to be sufficient. Average level of total protein in volunteers while measuring by the standard method totaled 68.49 ± 11.99 g/l, and by a new method totaled 69.84 ± 10.51 g/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of total protein count is accepted”. Hypothesis acceptance level Zβ (0.861) < Zкp (1.973) is deemed to be sufficient. Average level of total bilirubin in volunteers measuring by the standard method totaled 20.67 ± 10.36 mkmol/l, and by a new method totaled 20.83± 10.25 mkmol/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of total bilirubin is accepted”. Hypothesis acceptance level Zβ (0.787) < Zкp (1.996) is deemed to be sufficient. Average level of direct bilirubin in volunteers measuring by the standard method totaled 5.13 ± 3.49 mkmol/l, and by a new method totaled 5.50± 3.16 mkmol/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of
the standard and new methods for measurement of direct bilirubin is accepted”. Hypothesis acceptance level Zβ (0.107) < Zкp (1.996) is deemed to be sufficient. Average level of ceruloplasmin in volunteers while measuring by the standard method totaled 32.90 ± 16.47 g/l, and by a new method totaled 41.40 ± 2.75 g/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of ceruloplasmin count is accepted”. Hypothesis acceptance level Zβ (1.247) < Zкp (2.447) is deemed to be sufficient. Average level of hemoglobin in volunteers while measuring by the standard method totaled 136.54 ± 18.08 g/l, and by a new method totaled 138.84 ± 18.25 g/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of hemoglobin count is accepted”. Hypothesis acceptance level Zβ (0.125) < Zкp (1.973) is deemed to be sufficient. Average level of glucose in volunteers measuring by the standard method totaled 5.06 ± 1.05 mmol/l, and by a new method totaled 4.82± 0.98 mmol/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of glucose is accepted”. Hypothesis acceptance level Zβ (0.986) < Zкp (2.028) is deemed to be sufficient. Average level of hematocrit in volunteers measuring by the standard method totaled 41.01 ± 3.53 %, and by a new method totaled 40.44± 2.75 %, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of hematocrit is accepted”. Hypothesis acceptance level Zβ (0.383) < Zкp (2.262) is deemed to be sufficient. Average level of creatinine in volunteers measuring by the standard method totaled 69.23 ± 12.63 mkmol/l, and by a new method totaled 68.63± 11.53 mkmol/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of creatinine is accepted”. Hypothesis acceptance level Zβ (0.338) < Zкp (1.996) is deemed to be sufficient. Average level of leukocytes in volunteers measuring by the standard method totaled 10.26 ± 6.45 X10E9/l, and by a new method totaled 10.26± 6.40 X10E9/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of leukocytes is accepted”. Hypothesis acceptance level Zβ (0.009) < Zкp (1.973) is deemed to be sufficient. Average level of lymphocytes in volunteers while measuring by the standard method totaled 18.47 ± 8.07%, and by a new method totaled 18.95 ± 8.25%, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of lymphocyte count is accepted”. Hypothesis acceptance level Zβ (0.444) < Zкp (1.973) is deemed to be sufficient.
Average level of urea in volunteers measuring by the standard method totaled 5.18 ± 1.37 mmol/l, and by a new method totaled 5.38± 1.21 mmol/l, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of glucose is accepted”. Hypothesis acceptance level Zβ (1.111) < Zкp (1.973) is deemed to be sufficient. Average level of monocytes in volunteers while measuring by the standard method totaled 6.87 ± 2.35%, and by a new method totaled 7.84 ± 2.69%, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of monocyte count is not accepted”. Hypothesis acceptance level Zβ (2.886) < Zкp (1.973) is deemed to be sufficient. Average level of band neutrophiles in volunteers while measuring by the standard method totaled 5.76 ± 5.71%, and by a new method totaled 6.46 ± 4.92%, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of band neutrophile count is accepted”. Hypothesis acceptance level Zβ (0.991) < Zкp (1.973) is deemed to be sufficient. Average level of ESR in volunteers while measuring by the standard method totaled 19.41 ± 19.63 mm/h, and by a new method totaled 20.74 ± 17.69 mm/h, that is an uncertain difference (р > 0.05). When testing the hypothesis of equal variances with confidence interval of α = 0.05, the particular indicators of statistics (Zβ) allowed drawing a following conclusion “Hypothesis of the same accuracy of the standard and new methods for measurement of ESR is accepted”. Hypothesis acceptance level Zβ (0.538) < Zкp (1.973) is deemed to be sufficient. Thus, when statistically processing the blood values in volunteers (hemoglobin, AST, ALT, amylase, total protein, total bilirubin, direct bilirubin, ceruloplasmin, hematocrit, creatinine, leukocytes, lymphocytes, urea, ESR and band neutrophils), the hypothesis of the same accuracy of standard hematology analyzer and medical device “Automatic Noninvasive Express Screening Analyzer ANESA”, manufactured by “Biopromin” Ltd. (Ukraine) was accepted. It is recommended to exercise concurrent control of monocyte by the standard (common) laboratory methods.
Assessment of unexpected adverse reactions, risks and undesirable effects
No unexpected adverse reactions, risks and undesirable effects were reported within this study.
Assessment of safety During the study, no adverse effect of the medical device “Automatic Noninvasive Express Screening Analyzer ANESA” on the volunteers’ health was recorded.
CONCLUSIONS
1. Based on the results of comparative analysis of the medical device “Automatic Noninvasive Express Screening Analyzer ANESA”, manufactured by “Biopromin” Ltd. (Ukraine) it was determined that the test medical device ensures necessary repeatability of test blood values (hemoglobin, AST,
ALT, amylase, total protein, total bilirubin, direct bilirubin, ceruloplasmin, hematocrit, creatinine, leukocytes, lymphocytes, urea, ESR and band neutrophils) with the confidence interval of 95% during studies in volunteer in the neurological and alcoholic patient groups. At the same time, it was determined that the test medical device doesn’t ensure necessary repeatability of monocytes values with the confidence interval of 95% .
2. Taking into account a sufficiently restricted statistical sampling, it is recommended to use the
following medical device “Automatic Noninvasive Express Screening Analyzer ANESA”, manufactured by “Biopromin” Ltd. (Ukraine) for needs of medical practice in line with the generally accepted methods of blood analyses.
3. As far as no unexpected adverse reactions, risks and undesirable effect on human were reported, it
can be concluded that operation of the device both for a patient and an operator providing observance of the operating manual is deemed to be safe.
4. Study results show no adverse effect of the medical device ““Automatic Noninvasive Express
Screening Analyzer ANESA”, manufactured by “Biopromin” Ltd. (Ukraine) on the subject health status.
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