microlife BGS 300 DiaRite Blood Glucose Test Strips Instruction Manual

BGS 300 DiaRite Blood Glucose Test Strips
Instruction Manual

DiaRite
Blood Glucose
Test Strips
Model No.: BGS 300

Intended Use

Microlife DiaRite Blood Glucose Test Strips are used with the Microlife DiaRite Blood Glucose Meters. They are intended for self-testing by people with diabetes at  home and health care professionals in a clinical setting to monitor glucose concentrations in fresh capillary whole blood (drawn from the fingertips, forearm, upper arm,  palm, calf or thigh), or venous whole blood. The venous blood testing is limited to healthcare professional use only. They are for testing outside the body (in vitro diagnostic  use only). Do not use them for diagnosis of diabetes or testing on neonates.

Test Principle

Glucose in the blood samples mixes with a special chemical in the test strip and produces a small electric current. The amount of current produced changes with the amount  of glucose in the blood. The glucose meter measures the strength of the current and displays the results as a blood glucose level.

Characteristics

Each test strip is plasma-calibrated † , requiring a sample volume of 0.5 μL and taking just 5 seconds to return a test result. The test range is 20 to 600 mg/dL (or 1.1 to 33.3  mmol/L) with resolution at 1 mg/dL (0.1 mmol/L). † plasma-calibrated means the following :

• The traceable calibrator used is the YSI 2747 Glucose Standard, which is a NIST traceable glucose standard.
• The reference instrument used is the YSI 2300 Glucose  Analyzer, which is calibrated by YSI 2747 Glucose Standard.
• The margin of error of the Calibrated YSI Glucose Analyzer measurement is 0.289 mg/dL(0.016 mmol/L) when the blood glucose concentration is higher than 100  mg/dL(5.55 mmol/L), or 0.029 mg/dL(0.002 mmol/L) when the blood glucose concentration is lower than 100 mg/dL(5.55 mmol/L). (1 mmol/L= 18 mg/dL).
  †Test results produced on capillary whole blood samples by Microlife DiaRite System are compared with the results of the corresponding plasma samples tested by the  calibrated YSI 2300 Glucose Analyzer.

Limitations of the System

Microlife DiaRite Blood Glucose Test Strips provide accurate results when the following considerations are observed:

• Use fresh capillary whole blood only. Do not use serum or plasma The venous blood testing is limited to healthcare professional use only.
• The test strips are for single use only. Do not reuse.
• Hematocrit levels below 20% or above 60% can cause inaccurate results. Please consult your doctor if you do not know your hematocrit level.
• Dehydration may cause lower test results. If you are severely dehydrated, contact you physician immediately.
• Testing at altitudes up to 3,402 meters (or 11,161 ft) may affect the test results.

Storage and Handling

1. Follow the infection control procedures appropriate for your facility.
2. Microlife DiaRite Blood Glucose Test Strips are not validated for and should not be used for testing blood specimens other than capillary whole blood or venous blood.
3. Cholesterol concentrations up to 500 mg/dL (12.9 mmol/L) or triglycerides up to 2000 mg/dL (22.6 mmol/L) do not significantly affect test results. However, glucose  values in specimens beyond these levels should be interpreted with caution.
4. Inaccurate results may occur on severely hypotensive individuals or patients in shock. Inaccurate results may also occur when individuals are in hyperglycemic- hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with glucose meters.
5. Interference: Reducing substances occurring in the blood naturally (uric acid, bilirubin) or from therapeutic treatments (ascorbic acid, acetaminophen) will not   significantly affect results. The limiting concentration of several compounds are listed in below chart:

Compounds| Concentrations higher than the following values may cause inaccurate results
---|---
Acetaminophen| 8.0 mg/dL (0.53 mmol/L)
Ascorbic Acid| 5.0 mg/dL (0.28 mmol/L)
Aspirin| 60 mg/dL (3.33 mmol/L)
Bilirubin| 90 mg/dL (1.54 mmol/L)
Cholesterol| 500 mg/dL (12.9 mmol/L)
Creatinine| 5.0 mg/dL (0.44 mmol/L)
Dopamine| 2.0 mg/dL (0.11 mmol/L)
EDTA| 360 mg/dL (12.3 mmol/L)
Galactose| 900 mg/dL (50 mmol/L)
Gentisic Acid| 5.0 mg/dL (0.32 mmol/L)
Glutathione| 53 mg/dL (1.72 mmol/L)
Haemoglobin| 500 mg/dL (0.08 mmol/L)
Heparin| 8,000 U/dL
Hydroxyurea| 3.0 mg/dL (0.39 mmol/L)
Ibuprofen| 50 mg/dL (2.42 mmol/L)
Icodextrin| 13 mg/dL (0.01 mmol/L)
L-dopa| 10 mg/dL (0.51 mmol/L)
Maltose| 900 mg/dL (26.3 mmol/L)
Methyldopa| 3.0 mg/dL (0.13 mmol/L)
Pralidoxime Iodide| 25 mg/dL (0.94 mmol/L)
Salicylate| 60 mg/dL (4.34 mmol/L)
Tolazamide| 100 mg/dL (3.21 mmol/L)
Tolbutamide| 400 mg/dL (14.8 mmol/L)
Triglycerides| 2,000 mg/dL (22.6 mmol/L)
Uric Acid| 8.0 mg/dL (0.48 mmol/L)

Blood Glucose Testing Procedur

See your Microlife DiaRite User Guide and accompanying insert for detailed illustrations for all test procedures.

Test Results

Test results are shown in milligrams of glucose per deciliter of blood (mg/dL) or in millimoles of glucose per liter (mmol/L).
The meter is capable of displaying test results in the range of 20 to 600 mg/dL (or 1.1 to 33.3 mmol/L).
Glucose levels below 50 mg/dL (or 2.8 mmol/L) or above 250 mg/dL (or 13.9 mmol/L) may indicate a potentially serious medical condition. If your test result is below 50  mg/dL (or 2.8 mmol/L) or above 250 mg/dL (or 13.9 mmol/L), please consult your healthcare professional immediately.
Reference values: The normal adult fasting blood glucose range for a nondiabetic person is less than 100 mg/dL(or 5.56 mmol/L) and less than 140 mg/dL(7.78 mmol/L) up  to 2 hours after meals.
These are expected values for people without diabetes. Users are to work with their healthcare professional to determine their target blood glucose values.
Source: American Diabetes Association Website (http://www.diabetes.org)

Inconsistent Results

If you are getting test results which are inconsistent with your state of wellness or how you feel, please do the following:

• Make sure the blood sample applied completely fills the test strip channel.
• Check that the test strips have not expired.
• Verify the performance of the meter and the test strips using the control solution.

Consult your doctor if you continue getting the same high or low results.

Quality Control (QC) Testing

Run a control test anytime you want to check the performance of the meter, the test strip or your testing technique. Only use Microlife Control Solution. These control  solution is designed specifically for use with the system. The control results should fall within the control ranges printed on the test strip bottle.
Important: the control solution range may vary with each new box of test strips. Always use the control range on the label of your current vial of test strips.

Test Strip Chemical Components

Each blood glucose test strip contains

• FAD-Dependent Glucose Dehydrogenase (Aspergillus oryzae) 20 IU
• Potassium Ferricyanide 0.12 mg
• Non-reactive ingredients 1.8 mg

Performance Characteristics

Precision
Standard deviation (SD) for each glucose concentration < 100 mg/dL (5.55 mmol/L) and coefficient of variation (CV) for each glucose concentration ≥ 100 mg/dL (5.55  mmol/L) is ≤ 5.0 mg/dL (0.278 mmol/L) and ≤ 5.0%, respectively.
Intermediate precision

Control Solution
Level| Low 30-50 mg/dL
(1.6-2.7mmol/L)| Normal 96-144 mg/
dL (5.3-8.0mmol/L)| High 280420 mg/dL
(15.5-23.3mmol/L)
---|---|---|---
mg/dL| mmol/L| mg/dL| mmol/L| mg/dL| mmol/L
Pooled| Mean| 46.| 3.| 119.| 7.| 351| 19.50
SD| 2.| 3.| 10.
CV (%)| | 3.%| 3.%

Repeatability

Blood
Glucose
(mg/dL)| 30-50mg/dL
(1.6-2.7
mmol/L)| 51-110md/dL
(2.8-6.1
mmol/L)| 111-150mg/dL
(6.1-8.3
mmol/L)| 151-250mg/dL
(8.3-13.8
mmol/L)| 251–400mg/dL
(13.8-22.2
mmol/L)
---|---|---|---|---|---
mg/dL| mmol/L| mg/dL| mmol/L| mg/dL| mmol/L| mg/dL| mmol/L| mg/dL| mmol/L
Pooled| Mean| 44.| 2.| 79.| 4.| 131| 7.| 196| 11.| 326| 18.
SD| 3.| 3.| 3.| 5.| 10.
CV(%)| 6.%| 3.%| 3.%| 3.%| 3.%

System Accuracy :
For glucose concentration <100 mg/dL (5.55 mmol/L)

Within±5 mg/dL
(Within±0.28mmol/L)| Within±10 mg/dL
(Within±0.56mmol/L)| Within±15 mg/dL
(Within±0.83mmol/L)
---|---|---
133/180 (73.9%| 166/180 (92.2%)| 180/180 (100%)

For glucose concentration ≥ 100 mg/dL (5.55 mmol/L)

For glucose concentrations between 45.9 mg/dL (2.55 mmol/L) and 463.5 mg/dL (25.75 mmol/L)
Within±15 mg/dL (0.83 mmol/L) or ±15%
599/600 (99.8%)
The Microlife DiaRite Blood Glucose Monitoring System meets the requirements for System Accuracy as stated in EN ISO 15197:2015.

User Performance
A study evaluating glucose values from fingertip, palm, forearm, upper arm, calf, and thigh capillary blood samples obtained by 100 lay persons showed the following results:  100% within ± 15 mg/dL (± 0.83 mmol/L) of the medical laboratory values at glucose concentrations below 100 mg/dL (5.55 mmol/L), and fingertip 98.8% / palm 99.5%  / forearm 99.3% / upperarm 100% / calf 99.0% / thigh 99.0% within ±15 % of the medical laboratory values at glucose concentrations at or above 100mg/dL (5.55  mmol/L).

98/79/EC on in vitro diagnostic medical device.

Wholecare Biomedical
Corporation
8F, 443, RuiGuang Road11492 Nei-Hu, Taipei,
TAIWAN
Medical Device Safety
Service GmbH (MDSS GmbH)
Schiffgraben 41, 30175
Hannover, GERMANY
Distributor
Microlife AG
Espenstrasse 139
9443 Widnau / Switzerland
www.microlife.com
Made in Taiwan

IB_Strip Insert_DiaRite_2022

References

• Hypertension and Fever Management - Microlife AG

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