FORA 6 Blood Glucose Hemoglobin Test Strip Instruction Manual

Blood Glucose / Hematocrit /
Hemoglobin Test Strip

Warnings

► For in vitro diagnostic use (for use outside of the body only).
► For single use only.
► Healthcare professionals and other users testing multiple patients with this system should handle everything that has come into contact with human blood carefully to prevent transmitting infectious diseases, including sanitized objects.
► Please read this sheet and your FORA 6 Plus / Connect Multi-functional Monitoring System Owner’s Manual before you use this test strip. Use only FORA 6 Test Strips with FORA 6 Plus / Connect Multi-functional Monitoring System to obtain accurate results, and be covered by the manufacturer’s warranty.
► Results may be inaccurate when testing on patients with abnormally low blood pressure or those who are in shock.
► Please do not use FORA 6 Plus / Connect Multi-functional Monitoring System on critically ill patients. While the blood glucose result is extremely hyperglycemia (over 600 mg/dL (33.3 mmol/L)), the collection of capillary blood from the approved sample sites is not advised when the peripheral circulation is impaired as the delivery of physiological blood glucose level might not be a true reflection. The following circumstances may apply: severe dehydration as a result of diabetic ketoacidosis or due to stress hyperglycemic, hyperosmolar non-ketotic coma, shock, decompensated heart failure NYHA Class IV or peripheral arterial occlusive disease.
► Keep test strips and lancets away from small children. If swallowed, consult a doctor immediately for advice.

Intended Use

FORA 6 test strips, when used together with FORA 6 Plus / Connect Multi- functional Monitoring System is intended for the quantitative measurement of blood glucose, hematocrit and hemoglobin in fresh capillary whole blood from the finger. It is for in vitro diagnostic use only. This system is not intended for use in the diagnosis or screening of diabetes mellitus.
Professionals may test with capillary and venous blood sample; home use is limited to capillary whole blood testing. Use ONLY heparin for anticoagulation of whole blood samples. Please do NOT use EDTA for anticoagulation.

Limitations

• Hematocrit: The hematocrit level is limited to between 0% and 70%. Please ask your healthcare professional if you do not know your hematocrit level.

• Neonatal Use: This test strip can be used for the testing of newborns.

• Please see Appendix: Summary of substances and concentrations in excess of
  limitation with interference.

• Altitude Effects: Altitudes up to 3,275 m (10,742 ft) do not affect test results.

• Do not test blood glucose during or soon after a xylose absorption test. Xylose in the blood can produce elevated glucose results.

Storage and Handling

►Use each test strip immediately after taking it out of the vial or individual foil pack. Close the vial immediately after taking out a strip.
►IMPORTANT: Do not use the test strips if they have expired.
► Keep the vial closed at all times.
► Store the test strips in their original vial ONLY. Do not transfer them to a new vial or any other containers.
►Do not touch the test strips with wet hands.
► Do not bend, cut, or alter the test strip.
► Store the test strips in a cool, dry place between 2°C and 30°C (35.6°F and 86°F) and below 85% relative humidity.
► Keep the test strips away from direct sunlight. Do not store the test strips in high humidity.

Testing Your Blood Glucose

PLEASE WASH AND DRY YOUR HANDS BEFORE PERFORMING ANY TESTS.
Please refer to your Owner’s Manual for more information.
The used lancet and test strip are potentially biohazardous. Please dispose of them carefully according to your local regulations.

Reading Your Result

Your blood glucose readings deliver plasma equivalent results and are displayed in mg/dL or mmol/L. Your hematocrit readings will be displayed in % and hemoglobin readings in g/dL.

Reference values

Normal plasma glucose range for people without diabetes 1| Fasting and before meal| < 100 mg/dL (5.6 mmol/L)
---|---|---
2 hours after meals| < 140 mg/dL (7.8 mmol/L)
Hemoglobin 2| Male| 14 –17 g/dL
Female| 12 – 15 g/dL
Hematocrit *2| Male| 41%- 50%
Female| 36% – 44%

1.  American Diabetes Association (2014). Clinical Practice Recommendations. Diabetes Care, 37 (Supplement 1): S16.
2. NIH – National Heart, Lung, and Blood Institute (NHLBI) https://www.nhlbi.nih.gov/health-topics/blood-tests

Please consult your doctor to determine a target range that works best for you.
Questionable or inconsistent results
If your test results are unusual or inconsistent with how you are feeling:

• Make sure the confirmation window of the test strip is completely filled with blood.
• Check the expiry date of the test strips.
• Check the performance of your meter and test strip with the control solutions.

Please Note: Unusually high or low blood glucose levels may be symptoms of a serious medical condition. If most of your results are unusually high or low, please contact your healthcare professional.

Quality Control Testing

Our control solutions contain a known amount of glucose that can react with test strips.You can check the performance of the meter, test strip and your technique by comparing the control solution results with the range printed on the label or individual foil pack.Checking regularly can ensure your test results are accurate. Please refer to the Owner’s Manual for complete testing instructions.

IMPORTANT: The reference range of the control solutions may vary with each new test strip. Make sure you check the range on the label of vial or individual foil pack of your current test strip.

Chemical Components

Glucose dehydrogenase (E. coli) 8%
Enzyme protector 8%
Electron shuttle 55%
Non-reactive ingredients 29%

Additional Information for Healthcare Professionals

Always wear gloves and follow your facility’s biohazard control policy and procedures when performing tests involving patient blood samples. Use fresh whole blood samples only. Professionals may use test strips to test capillary and venous whole blood.
Sample Size: 0.5 μL
Reaction Time: 5 seconds
System Measurement Range:

• Blood Glucose Test: 10 ~ 600 mg/dL (0.55 ~ 33.3 mmol/L)
• Hematocrit Test: 0 ~ 70%
• Hemoglobin Test: 0 ~ 23.8 g/dL

Hematocrit Range: 0% to 70%
Accuracy
The table below displays how often FORA 6 achieves this target. The chart is based on a study carried out on 100 patients (each patient was tested six times which resulted in 600 test results) to see how well FORA 6 performed compared to Cobas Integra® 400 plus reference method results. [6] Table 1 Accuracy results for glucose concentration < 100 mg/dL (5.55 mmol/L)

Within ± 5 mg/dL (Within ± 0.28 mmol/L)| Within ± 10 mg/dL (Within ± 0.55 mmol/L)| Within ± 15 mg/dL* (Within ± 0.83 mmol/L)
---|---|---
33.3% (52/156)| 73.7% (115/156)| 98.7% (154/156)

Table 2 Accuracy results for glucose concentration ≥ 100 mg/dL (5.55 mmol/L)

Table 3 Accuracy results for glucose concentrations between 40 mg/dL (2.22 mmol/L to 456 mg/dL (25.3 mmol/L)

Within ± 15 mg/dL or ± 15% (Within ± 0.83 mmol/L or ± 15%)

99.3% (596/600)

Note: * According to the accuracy criteria of EN ISO 15197: 2015, 95% of all differences in glucose values (i.e., Cobas Integra® 400 plus reference values minus glucose values of FORA 6) should be within ±15 mg/dL (0.83 mmol/L) for glucose concentration < 100 mg/dL (5.55 mmol/L), and within ±15% for glucose concentration ≥ 100 mg/dL (5.55 mmol/L). When Test Strips results are compared to the reference values, difference values below 100 mg/dL (5.55 mmol/L) are expressed in mg/dL or mmol/L, while those above 100 mg/dL (5.55 mmol/L) are in percentage.

User performance
160 subjects were tested with blood samples taken from the fingertip and the alternative sites, the palm, the forearm and the upper arm. The tables show how well  FORA 6 performed compared to Cobas C311 reference method results.
Table 1 Difference distribution for glucose concentration < 100 mg/dL (5.55 mmol/L)

Tested sites| Difference within t 5 mg/dL| Difference within ± 10 mg/dL| Difference within ± 15 mg/dL
---|---|---|---
Fingertip| 26/43| (60.5.4)| 37/43| (86.0 ,L)| 43/43| (100)
Palm| 27/42| (64.3%)| 41/42| (97.6%)| 42/42| (100%)
Forearm| 31/42| (73.8%)| 39/42| (92.9%)| 42/42| (100%)
Upper arm| 29/42| (69.0%)| 38/42| (90.5%)| 41/42| (97.6%)

Table 2 Accuracy results for glucose concentration 100 mg/dL (5.55 mmol/L)

Tested sites| Difference within t 5%| Difference within t 10%| Difference within t 15%
---|---|---|---
Fingertip| 59/117 (50.4%)| 102/117 (87.2%)| 115/117 (98.3%)
Palm| 49/118 (41.5%)| 92/118 (78.0%)| 118/118 (100%)
Forearm| 43/118 (36.4%)| 84/118 (71.2%)| 115/118 (97.5%)
Upper arm| 49/118 (41.5%)| 87/118 (73.7%)| 116/118 (98.3%)

Precision
In both intermediate precision and repeatability tests, the standard deviation (SD) is within 5 mg/dL (0.28 mmol/L) for each glucose concentration < 100 mg/dL (5.55 mmol/L) and the coefficient of variation (CV) is less than 5% for each glucose concentration ≥ 100 mg/dL (5.55 mmol/L).

For self-testing ACS051
Use only with FORA 6 Plus / FORA 6 Connect Multi-functional meter.

Table A The test strip has no interference with the following substances within and beyond the therapeutic or physiologic concentration range.

Substance| Therapeutic / Physiologic
Concentration Range
(or Upper Limit) (mg/CL)| Concentration Tested (mg/dL)
---|---|---
Salicylic Acid| 10 – 30| 60
Bilirubin (Unconjugated)| 0 – 2| 40
Cholesterol| 300| 500
Creatinine| 2.| 30
Galactose| < 5| 1000
Gentisic Acid| 0.2 – 0.6| 2
Hemoglobin (Hemolysis Method)| 3.| 500
Heparin (Li)| 35 – 100 UfilL| 6800 U/dL
Heparin (Na)| 35 – 100 U/dL| 6800 U/dL
Ibuprofen| 1 – 7| 55
Icodextrin| 1200| 2000
Maltose| N/A| 1000
Tolbutamide| 4.32 – 24| 64

Table B The test strip has no interference with the following substances within the therapeutic or physiological concentration range. Concentrations outside therapeutic ranges may cause interference.

Substance| Limiting
Concentration
(mg/dL)| Therapeutic / Physiologic
Concentration Range
(or Upper Limit ) (mg/dL)
---|---|---
Acetaminophen (Paracetamol)| > 20| 0.45 – 3
Ascorbic acid| > 5.0| 2.0
Dopamine| > 2.5| 0.03
Levo – Dopa| > 2.1| 0.02 – 0.28
Methyl – Dopa| > 1.25| 0.1 – 0.5
Reduced Glutathione| > 30| 24.25 – 32.2
Tolazamide| > 20| 2 – 2.5
Uric acid| > 10| 2 – 8
Xylose| > 5.0| N/A
Lipemic Samples (Triglycerides)| > 3000| 30 – 300

Table C Summary of anticoagulant and concentrations with interference.

Substance| Limiting Concentration (mg/dL)| Concentration of Blood Drawing Tube (mg/dL)
---|---|---
K3EDTA| < 175.5| 176.
K2EDTA| < 180| 180

Table D The following compounds within the therapeutic or physiologic concentration range may produce elevated glucose results

Substance| Concentration Tested(mg/dL)| Therapeutic / Physiologic
Concentration Range
(or Upper Limit ) (mg/dL)
---|---|---
Prolidoxime lodide| > 5.0| ~ 10 (i.v. Dose 500 mg)

Reference

• McEnroe, J Robert, et al. National Committee for Clinical Laboratory Standards.
  Interference testing in clinical chemistry; Approved Guideline – 2nd edition. NCCLS :
  2005 – EP7-A2, volume 25, number 27.

• EN ISO 15197: 2015 (E): In vitro diagnostic test systems — Requirements for
  blood-glucose monitoring systems for self-testing in managing diabetes mellitus,
  Second edition, section 6.4.4 Interference Testing.

• Hardman JG, Limbird LE, Molinoff PB, et al. Goodman & Gilman’s the Pharmacological
  Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill; 1996: 1570-1571.

• Zaloga GP, Macgregor D. The Critical Care Drug Handbook. 2nd ed. St Louis, MO:
  Mosby-Year Book; 1997.

• Kost GJ, Vu HT, Lee JH, et al. Multicenter study of oxygen-intensive handheld glucose
  point-of-care testing in critical care/hospital/ambulatory patients in the United States
  and Canada. Crit Care Med. 1998;26:581-590.

• Institut für Diabetes Technologie. System accuracy evaluation of FORA 6 Connect
  Multi-functional Monitoring System based on ISO 15197:2013 & EN ISO
  15197:2015. Project No.: IDT-1739(2A)-FS; 2018

ForaCare Suisse AG
Neugasse 55, 9000, St. Gallen, Switzerland
www.foracare.ch| MedNet EC-REP GmbH
Borkstraβe 10, 48163,
Mϋnster, Germany
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