Product Manual

limitations carefully and consult your health care professional if you have
any questions.
Additional supplies
Additional Accutrend Glucose test strips, as well as Accutrend Glucose
Control solutions, may be purchased directly from your medical supply
distributor.
Health care professional information
This section of the method sheet contains information specific to health
care professionals. If you are a person with diabetes who uses this product,
read the Patient information section of this insert first. If you have questions
about the Health Care Professional information listed in this section, ask
your health care professional.
Health care professionals
Read the Patient information and the Health Care Professional information
sections of this method sheet.
Test principle
Quinonediimine oxide is reduced by glucose to a hydroxylamine derivate.
The reaction is catalyzed by glucose oxidase (GOD). The hydroxylamine
derivative decomposes to quinonediimine spontaneously. Quinonediimine is
reduced to phenylendiamine by glucose catalyzed by GOD. The
phosphomolybdic acid oxidizer receives two electrons from
phenylendiamine while regenerating quinonediimine. The reduced
phosphomolybdic acid thus becomes molybdenum blue to give the color
change measured by the meter.
3,4,5,6,7,8,9,10
Reagent composition
See the outside of the test strip box for reagent composition.
Precautions and warnings
For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory
reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.
Reagent handling
Refer to the Patient information section of this Method Sheet.
Storage and stability
Refer to the Patient information section of this Method Sheet.
Limitations of procedure
Accutrend Glucose test strips give dependable test results when the
following limitations are understood and followed:
1. System measurement range is 20‑600mg/dL.
2. Only fresh capillary whole blood is recommended for accuracy
determinations. Do not use venous or arterial blood.
3. The test pad reacts only to D‑glucose and not to other sugars which
may be present in the blood.
4. Hematocrit values between 30‑55% do not significantly affect test
results.
5. This system has not been proven for use with neonates.
6. In vitro bilirubin (unconjugated) up to 10mg/dL, uric acid levels up to
13mg/dL, and triglycerides up to 5,000mg/dL showed no interference.
7. At altitudes above 6,000ft., values obtained on the Accu-Chek
InstantPlus and Accutrend Plus meters may be higher than the actual
values.
8. In situations of decreased peripheral blood flow, fingerstick blood
glucose testing may not be appropriate as it may not reflect the true
physiological state. Examples would include, but are not limited to:
severe dehydration caused by diabetic ketoacidosis or the
hyperglycemic hyperosmolar nonketotic state, hypotension, shock or
peripheral vascular disease.
11,12,13
9. This system should be used at <85% relative humidity.
10. Intravenous infusion of ascorbic acid (VitaminC) or dialysis treatment
may affect test results.
11. Glucose measurements must be performed at 64‑95°F (18‑35°C).
12. Not for screening or diagnosis of diabetes.
13. Not for patients who are critically ill.
For diagnostic purposes, the results should always be assessed in
conjunction with the patient’s medical history, clinical examination and other
findings.
Performance characteristics
The data shown represents typical performance results for the
Accu‑ChekInstantPlus and AccutrendPlus meters.
Accuracy
In studies conducted by trained technicians at two professional sites,
patient results collected on Accu-ChekInstantPlus meters were compared
to a whole blood glucose hexokinase reference, yielding the following linear
regression statistics:
n 106 correlation coefficient 0.988
slope 0.973 standard error 13.4
intercept -0.4 range, mg/dL 59-510
Precision: Within‑run precision testing was performed using aqueous
materials. Results were very good at all levels of the dynamic range:
Low Level High Level
n 10 10
mean, mg/dL 72 184
SD 1.8 4.5
% CV - 2.4
References
1 Tietz NW. Textbook of Clinical Chemistry, 1994:2190
2 American Diabetes Association Position Statement, Diabetes Care,
Vol. 19, Supplement 1, Jan 1996:S4.
3 Hönes J, Müller P; Lodwig V, et al. Evaluation Report, Accutrend:
Development of a new non-wipe system for self-monitoring of glucose.
Roche Diagnostics 1991.
4 Müller P, Henrichs HR, Lemke C, et al. Accutrend: Evaluation of a new
non-wipe system for self-monitoring of blood glucose. Poster: BDA
Harrogate 26.-27.3.92, Abstract: Diabetic Medicine 9 (Suppl. 1):
1992;45A.
5 Müller P, Hönes J. Accutrend: Evaluierung eines neuen non-wipe
Systems zur Blutzuckerbestimmung. Poster: DDG Hannover
28-30.5.92, Abstract: Diabetes und Stoffwechsel 1992;1:155.
6 Koschinsky T, Dannehl K, Gries FA, et al. Accutrend technische und
klinische Beurteilung eines neuen Testsystems zur
Blutglucoseselbstkontrolle. Poster: DDG Hannover 28.-30.5.92,
Abstract Diabetes und Stoffwechsel 1992;1:155-156.:
7 Müller P, Henrichs HR, Lemke Ch, et al. Accutrend: Development and
evaluation of a new non-wipe system for self-monitoring of glucose.
Poster: AACC Chicago 19-23.7.92 Handout: Nr. 592-1476988 1,
Abstract: Clin Chem 1992;38:1035.
8 Kutter D, Kremer A. Erfahrungen mit Accutrend, einem neuen System
zur ambulanten Blutzuckerbestimmung, Fortschr, Diagn, 1992;3 Jg.
Nr.2.
9 Landgraf R, Schuon A, Koberstein R. Ein neues Kleinreflektometer zur
Blutzuckermessung Erpobung von Accurend in einem Diabeteslabor,
Blutzuckermessung Erprobung von Accutrend in einem Diabeteslabor,
Laboratoriums Medizin to be published Sept. 94/Okt.94.
10 Müller P, Henrichs HR, Lemke Ch, et al. Evaluierung des
Blutglucosesystems Accutrend mini engl. Version Broschüre:
“Accutrend Family,” “Recent Evaluation Results of New Family
Members,” Poster: DDG Ulm 20.-22.5.93 Abstract: Diabetes und
Stoffwechsel 1993;1:166.
11 Atkin SH, Dasmahapatra A, et al. Fingerstick Glucose Determination In
Shock. Annals of Internal Medicine 1991;114:1020-1024.
12 Sandler M, Low-Beer T. Misleading Capillary Glucose Measurements.
Practical Diabetes 1990;7:210.
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Accutrend Glucose
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