As a matter of good clinical practice, caution is advised in the interpretation of neonate blood glucose values below 50 mg/dL (2.8 mmol/L). The system has been tested with neonatal blood. Take caution to clear arterial lines before the blood sample is obtained and applied to the test strip. Venous, arterial, or neonatal blood may be used, but must be obtained by healthcare professionals. Practice the hygiene and safety policy of the laboratory or institution.Ī blood drop is required to perform a blood glucose test. Sample collection and preparation by healthcare professionals: When using the Accu-Chek Performa meter, always follow the recognized procedures for handling objects that are potentially contaminated with human material. Symbol to distinguish them from earlier test strips that were subject to a clinically relevant maltose interference.* The green symbol can be found on the test strip box and on the label of the test strip container.
#ACCU CHEK TEST STRIPS PROFESSIONAL#
(See Table 6.)Ĭontrol and linearity test kits (if available): Accu-Chek Performa control solution-Refer to the control solution package insert for details.Īccu-Chek linearity test kit-Refer to the linearity test kit package insert for details.Īccu-Chek Performa: Healthcare Professional Information: Important information: These test strips are labeled with a green This reaction creates a harmless DC electrical current that the meter interprets for the blood glucose result The sample and environmental conditions are evaluated using AC and DC signals. Q-GDH) from Acinetobacter calcoaceticus, recombinant in E.coli, converts the glucose in the blood sample to gluconolactone. Test principle: The enzyme on the test strip, mutant variant of quinoprotein glucose dehydrogenase (Mut.
Performance assessment by the user: A study evaluating glucose values from fingertip capillary blood samples obtained by 209 lay persons showed the following results: For glucose concentrations less than 100 mg/dL (less than 5.55 mmol/L), 97.6 % of the test results were within ☑5 mg/dL (within ☐.83 mmol/L) of the results obtained through laboratory testing.įor glucose concentrations equal to or greater than 100 mg/dL (equal to or greater than 5.55 mmol/L), 97.0 % of the test results were within ☑5 % of the results obtained through laboratory testing. Actual results may vary among users.System Accuracy: See Tables 1,2,3,4 and 5.
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