Quality Control; Performance Characteristics - EKF Diagnostics Quo-Test A1C Test Kit Gebrauchsanleitung

Quality Control

The Quo-Test A1C Control Kit must be used with the Quo-Test A1C
Test Cartridges to ensure that the system is operating correctly.
Only Quo-Test A1C Controls should be used with the Quo-Test A1C
Test.
Please read the IFU included with each Control Kit to ensure that the
correct procedure is followed.
Quality control should be run:
 With each new lot of Test Cartridges.
 With each new shipment of Test Cartridges.
 At any time there is concern that the result may be wrong, the
Test Cartridges may not have been stored correctly, the user is
unfamiliar with the test procedure or there is a concern that a
user may be performing the test incorrectly.
Use the Quo-Test A1C Control Kit in accordance with the quality
standards set by your local organization or laboratory.
If the Quo-Test A1C Controls do not give the results within the range
stated in the control kit IFU, contact your local distributor or contact
customer support on +49 39203 511 414 or support@ekf-
diagnostic.de

Performance Characteristics

Method Comparison
Quo-Test A1C results were compared with two commercially
available assays on two separate occasions. Comparison with a POC
system gave a linear regression of r = 0.971 (y = 0.911 + 0.688,
n = 50) and r = 0.98 (y = 0.925 + 0.505, n = 48). Comparison with a
laboratory HPLC system gave a linear regression of r = 0.984 (y =
0.912 + 0.434, n = 50) and r = 0.989 (y = 0.977 + 0.08, n = 48).
Precision
Blood samples with high (9.9 %) and low (5.3 %) A1C values were
tested in duplicate every morning and afternoon for twenty days on a
single Quo-Test Analyzer. The total imprecision for each level was
< 3 % CV respectively.
Linearity and Test Range
High and low pooled blood samples were used to create eleven
linearity standards, which were tested on the Quo-Test A1C Test to
establish the linear range. The Quo-Test A1C Test has a linear
working range of 4 to 15 % DCCT (20 mmol/mol to 140 mmol/mol
IFCC). If a result is outside of this range then the analyzer will display
an error message. Refer to the Quo-Test Analyzer System User
Manual for further details.
7 EN 3121-9101-0255_ML1_02.01_QT Test Kit - 05/2017