Accuracy Troubleshooting

Instrument Accuracy Measurement Kit
Instrument Verification
• Purpose is to verify condition of the instrument

after maintenance for:
– Temperature
– Dispensing
– Photometer
– Recommended frequency: after annual
maintenance
– Reference values are determined by Swedish
National Testing and Research Institute.
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Accuracy kit, Reagents composition:

Purpose No Chemicals used in the solutions
Temperature 1 * Cresol Red in 90 mmol/l TRIS buffer, pH 7.5
Temperature 2 * Cresol Red in Phosphate-barbital buffer, pH 7.8
Dispensing 3 Sulphuric acid 5 mmol/l
Photometer 6-10 * Dichromate < 0.1% in 5 mmol Sulphuric acid
Dispensing 11 Common Salt solution, NaN3 < 0.1 %
Dispensing 12 Common salt solution Coloured, NaN3 < 0.1 %
* values for these solutions are determined by

SP (swedish national research and testing
institute).
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– Test kit was designed to work in Konelab software version 4.0 or

greater
– Konelab sw window:
• F2 Instrument Actions/ F8/ F2 Accuracy results
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5
Factors and reference values are unique to

each lot.
• Factors and reference values are given in Accuracy Solution Kits
Package insert.
• Values must be carefully copied to the Accuracy factors window and
saved (F2 save changes).
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• A thermo labile and thermo stabile solutions

( sens and stab) are used.
• Thermo labile solutions pH depends on temperature. Solution
contains pH indicator (cresol red).
• Solution is Cresol red in Tris buffer at pH 7.5
• Thermo stabile solutions pH does not vary. Solution is Cresol red in
phosphate buffer at pH 7.8.
• Temperature is calculated from measured absorbances (6 repeats)
at 575 nm.
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Protocol Troubleshooting
Room temperature: 22 – 25°C  Room temperature below 20
 solutions stand at room temperature: 30 °C or above 25°C, standing
min times must be adjusted.
 solutions stand in analyser: 30 min
Solutions used:  Peltier / Thermistor cable
 130 µl thermo labile with 240 µl Extra  Heating resistance /
volume Thermistor cables
 130 µl thermo stabile with 240 µl Extra  Cooling module
volume
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• Two solutions from the Photometer linearity solutions are used.

(L340_2 and L340_4)
• Solutions are measured kinetically (n= 4) in six cuvette positions.
Standard deviations are compared and the highest is reported.
10
Max values are

reported
Solutions used:  Lamp
K2Cr2O 7 at 0.5 & 2.0 A  340 nm filter
130 µl of reagent with 240 µl Extra  Photocard
11
• Solutions L340_1 - L340_5 are measured at 340 nm.

• Measured absorbances are compared to absorbances
determined by Swedish National Testing and Research Institute
• To the results a linear function and a second order functions are
fitted. Slope, curvature and maximum bias from fitted linear
function are calculated.
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Solutions used:  Lamp
0 – 2.5 A  340 nm filter
130 µl of reagent with 240 µl Extra  Photocard
13
• The highest concentration of photometer linearity solutions is used

(L340_5).
• Dispensing ratio used is 1 + 15. Volume is calculated from
absorbances.
• Since all clinical chemistry reactions depend on the solution ratios
also the repeatability is measured (CV%).
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Solutions used:  Needle tip
10 µl K2Cr2O 7 - 2.5A (L340_5)  Bubbles in fluidic circuit
+  Ground cable
150 µl H2SO 4 - 0A (DISP_ACC)
15
• Dispensing linearity and repeatability are measured using a

coloured common salt solution.
• From solution 12 volumes 0, 2, 4, and 10 µl are dispensed into

common salt solution.
• 10 µl is fixed (dispensing ratio!) and the other volumes are

calculated proportionally to it using absorbances.
16
Solutions used:  Needle
Yellow food 24 A+ common salt  Bubbles
0, 2, 4, 10 µl  Ground cable
If these tests are failing,

repeat the Dispensing ratio
test also after fixing.
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Procedure is inside the Accuracy Solution Kit.

• Save customers database.
• Perform Stand by, exit user interface, restore accuracy database,
Start Konelab Software again and perform Start up.
• Check that cuvette exit limit is 11 and the water blank
limit is 2 mA (copy customers set values for restoring).
• Remove Cuvettes from incubator, after Start-up.
F2 Instrument Actions/ F2 Exit cuvettes
• F2 Start-up
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• Samples are pipetted from reagents as described in the procedure.

• Reagents are inserted into reagent register according to their
numbers.
• Let the reagents warm up to room temperature for at least 30 minutes.
Then let them stabilise in reagent register at least 30 minutes.
• In Konelab 20 and 30 reagents 1-3 and 6-11are used.
In Konelab 60 1-3 and 6-12 reagents are used.
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• Do not let the samples stand in the cups in the Konelab longer than
1 hour!
• Do not let the reagents stand open in the Konelab longer than 2
hours!
• From one set of bottles it is possible to perform the tests twice.
Second set is there because additional maintenances may take
longer than the half an hour that is left after the first test load is
analysed.
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• Insert the empty sample segment no 1 into the Konelab and press
Start.
• Insert segment no 2 immediately after segment 1 is measured (start
again if necessary) and then segment 3 once the segment no 2 has
been measured.
• After all 3 segments are ready. Check the Accuracy Factors window
for right: lot number, factors and reference values.
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• Return to the Accuracy Results Window and analyse the Results.

• If a test/ tests have failed, there are Big Black Arrows next to failed
test.
• If everything is OK,
Print the results and Sign the sheets.
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• Prepare the analyser for the customer

• Remove samples and reagent bottles
• Perform Stand by function
• Exit the Konelab software
• Do not select function Clear daily files, before existing the sw.
• Restore the customers saved database. Start Konelab Software again
and perform Start up.
• Restore water blank and cuvette exit limits.
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Accuracy Troubleshooting

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Accuracy Troubleshooting

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Instrument Accuracy Measurement Kit

• Purpose is to verify condition of the instrument

Accuracy kit, Reagents composition:

Temperature 1 * Cresol Red in 90 mmol/l TRIS buffer, pH 7.5

Temperature 2 * Cresol Red in Phosphate-barbital buffer, pH 7.8

Dispensing 3 Sulphuric acid 5 mmol/l

Photometer 6-10 * Dichromate < 0.1% in 5 mmol Sulphuric acid

Dispensing 11 Common Salt solution, NaN3 < 0.1 %

Dispensing 12 Common salt solution Coloured, NaN3 < 0.1 %

* values for these solutions are determined by

– Test kit was designed to work in Konelab software version 4.0 or

Factors and reference values are unique to

• A thermo labile and thermo stabile solutions

• Two solutions from the Photometer linearity solutions are used.

Max values are

• Solutions L340_1 - L340_5 are measured at 340 nm.

• The highest concentration of photometer linearity solutions is used

• Dispensing linearity and repeatability are measured using a

• From solution 12 volumes 0, 2, 4, and 10 µl are dispensed into

• 10 µl is fixed (dispensing ratio!) and the other volumes are

If these tests are failing,

Procedure is inside the Accuracy Solution Kit.

• Samples are pipetted from reagents as described in the procedure.

• Return to the Accuracy Results Window and analyse the Results.

• Prepare the analyser for the customer

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