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Background Information - Help Corner
Wavelengths A/B listed in the Instructions for Use for each test
The signal from two wavelengths is determined for some tests in order to correct the change in absorbance during the enzymatic reaction for a matrix background. The signal of the first wavelength, A, is the specific signal, whereas the signal from the second wavelength, B, is used to eliminate or decrease nonspecific background signals. The A/B wavelengths should not be confused with emission/extinction wavelengths of fluorescent dyes.
Wavelengths A/B may differ between Cedex Bio Analyzer and Cedex Bio HT Analyzer for the same test. Although the chemistry is identical for a test, as the optics of the two analyzers are slightly different, you see slight differences in the measured wavelengths.
Indication that a sample was measured with pre- or post-dilution or was a repeated measurement
Results from repeated measurements are flagged with ">", whereas results from diluted samples are flagged with "v". All result flags are shown on the results report printout.
Opening exported results
Files containing results can be exported via the tab Utilities (Utilities->Export->Full Results) in the Cedex Bio Analyzer. Result files are exported as .csv files, which can be opened via MS Excel. To view the results in MS Excel, use the import function "From Text" located under the Data tab and set the delimiter to semicolon.
Printing, sample, calibration, and QC results automatically
The Auto Print Results function (Utilities->Configuration->Workflow) is only available for automated print out of sample results. When this function is set to "On", the sample results will be automatically printed as soon as all results for a sample are accepted. Calibration and QC results cannot be automatically printed out.
Tracking which user is logged in at a specific date/time and has performed a measurement
It is not possible to track which user was logged in at a specific date or time. The top of the printout only displays the user who printed out the document and the time of the printout, not the user who performed the measurement or accepted the result. However, if the instrument is configured so that each result must be manually accepted, the user who accepted the result will be displayed in the exported .csv file containing the results. To permanently track on the printouts which user performed a measurement, one option would be to photocopy the printout then add the name and signature to the photocopy.
Time remaining for a test to be completed
On analyzers with software version 2.x installed, the time until the end of the analysis will be displayed in the Overview tab.
Information about cuvettes and reagents required, and available for requested measurements
When measurements have been requested on the analyzer, information about the type and number of tests required, as well as the total number of tests available on board, is located at Workplace -> Loadlist.
Note that the calculation does not include a calculation of reagents possibly required for a rerun.
If there are insufficient cuvettes or reagents onboard for the requested tests, a window will appear displaying the required reagents and cuvettes after clicking the Start button. An asterisk (*) indicates that not enough cuvettes / test reagents are onboard, and the number needed vs. number available is shown.
Note that orders that are still in the system but cannot be performed (e.g., no sample is onboard) are included in the calculations. To avoid miscalculations, it is recommended to delete unfinished orders that are no longer required.
Number of results that can be saved on the analyzer and consequences if exceeded
Analyzers with SW 2.x can store 600 results. If the maximum number of results is exceeded, the oldest existing results will be overwritten. The software will not give a warning when older results are overwritten. Therefore, it is recommended to export the result data at the end of each day when performing the end shift wizard.
Displaying results produced on a specific day
It is not possible to display results produced on a specific day via the software.
By ID (only one ID can be entered)
Not sent to host
To select results from a specific day, one option would be to export all files and use Excel to create a filter.
It is only possible to filter for the following parameters in the Results Review Menu of the Cedex Bio.
How to assign tests to specific test tabs
Test tabs show different screens in the Test Status menu of the Overview. The different tabs can be used to group tests. In the configuration menu -> Workflow -> Order mode, you can choose between "Easy" (only one tab available containing up to 25 tests) or "Full" (6 test tabs available, containing 20 tests each). In the same menu, you rename tabs or hide them by setting test tab visibility to "Off".
Each test can be assigned to one or more test tabs (Utilities -> Applications -> Laboratory parameters -> General -> Test Tabs).
Information note: If the Order mode has been set to "Easy" and a test has not been assigned to the "Easy" tab, the test will not be visible in the Test Status menu.
Unfinished tasks (results and orders) when starting the End Shift wizard
If there are unfinished tasks (e.g., results that are not yet validated or uncompleted orders), it is still possible to complete the End Shift wizard. However, unaccepted results and blocked orders will not be deleted.
Frequency of database backup for Cedex Bio
The frequency with which a database should be backed up on the Cedex Bio Analyzer depends on the number of tests performed. The Cedex Bio can store up to 300 results, in the case of software 1.x, and 600 results in the case of software 2.x. However, Roche recommends exporting and then deleting data before reaching this number in order to keep the system running smoothly and have a backup of the data. The general recommendation is to perform a backup on a daily basis using the End Shift wizard.
Not possible to schedule maintenance actions to be performed automatically via the Major Maintenance Day function
It is not possible to schedule maintenance actions to be performed automatically on the system. The Major Maintenance Day function provides a reminder that certain maintenance actions are due, but does not initiate them. On a Major Maintenance day, perform actions that are indicated in yellow, in addition to maintenance actions in red.
Not performing maintenance actions marked in yellow on a Major Maintenance day
Maintenance actions marked in yellow on a Major Maintenance day will stay yellow until they are due. When the actions are due, they will turn red.
Daily maintenance action still green although the action run the day before
Daily maintenance actions are due after 24 hours. The Cedex Bio Analyzer counts the time in hours rather than days, so if a daily maintenance was run less than 24 hours before, the maintenance action will remain green until 24 hours has passed. Even if the daily maintenance actions are shown as green, they should be run each morning before the start of the day's measurements to ensure the system is working properly.
Test reagent sets do not require a new calibration after the ABS lamp is changed
When the service action
Change ABS lamp
is performed, the instrument does a water/air calibration automatically as part of the maintenance action. The reagent sets are not affected by this action and do not have to be calibrated again.
The maintenance action "Clean ISE Tower Automatically" is part of the "Daily Prepare Actions", although it is run weekly
Although the maintenance action "Clean ISE Tower Automatically" is part of the "Daily Prepare Actions", the instrument only performs it once per week it is due.
"Prep > Select Mixing" menu in the Prepare wizard
The "Prep > Select Mixing" menu in the
wizard is not required for any Cedex Bio Analyzer assay. That function is only used for tests containing molecules that are coated on latex beads. No Cedex Bio test contains latex particles, and therefore this action can be ignored.
Calibration type and calibration interval are predefined for every test
The definition for the calibration type (lot or set), as well as the interval for the calibration, is defined individually for each test. The calibration definition is embedded in the barcode transfer sheet for each test and automatically loaded when the test is imported and installed. Roche strongly recommends not changing the predefined calibration type and interval.
Precision and accuracy of application tests
The precision varies from test to test. An overview of the precision, test range, and traceability is provided in the Instructions for Use for each test. An overview of the accuracy of the tests is provided in the document "Cedex Bio/Cedex Bio HT tests", located on the CustomBiotech Cedex Bio Analyzer product page under the section 'Assay Overview': http://www.custombiotech.roche.com/home/Product_Details/3_8_10_2_1_1.html
Reagent filling volume for Cedex Bio Analyzer tests
The approximate volume of reagent contained in each reagent bottle of a test kit is printed on the respective bottle label. The exact volume of reagent in the test reagent bottles is not relevant. The reagent flasks for each test are guaranteed to contain enough volume to ensure that 50 reactions can be performed with one reagent set. Any leftover reagent in the bottle after 50 reactions have been pipetted cannot be used for further tests, as the instrument will mark the bottles as empty after 50 reactions have been pipetted.
.tgz files cannot be modified
Data can be exported as .tgz files. .tgz files are archived files that cannot be modified.
Additional Equipment and Reagent Required
Additional Reagents and Consumables
NaCl Diluent 9% Bio, 8 x 12 mL
ISE Deproteinizer, 2 x 11 mL
Micro Cuvette Segments Bio
Cleaner Alkaline Bio
ISE Sodium Electrode Bio
ISE Potassium Electrode Bio
ISE Reference Electrode Bio
ISE Dummy Electrode Bio
ISE Calibration Kit Bio
ISE Reference Solution Bio
ISE Calibrator Indirect Bio
ISE Etcher Bio, 2 x 11 mL
Protocols - Help Corner
Rule 1 settings for Quality Control (QC)
Roche recommends starting with a three-fold of the value of the standard deviation, 1s, defined for each analyte in the relevant lot-specific Instructions for Use for Controls. The value is defined in Utilities->Configuration->QC->Rule 1->3s. However, each lab must determine the appropriate values according to local preferences or requirements.
Rule 2 settings for Quality Control (QC)
Roche recommends starting with a two-fold of the value of the standard deviation, 1s, defined for each analyte in the relevant lot-specific Instructions for Use for Controls. The value is defined in Utilities->Configuration->QC->Rule 2->2s. However, each lab must determine the appropriate values according to local preferences or requirements.
Number of measurement points taken by the Cedex Bio Analyzer
An application that uses absorbance photometer measurements consists of max. 40 instrument cycles (40 cycles x 18 sec = 720 sec => 12 min). Therefore, 12 min is the maximum time-to-result.
The time-to-result for each test depends on the last cycle, which is used for the result calculation (the "calc. last" value provided in the Instructions for Use of each test application). For some applications, the "calc. last" value will be less than cycle 40, which means a time-to-result of less than 12 min. To calculate the results, the instrument uses absorbance measurements obtained at "calc. first" cycle, when the reaction starts, and "calc. last" cycle. Both "calc. first" and "calc. last" cycles are listed in the Instructions for Use of each test.
Length of time for the Cedex Bio Analyzer to generate a measurement result
The length of time required to generate a test result depends on the test.
ISE tests take approximately three to four minutes.
In the case of absorbance tests, the duration of a single measurement can be calculated by the last instrument cycle used for calculation (see the Instructions for Use of a specific test application for information about the respective "calc. last") multiplied by the time one cycle requires (18 seconds):
["calc last" x 18 sec ] = time-to-result in seconds
Note that the calculated time only applies for a single test. If a sample is tested for several parameters, or several samples are measured, the instrument must coordinate different measurements and pipetting steps. After the first result is generated, subsequent test results may be generated every cycle (18 secs) or after several cycles. Therefore, it is not possible to calculate exactly how long it will take to generate all results from multiple test requests.
Recommended tube types
Any type of primary tube can be used, as long as their dimensions lay within prescribed limits:
Maximum height (including secondary tube): 102 mm
Minimum height: 70 mm
Maximum outside width: 16.3 mm
Minimum outside width: 11.8 mm
Recommended dead volume of sample cups and tubes
For recommended sample cup types:
1.5 mL reaction tube: 100 μL
Roche Diagnostics Standard false bottom tube: 75 μL
For other tube types:
13 x 75 mm 500 μL
13 x 100 mm 500 μL
16 x 75 mm 700 μL
16 x 100 mm 700 μL
ISE electrode stability and test frequency
The stability and exchange frequency of the electrodes does not depend on the number of tests performed. The stability only depends on the shelf-life and onboard stability of the electrodes.
The shelf-life (expiration date) is printed on the outer packaging label; the electrode must be put onboard before this date.
Shelf life of Na
, and Reference electrodes: 9 months
Shelf life of Dummy electrode: 36 months
The countdown for onboard stability starts as soon as the electrode is put onboard.
electrode: 238 days
electrode: 180 days (6 months)
Reference electrode: 360 days (1 year)
Dummy electrode: 2 years
The instrument indicates when the onboard stability is exceeded.
Performing measurements using electrodes with expired onboard stability
While it is theoretically possible to perform measurements using electrodes with an expired onboard stability, as long as the QC is within range, it is not generally recommended. Exchange the electrodes after expiration.
Order in which samples are processed on the Cedex Bio Analyzer
When orders are started, the sample placed on the left-most position (position 1) in the sample area is processed first. The other samples that have been ordered will be processed in a sequence from left to right. Once processing is in progress, the orders are processed according to the sequence in which they were defined in the software. Repeats and reruns of routine orders are performed before routine orders.
Sequence in which requested test applications are run for a sample
For a specific sample, the order in which the tests are processed is based on the time required to perform the tests (number of cycles), starting with the test that takes the longest.
The test order can be manually changed by defining a specific process sequence list in Utilities -> Applications -> Process Sequence. In the Process Sequence menu, select a test to be processed with high priority. Press ">" to move the test to the Priority list. The tests will be processed in the order displayed in the Priority list. After the priority tests are processed, the rest of the tests are processed in the normal sequence.
Not possible to run the same test on the same sample ID
It is not possible to run the same test on a tube with the same sample ID that was previously connected to that test. To measure a sample again with the same test, use a different sample ID (e.g., "Sample1
" instead of "Sample1").
Information displayed for a sample result outside the reference range ("valuation")
If a sample result is outside the upper or lower limit set for a reference range ("valuation"), the result is marked with, for example, ">RR" (above the reference range) or "<RR" (below the reference range).
Changing order information
It is possible to change information about an order. There are two scenarios:
: click on the sample in the Sample area of the "Overview" screen, click on the "+", then select or de-select tests. Alternatively, go to Workplace tab-> Orders and highlight the order to be modified. Click on the pencil, and select or de-select tests.
has been removed from the sample area
: Create a new order and enter the identical sample ID for the sample order to be changed. The instrument will recognize that the sample has already been processed. Tests cannot be de-selected, but additional tests can be added.
Changing an order for a sample that has been pipetted for tests
It is possible to add more tests for a sample that is onboard and has already been pipetted for tests. However, it is not possible to de-select tests that have already been pipetted. The buttons will be light green and cannot be pressed /de-selected.
Test marked in blue on the test status screen (Overview > Tests)
A test will be marked in blue on the test status screen if:
The corresponding reagent set is missing.
A required diluent or cleaner is not onboard.
Reagent marked in blue on the reagent status screen (Overview > Reagent disk)
The reagent set will be marked in blue on the reagent status screen if the reagent is on board, but the test is not active or installed.
Rerunning (post-dilution) a test for sample that has been measured with a D-Protocol
If a sample test has been measured using the D-Protocol, it is possible to rerun the test with an additional post-dilution using the Rerun function. The D-Protocol allows for the possibility to run a sample with additional post-dilution (Rerun) if the analyte concentration is > Test Range. The post-dilution factor used will be the same as the factor used by the D-protocol.
Setting up a pre-dilution of the sample before measurement
The Cedex Bio Analyzer does not allow for the possibility to set a specific pre-dilution of a sample before measurement. The only option for creating a pre-dilution before measurement is to install the "D-Protocol" (dilution protocol) for the relevant application. D-Protocols can be installed in addition to the standard test applications. The user can choose between the regular protocol and the D-Protocol, depending on the expected analyte concentration. The Barcode Transfer Sheets for the D-Protocols are located in the Instructions for Use for the respective tests.
Removing samples from the instrument after pipetting is completed
Samples can be removed from the instrument as soon as the tests have been pipetted. It generally takes approximately 2 to 3 minutes for the first sample to be pipetted after a run is started. It takes approximately 16 minutes until the 8
sample is pipetted when the LED changes to green.
Adding a standby calibration
It may be helpful to create a standby calibration for reagent bottle sets with a set calibration type (i.e., reagent bottle sets that must be calibrated before use), or for reagent bottle sets from a new lot. A reagent set for a test can be calibrated immediately after loading it onboard, even if an already calibrated reagent set for the same test is onboard. The new calibration will be called a "standby calibration", and the new reagent set can be used by the instrument as soon as the previous reagent set is empty. The standby calibration will be switched to the valid calibration for this test as soon as the previous reagent set is empty. This way the instrument will switch automatically to the new reagent set without any delay or blocking of orders.
If there are two or more reagent sets for the same test onboard when requesting a calibration for the test, the software will ask whether the current calibration should be replaced or whether a standby calibration should be created for the new reagent set.
Reagents that have a standby calibration can be removed from the instrument. As soon as they are placed onboard again, the instrument will recognize that a standby calibration exists for that reagent set. If that is the only reagent set for the test onboard, the software will turn the standby calibration into the current calibration and immediately use the reagent set for measurements.
To add a standby calibration for an additional test reagent set, refer to the Cedex Bio Analyzer Operator's Manual.
Information note: Each reagent set has unique bottle numbers in addition to the lot number; this allows the system to assign a specific calibration result to a specific reagent set.
Performing a Lot calibration
A Lot calibration can only be created when the test application is predefined as Lot calibration type. In addition, some tests also require a calibration after a certain interval has elapsed. To see whether a test application has been defined as a Lot calibration, as well as whether a time interval has also been assigned for the test calibration, refer to the relevant Instructions for Use. Once a valid Lot calibration has been created for a particular lot, the newly created calibration will apply to all reagent sets from the same lot as long as the reagent set from that lot is used within the defined interval, if an interval also applies.
There are two important criteria required for creating a Lot calibration:
A Lot calibration can only be created when the calibration is ordered for a reagent set that has been onboard less than 24 hours. If a calibration is ordered for a reagent set that has been
onboard longer than 24 hours, the calibration will automatically be assigned a Set calibration type. For a Set calibration type, the calibration will only apply to the specific reagent set that was calibrated. When a new reagent set is placed onboard, a new calibration must be performed.
Only unflagged calibration results can be assigned the Lot calibration type. If you accept a calibration that was flagged for any reason, the calibration will automatically be assigned a Set calibration type.
Ordering and starting a quality control (QC) measurement while the calibration is still in progress
It is only possible to order and start a QC measurement for a test while the calibration for that test is being processed if the option "Cal Auto Accept" has been set to "On" (Utilities->Configuration->Result Handling->Cal Auto Accept). However, the instrument will only start pipetting after the calibration result has been accepted. Roche generally recommends setting up the QC only after the calibration has been accepted to avoid controls standing on the instrument for a long time.
The test is marked yellow rather than green in the test status menu after a successful calibration
If "QC After Cal" is set to "On" for a test (Utilities->Applications->Test->Controls), the test will be marked as yellow rather than green until a Quality Control (QC) has been successfully run. It is possible to perform a measurement with a test marked as yellow. However, Roche recommends always running a QC after a calibration before running measurements with samples, in order to confirm the calibration curve.
If "QC After Cal" is set to "Off" for a test, the test will be marked green immediately after a successful calibration.
Information note: it is not recommended to set "QC After Cal" to "Off".
QC results are not deleted when results are deleted during the End of Shift wizard
When results are deleted during the End of Shift wizard, QC Results are only deleted from the QC Status Window. QC results remain saved in the QC History. Test applications that have been calibrated and have QC results remain green and don′t turn yellow; QC results remain valid.
Recommendations regarding the control setting "QC After Cal"
The setting "QC After Cal" (Utilities->Applications->Laboratory Parameters->Test->Control) is used to determine whether a Quality Control (QC) check is required after a calibration is run. Roche recommends doing a QC after each calibration for each test to ensure that the new calibration leads to correct results. Therefore, the setting "QC After Cal" should be set to "On".
Volume of calibrators and controls used during calibration and QC checks
In the case of a two-point calibration, the instrument must determine the absorbance of two different concentrations: the calibrator and water. Both measurements are performed in duplicate. Therefore, for a two-point calibration, the instrument requires two times the volume of the calibrator that is required for a sample measurement. For most tests, that means <10 μL. The exact sample volume required for a specific test application is provided in the respective Instructions for Use.
IgG and Acetate Bio are currently the only Cedex Bio tests that do not use a two-point calibration. Instead, they use a calibration curve consisting of different calibrator concentrations. The calibrator dilutions required to generate the different concentrations for the calibration curve are produced by the instrument onboard during the calibration. The required volume for the calibration of these tests is, therefore, much higher compared to the two-point calibrations. For the IgG Bio, the volume required also depends on the number of applications to be calibrated (e.g., all three IgG applications IGGLB, IGGHB, IGGHD). We recommend providing 500 μL of calibrator A for the IgG Bio calibration.
Measurement of a control for a test requires the sample volume required for a sample measurement. See the respective Instructions for Use.
Not possible to accept Quality Control (QC) results as a "batch" and repeat them all at once
QC results can be set up to be automatically accepted (Utilities->Configuration->Result Handling->QC Auto Accept/QC Acceptable Flags). However, if QC results have to be manually validated, they must be validated singly. Select each result individually and choose to accept, ignore, or repeat the run.
Frequency of control checks for Na
Running a quality control (QC) after a calibration is generally recommended for test applications on the Cedex Bio Analyzer. The ISE module is calibrated every day, which means a QC for Na
needs to be run every day. It is possible but not recommended to perform measurements without a daily QC check. However, each lab must test and determine the preferred frequency of QC checks, based on local preferences or requirements.
Acceptance criteria for Na
calibrations performed during BOD
1) The Calibration must be without flag.
2) The slope and Sol 1 Factor should be within the following ranges:
Sodium Electrode (Na+): 45 and 63
Potassium Electrode (K+): 45 and 62
Solution 1 Factor ranges
The ISE Solution 1 Factor should be normally 1 and can vary from 0.96 to 1.04.
The absolute range values are min. 0.85 and max. 1.15.
Entering concentration information for ISE solutions 1 and 2
The concentration values for ISE solutions 1 and 2 are fixed in the software, as each lot has the same concentrations. Only the lot and expiration dates need to be entered into the software.
Description of the ISE 1-point calibration
After each ISE measurement, the instrument automatically performs a 1-point calibration using the Calibrator Indirect that is onboard. After the calibration, the slope of the calibration curve is not changed but may be shifted.
ISE Solution 1 Factor
The ISE Solution 1 Factor is the slope of the ISE calibration curve.
ISE Calibrators used for the 2 point calibration of the ISE module
ISE Solution 1 and 2 are used for the 2 point calibration of the ISE module.
Troubleshooting - Help Corner
Instrument calculated a result with a negative concentration and flagged it "< test range"
This can occur if no analyte is present in the sample. In such a case, no absorbance is detectable, and the concentration is zero and flagged with " < test range".
A negative concentration may be shown in the following circumstances:
Water almost never has an absorbance of exactly 0.000 dA. If the absorbance values of the measurement of water (per definition set to 0.0 mmol/L) is slightly higher than the absorbance values in a sample that does not contain the analyte, the concentration of the analyte in the sample would be calculated with a negative concentration. This can also occur with water during calibration.
The Daily Prepare Action was unsuccessful
This may occur if there is a hardware error. However, it could be due to the SW. Do not use the software or touch the screen while maintenance actions are running, as this may disturb the instrument and the maintenance action.
Calibration for test application
The calibration material required for test applications varies by application. Refer to the Instructions for Use for the relevant test application for more information about calibration material.
Quality controls for test applications
Quality controls are available for the test applications. Refer to the Instructions for Use for the relevant test application for more information about the recommended quality controls.
Test Ranges Cedex Bio Analyzer
For information about the ranges of the various tests, please refer to the relevant Instructions for Use for the test. In addition, the document "Cedex Bio/Cedex Bio HT Analyzer tests", located on the CustomBiotech Cedex Bio HT Analyzer product page under the section 'Assay Overview', contains an overview of all of the tests:
Typical run time
1 cycle = 18 sec
Cedex Bio Analyzer Operator's Manual 3.4 SW 2.3 Jul 2018 - EN
Operators Manual V3.1 (EN)
Cedex Bio System Operators Manual 3.3 SW 2.2 - Dec 2017
CustomBiotech Cedex Bio and Bio HT Analyzer Osmolality Flyer
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