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MyExpertQC User's Guide

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Table of Contents

1 Introduction.................................................................................................. 4

2 Accessing the application .......................................................................... 4

3 General description of the application ...................................................... 6

4 Creating laboratory instruments ................................................................ 7

5 Combining reagents and instruments (manual mode only) .................... 9

6 Creating laboratory users ......................................................................... 11

7 Creating an IHN (Integrated Health Network) .......................................... 13

8 Entering IQC results .................................................................................. 15

8.1 Automatic mode .....................................................................................................15

8.2 Semi-automatic mode ............................................................................................15

8.2.1 Exporting IQC from the workstation .......................................................................15 8.2.2 Importing IQC into MyExpertQC.............................................................................16

8.3 Manual mode .........................................................................................................17

9 Validate the results .................................................................................... 19

10 Activity report ............................................................................................ 20

11 Producing statistical reports .................................................................... 21

11.1 Instantaneous report [QUICK] ................................................................................22

11.2 Periodic report [FULL] ............................................................................................24

11.3 Graphic report [GRAPHICAL] ................................................................................26

11.3.1 [Box Plot] type graph ..............................................................................................28 11.3.2 Trueness Indicators ...............................................................................................29 11.3.3 Youden plot ...........................................................................................................30 11.3.4 Historical Graph .....................................................................................................31 11.3.5 Quality Indicators ...................................................................................................31

Statistical Guide ..................................................................................................... 32


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1 Introduction

MyExpertQC is an application, which enables biology laboratories to check the accuracy of their IQC

by comparison with participating laboratories in real time.

The comparison groups consist of laboratories, which use:

- the same Stago quality controls with the same lot number,

- the same Stago reagent (irrespective of packaging),

- the same instrument, or family of instruments, and also all Stago instruments,

- which are in the same country or from throughout the world.

Associated with the Quality External Evaluation (EQA) performed on a regular basis, the eIQC is an

additional measurement tool that allows real-time audits of the performance of determination methods,

the accuracy and the trends of IQC.

Laboratories using IQC, EQA and eIQC supervise as closely as possible patient results.

Internet link to access the application: www.myexpertqc.com

Compatible browsers:

- Google Chrome

- Internet Explorer (version 10 or higher version)

2 Accessing the application

Go to the MyExpertQC website: www.myexpertqc.com

http://www.myexpertqc.com/

https://stago-eiqc-prod.cegedim-hds.fr/#!/Intro


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MyExpertQC homepage contains links to:

- MyExpertQC registration form (for laboratory manager),

- Information request form,

- password reset form to access the application if the password has been forgotten,

- administrator’s email and Stago group website.

Registration (only for laboratory manager):

Beforehand, the laboratory manager must register. Thereafter, they will be able to create sessions for

the other users of the laboratory.

Click [PRE REGISTRATION] to make a registration request for MyExpertQC.

Registration requests are submitted to MyExpertQC administrators for validation.

Once the registration is validated, the laboratory manager will have to:

1- If necessary, create the additional instruments of the laboratory (see chapter 4)

2- Set up the reagents and lots used (see chapter 5) in manual mode

3- Create the laboratory user accounts (see chapter 6)

Account access:

Click [LOG IN] to access your personal account.

Enter your username and password.

Click [LOG IN] to validate.

Note: Upon the first login, a window is displayed to reset the password and select the language of the

application. Then, MyExpertQC tutorial begins in a new window.


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3 General description of the application

1. Header

- Name of the current menu

- Tabs to access current menu options

- Action buttons for the current menu

2. Left panel (drop-down menu)

- Application main menus and submenus

- Application help. It contains tutorials, documentation, contact list and information about the

application version. It also allows the user to send a message to the administrator.

3. User button

- Information about the user

- Logout

4. Filter panel

Each user has its own list of favorite settings.

The favorite settings of the reports are different from the favorite settings for the QC results.

- Apply filters (date, instrument, lot…)

- Save filters in [Favorite settings]

Select filters to apply.

In [Favorite settings], click [Select...] to enter the filter's name then press Enter.

Click appearing near the filter's name then click [SAVE].


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- Change a filter saved in [Favorite settings]:

In [Favorite settings], select the required filter.

Change the required parameters of the filter.

Click appearing near the filter's name then click [SAVE].

- Delete a filter in [Favorite settings]:

In [Favorite settings], select the required filter then click .

Click [DELETE].

4 Creating laboratory instruments

Note: This option is only accessible by the laboratory managers (« Manager » profile).

Laboratory instrument creation and management are available in the [LABORATORY

INSTRUMENTS] menu.

In the left panel, click [Laboratory].

The [LABORATORY INSTRUMENTS] screen is displayed.

This screen displays the information concerning the laboratory on the left part of the screen and

concerning the laboratory instruments in the [INSTRUMENTS] section.

In order to add a new instrument, click the [ADD NEW INSTRUMENT] button on the header.

The following window is displayed:


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Complete the fields.

Note: If you have an STA Coag Expert workstation and it is connected to Connect.One, the input

mode is [Auto].

Note: The [Input mode] drop-down list enables to select the data entry method (automatic, semi-

automatic or manual). For the semi-automatic mode (results imported from a USB stick), select

[Manual].

Note: The [Temporarily disabled] option deactivates the instrument temporarily. If this option is

selected, data cannot be entered for the instrument and comparisons are not available.

Note: If you do not know the contract duration, select [1-year] in [Renew contract].

Click [SAVE].

The instrument is displayed in the [INSTRUMENTS] section.

Note: Adding a new instrument requires validation from MyExpertQC administrators. As long as the

instrument request is not validated, the instrument status is “Pending”. When the instrument request is

validated, the instrument status is “Valid”. The user may then modify the instrument information by

clicking [EDIT]. From that moment on, it can be used to enter and receive IQC data.

In order to update the laboratory information, click , on the left side of the customer number.

In order to modify the instrument information, click the [EDIT] button on the right side of the

instrument concerned.


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5 Combining reagents and instruments (manual mode only)

Note: This option is only accessible by the laboratory manager (« Manager » profile).

Note: This option must be only used for instruments in manual mode. For the instruments in automatic mode, the files already contain all the necessary data.

Combining reagents and instruments is available in the [LABORATORY INSTRUMENTS] menu.



Click [SETUP MANUAL ENTRY] to combine reagents with the instrument.


Click in the fields to select the controls, parameters and reagents used on the instrument.


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In order to select several parameters in one field, select the first parameter, then, when it is

displayed in the field, click below it to display the drop-down list again.

Click [SAVE].

Click the [LOTS] tab.

The [LABORATORY LOTS] screen is displayed.

Select the control name in the [Control product] drop-down list then tick the box corresponding to

the lot used on the instrument.

Note: Expired lots can be hidden by deselecting the option [Show expired lots] (the button is grayed

out).

Click [SAVE CHANGES].


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6 Creating laboratory users

Note: This option is only accessible by the laboratory managers (« Manager » profile).

Laboratory user creation and management are available in the [LABORATORY USERS] menu.

This menu enables the creation of new users, the display and modification of existing users.

In the left panel, click [Users].

The [LABORATORY USERS] screen is displayed.

Information displayed in the [LABORATORY MANAGER] section are related to the laboratory

manager and information displayed in the [USER] section are related to the existing users.

In order to add a new user, click [ADD NEW USER] in the header.



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Complete the fields.

Note: The [User code] field indicates the identifier for the user to enter MyExpertQC website. It must

be individual (for example email).

There are 2 different types of user profiles:

- User: allowing a laboratory member to enter quality control results and to consult reports,

- Manager: allowing access to the user and instrument management options and laboratory report

follow-up.

It is possible to have several users of each profile in a laboratory.

The password must contain at least an uppercase letter, a lowercase letter and a number.

The following fields are mandatory:

- [First name]

- [Last name]

- [Phone]

- [User code]

- [Email]

- [Password]

- [Retype password]

Click [SAVE].

The created user is displayed in the [USER] section.

In order to modify an existing user, click .


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7 Creating an IHN (Integrated Health Network)


The laboratory manager can create an IHN (Integrated Health Network) including his laboratory and

other invited laboratories. The laboratories can visualize the IQC of the network.

Creating and managing a laboratory network is available in the [Laboratory] menu.



Click [CREATE IHN] then enter the form fields.

The creation requires validation from MyExpertQC administrators.

Click [INVITE LAB] to invite a laboratory in the network. The invited laboratory receive an invitation

that can be refused or accepted.



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Complete the fields:

- [Laboratory name]: laboratory name as it is registered in MyExpertQC.

- [My Expert QC code]: MyExpertQC code of the invited laboratoiry. This code is available in the

[Laboratory] tab of the invited laboratory.

- [Email]: email address of the invited lab manager.

Click [INVITE].

When the invitation is accepted, the laboratory manager can visualize the network laboratories in

the [IHN LABORATORIES] menu by clicking [Laboratories].

Note: A laboratory can leave a network at any time by clicking [LEAVE IHN].


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8 Entering IQC results

The IQC results can be entered into the application in three different ways:

- in automatic mode: results from the STA Coag Expert workstation (from software version 5.10 or

later version, this information is displayed on the connection screen of the STA Coag Expert) are

automatically imported into MyExpertQC,

- in semi-automatic mode: results from the STA Coag Expert or STA Coag ConneXion workstation are

exported to a USB stick and then imported into MyExpertQC,

- in manual mode: the results (unit values or mean values) are entered manually into MyExpertQC.

8.1 Automatic mode

The automatic mode requires prior settings on the STA Coag Expert workstation from a field service

engineer.

During the setting, the user can choose the transmission frequency of results to MyExpertQC:

- it can be automatic (frequency to be set) or

- on demand by clicking [MyExpertQC] button on the STA Coag Expert [QUALITY CONTROL –

CURRENT VALUES] menu.

The IQC results are automatically displayed on the [QC LIST] screen according to the option set.

Note: Only validated IQC results on the current lot are transmitted to MyExpertQC.

8.2 Semi-automatic mode

IQC results are exported from the workstation used in the laboratory (STA Coag Expert or STA Coag

ConneXion) to a USB stick then imported manually in MyExpertQC.

8.2.1 Exporting IQC from the workstation

From an STA Coag Expert workstation

Click [MyExpertQC] in the [QUALITY CONTROL – CURRENT VALUES] screen.

Note: Only validated IQC results on the current lot are exported.



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Select the instruments, controls and period to export.

Click [Validate].

IQC results are exported in XML format in « C:\pilote\genfiles\EIQC ».

The name of the exported file is made of the customer code, the license number and the date and

hour.

Note: The location for the exported files can be modified during the STA Coag Expert setting.

From an STA Coag ConneXion workstation

In the Toolbar, click to open TrackTool 2.

TrackTool 2 identification window is displayed.

Type your username in capital letters then press Enter.

TrackTool2 opens, displaying the dashboard for Patients and Quality Controls.

Click [MyExpertQC] then [Export].

The [MyExpertQC] window is displayed.

Start a search for the requested period by selecting the start and dates and then, click [Search].

Note: To refine the search, select an analysis or an instrument.

The results found for the requested period are displayed.

Click [Export] to export the results.

Quality Controls are exported as HTML file to a folder selected by the user.

8.2.2 Importing IQC into MyExpertQC

From MyExpertQC, click [Data monitoring] then click [IMPORT] in the header.

Click [SELECT] then select the XML file to import.


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Click [UPLOAD FILE].

The list of the data contained in the file is displayed.

Click [CANCEL] to cancel the importation or [PUBLISH] to accept the data importation.

The IQC results are imported in the corresponding instrument tiles.

8.3 Manual mode

In the left panel, click [Data monitoring] then click [QC List].

The [QC LIST] screen is displayed.

In the left-hand [CONFIGURATION] panel, select the parameters to be applied using the 5 filters

described below to select the report to be generated.

Or select a favorite filter setting in [Favorite settings].

[Period]: select the comparison period for the IQCs from the following six options (only one option can

be chosen)

- [Today] = current day

- [Monthly] = a month to be selected

- [Custom] = a period to be defined

- [Current month] = current month

- [Last 12 months] = last 12 months

- [Last 30 days] = last 30 days

[Instruments]: choose the instrument for which the IQC results must be compared (several options

can be chosen)

[Controls] : choose the control for which the IQC results must be compared (several options can be

chosen)

[Parameters] : choose the parameter for which the IQC results must be compared (several options

can be chosen)

[Levels] : choose the level for which the IQC results must be compared (several options can be

chosen)

The results are shown in the main part of the window.

Click the tile that corresponds to the instrument, the test and the reagent used.

The chosen tile is displayed in the [QC VALUES] screen.

If the value to be entered is a unit value:

In the [ENTER NEW VALUES] panel, click the [VALUE] button.


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For each IQC value to be entered, enter the following information:

- The date: click then select the date of the IQC result.

- The time: use the arrows or enter the hour and minutes directly.

- The quality control lot number: click the [Reagent Lot] field then select the lot from the scroll list. If

the lot number is not in the list, enter the number then press Enter.

- The value: enter the IQC value in the [Value (unity)] field.

Note: Use a point as the separator for decimals.

Click the [ADD] button.

If the value to be entered is a mean of values:

In the [ENTER NEW VALUES] panel, click the [MEAN] button.

For each mean of IQC values to be entered, enter the following information:

- The start of the period: click in the [From] field then select the period start date.

- The end of the period: click in the [To] field then select the period end date.

- The quality control lot number: click the [Reagent Lot] field then select the lot from the scroll list. If

the lot number is not in the list, enter the number then press Enter.

- The mean value: enter the value in the [Mean (Unity)] field.

- The number of values used to calculate the mean: enter the number of values in the [Nb Values]

field.

- The standard deviation: enter the standard deviation value in the [SD] field.

Note: Use a point as the separator for decimals.

Click the [ADD] button.

The value(s) entered are displayed in the [HISTORY] zone.

They are sorted into date chronological order, from the most recent to the least recent. All the

values may be shown or they may be grouped together by month (by clicking on [MONTLHY] or by

week by clicking on [WEEKLY]). For the dates prior to the selected date filter, the values will not be

displayed unless the date filter is modified.

By passing the mouse cursor over the status of a value, a tooltip is displayed detailing its

associated modification history.


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9 Validate the results

In manual mode, the results must be validated so that they can be included in statistical reports.

Results cannot be modified once they are validated.

In case of typing mistakes on validated results, it is possible to contact the local administrator to

invalidate a result to correct it.

In the left panel, click [Data monitoring].

The [QC LIST] screen is displayed.

The number of results that are not validated is displayed for each tile on the right-hand side

.

In the left-hand [CONFIGURATION] panel, select the parameters to be applied using the 5 filters




be chosen)








can be chosen)

[Controls] : choose the control for which the IQC results must be compared (several options can be

chosen)

[Parameters] : choose the parameter for which the IQC results must be compared (several options

can be chosen)

[Levels] : choose the level for which the IQC results must be compared (several options can be

chosen)

The results are shown in the main part of the window.

Click the tile that corresponds to the instrument, the parameter and the reagent used and whose

results are to be validated.

The chosen tile is displayed in the [QC VALUES] screen.

Click the button located at the top right of the screen to validate at once all the

results that have not been validated yet, or click the button located on the line of the result to

be validated.

Click [VALIDATE] to confirm validation of the results.


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10 Activity report


[QC ACTIVITY] screen displays an overall view of IQC results.

In the left panel, move the mouse over [Data monitoring] then click [QC activity].

The [QC ACTIVITY] screen is displayed.

The total number of IQC and the total number of IQC with alerts and errors are displayed. They are

sorted by tests or by instrument.

Filters can be applied on the period, the instruments, the controls, the parameters and the levels of

control.

The button on the upper right side of the screen, enables to display or to hide the

instruments in the [TESTS] section and the tests in the [INSTRUMENTS] section. All the

information are displayed by default.

Click [EXPORT] to export the results in Excel format.

Click [PRINT PDF] to export the results in PDF format.


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11 Producing statistical reports

The IQC values are analyzed using several points of comparison: the instrument, the parameter and

geographic location.

The statistical use of the results is made available in the form of various types of reports:

instantaneous reports, graphic reports and periodic reports.

The statistics for an instrument are calculated with all the values validated by the participant, while the

statistics for the comparison group are calculated with the mean of the validated values for each

instrument. See example below:

1: All the values validated by the participant for the selected instrument

2: The mean of the values validated by the participant for the selected instrument

3: The mean of the values validated by the comparison group for each instrument

4: Mean value of the comparison group

This is applicable to every type of reports (quick, full or graphical).


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11.1 Instantaneous report [QUICK]

Generating an instantaneous report [QUICK] allows the principle indications relating to a laboratory's

IQC values to be seen in comparison with those of the other participants.

In the left-hand panel, click [Reports].

The [REPORTS] screen is displayed. The [QUICK] option is selected by default.

The [GENERAL INFORMATION] panel shows the laboratory's address, the user account in use,

the type of statistical report selected and the comparison mode chosen (instrument and geographic

zone).

In the left-hand [FILTERS] panel, select the parameters to be applied using the four filters




be chosen)








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[Compare with]: choose the comparison model from the 6 possible options (only one option can be

chosen)

- [World -compatible] = all compatible instrument models combined and all countries combined

(selected by default)

- [Country - compatible] = all compatible instrument models and same country

- [World - same Model] = same instrument model over the entire world

- [Country - same Model] = same instrument model and same country

- [IHN – same model] = same instrument model and same IHN

- [IHN – compatible] = all compatible instrument models and same IHN


can be chosen)

[Parameter]: choose the parameter for which the IQC results must be compared (several options can

be chosen)

Click [APPLY FILTER].

The results are displayed in the [INSTANT RESULTS] zone.

For each parameter chosen, the mean for the laboratory, the standard deviation, the coefficient of

variation (CV), the percentage of values with an alert (these values are taken into consideration in

the report) and the percentage of rejected values (these values are not taken into consideration in

the report) are displayed in comparison with the selected health network values selected (a line for

the normal control and a line for pathological control).


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11.2 Periodic report [FULL]

Generating a periodic report allows all indications relating to a laboratory's IQC values to be displayed

in comparison with those of the other participants.


The [REPORTS] screen is displayed.

Click .



zone).





be chosen)







[Compare with]: choose the comparison model from the 6 possible options (only one option can be

chosen)




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[Instrument]: choose the instrument for which the IQC results must be compared (several options can

be chosen)


be chosen)

The results are displayed in the [PERIODICAL RESULTS] zone.

For each parameter selected, the laboratory's results are displayed in comparison with the results

of the selected comparison group.




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11.3 Graphic report [GRAPHICAL]

Generating a graphic report allows the principle indications relating to a laboratory's IQC values to be

seen in comparison with those of the other participants in the form of a graph.


The [REPORTS] screen is displayed.

Click .



zone).





be chosen)








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Type of graph]: select the type of graph to be displayed (several options can be chosen)

- [Box Plot] = See Box Plot (paragraph 11.3.1)

- [Trueness indicators]: See Trueness Indicators (paragraph 11.3.2)

- [Youden Plot]: See Youden Plot (paragraph 11.3.3)

- [Historical Graph]: See Historical Graph] (paragraph 11.3.4)

[Compare with]: choose the comparison model from the 6 possible options (only one option can be chosen)








[Instrument]: choose the instrument for which the IQC results must be compared (several options can

be chosen)


be chosen)

The graphs and the results are shown in the [PERFORMANCE INDICATORS] zone.


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11.3.1 [Box Plot] type graph

The Box Plot is a graphical representation of the result distribution. It allows you to compare the

distribution of your results with your comparison group result distribution (country, instrument...).

A box-pot is a graph made up of a rectangle with a straight

line at each end (the "mustache") representing some elements

of the data.

The central value of the graph is the median (there are as

many higher values as there are lower values in the sample).

The edges of the rectangle are the quartiles. Lower edge or

first quartile (Q1): at least 25% of the values are below or

equal to Q1. The upper edge or third quartile (Q3): at least

75% of the values are below or equal to Q3.

The ends of the 'mustache' are calculated using the inter-

quartile interval (Q3 - Q1) according to the following formulas:

- Upper edge: Q3 + 1.5(Q3 - Q1)

- Lower edge: Q1 - 1.5(Q3 - Q1)

It can be seen that 50% of observations are located within the

box.

The values beyond the 'mustache' are represented by points. An observation beyond the 'mustache' is not necessarily

aberrant. On the other hand, this does indicate that this

observation must be studied in greater detail.


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11.3.2 Trueness Indicators

The Trueness Indicator graph is a graphic representation of the relative trueness of the participant in

relation with the comparison group for 2 levels of controls at the same time.

The Trueness Indicator (also called TRuness Index = TRI) is the gap between the laboratory mean

value and the mean value of the comparison group, expressed in standard deviation. The TRI can be

linked to the Z score used for the EQA method validation.

TRI interpretation:

-2 ≤ TRI ≤ 2 Good performance. No action required.

-3 ≤ TRI < -2 or 2 < TRI ≤ 3 A monitoring action must be set up.

TRI < -3 or TRI > 3 An impact analysis is required and a corrective action must be set

up, if necessary.


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11.3.3 Youden plot

A Youden plot is a representation of the mean comparison for both IQC levels.

A Youden graph is made up of:

- a horizontal axis = results of the 1st sample

- a vertical axis = results of the 2nd sample

The graph is centered on the robust mean. The values are shown using the unit being studied and are

assessed in relation to the standard deviation of the level of comparison used (comparison group).


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11.3.4 Historical Graph

This is a graph used to monitor the monthly mean for the laboratory and for the comparison group and

is used to display any variations or drift for the laboratory and for the comparison group.

11.3.5 Quality Indicators

The number of values selected by the filters are displayed in the [REPORT QUALITY INDICATORS].

For each parameter selected, the total number of values for the laboratory, the percentage of

values with an alert (these values are taken into consideration in the report) and the percentage of

rejected values (these values are not taken into consideration in the report) are displayed in

comparison with the values of the selected comparison group (a line for the normal control and a

line for the pathological control).




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Statistical Guide

The standard deviation1 is a measure of the variation of a statistical series around its mean.

Because it is closely linked to the mean, the standard deviation may be significantly affected if the

latter gives an incorrect measure of the central trend.

The arithmetic mean1 corresponds to the total sum of the observed values divided by the number of

values.

The variance2 is a measurement used to characterize the dispersion of a sample or of a distribution.

Since the variance is calculated from the square of the standard deviation, the measurement units are

not the same as those for the original observations.

Furthermore, if all the samples are equal to 0, then the variance has a null value.

1 http://www.statcan.gc.ca/edu/power-pouvoir/ch12/5214891-fra.htm 2 http://www.agro-montpellier.fr/cnam-lr/statnet/mod6/mod6lx.htm#46


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Coefficient of variation

The coefficient of variation is a measurement that relates to the dispersion of data around the mean.

The CV is calculated as being the ratio of the standard deviation to the mean. It is used to assess the

dispersion of values around the mean, that is, to compare the degree of variation of one sample with

another, even if the means are different.

PRecision Index (PRI)

The index of precision is calculated using the following formulae:

PRI = participant CV / CV of the comparison group

This ratio allows for the comparison of the laboratory performance in terms of dispersion (analytical

accuracy). PRI<1 means the performance is excellent, above the average of the peer group.

Trueness Index (TRI)

The TRI is calculated using the following formulae:

TRI = (Robust mean of the participant – Robust mean of the comparison group) / Standard deviation of the comparison group.

At the Heart of Haemostasis [email protected] : +33 (0)1 47 91 08 91Tél. : +33 (0)1 46 88 20 2092600 Asnières sur Seine (France)3 allée ThérésaDIAGNOSTICA STAGO S.A.S.

Accessing MyExpert QC (USA & Canada)

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Accessing MyExpert QC (USA & Canada)

MyExpert QC is now also available in the USA and Canada.

Go to the MyExpertQC website: https://us.myexpertqc.com/

Select the language (mark 1 below).

Navigate the application website, refering to the User Guide for detailed instructions.

To switch back to the application settings of the other areas, click the [EUROPE AND OTHER] button

(mark 2 below).

When clicking the [LOG IN] button (mark 3), the displayed window requests a confirmation of the

required area. If necessary, adjust the selection.

https://us.myexpertqc.com/

information contained in this document, in particular data

Documents