en

Alinity c

CCQ_02_en
Alinity c Assay File(s)
Please read the following information before installing assay files on your system.
• To install an assay file, follow the instructions in the Alinity ci-series Operations Manual, Section 2.
• When a new assay file is installed, all customer-editable assay parameters are set to the default values.
For instructions to configure customer-editable assay parameters, refer to the Alinity ci-series Operations
Manual, Section 2.
• For assay file versions that differ from the previous file versions and that require installation or reinstallation,
all customer-configured parameters are retained except the following parameters: Run calibrations for
reagents by lot or kit, calibrator replicates, full calibration interval, slope limit for ICT assays, correlation
factor, and intercept.
• If previously edited, these parameters will change to the default value in the updated assay file during
installation.
• Customer edits to the following assay parameters are not retained when a newer file version is installed if
the parameters were not provided (blank) in a previous file version and are configured in the newer file
version:
• Run controls for onboard reagents by lot or kit • Expected cal factor
• Blank absorbance range • Expected cal factor tolerance %
• Span definition • Sample dilutions
• Span absorbance range • Result interpretations

• Refer to the assay-specific information section before installing the assay file.
• Refer to specific Assay Instructions For Use for additional information.
Key to Symbols
Identifies products to be used together

Consult instructions for use

Manufacturer

In Vitro Diagnostic Medical Device

Alinity is a trademark of Abbott Laboratories in various jurisdictions.

Abbott GmbH & Co. KG
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580

www.abbottdiagnostics.com
November 2016
© 2016 Abbott Laboratories
 Assay File Name Assay Number Assay Version Assay List Number

Prealbumin 1062 5 09P86-1A

The Prealbumin assay file is available for product launch. The Alinity c Prealbumin assay file
requires Alinity ci-series System software V1.1 or higher.

January 2018

Assay File Name Assay Number Assay Version Assay List Number

IgG 1058 3 09P62-1A

The IgG assay file is available for product launch. The Alinity c IgG assay file requires Alinity
ci-series System software V1.1 or higher.

January 2018

Assay File Name Assay Number Assay Version Assay List Number

Magnesium 1070 5 08P19-1B

The Magnesium assay file has been updated with a new SmartWash.

March 2018

Assay File Name Assay Number Assay Version Assay List Number

MagnesiumU 1099 5 08P19-3B

The MagnesiumU assay file has been updated with a new SmartWash.

March 2018

Assay File Name Assay Number Assay Version Assay List Number

APOB 1054 3 09P47-1A

The APOB assay file is available for product launch. The Alinity c APOB assay file requires
Alinity ci-series System software V1.1 or higher.

February 2018
 Assay File Name Assay Number Assay Version Assay List Number

CHE 1972 3 09P94-1A

The CHE assay file is available for product launch. The Alinity c CHE assay file requires Alinity
ci-series System software V1.1 or higher.

February 2018

Assay File Name Assay Number Assay Version Assay List Number

IgA 1057 3 09P61-1A

The IgA assay file is available for product launch. The Alinity c IgA assay file requires Alinity
ci-series System software V1.1 or higher.

January 2018

Assay File Name Assay Number Assay Version Assay List Number

P Amylase 1953 4 01R04-1A

The P Amylase assay file is available for product launch. The Alinity c P Amylase assay file
requires Alinity ci-series System software V1.1 or higher.

February 2018

Assay File Name Assay Number Assay Version Assay List Number

HBDH 1954 4 01R01-1A

The HBDH assay file is available for product launch. The Alinity c HBDH assay file requires
Alinity ci-series System software V1.1 or higher.

March 2018

Assay File Name Assay Number Assay Version Assay List Number

APOA1 1053 3 09P46-1A

The APOA1 assay file is available for product launch. The Alinity c APOA1 assay file requires
Alinity ci-series System software V1.1 or higher.

February 2018
 Assay File Name Assay Number Assay Version Assay List Number

A1cWB 3074 5 08P43-3A

The A1cWB assay file is available for product launch. The following constituent assay files
will be installed with the A1cWB assay file: THbWB and HbA1cWB assay files. When A1cWB
is installed, the calibration panel for A1cWB is made available. The Alinity c A1cWB assay file
requires Alinity ci-series System software V2.0 or higher.

March 2018

Assay File Name Assay Number Assay Version Assay List Number

%A1cWB 3075 5 08P43-5A

The %A1cWB assay file is available for product launch. The following constituent assay files
will be installed with the %A1cWB assay file: THbWB and HbA1cWB assay files. When
%A1cWB is installed, the calibration panel for %A1cWB is made available. The Alinity c
%A1cWB assay file requires Alinity ci-series System software V2.0 or higher.

March 2018

Assay File Name Assay Number Assay Version Assay List Number

A1cH 3076 5 08P43-1A

The A1cH assay file is available for product launch. The following constituent assay files will
be installed with the A1cH assay file: THbH and HbA1cH assay files. When A1cH is installed,
the calibration panel for A1cH is made available. The Alinity c A1cH assay file requires Alinity
ci-series System software V2.0 or higher.

March 2018

Assay File Name Assay Number Assay Version Assay List Number

%A1cH 3077 4 08P43-7A

The %A1cH assay file is available for product launch. The following constituent assay files
will be installed with the %A1cH assay file: THbH and HbA1cH assay files. When %A1cH is
installed, the calibration panel for %A1cH is made available. The Alinity c %A1cH assay file
requires Alinity ci-series System software V2.0 or higher.

March 2018

Assay File Name Assay Number Assay Version Assay List Number

IgM 1059 4 09P63-1A

The IgM assay file is available for product launch. The Alinity c IgM assay file requires Alinity
ci-series System software V1.1 or higher.

November 2017

Assay File Name Assay Number Assay Version Assay List Number

C3 1055 4 09P56-1A

The C3 assay file is available for product launch. The Alinity c C3 assay file requires Alinity
ci-series System software V1.1 or higher.

October 2017

Assay File Name Assay Number Assay Version Assay List Number

C4 1056 3 09P57-1A

The C4 assay file is available for product launch. The Alinity c C4 assay file requires Alinity
ci-series System software V1.1 or higher.

October 2017

Assay File Name Assay Number Assay Version Assay List Number

Haptoglob 1060 3 09P59-1A

The Haptoglob assay file is available for product launch. The Alinity c Haptoglob assay file
requires Alinity ci-series System software V1.1 or higher.

October 2017