Assay Specific Information - 2

en
Alinity i
IAQ_02_en
Alinity i 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: interpretation, linearity
range and calibrator replicates.
• If previously edited, these parameters will be changed to the default value in the updated assay file upon
installation.
• 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
NT-proBNP 414 2 04S79-1A
The NT-proBNP assay file is available for product launch. The Alinity i NT-proBNP assay file
requires Alinity ci-series System software V1.1 or higher.
May 2018
ProGRP 173 2 09P32-1A
The ProGRP assay file is available for product launch. The Alinity i ProGRP assay file requires
Alinity ci-series System software V1.1 or higher.
March 2018
CYFRA 21-1 717 3 09P40-1A
The CYFRA 21-1 assay file is available for product launch. The Alinity i CYFRA 21-1 assay file
May 2018
SHBG 837 2 09P38-1A
The SHBG assay file is available for product launch. The Alinity i SHBG assay file requires
March 2018
Urine NGAL 454 2 09P29-1A
The Urine NGAL assay file is available for product launch. The Alinity i Urine NGAL assay file
January 2018
EBV VCA G 432 2 09P21-1A
The EBV VCA G assay file is available for product launch. The Alinity i EBV VCA G assay file
December 2017
EBV VCA M 436 2 09P22-1A
The EBV VCA M assay file is available for product launch. The Alinity i EBV VCA M assay file
December 2017
EBV EBNA-1 428 2 09P20-1A
The EBV EBNA-1 assay file is available for product launch. The Alinity i EBV EBNA-1 assay file
December 2017
tHCY-DIL 193 2 09P28-3A
The tHCY-DIL assay file is available for product launch. The Alinity i tHCY-DIL assay file
January 2018
tHCY-UNDIL 183 2 09P28-1A
The tHCY-UNDIL assay file is available for product launch. The Alinity i tHCY-UNDIL assay file
January 2018
C-Peptide 699 2 09P36-1A
The C-Peptide assay file is available for product launch. The Alinity i C-Peptide assay file
March 2018
VitaminB12 654 2 07P67-1A
The VitaminB12 assay file is available for product launch. The Alinity i VitaminB12 assay file
April 2018
Folate RBC 375 4 08P14-3A
The Folate RBC assay file is available for product launch. The Alinity i Folate RBC assay file
March 2018
Folate 66 5 08P14-1A
The Folate assay file is available for product launch. The Alinity i Folate assay file requires
March 2018
Progest 199 11 08P36-1A
The Progest assay file is available for product launch. The Alinity i Progest assay file requires
January 2018
LH 645 13 07P91-1A
The LH assay file is available for product launch. The Alinity i LH assay file requires Alinity
ci-series System software V1.1 or higher.
January 2018
FSH 88 4 07P49-1A
The FSH assay file is available for product launch. The Alinity i FSH assay file requires Alinity
ci-series System software V1.1 or higher.
January 2018
Insulin 774 2 04T75-1A
The Insulin assay file is available for product launch. The Alinity i Insulin assay file requires
December 2017
Anti-TPO 184 4 09P35-1A
The Anti-TPO assay file is available for product launch. The Alinity i Anti-TPO assay file
November 2017
Anti-CCP 237 2 09P27-1A
The Anti-CCP assay file is available for product launch. The Alinity i Anti-CCP assay file
January 2018
Anti-Tg 174 3 09P34-1A
The Anti-Tg assay file is available for product launch. The Alinity i Anti-Tg assay file requires
October 2017
Testo 420 2 07P68-1A
The Testo assay file is available for product launch.
April 2017
Alinity i BNP-JP 653 3 08P25-1A
The BNP-JP assay file is available for product launch. The Alinity i BNP-JP assay file requires
August 2017
Alinity i Chagas 638 2 09P19-1A
The Chagas assay file is available for product launch. The Alinity i Chagas assay file requires
September 2017
Alinity i Total PSA 355 6 07P92-1A
The Total PSA assay file is available for product launch.
August 2017
Alinity i Free PSA 358 3 07P93-1A
The Free PSA assay file is available for product launch.
June 2017
Alinity i AFP 10 5 07P90-1B
The AFP assay file version was updated for internal use. There are no changes to the assay
parameters.
July 2017
Estradiol 488 7 07P50-1A
The Estradiol assay file is available for product launch. The Alinity i Estradiol assay file
August 2017
Alinity i HE4 3024 3 08P50-5A
The POSTM ROMA assay file is available for product launch. The following constituent assay
files will be installed with the POSTM ROMA assay file: CA 125 II and HE4. When both PREM
ROMA and POSTM ROMA calculated assay files are installed, the patient panel for ROMA is
made available.
June 2017
The PREM ROMA assay file is available for product launch. The following constituent assay
files will be installed with the PREM ROMA assay file: CA 125 II and HE4. When both PREM
ROMA and POSTM ROMA calculated assay files are installed, the patient panel for ROMA is
made available.
June 2017
iPTH 64 3 08P31-1A
The iPTH assay file is available for product launch. The Alinity i iPTH assay file requires
July 2017
iPTH Stat 67 3 08P31-3A
The iPTH Stat assay file is available for product launch. The Alinity i iPTH Stat assay file
July 2017
The HE4 assay file is available for product launch.
June 2017
Alinity i CA 19-9XR 598 3 08P32-1A
The CA19-9XR assay file is available for product launch.
January 2017
Alinity i CA 15-3 349 2 08P51-1A
The CA 15-3 assay file is available for product launch.
January 2017
Alinity i CA 125 II 593 2 08P49-1A
The CA 125 II assay file is available for product launch.
January 2017
Alinity i BNP 657 2 08P24-1A
The BNP assay file is available for product launch.
December 2016
T-Uptake 280 3 08P12-1A
The T-Uptake assay file is available for product launch. The Alinity i T-Uptake assay file
June 2017
Alinity i Anti-HBe 309 2 07P63-1A
The Anti-HBe assay file is available for product launch.
January 2017
Alinity i Rubella IgG 735 5 08P46-1A
The RubellaIgG assay file is available for product launch.
January 2017
Total T4 263 3 07P95-1A
The Total T4 assay file is available for product launch.
May 2017
Free T4 106 6 07P70-1A
The Free T4 assay file is available for product launch.
May 2017
Cortisol 607 3 08P33-1A
The Cortisol assay file is available for product launch.
January 2017
Alinity i rHTLV-I/II 470 3 07P61-1A
The HTLV I/II assay file is available for product launch.

January 2017
Alinity i HAVAb IgM 800 3 02R28-1A
The HAVAb IgM assay file is available for product launch.
February 2017
Alinity i Total T3 259 2 07P94-1A

The Total T3 assay file is available for product launch.
February 2017
Alinity i Free T3 97 2 07P69-1A
The Free T3 assay file is available for product launch.
February 2017
Alinity i Toxo IgG 3010 11 07P46-1A

Avidity
The Toxo Avi assay file is available for product launch. The following constituent assay files
will be installed with the Toxo Avi assay file: Toxo IgM, Toxo IgG-R, Toxo Avi1, and Toxo Avi2.
Assay panels, calculated assays, and retest rules will also be installed automatically.
March 2017
Alinity i Toxo IgM 500 4 07P47-1A
The Toxo IgM assay file is available for product launch.
March 2017
Ferritin 68 3 07P65-1A
The Ferritin assay file is available for product launch.
November 2016

The Toxo IgG assay file is available for product launch.
February 2017
The Toxo IgG-R assay file is available for product launch.
February 2017
Alinity i HBeAg 288 2 07P64-1A
The HBeAg assay file is available for product launch.
December 2016
Alinity i HBeAg 325 3 07P64-3A
The HBeAgQuant assay file is available for product launch.
February 2017
Alinity i CMV Avidity 3000 6 07P43-1A
The CMV Avi assay file is available for product launch. The following constituent assay files
will be installed with the CMV Avi assay file: CMV IgM, CMV IgG R, CMV Avi1, and CMV Avi2.
Assay panels, calculated assays, and retest rules will also be installed automatically.
February 2017
Alinity i CMV IgG 542 2 07P42-3A

The CMV IgG R assay file is available for product launch.
January 2017
Alinity i Anti-HBs 694 2 07P89-1A
The Anti-HBs assay file is available for product launch.
February 2017
Alinity i Anti-HBs 693 2 07P89-3A
The AntiHBsdil assay file is available for product launch.
February 2017
Alinity i HIV Ag/Ab 396 2 08P07-1A

Combo
The HIV Ag/Ab assay file is available for product launch.
November 2016
Alinity i Anti-HBc 328 2 07P86-1A

IgM
The Anti-HBc M assay file is available for product launch.
December 2016
Alinity i CEA 47 4 07P62-1A

The CEA assay file is available for product launch.
November 2016
Syphilis 565 13 07P60-1A
The Syphilis assay file is available for product launch.
November 2016
Alinity i CMV IgG 536 3 07P42-1A
The CMV IgG assay file is available for product launch.
January 2017
Alinity i HBsAg
Qualitative II 3021 7 08P11-1A
Confirmatory
The HBsAgQua%N assay file is available for product launch. The following constituent assay
files will be installed with the HBsAgQua%N assay file: HBsAgQuaC2, and HBsAgQuaC1
assay files. When HBsAgQua%N is installed, the patient panel for HBsAgQuaPa is made
available.
March 2017
Alinity i Anti-HCV 385 4 08P06-1A
The Anti-HCV assay file is available for product launch.
November 2016
Alinity i HBsAg 336 3 08P10-1A
Qualitative II
The HBsAg Qua assay file is available for product launch.
February 2017
Alinity i Anti-HBc II 729 4 07P87-1A
The Anti-HBc assay file is available for product launch.
November 2016

Confirmatory V.1
The HBsAgQntC assay file is available for product launch.
February 2017
The HBsAg dil assay file is available for product launch.
December 2016
The HBsAg assay file is available for product launch.
December 2016
Alinity i Rubella IgM 458 3 08P47-1A

The RubellaIgM assay file is available for product launch.
March 2017
Alinity i CMV IgM 499 3 07P44-1A
The CMV IgM assay file is available for product launch.
January 2017
Alinity i HAVAb IgG 286 2 08P26-1A
The HAVAb-IgG assay file is available for product launch.
December 2016
Alinity i STAT High 468 4 08P13-1A

Sensitive Troponin-I
The hsTnI STAT assay file is available for product launch.
November 2016
Vit D25OH 797 5 08P45-1A
The Vit D25OH assay file is available for product launch.
November 2016
Alinity i AFP 10 3 07P90-1A
The AFP assay file is available for product launch.

November 2016
TSH 248 7 07P48-1A
The TSH assay file is available for product launch.
November 2016
Prolactin 207 5 07P66-1A
The Prolactin assay file is available for product launch.
January 2017
Alinity i Total ß-hCG 658 8 07P51-1A
The B-hCG assay file is available for product launch.
November 2016

Assay Specific Information - 2

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Assay Specific Information - 2

Uploaded by

Copyright:

Available Formats

en

Alinity i Assay File(s)

• Refer to specific Assay Instructions For Use for additional information.

Consult instructions for use

In Vitro Diagnostic Medical Device

Alinity is a trademark of Abbott Laboratories in various jurisdictions.

Abbott GmbH & Co. KG

NT-proBNP 414 2 04S79-1A

ProGRP 173 2 09P32-1A

CYFRA 21-1 717 3 09P40-1A

SHBG 837 2 09P38-1A

Urine NGAL 454 2 09P29-1A

EBV VCA G 432 2 09P21-1A

EBV VCA M 436 2 09P22-1A

EBV EBNA-1 428 2 09P20-1A

tHCY-DIL 193 2 09P28-3A

tHCY-UNDIL 183 2 09P28-1A

C-Peptide 699 2 09P36-1A

VitaminB12 654 2 07P67-1A

Folate RBC 375 4 08P14-3A

Progest 199 11 08P36-1A

Insulin 774 2 04T75-1A

Anti-TPO 184 4 09P35-1A

Anti-CCP 237 2 09P27-1A

Anti-Tg 174 3 09P34-1A

Testo 420 2 07P68-1A

The Testo assay file is available for product launch.

Alinity i BNP-JP 653 3 08P25-1A

Alinity i Chagas 638 2 09P19-1A

Alinity i Total PSA 355 6 07P92-1A

The Total PSA assay file is available for product launch.

Alinity i Free PSA 358 3 07P93-1A

The Free PSA assay file is available for product launch.

Alinity i AFP 10 5 07P90-1B

Estradiol 488 7 07P50-1A

Alinity i HE4 3024 3 08P50-5A

Alinity i HE4 3023 4 08P50-3A

iPTH Stat 67 3 08P31-3A

Alinity i HE4 594 3 08P50-1A

The HE4 assay file is available for product launch.

Alinity i CA 19-9XR 598 3 08P32-1A

The CA19-9XR assay file is available for product launch.

Alinity i CA 15-3 349 2 08P51-1A

The CA 15-3 assay file is available for product launch.

Alinity i CA 125 II 593 2 08P49-1A

The CA 125 II assay file is available for product launch.

Alinity i BNP 657 2 08P24-1A

The BNP assay file is available for product launch.

T-Uptake 280 3 08P12-1A

Alinity i Anti-HBe 309 2 07P63-1A

The Anti-HBe assay file is available for product launch.

Alinity i Rubella IgG 735 5 08P46-1A

The RubellaIgG assay file is available for product launch.

The Total T4 assay file is available for product launch.

Free T4 106 6 07P70-1A

The Free T4 assay file is available for product launch.

Cortisol 607 3 08P33-1A

The Cortisol assay file is available for product launch.

Alinity i rHTLV-I/II 470 3 07P61-1A

The HTLV I/II assay file is available for product launch.

Alinity i HAVAb IgM 800 3 02R28-1A

The HAVAb IgM assay file is available for product launch.

Alinity i Total T3 259 2 07P94-1A