17003-5.

0/02 F57 2022/09/22 REF 17003

Aldolase Alliance Application Sheet

Sentinel Diagnostics Reagent Preparation, Storage, and Stability

Aldolase Assay Application Sheet Note For reagent preparation, storage information, and
full product details, refer to the Instructions for Use.

For the Atellica CH Analyzer ®

REAGENTS

Refer to the appropriate Instructions for Use for
information regarding these reagents. Also refer
to the online help for instructions on filling and
loading operator-filled empty CH reagent packs.
Results of this test should always be interpreted in
conjunction with the patient’s medical history
clinical presentation and other findings.
The parameters defined in this application sheet
have been developed by Siemens Healthcare
Diagnostics to optimize product performance. Any
modification to these parameters may affect
performance of this and other assays in use on
your system and the resulting assay values. It is
the responsibility of the user to validate any
modifications and their impact on all assay
results.
Materials
These reagents are qualified for use with the
calibrator listed below.
Other material may be used for quality control
purposes.
These reagents are for serum use only.
SMN PRODUCT
Sentinel Siemens
Reagents Preparation and stability
REAGENT 1 = reconstitute the contents of a vial
of Reagent 1 with 20 mL of distilled water; let
stand for about 10 minutes and gently mix.
Stability: 2 week at 2-8°C.
REAGENT 2 = reconstitute the contents of a vial
of Reagent 2 with 1 mL of distilled water; let stand
for about 10 minutes and gently mix.
Stability: 4 week at 2-8°C.
REAGENT 3 = REAGENT 3, ready to use.
Stability: 4 months at 2-8°C.
Storage
Store at 2-8 °C. Reagents must be limpid.
Preparation of REAGENT working solution
(R1)
REAGENT working solution (R1) = mix 20 mL of
Reagent 1 with 0.4 mL of Reagent 2 and 0.1 mL
of Reagent 3.
Reagent Pack Preparation and Stability
Preparation Instructions
Transfer the appropriate reagent volumes into
Empty reagent packs (refer to Table 1).
For instrument stability information refer to
Table 2.

17003 10329216 Aldolase Table 1 – Reagent Pack Information

16550 10313439 Clin Chem Cal
N/A* 11097534 EMPTY Reagent Pack**
Contents Number
11538114 EMPTY1 Reagent Pack (8
N/A*
x Empty P1)**
of Tests
11538115 EMPTY2 Reagent Pack (8
N/A* Pack 1
x Empty P2)**
Well 1 (W1) 20 mL of Aldolase R1 4 x 167
*Not Applicable
working solution*

**Materials required but not provided. Well 2 (W2) Empty

*Do not adjust required fill volumes, otherwise a system error may
be generated.
 17003-5.0/02 F57 2022/09/22 REF 17003
Aldolase Alliance Application Sheet
Refer to the online help for instructions on filling Table 3 – TDEF Information
and loading operator-filled empty CH reagent Assay TDEF Code Time to First Result
packs.
Aldo 7068 8.9 minutes
Assay parameters have been predetermined in
the instrument software. The reagent pack must Explanation of symbols EN
be manually loaded on the Atellica® CH Analyzer.
Not all the symbols reported below could be present in the product
REAGENT / STANDARD / CALIBRATOR / CONTROL / DILUENT /
Table 2 - Calibration and Stability COLLECTION TUBE ( CT )
The terms refers to the: single reagent / standard / calibrator / control /
diluent / collection tube
Pack Calibration Lot Calibration Onboard Stability
IVD REF LOT
30 days 30 days 30 days In vitro Diagnostic Catalogue number Batch code
Medical Device

Cont. Distributed by
Important Information Contents of kit Distributed by Manufacturer
For performance characteristics, intended use,
limitations and a detailed description how to Caution, consult accompanying documents
perform the method, refer to the Aldolase REF Consult instructions for use Temperature limitation
17003 Assay Instructions for Use.
Made in Italy
Made in Italy
Do not reuse Use by
Procedure
1. For serum/plasma, dispenses 50µL primary Contains sufficient
Date of Manufacture Dispose of properly
sample and 200µL of Atellica Sample Diluent for <n> tests
into a dilution cuvette.
D. ID. N.
2. Dispenses 100 µL of Reagent 1 and 20 µL of Date Identification Name
special reagent water into a reaction cuvette.
3. Dispenses 25 µL of pre-diluted sample into a Rx only For use by or on the order of a physician only
(applicable to USA classification only).
reaction cuvette.
4. Measures the absorbance after sample
Note: changes in comparison to the previous version are
addition. indicated by a vertical bar in the text margin.
5. Mixes and incubates the mixture at 37°C
6. Reports results
Atellica® is a trademark of Siemens Healthineers.
Manufactured by Sentinel and distributed by Siemens
Calibration Healthineers.
Prepare a calibration by using the Clin Chem Cal.
Recalibtrate as indicated by control results. CONTACT INFORMATION
For orders and technical support, contact Siemens
Healthineers. Please contact your local representative.
Results
Results are reported in U/L. In Atellica software Siemens Healthcare Diagnostics Inc.
versions greater than or equal to 1.25.2, the 511 Benedict Avenue
assay has an automatic 1:2 dilution for samples Tarrytown, NY 10591
measuring >30U/L. Earlier versions of software siemens-healthineers.com
contain a 1:10 autodilution for these samples.
Distributed By: Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue, Tarrytown, NY 10591
Siemens-healthineers.com