Rev. Date: 03/2024 ● After thoroughly mixing (do not shake) the control serum is ready for use.

EU Rev. MAC-100324
STORAGE AND STABILITY
AIA-PACK MULTI ANALYTE CONTROL ● Unopened vials of multi analyte control are stable at 2°-8°C up to the expiry date printed on the
label.
MAC ● The reconstituted control materials remain stable for 7 days, provided that the vials are kept tightly
sealed and refrigerated at 2°-8°C. Since some of the analytes have a limited stability one shall
INTENDED PURPOSE check the note of the EXTRA INFO AIA-PACK MULTI ANALYTE CONTROL. See Reference
The AIA-PACK MULTI ANALYTE CONTROL is intended for in vitro diagnostic use only for performing Documents section for location of the document.
quality control procedures, by healthcare professionals, with the Tosoh Automated Immunoassay ● Freshly reconstituted control sera can be frozen once in aliquots of not less than 0.5 ml at -20° C to
Analyzers for the analytes listed in the EXTRA INFO AIA-PACK MULTI ANALYTE CONTROL. -80°C and are stable for 4 weeks. Since some of the analytes have a limited stability one shall
check the note of the EXTRA INFO AIA-PACK MULTI ANALYTE CONTROL. See Reference
SUMMARY AND EXPLANATION Documents section for location of the document.
The AIA-PACK MULTI ANALYTE CONTROL is a stable, lyophilised control serum based on human PROCEDURE
serum. The performance of the analyser can be checked with the three significant levels for Internal
Quality Control (IQC) provided in this product. The AIA-PACK MULTI ANALYTE CONTROL is prepared Set up the AIA / AIA-CL analyzer for analysis. Refer to the AIA Analyzer Operators’ Manual.
from pooled human serum with the addition of components of human origin to achieve levels of clinical This product should be treated the same as patient specimens and run in accordance with the
significance. instructions accompanying the reagent being used.
The device itself is not automated but is intended for use with an automated instrument (AIA and AIA-
CL analyzers from Tosoh). It is to be used together with the relevant AIA-PACK and/or CL AIA-PACK 1. Load the appropriate amount of AIA / CL AIA-PACK test cups on the analyser.
reagents and calibrators. More details can be found in document "Overview Material required, not 2. Add the appropriate amount of each control to sample cups. (Refer to the analyser work list for the
provided". See Reference Documents section for location of the document. sample volume.)
These products are intended to be used exclusively by the healthcare professionals. The AIA-PACK 3. Print a work list and place the sample cups in the position indicated.
MULTI ANALYTE CONTROL is intended as a quality control material to evaluate and monitor the 4. Select START. Verify that the positions on the work list match the starting position on the screen.
performance Tosoh analyzers by being assayed as sample. ASSIGNMENT OF VALUES
MATERIAL SUPPLIED 1. The confidence limits are the assigned values plus/minus two times the overall standard deviation
Cat. No. 0960474 of the value assignment.
2 x 3 ml Control Level 1 2. Values are provided by the EXTRA INFO AIA-PACK MULTI ANALYTE CONTROL on the webpage:
2 x 3 ml Control Level 2 https://www.diagnostics.eu.tosohbioscience.com/service-support/instructions-for-use. See
2 x 3 ml Control Level 3 Reference Documents section for location of the document.
3. It is recommended that each laboratory establish its own means and acceptable ranges and use
WARNINGS AND PRECAUTIONS the provided values only as guides.
● The AIA-PACK MULTI ANALYTE CONTROL is intended for in vitro diagnostic use. 4. Please be aware that the assigned values available in this EXTRA INFO AIA-PACK MULTI
● The control material has been tested and found negative for the presence of HBsAg and antibodies ANALYTE CONTROL are likely to get updated during the lifetime of the product.
to HIV-1, HIV-2 and HCV. Since no testing method can give complete assurance that products Therefore the assigned values must be regularly consulted on the webpage:
derived from human blood will not transmit infectious agents, this product shall be handled with the https://www.diagnostics.eu.tosohbioscience.com/service-support/instructions-for-use. See
same precautions as those used for patient samples. Reference Documents section for location of the document.
● Do not use beyond the expiry date. LIMITATIONS
● For safe waste disposal, it is recommended that each laboratory complies with established
laboratory procedures and local, state, and federal regulations. The AIA-PACK MULTI ANALYTE CONTROL is designed solely for use with the Tosoh Automated
● Inspect the packaging and the exterior of the vials for any sign of damage before use. If any Immunoassay Analyzers.
damages are visible, contact your local Tosoh sales representative. 1. This product should not be used past the expiry date.
● Any serious incident that has occurred in relation to the device should be reported to the 2. If there is evidence of microbial contamination or excessive turbidity in the reconstituted product,
manufacturer and the regulatory authority (e.g. EU competent authorities) in the country where the discard the vial.
user and/or patient is established. 3. This product is not intended for use as a standard.
● Refer to the Eudamed website: https://ec.europa.eu/tools/eudamed using the Basic UDI-DI, for REFERENCE DOCUMENTS
Summary of Safety and Performance.
● Refer to the document "Reference standard AIA+AIA CL" for more information on the metrological Location: https://www.diagnostics.eu.tosohbioscience.com/service-support/instructions-for-use
traceability of the AIA-PACK and CL AIA-PACK used with this product. See Reference Documents
section for location of the document. Additional reference documents Details
Overview Material required, not provided Filter By Doctypes > General Documents
PREPARATION OF REAGENTS Reference standard AIA+AIA CL Filter By Doctypes > General Documents
● Bring the controls to 18° -25 °C for use. (metrological traceability)
● Remove the screw cap and the rubber stopper carefully in order to prevent the loss of substance Analytes with limited stability lot xxxx Filter By Doctypes > EXTRA INFO
when the pressure is equilibrated. Documents: "MAC-xxxx_EXTRA_INFO-AIA" or
● Add exactly 3.0 ml of reagent water defined by CLSI GP40-A4-AMD guideline using volumetric "MAC-xxxx_EXTRA_INFO-AIA-CL"
pipettes, put the stopper back on the vial and allow the reconstituted material to stand for at least 30
minutes at +18°C to +25°C.

1-3 2-3
Additional reference documents Details
EXTRA INFO AIA-PACK MULTI ANALYTE Filter By Doctypes > EXTRA INFO
CONTROL lot xxxx Documents: "MAC-xxxx_EXTRA_INFO-AIA" or
"MAC-xxxx_EXTRA_INFO-AIA-CL"

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Net Volume (after reconstitution

for lyophilised material)

3-3