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NOTES IMPORTANTES:
- Water quality: Use imperatively water of class I quality according to the CAP (College of American Pathologists) or type 1
according to the CLSI (Clinical and Laboratory Standards Institute)
- Storage and stability before opening: Unused reagents stored in an upright position at 2 ° - 8 ° C are stable until their expiration
date. Before preparation and / or use, bring reagents refrigerated to room temperature (18 ° -25 ° C).

COMMON REAGENTS AND QUALITY CONTROL MATERIALS

AIA-PACK WASH CONCENTRATE (Ref. 0020955) and AIA-PACK DILUENT CONCENTRATE (Ref. 0020956)

- Packaging : 4 bottles of 100 mL

- Preparation :
• WASH CONCENTRATE : Add the entire content of 2 bottles of 100 mL to aroun 4,0 L of water. Mix well and
adjust to final volume to 5,0 L
• DILUENT CONCENTRATE : Add the entire content of 1 bottle of 100 mL to aroun 4,0 L of water. Mix well and
adjust to final volume to 5,0 L
- Storage and stability after opening : Once diluted, both solution are stable for 30 days at 18°- 25°C

AIA-PACK SUBSTRATE SET II (Ref. 0020968)

- Packaging :
• 2 bottles of lyophilised AIA-PACK SUBSTRATE REAGENT II (= solution A)
• 2 bottles of AIA-PACK SUBSTRATE RECONSTITUENT II of 100 mL each (= solution B)
- Preparation :
• Add the entire bottle of solution B into 1 bottle of lyophilised substrate (solution A)
• Leave it rest for 30 minutes then mix thoroughly to dissolve all solide materials
- Storage and stability after opening:
• Always store the SUBSTRATE in a clean environment, protected from light (direct sunlight and ultraviolet light)
• The reconstiuted solution is stable for 3 days at 18°- 25°C (continous use onboard), or 30 days kept in the fridge
at 2°- 8°C.

AIA-PACK MULTI ANALYTE CONTROL (MAC. Ref. 0960474)

- Packaging : 2 x 3 mL x 3 Levels
- Preparation :
• Reconstitute with exately 3 mL of water. Close the bottle then homogenize after 10 minutes by inversion
• Allow the reconstituted material to stand for at least another 20 minutes at 18°- 25°C
- Storage and stability after opening:
• Once reconstituted, the control materials are stable for 7 days at 2°- 8°C for most of the analytes (see IFU extra-
info) or up to 4 weeks once in frozen aliquots of not less than 0.5mL frozen at -20°C
• Attention : some analytes have a limited stability(2-3 hours), See Extra Info AIA-PACK Multi Analyte Control.

SPECIFIC REAGENTS
AIA-PACK CONTROL SET : ACTH (Réf. 0025421), BNP (0025428), Cystatin C (0025417), D-Dimer (0025432), HCY (0025426), KL-6 (0025444),
Osteocalcin (0025436), PIVKAII (0025433), PSEP (0025442), SCC (0025437), SHBG (0025438), Tg (0025427), TgAb (0025491), TPOAb (0020490)

Packaging : 2x2x4 mL (Cystatin C, HCY, TPOAb), 2x2x1 mL (ACTH, BNP, D-Dimer, KL-6, Osteocalcin, PIVKAII, PSEP, SHBG, SCC, Tg),
6x2x1 mL (TgAb)
- Preparation :
• For TPOAb, Cystatin C,and HCY, the control materials are ready-to-use
• For ACTH, BNP, D-Dimer, Osteocalcin, PIVKAII, PSEP, SHBG, SCC, Tg, TgAb :
o Reconstitute the lyophilised materials into 1 mL of water then homogenize after 10 minutes by inversion
o Allow the reconstituted material to stand for another 20 minutes then mix thoroughly to dissolve all solide materials
- Storage and stability after opening: the control materials are stable for 7 days at 2°- 8°C, and up to 14 days for SCC/KL6/PIVKAII

CALIBRATOR SET

- Packaging : 2 sets of calibrators in 2 or 6 points (liquids and/or lyophilised)

- Preparation :
• Bring calibrators to 18°- 25°C
• Reconstitute the lyophilised materials into 1 mL of water
• Wait for the lyophilisate to dissolve completely then gently mix the calibrators
- Storage and stability after opening:
• Use the calibrators within 1 days of opening or reconstituted provided the sealed vials are kept at 2°- 8°C
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SAMPLE DILUTING SOLUTION

- Packaging : 4x100 mL (CPR2, Cyst.C, 27.29, KL-6, SHBG,TPOAb, TgAb), 4x10 mL (BMG), 4x4 mL (other analytes)
- Preparation : Specific diluents are ready to use, except for the test BMG :
• Add 90 mL of water to AIA-PACK BMG SAMPLE DILUTING CONCENTRATE then thoroughly mix
- Storage and stability after opening: refer to the following categories (See IFUs)

GROUP 1 GROUP 2 GROUP 3 GROUP 4

iE2, hsE2, CK-MB, cTnI3, TT3, PAP, HGH, 27.29, CPR2, BMG, Cystatin C, TPOAb,
Sample Diluting Solution (SDS) All other analytes
B12 RBC FOL, ACTH, OVCA, PIVKA TgAb, SHBG, KL-6
Stability after opening
Storage at 2°-8°C (24h/24h) 90 days 90 days 90 days 90 days
Storage at 18°-25°C (24h/24h) 1 jour 2 days 3 days 10 days
Cyclic storage :
3 days 6 days 9 days 30 days
8h at 18°-25°C + 16h at 2°-8°C

CONJUGATE (TPOAb, TgAb, hsE2, VitD; PIVKAII)

- Packaging : 5x5 mL (except 4x4 mL PIVKAII), ready-to-use and included in the AIA-PACK test Cups boxes
- Storage and stability after opening: The conjugate for PIVKAII, TPOAb and TgAb are stable for 2 days in continous use on-board at 18°-
25°C, 6 days in cyclic use (8h on-board + 16h in fridge at 2°C-8°C), 14 days of storage continously at 2°- 8°C. The conjugate for hsE2 and
VitD are stable 1 day of continous use on-board, 3 in cyclic use, 10 days of storage continously at 2°- 8°C.

PRETREATMENT (B12, FOL, RBC FOL, HCY, VitD)

- Packaging : 6x5 mL pretreatments 1 and 2 (HCY)

6x5 mL pretreatment 1 and 3 + 1x32 mL pretreatment 2 (B12, FOL, RBC FOL)
1x32 mL pretreatment 1+ 6x5 mL pretreatment 2 + 6 empty vials for pretreatment 1 (VitD)
- Preparation :
• VitD pretreatments are ready for use
• For B12, FOL, RBC FOL et HCY : Reconstitute the lyophilised pretreatment 1 with 5 mL of pretreatment 2. Let it stay until completely
dissolved. The pretreatment 3 is ready for use.
- Storage and stability after opening:
• Reconstituted pretreatments 1 B12, FOL, RBC FOL, and HCY should be used within 24h
• VitD Pretreatment 1 should be used withing 24h once distributed into the Reagent vials. VitD pretreatment 2 is stable for 1 day on-
board at 18°-25°C, 3 days in cyclic use (8h on-board + 16h sealed in fridge at 2°C-8°C)

TEST CUPS

AIA-PACK SAMPLE TREATMENT CUP (Réf. 0020971) et AIA-PACK DETECTOR STANDARDIZATION TEST CUP (Ref. 0020970)

- Packaging : 10 Trays of 20 cups ready for use

- Storage and stability after opening: ‘STC’ and ‘STD’ cups remain stable until expiration date if stored between 1°- 30°C

AIA-PACK Test Cups

- Packaging : 5 Trays of 20 cups ready for use

- Storage and stability after opening: refer to the following categories (See IFUs)

GROUPE 1 GROUPE 2 GROUPE 3 GROUPE 4 GROUPE 5

FT4, Sla, BMG, Cystatin C, DHEA-S, D- AFP, CPR2, HCGII, PRL,

Cupules tests BNP, HCY All other analytes
FOL Dimer, iFT3, IRI, PTH, RBCFOL OVCA, SCC, SHBG
Stabilité après ouverture
Storage at 2°-8°C (24h/24h) 30 days 30 days 30 days 30 days 30 days
Storage at 18°-25°C (24h/24h) 1 jour 2 days 4 days 7 days 10 days
Cyclic storage :
3 days 6 days 12 days 21 days 30 days
8h at 18°-25°C + 16h at 2°-8°C

The information contained in this document is believed to be correct at the date of revision (see code at the top of the
page). In the future, please refer to the latest versions of the operating instructions or other Tosoh documents
containing specifications.
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Dilution
Parameters Specific Sample Volume Sample Max Stability
Pretraitment Conjuguate Recommended Tubes Factors
Control
Sandw. / Compet (µL) by default 2-8°C -20°C
ACTH / / ✓ EDTA plasma 50 8H 60D
AFP / / ● Heparinised plasma, serum 25 7D 60D
B12 ✓ / ● serum 200 7D 60D
βHCGII / / ● Heparinised plasma , serum 10 7D 60D
51 (Blood)
BMG
/ / ● Heparinised plasma, serum, urine 15 5 (Urine) 7D 60D
BNP / / ✓ plasma EDTA 50 8H 60D
CA 125 (OVCA) / / ● Heparinised plasma, serum 100 7D 60D
CA 15.3 (27.29) / / ● Heparinised plasma, serum 20 21 7D 60D
CA 19.9 (Sla) / / ● Heparinised plasma, serum 50 7D 60D
CEA / / ● Heparinised plasma, serum 100 7D 60D
CK-MB / / ● Heparinised plasma, serum 50 7D 60D
CORT / / ● Heparinised or EDTA plasma, serum 10 7D 60D
C-Pept II (CPR2) / / ● Heparinised or EDTA plasma, serum, urine 10 24H 60D
Cystatin C / / ✓ Heparinised or EDTA plasma, serum 10 25 7D (24H Dil.) 60D
D-Dimères / / ✓ Citrated plasma 10 24H 60D
DHEA-S / / ● Heparinised or EDTA plasma, serum 10 7D 60D
hsE2 / ✓ ● Heparinised plasma, serum 75 7D 60D
iE2 / / ● Heparinised plasma, serum 75 7D 60D
FER / / ● Heparinised plasma, serum 20 7D 60D
FOL ✓ / ● Serum 160 7D 60D
FSH / / ● Heparinised plasma, serum 50 7D 60D
iFT3 (no Dil.) / / ● Heparinised plasma, serum 50 7D 60D
FT4 (no Dil.) / / ● Heparinised plasma, serum 10 7D 60D
Plasma, serum :
HCGII / / ● Heparinised plasma, serum, urine 10 7D 60D
Urine : 3 Dours
HCY ✓ / ✓ Heparinised or EDTA plasma, serum 40 24H 60D
HGH / / ● Heparinised plasma, serum 75 7D 60D
IgE II / / ● Heparinised plasma, serum 10 7D 60D
IRI (Insuline) / / ● Heparinised or EDTA plasma, serum 50 24H 60D
KL-6 / / ✓ serum 10 51 7D (24H Dil.) 60D
LHII / / ● Heparinised plasma, serum 40 7D 60D
MYO / / ● Heparinised plasma, serum 10 7D 60D
Osteocalcin / / ✓ plasma EDTA, serum 10 3D 60D
PAP / / ● Heparinised plasma, serum 75 7D 60D
PIVKA-II / ✓ ✓ Heparinised plasma, serum 50 7D 60D
PRL / / ● Heparinised plasma, serum 30 7D 60D
PROGIII / / ● Heparinised plasma, serum 30 7D 60D
PSAII / / ● Heparinised plasma, serum 20 7D 60D
fPSA / / ● Heparinised plasma, serum 20 7D 60D
PTH intacte / / ● EDTA plasma, serum 75 24H 200D
PSEP / / ✓ EDTA plasma 20 3D 60D
Whole PTH / / ● EDTA plasma, serum 100 24H 60D
RBC FOL ✓ (+Hem.Sol.) / ● Heparinised or EDTA plasma 160 7D 60D
SCC / / ✓ Heparinised plasma, serum 25 7D 60D
SHBG / / ✓ Heparinised plasma, serum 15 20 7D (24H Dil.) 60D
T4 / / ● Heparinised plasma, serum 10 3D 60D
TES / / ● Heparinised plasma, serum 85 7D 60D
Tg / / ✓ Heparinised plasma, serum 30 7D 60D
TgAb / ✓ ✓ Heparinised plasma, serum 50 51 7D (24H Dil.) 60D
TPOAb / ✓ ✓ Heparinised plasma, serum 10 51 7D (24H Dil.) 60D
cTni3 / / ● Heparinised or EDTA plasma, serum 50 24H 60D
TSH / / ● Heparinised plasma, serum 100 7D 60D
TT3 / / ● Heparinised plasma, serum 25 7D 60D
VitD (no dil.) ✓ ✓ ● Heparinised or EDTA plasma, serum 60 48H 60D
✓ Additional reagent / = NON ADAPTED • Multi-analyte
●= NON SYSTEMATIC
control MAC H: Hours ; D: Days

Conjugates are fragile reagents subject to contamination. In the event of a control result
out of acceptance limits, rerun the control with a fresh conjugate. Calibrations must always
be carried out with fresh cups, specific diluents, pretreatments and conjugates.
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TOSOH WEB SITE : INSTRUCTION FOR USE AND OPERATOR’S MANUAL

In compliance with the directive MEDDEV.2.14/3 rev.1 of January 2007

All the Instructions For Use for Tosoh reagents as well as the Instrument Operator Manual are available on the website:

www.diagnostics.eu.tosohbioscience.com
Section: Service & Support ➔ Instructions For Use (IFU)

- The document "IFUs available on web" (General Document Filter Selection) lists all the documents published on the site and
specifies for each of them their current version number
• A new version number in the IFU REVISION TABLE will be assigned when one of these documents has changed version
• All changes will appear highlighted in yellow

- In case of major changes due to corrective measures or a change of product

• A label will be affixed to the product and will invite you to download the latest version of the manual from our website
• TOSOH EUROPE N.V. will also send to its customers a letter indicating this change.

- If you wish to be alerted by email whenever a new version of the manual and / or user manual is available on our website, contact
us by email at: support.produits@tosoh.com

- For any questions relating to the TOSOH website, contact us by e-mail at the following address: info.raqa.eu@tosoh.com

The information contained in this document is believed to be correct at the date of revision (see code at the top of the
page). In the future, please refer to the latest versions of the operating instructions or other Tosoh documents
containing specifications.