EU rev. 27.29-011011 cycles of 8 hours on board and 16 hours in the refrigerator).

The sample diluting solution should not

be used beyond 90 days after opening, even if it is sealed and stored in the refrigerator.
Attention: This IFU complies with IVD directive 98/79/EC and is intended for use by customers ● For automatic dilution with the AIA-600 II, the use of a 30 mL vial is required for the sample diluting
operating in a member state of the European Union solution. The sample diluting solution moved from the original 100 mL bottle into the 30 mL vial can
be left on-board of the AIA-600 II (18-25°C) for a maximum of 2 days (2 x 24 hours). When stored
overnight at 2-8°C, the sample diluting solution can be used for up to 6 days (6 cycles of 8 hours on
AIA-PACK 27.29 SAMPLE DILUTING SOLUTION board and 16 hours in the refrigerator)..

PROCEDURE
INTENDED USE Refer to the Tosoh AIA System Operators’ Manual for additional procedural instructions regarding sample
The AIA-PACK 27.29 SAMPLE DILUTING SOLUTION is intended for in vitro diagnostic use only to dilute dilution.
patient samples. 1. All serum or heparinised plasma samples should be diluted by 21 fold with AIA-PACK 27.29
SAMPLE DILUTING SOLUTION before analysis.
MATERIAL SUPPLIED 2. If a specimen is found to contain more than 400 U/mL of CA 27.29 in the specimen, the specimen
Cat. No. 0020502 should be diluted with the sample diluting solution and assayed in accordance with the
4 x 100 mL AIA-PACK 27.29 SAMPLE DILUTING SOLUTION PROCEDURE in the insert sheet of the ST AIA-PACK 27.29.
Buffered bovine serum albumin containing no detectable concentration of CA 27.29 3. The AIA Nex•IA / AIA-21, AIA-600 II, AIA-900, AIA-1800 and AIA-2000 will perform dilutions
with sodium azide as a preservative. automatically if the dilution factors are entered on the software before assaying the diluted sample.
4. The recommended dilution for specimens containing more than 400 U/mL is 10 or 100-fold dilution.
WARNINGS AND PRECAUTIONS
It is desirable to dilute the specimen so that the diluted specimen will read between 2.1 and
1. The AIA-PACK 27.29 SAMPLE DILUTING SOLUTION is intended for in vitro diagnostic use only. 400 U/mL.
2. Inspect the packaging and the exterior of the bottles for any sign of damage before use. If any
damages are visible, contact your local TOSOH sales representative.
RESULTS
3. This material contains sodium azide, which may react with lead or copper plumbing to form potentially When auto-dilution is performed, the Tosoh AIA System Analysers will calculate the final result.
explosive metal azides. When disposing of such reagents, always rinse with large volumes of water
LIMITATIONS
to prevent any azide accumulation.
4. Although material derived from human blood is not used for the SAMPLE DILUTING SOLUTION, it is The AIA-PACK 27.29 SAMPLE DILUTING SOLUTION is designed solely for use with ST AIA-PACK
recommended that this product be handled with the same precautions as those used for patient 27.29 assay procedures.
samples.
5. Do not use beyond the expiry date.
6. For safe waste disposal, it is recommended that each laboratory complies with established laboratory
procedures and local, state, and federal regulations.
7. After opening, the bottle of the sample diluting solution should be kept tightly sealed with a clean cap. TOSOH CORPORATION
Sealing with dirty material may cause deterioration of the reagent. 3-8-2, Shiba, Minato-ku
8. The remaining sample diluting solution after use should not be mixed with another bottle but be TOKYO 105-8623 (JAPAN)
discarded to avoid contamination. Tel.: +81 (0)3 5427 5181 Fax: +81 (0)3 5427 5220
9. For automatic dilution with the AIA-600 II, the use of a 30 mL vial is required for the sample diluting
TOSOH EUROPE N.V.
solution. The 30 mL vial must be clean and free from contaminants. Transportstraat 4
B-3980 TESSENDERLO BELGIUM
PREPARATION OF REAGENTS
Tel.: +32 (0)13 66 88 30 Fax: +32 (0)13 66 47 49
The AIA-PACK 27.29 SAMPLE DILUTING SOLUTION is supplied ready for use. The sample diluting
solution should be used after equilibrating to 18-25°C for about 30 minutes TOSOH BIOSCIENCE, INC.
6000 Shoreline Court, Suite 101
STORAGE AND STABILITY South San Francisco, CA 94080, USA
Phone: +1 650 615 4970
● Always store the AIA-PACK 27.29 SAMPLE DILUTING SOLUTION in an upright position.
● When stored unopened and refrigerated at 2°-8°C, the sample diluting solution will remain stable
until the expiry date shown on the label. After opening, the sample diluting solution can be left Net Volume (after reconstitution
on-board of the TOSOH AIA System Analyzers (18-25°C) for a maximum of 10 days (10 x 24 hours). for lyophilised material)
When stored overnight at 2-8°C, the sample diluting solution can be used for up to 30 days (30

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