QUANTIA ASO STANDARD

INTENDED USE
The Quantia ASO Standard is intended for use in establishing the
en
6K46-01
calibration for the Quantia ASO assay by turbidimetry. This standard is
intended to be used together with the Quantia ASO reagents. Carefully
read the instructions with the corresponding reagents before use.

PRINCIPLE PREPARATION
When the standard, which contains antistreptolysin-O, is mixed with Reconstitute the standard with 1 mL of distilled water. Allow reconstituted
the Quantia ASO reagent, a clear agglutination occurs which can be material to stand for 5 minutes. Prior to use, gently swirl the vial. Once
measured by turbidimetry. reconstituted, the standard contains the concentration in IU/mL given on
the vial label.
CONTENTS
6K46-01 Quantia ASO Standard, 6 x 1 mL (lyophilized) QUALITY CONTROL
This product is of human origin which is standardized by the hemolytic After calibration, the control values should be within the established
method to the WHO International Standard. The concentration in range. Otherwise, corrective measures should be taken by the user.
IU/mL is indicated on the vial label. Contains Bronidox (0.02%) as
preservative. REFERENCES
NOTE: Substituting components from other manufacturers may affect 1. US Department of Labor, Occupational Safety and Health
the results of the assay. Administration. 29 CFR Part 1910.1030. Bloodborne Pathogens.
2. US Department of Health and Human Services. Biosafety in
PRECAUTIONS Microbiological and Biomedical Laboratories, 5th ed. Washington, DC:
• US Government Printing Office, December 2009.
• For In Vitro Diagnostic Use. 3. World Health Organization. Laboratory Biosafety Manual, 3rd ed.
Geneva: World Health Organization, 2004.
• Do not use components beyond the expiration date.
4. Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
• Do not mix materials from different kit lot numbers.
Workers from Occupationally Acquired Infections; Approved
• Do not mix fresh reagents with in-use reagents. Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and Laboratory
• CAUTION: Quantia ASO Standard contains human sourced Standards Institute, 2005.
and/or potentially infectious components. For a specific
listing, refer to the CONTENTS section of this package
insert. No known test method can offer complete assurance
that products derived from human sources or inactivated
microorganisms will not transmit infection. Therefore, all
human sourced materials should be considered potentially
infectious. It is recommended that this standard and human
specimens be handled in accordance with the OSHA
Standard on Bloodborne Pathogens.1 Biosafety Level 22
or other appropriate biosafety practices3,4 should be used
for materials that contain or are suspected of containing
infectious agents.
Donor units of human sourced materials have been tested
and found to be nonreactive for HBsAg, anti-HIV-1/HIV-2, and
anti-HCV.
• The following warnings and precautions apply to the Quantia ASO
Standard:
WARNING:
H315 Causes skin irritation.
H319 Causes serious eye irritation.
Prevention
P264 Wash hands thoroughly after handling.
P280 Wear protective gloves/protective clothing/eye
protection.
Response
P305+P351 IF IN EYES: Rinse cautiously with water for
+P338 several minutes. Remove contact lenses, if
present and easy to do. Continue rinsing.
P337+P313 If eye irritation persists: Get medical advice/
attention.
P302+P352 IF ON SKIN: Wash with plenty of water.
P332+P313 If skin irritation occurs: Get medical advice/
attention.
P362 Take off contaminated clothing and wash before
reuse.

STORAGE
Unopened standard is stable until the expiration date shown on the label
when stored at 2 to 8°C.
All Quantia products contain preservatives, but are still susceptible to
contamination. Handle with normal precautions.
Once reconstituted, the standard is stable for 15 days when stored at
2 to 8°C. For longer periods, it should be distributed into aliquots and
stored at -20°C. Freeze and thaw only once.

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 QUANTIA ASO STANDARD
6K46-01

Key to Symbols Used

BIOKIT, S.A.
Calibrator Can Malé, s/n
08186 Lliçà d’Amunt
Distributed by Barcelona - Spain
Identifies products to be used together

Global Trade Item Number

PRODUCT OF SPAIN Product of Spain

Distributed by
ABBOTT
Warning: Causes serious eye irritation 65205 Wiesbaden, Germany

Warning: Causes skin irritation February 2013

306088/R01

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