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EN Instruction for use 1
AL0311 25
Axon Biotech GmbH Distributor:
Im Oberfeld 2, DE-94491 Hengersberg
mail@medco.eu, www.medco.eu Axon Lab AG
Version: 02, 13/06/2022 A Company of Axonlab www.axonlab.com
Parasite detection kit for stool samples
For in vitro diagnostic use
Intended use Disposal
Transport tube with SAF solution for the detection of parasites (protozoa and worm eggs) in stool. All laboratories are responsible for disposal of waste in accordance with the legal requirements.
Package contents Reporting information
25 tubes with spoon and 7.5 ml SAF solution, 25 filtration funnels and 25 centrifuge tubes. A report must be submitted to the responsible authority of the Member State in which the user is located and to the
manufacturer in the event of a serious incident in connection with this product.
Principle
StorAX SAF is used to preserve parasites in stool during sample transport. References
NCCLS Publication: Quality Assurance Standards for Commercially
Storage Prepared Microbiological Culture Media Volume 24:19, 2004
The StorAX SAF tubes are stored at 15°C-30°C. Do not freeze. Do not use the product after the expiration date specified MiQ 04/2013; Qualitätsstandards in der mikrobiologisch-infektiologischen
on the package. Once the packaging has been opened, test tubes can be used up to the expiry date if stored properly. Diagnostik; Parasitosen; K. Janitschke et al.; 2.
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roduct after the expiration date specified MiQ 04/2013; Qualitätsstandards in der mikrobiologisch-infektiologischen
on the package. Once the packaging has been opened, test tubes can be used up to the expiry date if stored properly. Diagnostik; Parasitosen; K. Janitschke et al.; 2. Auflage; Urban & Fischer
Warnings and Precautions
For professional, single use only. Do not use if evidence of microbial contamination, discoloration, ruptures, or other
signs of deterioration; ensure proper product disposal.
Composition
Obtaining stool samples
Basic composition %
1 2 3 4 Sodium acetate 1.5
Acetic acid 2.0
Formaldehyde 1.5
pH 4.1 - 4.5
Reagent
Unfilled StorAX SAF.
Product/Symbol Hazard- and Precautionary-statements
Write the variable data onto the label on the tube.
Use the spoon to place the freshly obtained stool sample into the SAF transport medium. A spoon-sized sample is
StorAX SAF Hazard-statements:
sufficient (5 gr. approximately). On suspicion of infestation by intestinal parasites, it is necessary to take at least
Danger! H315 Causes skin irritation.
3 stool samples on three days in order to isolate eggs and encysted forms. H319 Causes serious eye irritation.
Screw on the lid tighlty. H317 May cause an allergic skin reaction.
H341 Suspected of causing genetic defects.
Transporting the stool samples with StorAX SAF
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H341 Suspected of causing genetic defects.
Transporting the stool samples with StorAX SAF H350 May cause cancer.
The stool samples can be transported at 15°C-30°C. Laboratory processing should occur within 48 hours.
Precautionary-statements:
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
Quality control
P280: Wear protective gloves/protective clothing/eye protection/face protection.
Quality controls are carried out of every lot. P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
P308+P313: IF exposed or concerned: Get medical advice/attention.
P405: Store locked up.
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EN Instruction for use 2
AL0311 25
Axon Biotech GmbH Distributor:
Im Oberfeld 2, DE-94491 Hengersberg
mail@medco.eu, www.medco.eu Axon Lab AG
Version: 02, 13/06/2022 A Company of Axonlab www.axonlab.com
Parasite detection kit for stool samples
For in vitro diagnostic use
1 2 3 4 5
1. Use the spoon to place the freshly obtained stool sample into the SAF transport medium. Abbreviations/Symbols
2. Stir the test tube containing the stools thoroughly and homogenize. Symbol Signification
Catalogue number
3. Remove the screw cap from the orange test tube and screw on the filtration funnel.
In vitro diagnostic medical device
4. Keep the test tube with the filtration funnel in a vertical position in order to screw the centrifuge tube onto the other side of the filtration funnel. Contains sufficient for <n> tests
Invert the stool tube with the filtration funnel and centrifuge tube and stand it in a sample rack until the entire liquid section has flowed into the
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side of the filtration funnel. Contains sufficient for <n> tests
Invert the stool tube with the filtration funnel and centrifuge tube and stand it in a sample rack until the entire liquid section has flowed into the centrifuge tube.
Manufacturer
Possibly add 1-2 ml ether to the filtered stool suspension. Vortex it. Centrifuge for 10 minutes at 1700 rpm. Carefully decant the upper layers.
Add 2-3 drops of physiological sodium chloride solution to the sediment. Temperature limit
Use-by date
5. Analyze the sediment under the microscope.
Batch code
Consult instructions for use
Storage
Do not re-use
Store the filtration units at 15°C-30°C. Do not freeze. Do not use the product after the expiration date specified on the package.
Once the packaging has been opened, test tubes can be used up to the expiry date if stored properly. CE marking
Change history: Adapted to IVDR specifications
Warnings and Precautions
For professional, single use only. Do not use if evidence of microbial contamination, discoloration, ruptures,
or other signs of deterioration; ensure proper product disposal.
062022 B 03090007
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062022 B 03090007
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