Product Manual

MedSchenker® Smart Collection System, SCK-KIT-0001-Q121 24
th
February 2021 Ver.2.0
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results. Follow recommended guidelines for specimen collection.1,2,3,4,7,10.
3.Repeated freezing and thawing of specimens may reduce the recovery of viable organisms.
4.STM™ is intended for use as a collection and transport medium for viral agents only. This medium can serve as a
cryoprotectant for clinical viruses.
5.Because calcium alginate swabs are toxic for many enveloped viruses and may interfere with fluorescent antibody tests,
they should not be used for specimen collection. Wooden shaft swabs may contain toxins and formaldehydes and should
not be used. Polyester (Dacron) tipped swabs and Flocked Swabs are suitable when specimen collection by a swab is
appropriate.
6.The STM™ is intended to be used with the CavSwabs provided with the System. The use of swabs from any other source
could affect the performance of the product.
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WARNINGS
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• Do not re-sterilize unused swabs.
• Do not re-pack.
• Not suitable to collect and transport microorganisms other than viruses.
• Not suitable for any other application than intended use.
• The use of this product in association with a rapid diagnostic kit or with diagnostic instrumentation should be previously
validated by the user.
• Do not use if the swab is visibly damaged (i.e., if the swab tip is broken)
• Applicator swab is qualified as Class II a Medical Device according to European Medical Device Directive 93/42/EEC -
Surgically Invasive Transient Use Class II a means swabs can be used for sampling body surfaces, body orifices (e.g., nose,
throat and vagina and deep invasive surgical wounds)
• Do not ingest the medium
• To be handled by trained personnel only
• Do not use the STM™ for premoistening or prewetting the applicator swab prior to collecting the sample or for rinsing or
irrigating the sampling sit
RESULTS
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Results obtained will largely depend on proper and adequate specimen collection, as well as timely transport and processing in
the laboratory.
*Currently undergoing further testing and analysis to provide full spectrum of virus transportation data.
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The MedSchenker® Smart Transport Medium (STM™) was able to maintain the viability of the following organisms for at
least 48 hours at both room temperature (20-25ºC) and in the refrigerator (2-8ºC) under the test conditions described above.
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The MedSchenker® Smart Transport Medium (STM™) is a collection and a
transport medium that serves as a culture media, non-propagating transport.
This Transport Medium has been reviewed by the FDA*
Specimen stability for this media was not validated for recovery of viral infectious particles using a culture-based assay*
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