Product Manual

MedSchenker® Smart Collection System, SCK-KIT-0001-Q121 24
th
February 2021 Ver.2.0
MedSchenker® Smart Collection System™
A FDA listed collection and transport system suitable for maintenance and long-term
storage of clinical specimens containing viruses. Comes with a Nasopharyngeal
CavSwab™ and a vial of Smart Transport Medium (STM™).
Product Information and How-to-Use
INTENDED USE
The MedSchenker® Smart Collection System™ is intended for the collection and transport of clinical specimens
containing viruses, from the collection site to the testing laboratory. It provides a Nasopharyngeal CavSwab™ for
specimen collection and a vial of STM™ for the transport of organisms in one system. The STM™ can be processed
using standard clinical laboratory operating procedures for viral cultures.
SUMMARY AND EXPLANATION
One of the routine procedures in the diagnosis of infections caused by viruses, involves the collection and safe
transportation of biological samples. This can be accomplished using the MedSchenker® Smart Collection System™. The
MedSchenker® Smart Collection System™ includes a Nasopharyngeal CavSwab™ and STM™ which is room
temperature stable and can sustain viability (and infectivity) of a plurality of organisms that include clinically important
viruses during transit to the testing laboratory. The formulation of STM™ includes protein for stabilization, antibiotics to
minimize bacterial and fungal contamination and a buffer to maintain a neutral pH.
The MedSchenker® Smart Collection System™ is supplied as a sample collection kit that comprises a blister pack
containing one screw-cap tube of STM™ and one or two sterile specimen collection CavSwabs.
Once a sample using a Nasopharyngeal CavSwab™ is collected it should be placed immediately into the transport tube
where it comes into contact with the transport medium. CavSwab™ specimens for virus, isolation should be submitted to
the laboratory as quickly as possible after collection. Although the STM™ can maintain fragile organisms for long periods
of time at room temperature, it is recommended that specimens be refrigerated at 2-8°C or kept on wet ice following
collection and while in transit. If there will be a long delay before processing, specimens should be frozen at - 70°C or
colder and transported on dry ice. Storage at -20°C is less satisfactory than storage at 4°C or -70°C and can result in the loss
of infectivity.
PRINCIPLE
The STM™ consists of liquid medium which have ingredients that inhibits growth of competing bacteria and yeast. The
medium is isotonic and non-toxic to mammalian host cells. The presence of sucrose acts as a cryoprotectant which aids in
the preservation of viruses if specimens are frozen (-70ºC) for prolonged storage.
PRECAUTIONS
•
This product is For In Vitro Diagnostic Use.
•
Observe approved biohazard precautions and aseptic techniques. To be used only by adequately trained and qualified
personnel.
•
All specimens and materials used to process them should be considered potentially infectious and handled in a manner which
prevents infection of
laboratory personnel. Sterilize all biohazard waste including specimens, containers and media after their use.
•
Directions should be read and followed carefully.
STORAGE
This product is ready for use and no further preparation is necessary. The product should be stored in its original container
at 2-25°C until used. Do not overheat. Do not incubate or freeze prior to use. Improper storage will result in a loss of
efficacy. Do not use after expiration date, which is clearly printed on the outer box and on each individual sterile pouch
and the specimen transport tube label.
PRODUCT DETERIORATION
Unless expressly approved by the manufacturer, MedSchenker® STM™ and CavSwabs should not be used if (1) there is