Product Manual

MedSchenker Universal Smart Transport System (STM), April 7, 2020
SKU
STM Tube Description
Pack Size
Sampling Sites*
STM15-A
1.5 mL Screw cap with Tube
50 qty
Culture: all Viruses, Chlamydia, Mycoplasma and Ureaplasma
STM15-D
1.5 mL Screw cap with Tube
50 qty
Culture: all Viruses, Chlamydia, Mycoplasma and Ureaplasma
STM-20-A
1.5 mL Screw cap with Tube
50 qty
Culture: all Viruses, Chlamydia, Mycoplasma and Ureaplasma
STM-20-D
1.5 mL Screw cap with Tube
50 qty
Culture: all Viruses, Chlamydia, Mycoplasma and Ureaplasma
STM 30-A
3.0 mL Screw cap with tube
50 qty
Culture: all Viruses, Chlamydia, Mycoplasma and Ureaplasma
STM 30-D
3.0 mL Screw cap with tube
50 qty
Culture: all Viruses, Chlamydia, Mycoplasma and Ureaplasma
*Performance testing with MedSchenker STM System was conducted using laboratory strains spiked onto a swab and not using
human specimens.
Specimens should be collected as soon as possible after the clinical onset of disease. Highest viral titers are present during the acute illness
For STM-RT Medium Tubes
1. Aseptically remove cap from tube
2. Aseptically place vesicle aspirates, corneal or conjunctival scrapings, small pieces of tissue or stool samples into the tube with
STM-RT medium
3. Replace cap to tube and close tightly
4. Label with appropriate patient information
5. Send to the laboratory for immediate analysis
QUALITY CONTROL
All lot numbers of the STM-RT medium are tested for microbial contamination, toxicity to host cells and the ability to maintain viability of desired agents. Procedures for quality control of
STM-RT transport medium and virus culture media are described in a number of publications by the American Society for Microbiology
3,7,10
and by NCCLS
5,6
If aberrant quality control results
are noted, patient results should not be reported.
LIMITATIONS
1. Specimens should be handled aseptically.
2. Condition, timing, and volume of specimen collected for culture are significant variables in obtaining reliable culture 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-RT is intended for use as a collection and transport medium for viral, chlamydial, mycoplasma and ureaplasma agents
only. This medium can serve as a cryoprotectant for clinical viruses, including Cytomegalovirus and Varicella Zoster Virus.
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. STM-RT kits are intended to be used with the medium tubes and swabs provided in the kit. The use of tubes of medium or swabs from
any other source could affect the performance of the product
WARNINGS
• Do not re-sterilize unused swabs.
• Do not re-pack
• Not suitable to collect and transport microorganisms other than viruses, chlamydiae, mycoplasma and ureaplasma
• 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-RT medium for premoistening or prewetting the applicator swab prior to collecting the sample or for rinsing
or irrigating the sampling sites
RESULTS
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
MedSchenker STM System 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
Influenza A H1N1
Manufacturer:
Korea Standard
Jeollanamdo, South Korea
Exclusive Distributor:
Vectornate USA Inc
10 Industrial Ave Suite 4
Mahwah NJ, 07430 USA
Tel: [phone]
E-mail: [e-mail]
Website: www.vectormed.co