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MedSchenker Universal Smart Transport System (STM), April 7, 2020

MedSchenker Smart Transport Medium (STM)

A combined viral transport medium and transport for viruses, chlamydia, mycoplasma and ureaplasma

Product Information and How-to-Use

INTENDED USE

MedSchenker Smart Transport Medium (STM) System is intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma or ureaplasma from the

collection site to the testing laboratory. It provides a viral transport medium and a transport for the aforementioned organisms in one system. STM-RT can be processed using standard clinical

laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture

SUMMARY AND EXPLANATION

One of the routine procedures in the diagnosis of infections caused by viruses, chlamydiae, mycoplasma or ureaplasma involves the collection and safe transportation of biological samples. This

can be accomplished using the MedSchenker Smart Transport Medium (STM) System. Whereas in the past there had been transport systems that were dedicated for viral transport or chlamydia

or mycoplasma/ureaplasma transport, MedSchenker STM provides a universal transport medium for the four organisms groups. MedSchenker STM System includes a universal transporting

medium that is room temperature stable, hence the designation RT, which can sustain viability (and infectivity) of a plurality of organisms that include clinically important viruses, chlamydiae,

mycoplasma and ureaplasma during transit to the testing laboratory. The formulation of STM-RTmedium includes protein for stabilization, antibiotics to minimize bacterial and fungal

contamination, and a buffer to maintain a neutral pH

MedSchenker STM System medium is provided in labeled screw-cap tubes designed for transport of the clinical sample. MedSchenker STM System is also supplied as a sample collection kit

that comprises a package which contains one screw-cap tube of STM-RT medium and a peel pouch incorporating one or two sterile specimen collection swabs. A range of STM-RTv sample

collection kits are available which incorporate different types of shaft swabs which facilitate the collection of specimens from different sites of the patient as described below in the Directions for

Use section.

Once a swab sample is collected it should be placed immediately into the transport tube where it comes into contact with the transport medium. Swab specimens for virus, chlamydia,

mycoplasma and ureaplasma isolation should be submitted to the laboratory as quickly as possible after collection. Although MedSchenker STM medium 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

MedSchenker STM medium consists of modified Hank's balanced salt solution supplemented with bovine serum albumin, cysteine, gelatin, sucrose, and glutamic acid. The pH is buffered with

HEPES buffer. Phenol red is used to indicate pH. Vancomycin, amphotericin B, and colistin are incorporated in the medium to inhibit 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 and chlamydiae if specimens are frozen (-70ºC) for

prolonged storage

STM-RT MEDIUM FORMULATION

Amphotericin B, Bovine Serum Albumin, Colistin, Gelatin, Hank’s Balanced Salt Solution, HEPES, L-cystein, L-glutamic, Phenol Red, Sucrose, Vancomycin,

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 unit and the specimen

transport tube label

PRODUCT DETERIORATION

MedSchenker STM should not be used if (1) there is evidence of damage or contamination to the product, (2) there is evidence of leakage, (3) the color of the medium has changed from light

orange-red, (4) the expiration date has passed, (5) the swab pouch is open, or (6) there are other signs of deterioration.

SPECIMEN COLLECTION, STORAGE AND TRANSPORTATION

Specimens for virus, chlamydia, mycoplasma or ureaplasma investigation should be collected and handled following published manuals and guidelines.

2,3,4,7,9,10,11

To maintain optimum viability,

transport the specimen to the laboratory as soon as possible. Best recovery is obtained when specimens are 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. Specific requirements for the shipment and handling of specimens should

be in full compliance with state and federal regulations

8,11,12

Shipping of specimens within medical institutions should comply with internal guidelines of the institution. All Specimens should be

processed as soon as they are received in the laboratory

MATERIALS SUPPLIED

MedSchenker STM System includes a screw-cap tube containing 1.5ml of transport medium

MATERIALS REQUIRED BUT NOT SUPPLIED

Appropriate materials for isolating, differentiating and culturing viruses, chlamydiae, mycoplasma and ureaplasma. These materials include tissue culture cell lines, tissue culture medium,

incubation systems and reading equipment. Refer to appropriate references for recommended protocols for isolation and identification of viruses, chlamydiae, mycoplasma and ureaplasma

agents.

2,3,4,7,10

DIRECTIONS FOR USE

MedSchenker STM System is available in the product configurations indicated in the table below

Summary of content (2 pages)

PAGE 1
MedSchenker Smart Transport Medium (STM) A combined viral transport medium and transport for viruses, chlamydia, mycoplasma and ureaplasma Product Information and How-to-Use INTENDED USE MedSchenker Smart Transport Medium (STM) System is intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory. It provides a viral transport medium and a transport for the aforementioned organisms in one system.
PAGE 2
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.