Foam transport system for virus, chlamydia, mycoplasma and ureaplasma

Devices ready to use, composed by a foam swab with a plastic shaft and a test tube with screw cap containing a  room  temperature  stable  viral  transport  medium, suitable  for  the  transportation  and  preservation  of  
Viruses  (such  as  Influenza  H1N1), Chlamydia, Mycoplasma and Ureaplasma specimens.  
The Devices standard dimensions make them suitable both for use with automatic instruments whether for  manual use. The liquid medium type allows to dilute the samples easily and rapidly obtaining a homogeneous  
solution ready to be used and appropriate in order to obtain many samples equal rates to carry out different  analysis.  
Foam Virus Liquid Swabs are packed in peel-pack, easy opening for the Devices optimal protection. The Devices  are  produced  according  to  GMP  (Good  Manufacturing Practice),  classified  and  certified  as  Medical  Devices.  
Foam  Virus  Liquid  Swabs  are  sterile  (SAL  10^-6 ), Pyrogen free & Latex free.  

CE MD marked sterile Swab-manufactured in compliance with 93/42/EC Directive (Italian D.lgs 46 del 24/02/1997) + 2007/47/EC  
CE IVD marked sterile Test Tube with medium – manufactured in compliance with 98/79/EC Directive (Italian D.lgs 332 del 08/09/2000) 

INTENDED PURPOSE  
Swab  Intended  purpose  is  “MEDICAL  DEVICE”  CLASS  IIA STERILE. Swabs are sterile and ready-for-use systems intended for  clinical  samples  drawing,  transport  and  maintenance  for cultural exam. The swab is suitable for short contact with the 
human body including surgical wounds. Test Tubes are  classified as IVD and are intended only for the preservation of samples. Product must be used as directed, Microbiotech is not responsible for any unauthorized use.  
For professional use only.  
National classification of medical devices (CND – For Italian law) > V901302 (Transport swabs for collection sample) 

APPLICATOR
Special  polyurethane  foam,  medical  grade,  swab  tip  that allows  a  better  clinical  sample  collection  and  the  following immediate release into the liquid transport medium. The soft foam bud is more comfortable for patients, and has significant 
advantages  for  both  conventional  and  molecular  methods. It has  a  plastic  shaft  with  "breakpoint"  to  allow  the  swab breaking into the test tube and the successive collection by the screw "capture" cap after the tube closing. It allows to dispose 
of the swab together with the cap in a safer way.  

Available in two versions on sampling site base:  

1. Standard tip: swabs, standard dimensions, for buccal, nasal, throat, vagina, rectal, cutaneous and wound sampling;  this  specialty  applicator  is  tipped  with  medical  grade polyurethane foam. It is bonded securely to the plastic handle. The  best  choice  for  buccal  swab,  for  general  specimen collection  for  testing  and  screening.  Used  in  Pediatrics, Opthamology,  Veterinary  care,  and  oropharyngeal applications.  

Overall Length: 152.4 mm (6”) 
Tip Ø 4.775 mm (0.188”) – Length 16.002 mm (0.63”)
Handle Ø 2.54 mm (0.1”) – Length 149.225 mm (5.875”)  

2. Fine tip:  swabs,  small  dimensions,  for  paediatric,  urethra, urogenital and nasopharyngeal sampling.  The  special  small  applicator  is  tipped  with  medical  grade polyurethane foam. It is bonded securely to the plastic handle. The  best  choice  for  paediatric,  urethral  and  nasopharyngeal applications. 

Overall Length 152.4 mm (6.”)  
Tip Ø 1.981 mm (0.078”) – Length 17.45 mm (0.687”) 
Handle Ø 2.159 mm (0.085”) tapered to Ø 1.016 mm (0.040”) – Length 148.539 mm (5.848”)  

TEST TUBE  

Liquid Transport Medium is contained in a cylindrical test tube Ø 13×80 mm, in transparent, unbreakable medical polypropylene (PP), to preserve sample and users safety. With screw cap in polyethylene (HDPE) 
with “capture cap” technology, The specific color cap identifies instantly and secure the medium content. Pre-labelled  on  test  tube  to allow  a  correct  patient and sample identification. Item code, lot number  
and  expiry  date  printed  on  each  label  for  a  full tracciability.  

VIRUS LIQUID TRANSPORT MEDIUM 

Swabs with red screw cap test tube containing 1 or 3 ml of liquid VIRAL transport medium  for the collection and transport of clinical samples containing viruses, 
chlamydiae, mycoplasmas and ureaplasmas from  the collection site to the testing laboratory. The specimen transported in the Foam Virus Liquid Swabs can be used in  the  
laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture.  
Viral transport medium, stable at room temperature, consists of a balanced buffer  solution to maintain neutral pH, anti-microbial agents and a preservative. 
Organisms viability maintained at room temperature and on ice. Suitable also for long term freeze storage. This product is not intended to be used for the collection and 
transport of general bacterial and fungal specimens.   

 RESULTS 

The survival and recovery of viruses, chlamydiae, mycoplasmas and ureaplasmas depends upon a series of factors such as infectious organisms type, transport time, preservation temperature, infectious organisms concentration in the sample. 
Specimens should be collected soon after the onset of symptoms when microorganism titers are at their highest.  
Specimens should be placed in the transport medium immediately following collection and promptly transferred  to  the laboratory for processing. For optimum recovery, specimens should be refrigerated during transport. 
For long term storage, specimens should be frozen at -70°C or colder.   
Use of the Foam Virus Liquid Swabs in conjunction with rapid diagnostic kits and instruments must be validated prior to use by the user. 

PRECAUTIONAL MEASURES  

• Transport medium (if present) and the defined sampling site;  
• Use only for the collection and transport of human biological samples for the detection of potential pathogens    such as viruses, chlamydiae, mycoplasmas and ureaplasmas, compatible with the type of device selected;  
• Do not deviate from the intended use;  
• Do not use the product if it is expired or the package is opened/damaged. Sterility guaranteed if unopened;  
• Use the device following aseptic procedures;  
• Single-use device; do not reuse. Reusing the device could contaminate the sample and/or the patient;  
• Keep the device away from flames and heat sources;  
• The fiber is only guaranteed to adhere to the shaft for instant sampling;  
• The shaft is breakable, exert moderate pressure during sample collection;  
• Store in a cool, dry place at a temperature between +2°C (35.6°F) and +25°C (77°F). Do not freeze;  
• After use, the device may contain infectious microorganisms.  Use appropriate PPE and dispose of the test tube and swab according to current regulations for medical waste.  
• Keep out of flame or heat sources which might damage the product.  
• Keep out of reach of children.  
• Strictly follow the user’s instructions.  

• Foam swab
• Test tube with screw cap containing a liquid medium
• For automatic instruments whether for manual use
• Packed in peel-pack
• Produced  according to GMP (Good Manufacturing  Practice)
• Classified and certified as Medical Devices Class II sterile (invasive surgery for temporary use)
• Sterile (SAL 10-6)
• Pyrogen free & Latex free