Puritan Diagnostics UniTranz-RT Manual Del Usuario página 2

Puritan UniTranz-RT
CONTENTS
English . . . . . . . . . . .Pages 2 – 6
Français . . . . . . . . . Pages 7– 11
Deutsh . . . . . . . Seiten 11 – 15
Italiano . . . . . . .Pagine 16 – 20
Español . . . . . . Páginas 20 – 24
INTENDED USE
Puritan UniTranz-RT Collection and Transport System is intended 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 Puritan UniTranz-RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture.
SUMMARY AND EXPLANATION
Proper specimen collection and transport plays a critical role in laboratory diagnosis of infectious diseases associated with
viruses, chlamydiae, mycoplasmas and ureaplasmas. Puritan UniTranz-RT is a self-contained, ready-to-use system that
allows for the collection and safe transport of clinical samples from the collection site to the testing laboratory. Puritan
UniTranz-RT transport medium is stable at room temperature, and consists of a balanced buffer solution to maintain
neutral pH, antimicrobial agents, a source of protein, and sucrose as a preservative.
The system is offered with a self-centering cap and vial to safely contain and transport biological specimens and a single or
double scored plastic shaft swab to collect the specimens.
PRINCIPLES OF THE PROCEDURE
Each vial of Puritan UniTranz-RT consists of modified Hank's balanced salt solution, gelatin and bovine serum albumin as
stabilizers, sucrose, glutamic acid and (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid) HEPES. The presence of buffered
salts in the medium protects pathogens that are sensitive to pH changes. Gelatin and bovine serum albumin are source of
nutrition to support viability of fastidious bacteria during storage and transport. Sucrose aids in the preservation of viruses
and chlamydiae when specimens are frozen for prolonged storage. Antimicrobial agents are incorporated to minimize
commensal bacterial and fungal contamination. Phenol red is added to act as a pH indicator.
REAGENTS
Hank's Balanced Salts
Bovine Serum Albumin
Gelatin
Sucrose
L-Cysteine
HEPES
PRECAUTIONS
For in vitro diagnostic use only.
• To be used by trained and qualified professionals.
• Read the information in this package insert and follow directions carefully.
• Follow standard microbiological aseptic techniques.
• There is always a potential for the presence of blood borne viruses including human immunodeficiency virus and
hepatitis viruses in the specimens. Special precautions should be taken when handling specimens that may have
come in contact with blood and other bodily fluids. Follow state, local and institutional guidelines for the handling
and disposition of this and all biohazard waste.¹¯⁶
• This product is not intended to be used for the collection and transport of general bacterial and fungal specimens.
Carefully read and follow the instructions outlined in the package insert.
• Do not ingest the medium inside the vial.
• Do not re-pack.
• Do not bend flocked swab prior to specimen collection.
• Do not premoisten the applicator before use.
• Do not re-sterilize swabs.
• Do not use if the swab is damaged or broken.
• Do not use if the package is damaged.
• Do not use if the medium is contaminated (medium change color from pink to yellow or turn turbid).
STORAGE
Optimum storage temperature is 36-77°F (2-25°C) until used.
SPECIMEN COLLECTION PROCEDURES
Proper specimen collection is critical for successful isolation and identification of infectious organisms. Specimens should
be collected soon after the onset of symptoms when microorganism titers are at their highest.⁷⁻¹² 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.¹³ ̕ ¹⁴ ̕ ¹⁶ Refer to the recommended guidelines, referenced standards and manuals for additional
information on specimen collection procedures.⁵ ̕ ¹⁰ ̕ ¹⁵ ̕ ¹⁶
2
*
L-Glutamic Acid
Phenol Red
Colistin
Amphotericin B
Vancomycin
pH: 7.3 ± 0.2
*Room Temperature