Test Procedure - Puritan Diagnostics UniTranz-RT Manual Del Usuario

MATERIALS PROVIDED
Puritan UniTranz-RT is comprised of one polypropylene vial affixed with a polyethylene cap, filled with 1 or 3 ml of
transport medium and 3 glass beads. The system is offered with one of the following configurations:
Puritan Part # Description
UT-100 Vial with 1ml universal transport medium
UT-106 Vial with 1ml universal transport medium, large PurFlock Ultra® swab
UT-116 Vial with 1ml universal transport medium, mini-tip PurFlock Ultra® swab
UT-117 Vial with 1ml universal transport medium, ultrafine PurFlock Ultra® swab
UT-300 Vial with 3ml universal transport medium
UT-302 Vial with 3ml universal transport medium, regular and mini-tip polyester swabs
UT-306 Vial with 3ml universal transport medium, elongated PurFlock Ultra® swab
UT-316 Vial with 3ml universal transport medium, mini-tip PurFlock Ultra® swab
UT-317 Vial with 3ml universal transport medium, ultrafine PurFlock Ultra® swab
UT-361 Vial with 3ml universal transport medium, regular polyester tipped swab
UT-362 Vial with 3ml universal transport medium, two regular polyester tipped swabs
UT-366 Vial with 3ml universal transport medium, mini-tip and regular polyester swabs
UT-367 Vial with 3ml universal transport medium, elongated and ultrafine PurFlock Ultra® swabs
MATERIAL REQUIRED BUT NOT PROVIDED
Materials required for the isolation, culturing and identification of viruses, chlamydiae, mycoplasmas and ureaplasmas.
Tissue culture medium, cell lines, instruments for incubation and enumeration.
Refer to the corresponding standards, guidelines and references for optimum recovery and identification results.⁸ ̕ ¹⁰ ̕ ¹²

TEST PROCEDURE

Puritan UniTranz-RT system
1. Peel open the sealed pouch pack.
2. Remove one swab from the pouch and collect the specimen without bending the swab.
3. Aseptically remove the cap from the vial.
4. Insert the swab into the vial containing medium.
5. Break the swab shaft by bending the swab against the vial rim at the scored point.
6. Replace the cap and secure the lid tight.
7. Record the patient's information on the label.
8. Transfer the vial containing the specimen to laboratory for analysis.
Puritan UniTranz-RT vial only (for specimen collection by aspiration, scraping, small tissues and stool samples)
1. Aseptically remove the cap from the vial.
2. Transfer the specimen into the vial containing medium.
3. Replace the cap and secure the lid tight.
4. Record the patient's information on the label.
5. Transfer the vial containing the specimen to laboratory for analysis.
Antibacterial and antifungal agents have been added to the Puritan UniTranz-RT medium to inhibit bacterial and fungal
growth. To further control the potential for microbial overgrowth, it is also recommended that specimens be refrigerated
and processed as soon as possible. Refer to recommended laboratory referenced standards for proper specimen processing
and cultivation.¹⁰
Quality Control
Each lot of Puritan UniTranz-RT is tested for bacterial and fungal contamination, medium pH, and ability to maintain
viability of selected microbial agents of clinical significance. Refer to CLSI, Journals of Clinical Microbiology and ASM
publications for detailed quality control procedures of Universal Viral Transport Medium.¹⁰ ̕ ¹⁷ ̕ ¹⁸
RESULTS
Accuracy of culture results largely depends on proper specimen collection and transportation time, as well as specimen
handling in the testing laboratory.
LIMITATIONS
Conditions such as extreme temperature fluctuation and prolonged specimen transit time could impact reliability of the
culture results.
1. Puritan UniTranz-RT is only recommended for collection and transport of viruses, chlamydiae, mycoplasmas and
ureaplasmas.
2. Do not use Puritan UniTranz-RT as a replacement for tissue culture medium for isolation of viruses and chlamydiae.
3. Repeated freezing and thawing of specimens may reduce the recovery of organisms
4. Calcium alginate fiber and wooden shaft swabs are not recommended for use with Puritan UniTranz-RT transport
systems as they may affect organism viability.
5. Puritan UniTranz-RT transport system is validated solely with the use of Puritan polyester flocked swabs. Swabs
and transport medium from other sources have not been validated and could adversely affect the performance
characteristics of the product.
6. Any usage of this product in conjunction with a rapid diagnostic test or instrument should be validated by the user.
7. The performance of the Puritan UniTranz-RT for storage time over 48 hrs has not been evaluated.
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