CVM TRANSPORT MEDIA

Cat. no. R96	CVM Transport, 15x120mm Polypropylene Centrifuge Tube, 2ml	20 tubes/box
Cat. no. R96KF	CVM Flocked Swab Female, 15x120mm Polypropylene Centrifuge Tube, 2ml, with 1 Nylon Flocked Swab in a Zip-lock Bag	25 kits/jar
Cat. no. R96KM	CVM Flocked Swab Male, 15x120mm Polypropylene Centrifuge Tube, 2ml, with 1 Nylon Flocked Swab in a Zip-lock Bag	25 kits/jar
Cat. no. R96KNP	CVM Flocked Swab Nasopharynx, 15x120mm Polypropylene Centrifuge Tube, 2ml, with 1 Nylon Flocked Swab in a Zip-lock Bag	25 kits/jar
Cat. no. R296	CVM Transport, 16x100mm Polystyrene Centrifuge Tube, 1ml	20 tubes/box
Cat. no. R296K	CVM Transport Kit, 16x100mm Polystyrene Centrifuge Tube, 1ml, with 2 Dacron Swabs in a Zip-lock Bag	100 kits/box
Cat. no. R396	CVM Transport with Beads, 15x120mm Polypropylene Centrifuge Tube, 2ml	20 tubes/box
Cat. no. R396K	CVM Transport with Beads Kit, 15x120mm Polypropylene Centrifuge Tube, 2ml, with 1 Dacron Swab in a Zip-lock Bag	100 kits/box

CVM Transport Media Kits include:

R96KF	1 tube of transport media, 1 sterile nylon flocked swab on a scored plastic shaft in a zip-lock bag; packed 25 kits per jar.
R96KM	1 tube of transport media, 1 sterile nylon flocked swab on a scored plastic shaft in a zip-lock bag; packed 25 kits per jar.
R96KNP	1 tube of transport media, 1 sterile nylon flocked swab on a scored plastic shaft in a zip-lock bag; packed 25 kits per jar.
R296K	1 tube of transport media, 2 sterile dacron swabs on a scored plastic shaft in a zip-lock bag; packed 100 kits per box.
R396K	1 tube of transport media with clear glass beads, 1 sterile dacron swab on a scored plastic shaft in a zip-lock bag; packed 100 kits per box

INTENDED USE

Hardy Diagnostics CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of chlamydial, viral, and mycoplasmal agents including: Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Influenzae A, Influenzae B, Respiratory Syncytial Virus (RSV), Echovirus, Adenovirus, Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma hominis, Mycoplasma pneumoniae and Ureaplasma urealyticum.

SUMMARY

CVM Transport consists of Modified Hank's Balanced Salt Solution supplemented with bovine serum albumin, sucrose, glutamic acid, and gelatin. A buffer is used to maintain a pH of 7.3 +/- 0.2. Phenol red is used as a pH indicator. Amphotericin B (4ug/ml), colistin (7.5ug/ml), and vancomycin (100ug/ml) are added to inhibit contaminants. The media contains cryoprotectorants to ensure viability of organisms during freezing and thawing. Some users prefer the presence of beads in the tube (Cat. no R396 and R396K) in order to assist in the lysing of tissue cells to release the pathogenic agent.

Some of the CVM kits (R96KF, R96KM, and R96KNP) are now supplied with nylon flocked swabs. Diagnostic sensitivity of test procedures can vary depending on the number of cells and free organisms released by the transport swab. Based on recent studies, samples collected with nylon flocked swabs yield more epithelial cells than those collected using rayon or dacron swabs, thus providing better clinical specimens for diagnosis. Flocked swabs are compatible with rapid antigen kits, DFA, culture, and PCR.^(6,7)

STORAGE AND SHELF LIFE

Storage: Upon receipt store at 2-8 degrees C. away from direct light. Media should not be used if there are any signs of deterioration (shrinking, cracking, or discoloration), hemolysis, contamination, or if the expiration date has passed. Product is light and temperature sensitive; protect from light, excessive heat and freezing at temperatures above -70 degrees C.

The expiration date applies to the product in its intact packaging when stored as directed.

This product has the following shelf life from the date of manufacture:

180 Days:	R96	CVM Transport
	R296	CVM Transport
	R396	CVM Transport
	R96KF	CVM Flocked Swab Female
	R96KM	CVM Flocked Swab Male
	R96KNP	CVM Flocked Swab Nasopharynx
	R296K	CVM Transport Kit
	R396K	CVM Transport Kit

Refer to the keyword "Storage", in the Hardy Diagnostics software program HUGO™, for more information on storing culture media.

PRECAUTIONS

This product is for in vitro diagnostic use only and is to be used only by adequately trained and qualified laboratory personnel. Observe approved biohazard precautions and aseptic techniques. All laboratory specimens should be considered infectious and handled according to "standard precautions". The "Guideline for Isolation Precautions" is available from the Centers of Disease Control and Prevention at www.cdc.gov/ncidod/dhqp/gl_isolation.html.

For additional information regarding specific precautions for the prevention of the transmission of all infectious agents from laboratory instruments and materials, and for recommendations for the management of exposure to infectious disease, refer to CLSI document M29.

Sterilize all biohazard waste before disposal.

Refer to the keyword "Precautions", in the Hardy Diagnostics software program HUGO™, for more information regarding general precautions when using culture media.

Refer to the keyword "MSDS", in the Hardy Diagnostics software program HUGO™, for more information on handling potentially hazardous material.

PROCEDURE

Aseptically collect sample. Use swabs and shafts that are non-toxic to chlamydial, mycoplasmal, ureaplasmal, and viral agents, such as dacron or nylon flocked swabs on plastic shafts. Do not use cotton or calcium alginate swabs for collection of specimens.

After collection of specimen, remove cap from tube, insert swab. Submerge the tip of the swab into the media so the tip contacts the bottom of the tube. Break off the top third of the swab by bending the shaft against the rim of the tube. The shaft is scored to facilitate breaking. Re-cap the tube securely. Label the sample. Transport immediately to the lab at 2-30 degrees C. within 48 hours. Upon arrival to the lab, refrigerate at 2-8 degrees C. For long-term storage, freeze at -70 degrees C. Do not freeze at temperatures higher than -70 degrees C. For more information, consult listed references.^(2-5)

More than one tube may be submitted if more than one type of culture is requested to ensure adequate specimen for culture set-ups.

All specimens should be shipped in compliance with all federal, state and hospital guidelines.

INTERPRETATION OF RESULTS

Consult listed references for isolation and identification procedures for specific organisms recovered from transport media.^(2-5)

LIMITATIONS

Inoculate specimens as soon after collection as possible. This transport has been validated to maintain viability of organisms during transport at room temperature for 48 hours. If there is to be a delay in inoculating, store at 2-8 degrees C. For long-term storage of specimens for recovery of chlamydial, viral, and mycoplasmal agents, freeze at -70 degrees C. Freezing at higher than -70 degrees C. is not recommended.

Repeated freezing and thawing of frozen specimens may reduce the recovery of viable organisms.

Nylon flocked swabs, dacron or rayon tipped swabs are recommended. Calcium alginate or cotton swabs, as well as wooden stick swabs, should not be used.

Determinations for recovery of specific serotypes of C. trachomatis were not included in the study (see Performance Characteristics section).

Data represented in the Performance Characteristics section is for culture only. Performance has not been established for EIA testing. It is recommended that each laboratory establish performance characteristics of this product in conjunction with its chlamydial, viral, and mycoplasmal testing methods.

If culturing for cytomegalovirus and transport is at room temperature, the transport time should not be greater than 24 hours. If transported at 2-8 degrees C. the transport time should not be greater than 72 hours.

Refer to the keyword "Limitations", in the Hardy Diagnostics software program HUGO™, for more information regarding general limitations on culture media.

MATERIALS REQUIRED BUT NOT PROVIDED

Standard microbiological supplies and equipment such as loops, incinerators, incubators, centrifuge, pasteur pipets, culture media and cell culture media, etc., as well as serological and biochemical reagents, are not provided.

QUALITY CONTROL

The following organisms are routinely used for testing at Hardy Diagnostics.

After inoculation to the CVM Transport Media, the organisms listed below are held at 2-30 degrees C., for the indicated time, and then subcultured to appropriate culture media.

Test Organisms	Time	Reaction
Mycoplasma pneumoniae ATCC® 15531	48hr	Viability maintained
Herpes Simplex Type I McIntyre ATCC® VR-539	48hr	Viability maintained

PERFORMANCE CHARACTERISTICS

CVM Transport was compared to a commercially available multimicrobe transport media. Both transports are intended for use in the transport and maintenance of specimens for the recovery of viral, chlamydial, mycoplasmal and ureaplasmal agents. The results for the thirteen organisms (wild-type strains) tested in CVM Transports were as follows:

Organism (Wild-Type Strains: one isolate/organism)	Inoculum Concentration	Maximum Holding Time (Percent of recovery was not determined)
		2-8oC.	15-30oC.
Herpes Simplex Type I	10-3 TCID50	96 hours	96 hours
Herpes Simplex Type II	10-3 TCID50	96 hours	96 hours
Cytomegalovirus	n/t	72 hours	24 hours
Influenzae A	10-1 TCID50	72 hours	72 hours
Influenzae B	10-1 TCID50	72 hours	48 hours
RSV	10-1 TCID50	72 hours	72 hours
Echovirus	10-1 TCID50	96 hours	96 hours
Adenovirus	10-1 TCID50	96 hours	72 hours
Chlamydia pneumoniae*	10-1 IFU	72 hours	48 hours
Chlamydia trachomatis	10-1 IFU	72 hours	48 hours
Mycoplasma hominis	10-1 CFU	96 hours	96 hours
Mycoplasma pneumoniae	10-1 CFU	96 hours	72 hours
Ureaplasma urealyticum	10-1 CFU	96 hours	96 hours

* Chlamydia pneumoniae ATCC^® CCL-23.

REFERENCES

1. August, M.J., et al. 1990. Cumitech 3A; Quality Control and Quality Assurance Practices in Clinical Microbiology, Coordinating ed., A.S. Weissfeld. American Society for Microbiology, Washington, D.C.

2. Murray, P.R., et al. 1995. Manual of Clinical Microbiology, 6th ed. American Society for Microbiology, Washington, D.C.

3. Forbes, B.A., et al. 1998. Bailey and Scott's Diagnostic Microbiology, 10th ed. C.V. Mosby Company, St. Louis, MO.

4. Clyde, W.A., et al. 1984. Cumitech 19; Laboratory Diagnosis of Chlamydial and Mycoplasmal Infections. Coordinating ed., W.L. Drew. American Society for Microbiology, Washington, D.C.

5. Isenberg, H.D. Clinical Microbiology Procedures Handbook, Vol. I & II. American Society for Microbiology, Washington, D.C.

6. Daley, P., Castriciano, S., Chernesky, M., and Smieja, M. 2006. Comparison of Flocked and Rayon Swabs for Collection of Respiratory Epithelial Cells from Uninfected Volunteers and Symptomatic Patients. Journal of Clinical Microbiology, p. 2265-2267.

7. Castriciano, S., Petrich, A., Smieja, M., and Chernesky, M.A. 2007. Flocked Swabs and UTM-RT are Pre-analytical Tools Suitable for Rapid Antigen Kits, Direct Immunofluorescence, Culture and PCR Diagnostics Assay for Viral Infections. 17th European Congress of Clinical Microbiology and Infectious Diseases Munich, Germany.

ATCC is a registered trademark of the American Type Culture Collection.

082108md