Sample Transport ☆ Culture ☆ Result

A selective culture device for the diagnosis of Human Trichomonas vaginalis

InPouch® TV

InPouch TV is a self-contained broth media device for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples. The selective, nutritive media provides presumptive-positive results of one or more live trichomonads in a little over 15 minutes — while inhibiting the growth of other microorganisms, which can interfere with a reliable diagnosis.

Human trichomoniasis is a sexually transmitted infection (STI) caused by the flagellated protozoan Trichomonas vaginalis. It is recognized as one of the most prevalent sexually transmitted infections world-wide, in both males and females. The CDC estimates five million new cases occur in the U.S. annually.

The pouch is designed for user-friendly and convenient early microscopic detection by culture confirmation of T. vaginalis. The pouch consists of a high-barrier, oxygen-resistant, plastic with two V-shaped-chambers connected by a narrow passage that, together, provide a variety of benefits. The pouch allows users to easily inoculate a specimen, immediately observe (wet mount) the specimen, store and/or transport (optional) before transfer to the lab for incubation and recording.

Specifications

Product Principal

Combine collection, culture, result and microscopic observation in one IVD device.
Highly selective, culture media detection of Trichomonas vaginalis, in a cost-effective, easy to use, broth media device. Collection, incubation, and detection happen in one device.
No plating or wet mount slide preparation needed — place directly on the microscope stage for low power (100x) observation.

Simple Convenience

InPouch is designed for specimen collection / inoculation at point-of-care
Saves time, material cost and waste, reducing exposure to collected sample
Place directly on the microscope tray for observation
Selectively allows for growth and observation for trichomonads

Accurate Detection

Specially formulated medium is selective for positive growth of resistant strains of T. vaginalis, while inhibiting fungi and bacteria.

Test Strain	Result #
T. vaginalis	Growth
E. coli	Inhibited
C. albicans	Inhibited
E. faecalis	Inhibited
S. aureus	Inhibited

Time to Result

Presumptive positive results in 15 minutes.
Examine every 24 hours for 7 days

Storage

Extended 12 Months shelf life from the date of manufacture
Inoculated Pouches can be kept at room temperature for up to 48 hours (18-25°C), before incubation at 37°C is required

Specimen

Urine
Vaginal swab
CST
Seminal fluid

CPT Codes

87081 | 87088 | 87210

Features and Benefits

Product Principle

InPouch is engineered for user-friendly and convenient early microscopic detection by culture confirmation of T. vaginalis. The pouch consists of a high-barrier, oxygen-resistant, plastic with two V-shaped-chambers connected by a narrow passage that, together, provide a variety of benefits. This allows users to easily inoculate a specimen, immediately observe (wet mount) the specimen, store and/or transport (optional) before transfer to the lab for incubation and recording.

KEY FEATURES

Nutritive culture medium, formulated for selectivity and specificity

YOU'LL EXPERIENCE AN IMMEDIATE REDUCTION IN:

Time-to-result
Cost of laboratory materials
Medical waste
Risk of exposure or contamination

Articles and Whitepapers

Ohlemeyer: Diagnosis of Trichomonas vaginalis in Adolescent Females: InPouch TV culture versus Wet-Mount Microscopy
Journal of AdolescentHealth 1998;22:205-208
Barenfanger, Drake, and Hanson: Timing of inoculation of the pouch makes no ifference in increased detection of Trichomonas vaginalis ...
J Clin Microbiol , Apr. 2002, p1387–89
Article: Individuals infected with T. vaginalis have a higher risk of cervical cancer,
www.ncbi.nlm.nih.gov
Hobbs MM, et al. 2006. Methods for detection of T. vaginalis in the male partners of infected women.
J Clin Microbiol 44(11):3994-9
Garber GE. 2005. The laboratory diagnosis of T. vaginalis.
Can J Infect Dis Med Microbiol 16(1):35-8
Ohlemeyer Cl, et al. 1998. Diagnosis of T. vaginalis in adolescent females.
J Adolesc Health 22(3):205-8
Borchardt KA, et al. 1997. A comparison of the sensitivity of InPouch TV, Diamond's and Trichosel media.
Genitourin Med 73(4):297–298.
Borchardt KA, et al. 1996. An in-vitro metronidazole susceptibility test using InPouch TV.
Genitourin Med 72(2):132-135.

Regulatory

CE IVD Marked
FDA Clearence

⚠ WARNING: This product can expose you to chemicals including Iron Dextran and Chloramphenicol, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to P65Warnings.ca.gov.

Product	Qty	Item #
InPouch TV	10 pack	11-031-001
InPouch TV	100 pack	11-031-002
TVC - No Live Culture	10 pack	11-051-004
Lab Kit (US)	1	11-035-001
Lab Kit (International)	1	11-035-002
TV LIVE Culture (US Only)	1	11-041-003