Description
Description
A self-contained broth media device for the recovery and detection of T. vaginalis
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 under the microscope immediately after inoculation of specimen — 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.
InPouch is designed for user-friendly and convenient early microscopic detection by culture confirmation of T. vaginalis. InPouch 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 — and allows users to easily inoculate a specimen, immediately observe (wet mount) the specimen, store and/or transport (optional) before transferring to the lab for incubation and recording.
Regulatory
- CE IVD Marked
- FDA Clearance
Specifications
| Product Principle |
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| Simple Convenience |
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| Accurate Detection |
Specially formulated medium is selective for positive growth of resistant strains of T. vaginalis, while inhibiting fungi and bacteria.
|
| Time to Result |
Presumptive positive results when trichomonads are observed microscopically. If negative upon initial observation, incubate at 37°C and examine every 24 hours for 5 days. |
| Storage |
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 |
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| CPT Codes |
87081 | 87088 | 87210 |
Principles
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
Advantages
- Quick time-to-result
- Triple sealed InPouch lowers risk of exposure or contamination of sample
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.
WARNING: This product can expose you to Iron Dextran, which is known to the State of California to cause cancer. For more information go to P65Warnings.ca.gov.
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