PT5012 - GIARDIA II
A second generation monoclonal antibody-based ELISA for the qualitative detection of Giardia lamblia in fecal specimens.
Giardia lamblia is a binucleated flagellated protozoan parasite that infects the small intestine. Infection typically results in chronic debilitating diarrhea, weight loss and malabsorption. The disease often results following the drinking of contaminated water and travel to areas that have endemic giardiasis. Transmission also occurs by direct contact, especially with asymptomatic carriers and by food contamination. High risk categories include young children, immunocompromised patients, and those without previous exposure. More recently, giardiasis has been recognized as a sexually transmitted disease. The GIARDIA II test is a monoclonal antibody-based ELISA for the rapid detection of Giardia lamblia cyst antigen in fecal specimens. The test serves as an in vitro diagnostic aid for giardiasis.
Features
- Rapid (results in less than 2 hours)
- Specific for Giardia lamblia
- Easy to perform
- Highly standardized
- High correlation with IFA-confirmed microscopy
Further Information
Package Insert Issued 10/06
CPT Codes Issued 3/08
Material Safety Data Sheet Issued 2/06
Poster Presentation
EVALUATION OF GIARDIA II - A Fecal Diagnostic ELISA for the Detection of Human Giardia Infection
American Society for Microbiology meeting, June 2005, Atlanta, GA
Poster Presentation
Evaluation of a New Direct ELISA, the GIARDIA II Test, for the Detection of Giardia Lamblia Antigen in Fecal Specimens.
American Society for Microbiology meeting, May 2003, Washington DC
Frequently Asked Questions
Q: Can I read the GIARDIA II test visually?
A: Yes, the back of the instructional card contains a color chart. This guide will enable you to interpret the test results without the aid of a spectrophotometer.
Q: What type of sample can I use in the GIARDIA II test?
A: Samples that arrive in fixatives such as 10% formalin or SAF and those that are either fresh or frozen can be used. Follow the package insert carefully to ensure proper dilution of samples. Fresh or frozen samples require a different dilution than preserved samples. Remember to cover the plate to prevent evaporation of samples that are in alcohol based preservatives as evaporation of the samples will cause them to adhere to the plate and make washing extremely difficult.
Q: What species of Giardia does the GIARDIA II test detect?
A: Giardia lamblia is the species that infects humans and is detected by the GIARDIA II test. It is not known if other species of Giardia react in the test.
Q: Does the test detect trophozoites?
A: The antigen that the test detects (cyst wall protein 1 or CWP1) is produced during the encystment stage of the life cycle of the organism. It is the same antigen detected by the competitor's Giardia tests and it is present on both the encysting trophozoites and cysts. During an infection the intestine contains organisms in all stages of the life cycle as well as CWP1. This means that the test is able to detect an infection when the organism itself is not being shed into the feces and when conventional microscopy is negative.
Q: Can I test canine fecal samples in the GIARDIA II test?
A: The GIARDIA II test has been cleared by the FDA for use with human fecal specimens only. Any laboratory wishing to use fecal samples from dogs in the GIARDIA II test should first consult USDA regulations. In-house studies show no cross-reactivity when fecal samples from healthy dogs are assayed in the GIARDIA II test. If dog samples are used in the GIARDIA II test, TECHLAB® may require a disclaimer acknowledging that such testing represents an "off-label use".
Q: Can I test duodenal aspirates?
A: We don't have sufficient data to recommend the test be used on this type of sample. The test was designed for use on diarrheal samples.
Q: What is the CPT code for the GIARDIA II?
A: According to the 2006 coding, the CPT code is 87329.