INTRODUCTION

The Giardia Lamblia Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of Giardia lamblia antigens human fecal specimens. It is intended to be used by healthcare professionals as an aid in the diagnosis of Giardia infection. The test only provides preliminary analysis results but not critical diagnosis criteria. Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s) and clinical findings based on professional judgment of healthcare providers.

INTENDED USE

The etiological agent of Giardiasis, Giardia duodenalis (syn. G. intestinalis, G. lamblia) is one of the most prevalent intestinal protozoan flagellate of the human. The life cycle of Giardia species is simple and it is included of two active trophozoite and cystic forms. This parasite transmits via fecal-oral route through direct or indirect ingestion of infectious cysts. The incubation period varies from 9 to 15 days after ingestion of cysts. Symptoms of infection are varied from the absence of symptoms to acute watery diarrhea, nausea, epigastric pain and weight loss1,2. Giardiasis has a global distribution and it is common in both children and adults. The prevalence of Giardia infection is higher in developing countries. It is reported that more than 200 million cases of giardiasis are annually diagnosed worldwide. Since 2004, World Health Organization (WHO) announced Giardia has been included in the “neglected diseases initiative”3 . The infection rate in asymptomatic children has been reported from 8% to 30% in developing countries and 1-8% in developed countries4 . The occurrence of giardiasis is probably higher in individuals with diarrhea. Correct diagnosis of giardiasis is important for treatment and prevention of diseases. The laboratory diagnosis of Giardia spp. is mainly based on finding and demonstration of microscopic cyst in stool samples. The Giardia Lamblia Antigen Rapid Test Kit utilizes anti-Giardia antibodies to detect Giardia lamblia antigens in human fecal specimens at 15-20 minutes.