R-Biopharm AG

Parasite Diagnostics – Rapid and reliable detection by real-time PCR

• RIDA®GENE Parasitic Stool Panel • RIDA®GENE Parasitic Stool Panel I • RIDA®GENE Parasitic Stool Panel II • RIDA®GENE • RIDA®GENE

R-Biopharm – for reliable diagnostics. R-Biopharm AG

Human pathogenic parasites

Giardia lamblia, Cryptosporidium spp., water and food, as well as by faecal-oral route Entamoeba histolytica and Dientamoeba fragilis from person to person. are the most important -causing proto- Entamoeba histolytica is the only human patho- zoa. genic species of the genus Entamoeba and the causative agent of . Infection with According to the CDC (Center for Disease Con- Entamoeba histolytica occurs by ingestion of trol) about 2 % of all adults and 6 - 8 % of all cysts in contaminated food, drinking water or by children in developed countries and about a faecal-oral route from person to person. third of all people in developing countries are infected with Giardia lamblia (synonym G. intes- In 10 % of Entamoeba histolytica cases, the infec- tinalis or tion leads to amoebic and on rare occa- G. duodenales).1 Also, the CDC estimates about sions to extraintestinal amoebiasis, mostly to the 77,000 cases of each year in the U.S.2 liver (amebic ). The WHO estimates Infection with G. lamblia occurs by ingestion of that about 50 million people worldwide suffer cysts in contaminated food, drinking water or by from amoebiasis each year, resulting in 100,000 faecal-oral route from person to person. deaths each year.2,5

Cryptosporidium parvum is one of several spe- Dientamoeba fragilis is distributed worldwide, cies of the genus Cryptosporidium. Besides however it is also one of the most underesti- C. parvum, also C. hominis most commonly mated diarrhea-causing . Recent stud- causes cryptosporidiosis in humans.3 However, ies demonstrated the pathogenic potential and also infections by other Cryptosporidium spp. implicated it as a common cause of gastrointes- such as C. felis, C. meleagridis, C. canis, and tinal disease. Symptoms of dientamoebiasis are C. muris may lead to clinical symptoms.4 Each abdominal pain and diarrhea. The prevalence of year estimated 748,000 cases of cryptosporidiosis Dientamoeba fragilis varies from 0.3 % to 52 % occur in the United States.3 The infection occurs and often exceeds that of Giardia lamblia.6,7 after the ingestion of oocysts in contaminated

The R-Biopharm RIDA®GENE real-time PCR assays for parasite diagnostics detect and differentiate the most important diarrhea causing parasites: Giardia lamblia, Cryptosporidium spp., Entamoeba histolytica and Dientamoeba fragilis.

Parasite RIDA®GENE Product Giardia Cryptosporidium Entamoeba Dientamoeba lamblia spp. histolytica fragilis (melting curve)* PG1705 Parasitic Stool Panel l l l l* PG1715 Parasitic Stool Panel I l l l l PG1725 Parasitic Stool Panel II l l l PG1735 Entamoeba histolytica l PG1745 Dientamoeba fragilis l

1. Centers for Disease Control and Prevention 2011. Giardia Epidemiology & Risk Factors, 5. Fotedar R et al. Laboratory diagnostic techniques for Entamoeba species. Clin Microbiol http://www.cdc.gov/parasites/giardia/epi.html. Aufgerufen am 10.07.2012. Rev. 2007, 20(3):511-532. 2. Food and Drug Administration (FDA) 2011. Bad Bug Book 2nd Edition. http://www.fda. 6. Stark D et al. A review of the clinical presentation of dientamoebiasis. Am J Trop Med gov/food/foodsafety/foodborneillness/foodborneillnessfoodbornepathogensnatural- Hyg. 2010, 82(4):614-9. toxins/badbugbook/default.htm. Aufgerufen am 10.07.2012. 7. Baratt JLN et al. A review of Dientamoeba fragilis carriage in humans: several reasons 3. Leitch GJ and Qing He. Cryptosporidosis - an overview. J Biomed Res. 2012, 25(1): 1-16. why this organism should be considered in the diagnosis of gastrointestinal illness. 4. Centers for Disease Control and Prevention. http://www.cdc.gov/parasites/crypto/ Gut Microbes. 2011, 2(1):3-12. biology.html. Accessed 07.03.2014. Flexible – can be run on the commonly used real-time PCR instruments RIDA®GENE Parasitic Parasitic Parasitic E. histolytica D. fragilis Stool Panel Stool Panel I Stool Panel II Art . No. Art . No. Art . No. Art . No. Art . No. Real-time PCR instruments PG1705 PG1715 PG1725 PG1735 PG1745 Roche LightCycler® 2.0 2 2 LightCycler® 480 1 3 1   Cepheid SmartCycler®     Applied Biosystems ABI 7500 ABI     7500 FAST Abbott m2000rt     Stratagene MX3005P      Qiagen Rotor-Gene Q     Biorad CFX96TM    

1 RIDA®GENE Color Compensation Kit I required 2 RIDA®GENE Color Compensation Kit II required 3 RIDA®GENE Color Compensation Kit IV required

Efficient – simultaneous processing of all RIDA®GENE Parasite tests due to one common DNA profile

Time to result • LightCycler® 2.0, SmartCycler® approx. 30 min • Mx3005P, LightCycler®480, ABI 7500, m2000rt and CFX96™ approx. 60 min • Rotor-Gene Q approx. 80 min

Complete – contains all necessary components

• RIDA®GENE Parasitic Stool Panel Kit Code Reagent Amount Lid Color • RIDA®GENE Parasitic Stool Panel I 1 Reaction Mix 2 x 1100 µl yellow 2 Taq-Polymerase 1 x 11 µl red • RIDA®GENE Parasitic Stool Panel II D Internal Control DNA 2 x 1800 µl orange • RIDA®GENE Entamoeba histolytica N PCR Water 1 x 500 µl white • RIDA®GENE Dientamoeba fragilis P Positive Control 1 x 200 µl blue

Reliable – an included extraction control (Internal control DNA, ICD) detects PCR inhibition, monitors reagent integrity and confirms that nucleic acid extraction was sufficient R-Biopharm AG

Ordering Information

Product Description Tests Matrix Art. No. RIDA®GENE Real-time PCR Parasitic Stool Panel Real-time multiplex PCR for the direct qualitative 100 stool PG1705 detection and differentiation of Giardia lamblia, Entamoeba histolytica, Cryptosporidium spp. and Dientamoeba fragilis in human stool samples (melting curve) Parasitic Stool Panel I* Real-time multiplex PCR for the direct qualitative 100 stool PG1715 detection and differentiation of Giardia lamblia, Entamoeba histolytica, Cryptosporidium spp. and Dientamoeba fragilis in human stool samples Parasitic Stool Panel II Real-time multiplex PCR for the direct qualitative 100 stool PG1725 detection and differentiation of Giardia lamblia, Entamoeba histolytica and Cryptosporidium spp. in human stool samples Entamoeba histolytica Real-time PCR for the direct qualitative detection of 100 stool PG1735 Entamoeba histolytica in human stool samples Dientamoeba fragilis Real-time PCR for the direct qualitative detection of 100 stool PG1745 Dientamoeba fragilis in human stool samples

* available soon 04/2014

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