1. OnSite Rota/Adeno Ag Rapid Test
Detection of Two Most Common Viruses in One Test Makes Diarrhea Diagnosis Easier

2. Diarrhea
Defined as the passage of three or more loose or liquid stools per day, or more frequent passage than is normal for the individual
Major risk factors
Dehydration
Malnutrition

3. Diarrhea - Common Illness, Global Killer in Children
2.5 billion cases in all ages worldwide in 2004
One of the main causes of childhood morbidity and mortality worldwide, resulting in:
1.7 billion new cases
2.5 million deaths annually
1 in 9 child deaths worldwide, (801,000/year; 2,195/day)
The 2nd leading cause of death among children under 5
Diarrheal Diseases World Map In WHO

4. Virus, Leading Cause of Infectious Diarrhea in Children
Viruses account for 70% of infectious diarrhea in children
Well-known viruses impacting child health
Rotavirus
Norovirus
Adenovirus
Astrovirus
Rotavirus is the most common cause in children
Adenovirus, especially types 40 and 41, is the most common cause in children under 2

5. Rotavirus/Adenovirus Infection in Children with Diarrhea
Rotavirus infection
Almost every child infected by age five worldwide
Account for:
20% of diarrhea cases
50% of cases requiring hospitalization
37% of deaths due to diarrhea
5% of all deaths in age younger than 5
Adenovirus infection
Primarily infects children under 2
Account for 20% of the viral gastroenteritis cases

6. Why Differentiate Rotavirus/Adenovirus Infection?
Diarrhea caused by rotavirus is more severe, and leads to high fever and dehydration more often
Infection duration is longer with adenovirus infection
Rotavirus infection is higher contagious, earlier diagnosis helps to control infection spreading
Vaccination against rotavirus may prevent 228,000 deaths annually

7. Why Test Rotavirus/Adenovirus at the Same Time?
Co-existence of more than one agent is not rare in gastroenteritis
Both of them are the most common causes of diarrhea in children
Earlier diagnosis avoids unnecessary use of antibiotics
Earlier diagnosis helps earlier treatment and avoids malnutrition in future
Even benefit for doctor and other medical staffs to avoid “hospital acquired infection”

8. Current Diagnostic Methods
Detection of virus Ag in stool
Enzyme immunoassay (EIA)
Latax agglutination test (LAT)
Immunochromatograpic Test (ICT)
PCR
Detection of virus in stool
Electron microscopy (EM)
Culture
Serology for epidemiologic studies (no common in clinic)

9. Comparison of Different Diagnostic Methods
ICT
LAT
EIA
PCR EM
Culture
Advantage
Simple; Rapid; Sensitive; Specific
Simple; Rapid; Specific
Typical for pathogens that are difficult to isolated directly
Sensitive; Specific; Quantita-tive
Audio-visual
Gold standard
Preparation
None
Dilution
Required
Time to result
15 min
15 min-1 h
1-4 hours
> 4 hours
2-3 days
>3 days
Facility
Anywhere
General Lab
Special Lab
Equipment No
Shaker or no
Reader, incubator, pipette
Expensive
Expensive, microscopy
Incubator,
microscopy
Skill
Minimal
Moderate training
Moderate Training
Well trained
Specialist
Comments
Less sensitive
Costly
Costly, time consuming
ICT can be performed virtually anywhere, including laboratories, doctor office or the field. It is especially suitable in underdeveloped countries where diagnostic facilities are limited.

10. OnSite Rota/Adeno Ag Rapid Test
Catalog # R0196C
Feature
Qualitative detection and differentiation of Rota/Adeno Ag in fecal specimen
Procedure
Simple, in 3 steps
Time to results
15 minutes
Equipment
None
Required training
Minimal: Basic pipetting
Storage
Room temperature or refrigerated

11. Specimen Collection and Handling
Easy Test Procedure
Specimen Collection and Handling
Solid stool samples
Watery stool samples

12. Three Steps, Fast Result
Easy Test Procedure
Three Steps, Fast Result
Assay procedure
Dispenser cap
Add 2 drops of sample
Read result

13. Clear Test Interpretation
Easy Test Procedure
Clear Test Interpretation
Only the C line (+)
Negative
Positive
Presence of the C line &
A line - Adenovirus Ag (+)
R line - Rotavirus Ag (+)
R&A line - Both Ags (+)

14. Excellent Sensitivity & Specificity OnSite Rota/Adeno Ag Rapid Test
Clinical Performance
Excellent Sensitivity & Specificity
Clinical performance of rotavirus Specimens
107 fecal samples collected from subjects with symptomatic diarrhea and non-diarrhea symptoms were tested with the OnSite Rota/Adeno Ag Rapid Test and with a reference rapid test
OnSite Rota/Adeno Ag Rapid Test
Reference
Positive
Negative
Total 36 2 69 71 38
107
Relative Sensitivity: 100%, Relative Specificity: 97.2%, Overall Agreement: 98.1%

15. Excellent Sensitivity & Specificity OnSite Rota/Adeno Ag Rapid Test
Clinical Performance
Excellent Sensitivity & Specificity
Clinical performance of adenovirus Specimens
107 fecal samples collected from subjects with symptomatic diarrhea and non-diarrhea symptoms were tested with the OnSite Rota/Adeno Ag Rapid Test and with a reference rapid test
OnSite Rota/Adeno Ag Rapid Test
Reference
Positive
Negative
Total 10 2 95 97 12
107
Relative Sensitivity: 100%, Relative Specificity: 97.9%, Overall Agreement: 98.1%

16. Clinical Performance No Known Cross-Reactivity
The cross reactivity of the OnSite Rota/Adeno Ag Rapid Test was assessed by testing fecal specimens from patients with other gastrointestinal infectious diseases
Fecal Specimens
Sample Size
Rotavirus Ag Reactivity
Adenovirus Ag Reactivity
Typhoid fever 6
Negative
Rotavirus 15
Positive
Adenovirus 10
H. Pylori
Cholera (spiked) 3

17. OnSite Rota/Adeno Ag Rapid Test Competitive Advantages
USA brand: designed and developed by CTK San Diego Office
2 tests in 1 device: reduce test time and cost
Higher accuracy: no false positive or negative complaints
High quality meets market demand: double order from Europe

18. OnSite Rota/Adeno Ag Rapid Test
Meets Market Demand
Suitable for large population screening everywhere
Fast results within 15 minutes
Both solid and watery stool sample can be tested
Simple procedure with only 3 steps
No additional equipment needed
Minimal training
Room temperature storage
2 in 1 test complies cost-effective
2 In 1

19. OnSite Range of GI Tract Infection Rapid Test Kits
More products available
Rotavirus Ag rapid test Fecal
Cholera Ag rapid test Fecal
H. pylori Ab combo rapid test S, P
H. pylori Ab combo rapid test (strip) coming soon
H. pylori Ag rapid test Fecal
Typhoid IgG/IgM rapid test S, P
Typhoid IgG/IgM combo rapid test S,P,WB
OnSite Rapid Tests
the initial step for prompt management of GI Infection

20. Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA USA
Telephone: 1 (858) Fax: 1 (858)

21. QUALITY . INNOVATION . SIMPLICITY
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