Transcript Rotavirus and Adenovirus Ag Rapid Test Presentation

OnSite Rota/Adeno Ag Rapid Test
Detection of Two Most Common Viruses in One Test Makes Diarrhea Diagnosis Easier
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
o Dehydration
o Malnutrition
Diarrhea - Common Illness, Global Killer in Children
• 2.5 billion cases
worldwide in 2004
in
all
ages
• One of the main causes of
childhood morbidity and mortality
worldwide, resulting in:
o 1.7 billion new cases
o 2.5 million deaths annually
o 1 in 9 child deaths worldwide,
(801,000/year; 2,195/day)
o The 2nd leading cause of death
among children under 5
Diarrheal Diseases World Map In 2004 - WHO
Virus, Leading Cause of Infectious Diarrhea in Children
• Viruses account for 70% of infectious diarrhea in children
• Well-known viruses impacting child health
o Rotavirus
o Norovirus
o Adenovirus
o Astrovirus
• Rotavirus is the most common cause in children
• Adenovirus, especially types 40 and 41, is the most common cause in
children under 2
Rotavirus/Adenovirus Infection in Children with Diarrhea
Rotavirus infection
• Almost every child infected by age five worldwide
• Account for:
o 20% of diarrhea cases
o 50% of cases requiring hospitalization
o 37% of deaths due to diarrhea
o 5% of all deaths in age younger than 5
Adenovirus infection
• Primarily infects children under 2
• Account for 20% of the viral gastroenteritis cases
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
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”
Current Diagnostic Methods
• Detection of virus Ag in stool
o Enzyme immunoassay (EIA)
o Latax agglutination test (LAT)
o Immunochromatograpic Test (ICT)
o PCR
• Detection of virus in stool
o Electron microscopy (EM)
o Culture
• Serology for epidemiologic studies (no common in clinic)
Comparison of Different Diagnostic Methods
Method
Advantage
ICT
LAT
EIA
PCR
EM
Culture
Simple;
Rapid;
Sensitive;
Specific
None
Simple; Rapid; Typical for
Specific
pathogens that
are difficult to
isolated directly
Dilution
Required
Sensitive;
Specific;
Quantitative
Required
Audiovisual
Gold
standard
Required
Required
Time to
result
Facility
15 min
15 min-1 h
1-4 hours
> 4 hours
2-3 days
>3 days
Anywhere
General Lab
General Lab
Special Lab
Special Lab
Special Lab
Equipment
No
Shaker or no
Expensive
Skill
Minimal
Moderate
training
Less sensitive
Reader, incubator,
pipette
Moderate Training
Expensive,
microscopy
Specialist
Incubator,
microscopy
Specialist
Costly
Costly, time
consuming
Preparation
Comments
Costly
Well
trained
Costly
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.
OnSite Rota/Adeno Ag Rapid Test
Catalog # R0196C
Feature
Procedure
Time to results
Equipment
Required training
Storage
Qualitative detection and differentiation of Rota/Adeno
Ag in fecal specimen
Simple, in 3 steps
15 minutes
None
Minimal: Basic pipetting
Room temperature or refrigerated
Easy Test Procedure
Specimen Collection and Handling
•
Solid stool samples
•
Watery stool samples
Easy Test Procedure
Three Steps, Fast Result
•
Assay procedure
Dispenser cap
Add 2 drops of sample
Read result
Easy Test Procedure
Clear Test Interpretation
Negative
Only the C line (+)
Positive
Presence of the C line &
• A line - Adenovirus Ag (+)
• R line - Rotavirus Ag (+)
• R&A line - Both Ags (+)
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
Positive
36
0
36
Negative
2
69
71
Total
38
69
107
Relative Sensitivity: 100%, Relative Specificity: 97.2%, Overall Agreement: 98.1%
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
Positive
10
0
10
Negative
2
95
97
Total
12
95
107
Relative Sensitivity: 100%, Relative Specificity: 97.9%, Overall Agreement: 98.1%
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
Sample Size
Rotavirus Ag
Reactivity
Adenovirus Ag
Reactivity
Typhoid fever
6
Negative
Negative
Rotavirus
15
Positive
Negative
Adenovirus
10
Negative
Positive
H. Pylori
10
Negative
Negative
Cholera (spiked)
3
Negative
Negative
Fecal Specimens
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
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
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
Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739
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