Detection of Two Most Common Viruses in One Test Makes Diarrhea Diagnosis Easier

OnSite Rota/Adeno Ag Rapid Test

• 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 factorso Dehydrationo Malnutrition

Diarrhea

• 2.5 billion cases in all ages worldwide in 2004

• One of the main causes of childhood morbidity and mortality worldwide, resulting in: o 1.7 billion new caseso 2.5 million deaths annuallyo 1 in 9 child deaths worldwide,

(801,000/year; 2,195/day)o The 2nd leading cause of death

among children under 5

Diarrhea - Common Illness, Global Killer in Children

Diarrheal Diseases World Map In 2004 - WHO

• Viruses account for 70% of infectious diarrhea in children

• Well-known viruses impacting child healtho Rotaviruso Noroviruso 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

Virus, Leading Cause of Infectious Diarrhea in Children

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 hospitalizationo 37% of deaths due to diarrheao 5% of all deaths in age younger than 5

Adenovirus infection

• Primarily infects children under 2

• Account for 20% of the viral gastroenteritis cases

• 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 Differentiate Rotavirus/Adenovirus Infection?

• 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”

Why Test Rotavirus/Adenovirus at the Same Time?

• Detection of virus Ag in stoolo 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)

Current Diagnostic Methods

Method ICT LAT EIA PCR EM CultureAdvantage 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 Required Required Required

Time to result

15 min 15 min-1 h 1-4 hours > 4 hours 2-3 days >3 days

Facility Anywhere General Lab General Lab Special Lab Special 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 Specialist

Comments Less sensitive Costly Costly Costly Costly, time consuming

Comparison of Different Diagnostic Methods

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.

Catalog # R0196CFeature Qualitative detection and differentiation of Rota/Adeno

Ag in fecal specimenProcedure Simple, in 3 stepsTime to results 15 minutesEquipment NoneRequired training Minimal: Basic pipettingStorage Room temperature or refrigerated

OnSite Rota/Adeno Ag Rapid Test

• Solid stool samples

• Watery stool samples

Easy Test ProcedureSpecimen Collection and Handling

• Assay procedure

Easy Test ProcedureThree Steps, Fast Result

Dispenser cap

Add 2 drops of sample Read result

Only the C line (+)

Negative

Positive Presence of the C line &

• A line - Adenovirus Ag (+)

• R line - Rotavirus Ag (+)

• R&A line - Both Ags (+)

Easy Test ProcedureClear Test Interpretation

OnSite Rota/Adeno Ag Rapid TestReference Positive Negative TotalPositive 36 0 36Negative 2 69 71

Total 38 69 107

Relative Sensitivity: 100%, Relative Specificity: 97.2%, Overall Agreement: 98.1%

● 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

Clinical PerformanceExcellent 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 PerformanceExcellent Sensitivity & Specificity

Fecal Specimens Sample Size Rotavirus Ag Reactivity

Adenovirus Ag Reactivity

Typhoid fever 6 Negative NegativeRotavirus 15 Positive NegativeAdenovirus 10 Negative PositiveH. Pylori 10 Negative NegativeCholera (spiked) 3 Negative Negative

● The cross reactivity of the OnSite Rota/Adeno Ag Rapid Test was assessed by testing fecal specimens from patients with other gastrointestinal infectious diseases

Clinical PerformanceNo Known Cross-Reactivity

OnSite Rota/Adeno Ag Rapid TestCompetitive 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

• 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 Rota/Adeno Ag Rapid TestMeets Market Demand

2 IN 1

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 Range of GI Tract Infection Rapid Test Kits

OnSite Rapid Tests

the initial step for prompt management of GI Infection

Contact Info.:10110 Mesa Rim Rd. San Diego, CA 92121 USAEmail Address: tech@ctkbiotech.com Telephone: 1 (858) 457-8698Fax: 1 (858) 535-1739

Technical Support

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