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OnSite Typhoid IgG/IgM Rapid Test
Simplifying Diagnostics of S. typhi & paratyphi Infection
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Contents S. typhi and paratyphi infection Current detection methods
OnSite Typhi IgG/IgM Rapid Test To be aware of
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S. typhi and paratyphi Infection
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S. Typhi and Paratyphi Type A, B, C
Gram negative Facultative rod-shaped bacterium Enterobacteriaceae family
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Structure of Typhi Bacterium
Somatic “O” antigen Flagellar “H” antigen O and H antigen are the most predominant antigens which induce antibody production during infection IgM to O antigen is seen in primary infection and re-infection H antigen is a strong IgG immunogen
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S. Typhi & Paratyphi Transmission
Contaminated food or water Raw food Poor water sanitation Traditional sanitary style Inappropriate food & water preparation or storage Traveler disease!
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High Prevalence of Typhi and Paratyphi in Developing Countries
In 2000, Typhi and Paratyphi cause Over 2.16 million episodes worldwide 216,000 deaths More than 90% occurred in Asia
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S. Typhi & Paratyphi Infection Trend
S. Typhi infection decreases dramatically Paratyphi infection is predominant now Detection of both S. typhi and paratyphi are critical
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Typhi & Paratyphi Fever Symptoms
Daily increase of fatigue Headache Diarrhea Malaise Anorexia Transient macular rash of rose-colored spots on body trunk Daily increase in fever of 38.5℃ to 40℃ by the 3rd or 4th day of illness Constipation or diarrhea Enlarged lymph nodes, spleen and liver
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To Be Differentiated from
Present with similar symptoms (diarrhea, vomiting, fever, nausea or share similar transmission route (contaminated water source): Malaria Norovirus Cholera Influenza Filariasis Rotavirus Leptospirosis Dengue fever
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Disease Course Early and accurate diagnosis is critical:
6-30 day incubation Last for one month if untreated Serious complications: - Intestinal Hemorrhage - Intestinal Perforation Long term carrier “Typhi Mary” Early and accurate diagnosis is critical: Facilitate proper treatment for early recovery and prevent deaths Prevent spread
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Current Diagnostic Methods
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Current Diagnostic Methods
Culture - Blood culture Bone marrow culture Stool culture Serological Ab Detection - Agglutination (widal test) - ELISA (Typhi dot) - Lateral flow chromatographic immunoassay (OnSite rapid test) Molecular Dx - Not clinically practical Typhi Ag
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Culture Detection A 3+ day procedure. Not a screening test
Antibiotic administration reduces detection rate
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Widal Test: the Most Over Used Test
A test method developed in1896 Pre-dilute specimen to a series of dilutions Old method Prone to operator error Time consuming Require skillful technician Cross reaction A dilution series with each target O, H, AH and BH Not recommended by WHO Add O, H, AH, BH Widal Test reagents to all of the tubes Incubate at 37C overnight or rock by hands for 1 minute
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Typical Problems with Widal Test
False Positive False Negative Cross reaction with non-Typhi Salmonella or malaria Cross reactivity with other LPS of enterobacteriaceae Operator error Inadequate application of bacterial antigen on test tubes or slides Variability in preparation of commercial antigens Operator error Low reproduce-ability Unreliable with less sensitivity and specificity
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Typhi Dot IgM or IgG Test
Limited to S. Typhi, no indication of infection stage Dot EIA for the detection of IgM and IgG antibodies against a specific antigen for Salmonella typhi. One hour long, 6 test procedures 79% sensitivity and 89% specificity Does not detect Abs to S. paratyphi Product needs to be refrigerated 12 month shelf life only No built-in procedure control
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On market in the last ten years but not popular
Tubex IgM Test On market in the last ten years but not popular Multiple procedures Expensive Does not detect Paratyphi IgM Does not detect IgG antibodies in chronic or relapsing patient
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OnSite Typhoid IgG/IgM Rapid Test
First Choice for Screening of Typhi and Paratyphi Fever Trusted by Pathologists of 50 countries
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Identify Different Stages of Infection
IgM : Develops in 5-7 days, Declines in one month IgG: Rises in days Last for months
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OnSite Rapid Test Principle Rabbit IgG gold (control)
specimen IgM IgG capillary flow sample Pad conjugating Pad Test Line1 Test Line2 Control Line specimen Detection of anti typhi IgM Detection of anti typhi IgG control IgM IgG Ag Ag Ag Ag Ag-gold conjugate Rabbit IgG gold (control) Immobilized anti human IgM Reagent to bind human IgG Immobilized Anti rabbit IgG
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OnSite Typhoid IgG/IgM Rapid Test
Qualitatively detects and differentiates IgG & IgM to S.typhi and paratyphi in: Serum Plasma whole blood Utilizes O & H antigens that do not present in healthy individuals
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OnSite Typhoid IgG/IgM Test “1-2” Easy Steps
Step 1: drop of specimen Step 2: drop of sample diluent Step 3: Read result
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OnSite Typhoid IgG/IgM Rapid Test
Test Result Interpretation Negative IgM Positive IgG/IgM Positive IgG Positive Invalid No Infection Early primary Active primary, Late stage or, infection repeat infection latent infection Re-Test
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OnSite Typhoid IgG/IgM Test Cross Reactivity
No cross reactivity to the diseases with similar symptoms H. Pylori Rotavirus Leptospirosis Dengue fever Cholera Influenza Malaria Pneumonia
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OnSite Typhoid IgG/IgM Rapid Test OnSite Typhoid IgG/IgM Rapid Test
OnSite Typhoid IgG/IgM Rapid Test Performance Clinical study for IgM Test OnSite Typhoid IgG/IgM Rapid Test ELISA Positive Negative Total 31 3 34 2 198 200 33 201 234 Relative sensitivity: 91.2% Relative specificity: 99% Overall agreement: 97.9% Clinical study for IgG OnSite Typhoid IgG/IgM Rapid Test ELISA Positive Negative Total 13 1 14 2 198 200 15 199 214 Relative sensitivity: 92.9% Relative specificity: 99% Overall agreement: 98.5%
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OnSite Typhoid IgG/IgM Rapid Test Evaluation
Distributed to more than 50 countries Country China Indonesia Madagascar Pakistan Zimbabwe Specimens 11 Typhi 9 Paratyphi A 60 Typhi-Paratyphi 20 Suspicious specimens 20 suspicious specimens 138 specimens Reference test kit Test kit Blood culture Widal test Tubex IgM test Result 100% Positive 69% Positive (H) 20% Positive (H) 100% Positive 12 positive, 126 negative OnSIte Typhoid IgG/IgM Rapid Test 95% Positive 88% IgG Positive 30% IgG Positive 100% positive via extended protocol 100% sensitivity 93.7% specificity
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OnSite Typhiod IgG/IgM Rapid Test
The 1st choice Test Detection Procedure Test time Cost OnSite IgG/IgM Test IgG and IgM to S. typhi & S.paratyphi O & H antigens 2 simple procedures 15 min Low Widal Test Antibody to S. typhi & S. paratyphi O & H antigens Dilution, Incubation 2 min – > 18 hrs Typhi dot Test IgM and IgG to S. typhi OMP antigen 6 procedures 60 min Culture Live bacterial replication 2-3 days High
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Widal Test vs OnSite Rapid Test OnSIte Typhoid IgG/IgM Rapid Test
Parameter Widal Test OnSIte Typhoid IgG/IgM Rapid Test Principle Agglutination immunoassay Lateral flow immunoassay Antigen used S. typhi & S.paratyphi O and H antigens S.tphi & S.paratyphi O and H antigens Test procedure Dilute specimen to a series of 8 dilutions Add O, H, AH, BH reagents to all of the 8 tubes Incubate at 37C overnight Add specimen to the test device Add Sample Diluent to the test device Result reading Visually observe sediments Visually observe colored IgG or IgM band in 15 minutes Requirement Dedicated lab staff Tubes, water bath or incubator No equipment required Minimal training Sensitivity 63.2 % sensitivity to culture Cite: J. Clinical and Diagnostic Research: 6(2): 198:199, 2012 95%-100% sensitivity to culture Comments Time consuming Prone to operator error Losing its relevance in western and European nations Cross reactive Required be stored at 2-8◦C Fast & inexpensive Stored in a wide range of temperatures High reproducibility Can use whole blood specimen Co-relation Widal Test Typhi O antigen : 40: OnSite IgM Negative Widal Test Typhi O antigen : 80: OnSite IgM Positive Widal Test Paratyohi H antigen : 80: OnSite IgG positive Widal Test Paratyohi H antigen 1: 160: OnSite IgG positive * Study in Madacascar, 2011
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OnSite: Practical Advantages- DRUQ
Detection Advantages Detects antibodies to S.typhi & paratyphi A， B， C Differentiates IgG from IgM in the same test device Easily accessible specimens serum, plasma, whole blood, suitable for emergency care Result Advantages Result in 15 minutes, enabling doctor to take immediate action Highly accurate & reproducible: Performance is verified in multiple regions across the world The most reliable test on the market User Advantages Can be performed by health professionals with minimal training No equipment no electricity is required 24 month stability at a wild range of temperature Quality Advantages Launched since 2005, millions of tests are sold in more than 50 countries Key raw materials made in house in compliance with ISO to ensure product quality and delivery quality
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Final Message to Doctors
For fast, reliable and simple screening of Typhi & Paratyphi fever Rely On Onsite Typhoid IgG/IgM Rapid tests (R0160C, R0161C) #1 brand of typhi IgG/IgM rapid test Established in 2007 Widely accepted in over 50 countries Passed MOH evaluation studies and registered in many countries
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QUALITY . INNOVATION . SIMPLICITY
Together, we grow CTK
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To Be Aware Of
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To Be Aware Of #1 Without symptoms
IgG or IgM positive = Infection or Exposure With symptoms IgG or IgM positive = Disease
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To Be Aware Of #2 Detectable level
Typhi is an acute infection. It progresses rapidly. Test result at initial test is negative, but can turn to positive few days late Re-sampling is necessary if symptoms persist
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To Be Aware Of #3 Proper action to be followed
Verify by confirmatory tests to make final diagnostic decision Conduct antibiotic sensitivity test to select proper antibiotic for effective treatment
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Together, we grow CTK The Common Typhi Tests on Market
Parameter Blood Culture Widal Test Typhoi Dot OnSIte Typhoid IgG/IgM Rapid Test Principle Live bacterial replication Agglutination immunoassay Enzyme Immunoassay Lateral flow immunoassay Antigen used N/A S. typhi & S.paratyphi O and H antigens S. typhi OMP antigen S.tphi & S.paratyphi O and H antigens Test procedure Culture blood in broth from pro-enrichment Dual selection enrichment Dual plating. Total 3-4 day procedure Pre-dilute specimen to a series of 8 dilutions Add O, H, AH, BH Widal Test reagents to all of the 8 tubes Incubate at 37C overnight Add 4 drops of specimens Incubate for 10 mins Wash Incubate HRP-anti human IgG or IgM Add TMB Add specimen to the test device Add Sample Diluent to the test device Result reading Traditional or biochemical identification Visually observe sediments Visually observe IgG or IgM color dot Visually observe colored IgG or IgM band in 15 minutes Requirement Incubator Electricity Trained personnel Dedicated lab staff Tubes, water bath or incubator Minimal training Refrigerator No equipment required Comments Gold Standard method Not a screening test Time consuming Prone to operator error Losing its relevance in western and European nations Cross reactive 1 hour long, 7 step test procedure Does not detect Paratyphi Test components must be stored at 2-8°C No built-in procedure control Fast & inexpensive Can be used and stored in a wide range of temperatures Detects both S. typhi & Paratyphi infections Detects latent or chronic infection High reproducibility QUALITY . INNOVATION . SIMPLICITY Together, we grow CTK After Slide
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