onsite leishmania ab rapid test (strip) leishmania igg / igm rapid test a leading product on market...
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OnSite Leishmania Ab Rapid Test (Strip)Leishmania IgG / IgM Rapid Test
A Leading Product On Market by Using CTK Licensed Patented Antigen
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• 300,000 new cases and over 20,000 deaths annually
• 90% in:o Indian subcontinent, such as
Bangladesh, India, Nepalo Sudano Ethiopia o Brazil
• Transmitted by the sandfly
Visceral Leishmaniasis (VL)
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• Fever
• Weight loss
• Affects spleen, liver, and bone marrow
• Nearly always Fatal if not treated
Clinical Feature of V. Leishmaniasis
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Diagnostic Methods of V. Leishimaniasis
Methods Specimen Test Time RemarksMicroscopydetects amastigote
Splenic aspirate, liver biopsy or bone marrow biopsy
≥ 30 min • Invasive procedure to obtain specimen•Requires skilled technician•Accuracy depends on the microscopist•Amastigotes may be scant and difficult to view
Culturedetects amastigote
Splenic aspirate, bone marrow biopsy
10-21 days • Invasive procedure to obtain specimen•Undetectable since the amastigote stage can
transform into the promastigote stage
Serodiagnosisdetects Ab
DAT* Serum, plasma Over night •Dilute specimens prior to assaying•Need microtitration plates & incubator• Slight variations in reading result
IFA** Serum, plasma ≥ 1 hour •Dilute specimen prior to assaying•Requires fluorescence microscope• Cross reacts with Trypanosoma cruzi
ELISA Serum, plasma ≥ 1 hour • Trained technician•Requires incubator and ELISA reader• IgG/IgM tested separately
Rapid Tests
Serum, plasma, whole blood
15 min •No equipment required•Minimal training• Irrespective of parasite stage
*DAT: Direct Agglutination Test **IFA: Immunofluorescence Assay
Rapid Test is the simplest diagnostic method
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OnSite Leishmania Rapid Test kitsTwo Formats Meet Different Needs
OnSite Leishmania Ab Rapid Test• Strip • Serum/Plasma• Detect Abs• Cost effective
OnSite Leishmania IgG/IgM Rapid Test• Cassette• Serum/Plasma/Whole Blood• Detect and differentiate IgG and IgM• High accuracy
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OnSite Leishmania Rapid Test kitsUtilize rK39 for Better Performance
CTK Licensed patented rK39 antigen from IDRI to make the product • With excellent performance• More sensitive than rKE16 based product• WHO qualified
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OnSite Leishmania Ab Rapid Test (strip)Simple Procedure, Fast Result, Cost Effective
Catalog # R0122S
Intended use Qualitatively detects anti-VLby using rk39 antigen
Specimen type Serum/Plasma
Reading time 15 minutes
Equipments No
Training minimal
Shelf life 18 months
Package size 50 tests
Control lineTest line
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5 μL of specimen 2 drops of sample diluent 15 minutes
OnSite Leishmania Ab Rapid Test (strip)Simple, Rapid Procedure
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Only C line is developed
OnSite Leishmania Ab Rapid Test (strip)Clear, Easy-To-Read Result
Negative
PositiveBoth C and T line are developed
No C line is developedInvalid
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● A total 200 samples from susceptible subjects were tested by the OnSite Leishmania Ab Rapid Test and by a reference Kalazar Ab rapid test
OnSite Leishmania Ab Rapid Test
Reference Positive Negative TotalPositive 31 0 31Negative 0 169 169
Total 31 169 200Relative Sensitivity: 100%, Relative Specificity: 100%, Overall Agreement: 100%
OnSite Leishmania Ab Rapid Test (strip)Excellent Performance Comparing To Competitor
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• WHO evaluation series• Sensitivity, specificity and reproducibility
OnSite Leishmania Ab Rapid Test (strip)Leading Product On Market
Parameter Sensitivity(n=250)
Specificity(n=249)
Average Score(Highest 18)
OnSite 99.6%(97.8-99.9%)
96.8%(93.8-98.4%)
13.5
Participant A 92.8%(88.9-95.4%)
99.2%(97.1-99.8%)
9.9
Participant B 98.8%(96.5-99.6%)
97.6%(94.8-98.9%)
11.0
Participant C 99.6%(97.8-99.9%)
96.0%(92.8-97.8%)
11.8
Participant D 100%(97.9-100%)
100%(97.8-100%)
10.9
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OnSite Leishmania Ab Rapid Test (strip)Leading Product on Market
ParameterProportion positive results among cases
(n=20)
Proportion Negative results among cases
(n=4)
Proportion Invalid results (n=24)
4℃ 37℃ 45℃ 4℃ 37℃ 45℃ 4℃ 37℃ 45℃
OnSite 100% 100% 100% 100% 100% 100% 0% 0% 0%Participant A 95% 90% 90% 100% 100% 100% 0% 0% 0%Participant B 100% 100% 0% 100% 100% 100% 0% 0% 100%Participant C 100% 100% 100% 100% 100% 100% 0% 0% 0%
• WHO evaluation series• Heat Stable
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OnSite Leishmania Rapid Test KitsThe Right Choice for You
• Non-invasive
• High accuracyo sensitivity >99.6%o specificity > 96.8%
• WHO qualified o Average score: 13.5 (highest 18)
• Simple procedure, fast result with minimal training requirement
• Low cost
• Strip or cassette format, wide-ranging specimen (S/P/WB)
• More product availableo Leishmania Ab ELISA Kit
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Technical Support
Contact Info.:10110 Mesa Rim Rd. San Diego, CA 92121 USAEmail Address: [email protected] Telephone: 1 (858) 457-8698Fax: 1 (858) 535-1739
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THANK YOU
QUALITY . INNOVATION . SIMPLICITY