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Tuberculosis Tests:
OnSite TB IgG/IgM Rapid Test

 TB Facts
  • A contagious disease, transmitted through the air
  • Estimated 8.9 million new cases per year
  • Mortality rate: 1.7 million per year
  • HIV co-infection will increase mortality rate
  • Each untreated active patient infects 10-15 people per year
  • Curable Disease!!
  
 OnSite TB IgG/IgM Test
  • Lateral flow rapid test
  • Detects IgC and IgM anti- M.TB simultaneously
  • IgM positive for fresh infection, regardless of BCG vaccination
  • IgC positive for previous or chronic infection
  • Applicable to all patients, including smear negative individuals
  • Suitable for both pulmonary and extra-pulmonary TB
  • CE marked, US FDA exportation certified
  
 
tuberculosis
 Procedure
  • Simple, rapid, no special training required
    1. Add drops of specimen
    2. Wait for 10-15 minutes
    3. Visual result, easy interpretation
  
 Ordering Information
Catalog Product Cs Ds Specimen
CE R0051 OnSite TB IgG/IgM Rapid Test 30T/Kit 50T/Kit S,P
CE R0053 OnSite TB IgG/IgM Combo Rapid Test 30T/Kit 50T/Kit S,P, WB
R0055 OnSite TB Plus (HIV) Rapid Test coming soon! 30T/Kit 50T/Kit S,P
Specimen Key: S = serum, P = plasma, WB = whole blood
  
 Comparisons of OnSite TB IgG/IgM Rapid Test
Latent TB Infection
Test Category Limitation OnSite TB IgG/IgM
PPD Skin Test
(Standard of care)
Limited sensitivity and specificity High sensitivity and specificity
    Igm positive for fresh infection regardless of BCG vaccination
Quantiferon Test
(Recently released)
Complicated procedure One step procedure
  Requires well-trained technician No special training required
  Not applicable in resource-limited settings No equipment required
 
Active TB Infection
Test Category Limitation OnSite TB IgG/IgM
M.TB in smear
(Gold standard)
Not applicable to extra pulmonary TB Pulmonary and extra-pulmonary TB
  Specimen not obtainable in some patients Serum, plasma, whole blood readily available
M.TB in culture
(Gold standard)
Result takes weeks to months Visual result in 10-15 minutes
Nucleic Acid detection & Amplification
(Recently released)
Low sensitivity in smear negative case Regardless of smear condition
  Difficulty in resource-limited settings Inexpensive
  
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