Quantiferon-TB Gold Test

Quantiferon-TB Gold Test Kits

Introduction

An interferon-gamma release assay (IGRA) used to detect Mycobacterium tuberculosis infection by measuring the immune response to specific TB proteins in whole blood samples.

Test Components

  • Collection Tubes:
    • Nil Control (Grey cap)
    • TB Antigen (Red cap)
    • Mitogen Control (Purple cap)
    • Optional: TB7.7 Antigen (Yellow cap)
  • Kit Contents:
    • Blood collection tubes
    • Package insert
    • Tube labels
    • Specimen transport bags

Clinical Applications

  • Primary Uses:
    • Latent TB infection screening
    • Active TB disease assessment
    • Contact investigations
    • Healthcare worker screening
    • Immigration screening
  • Advantages in Pediatrics:
    • Single patient visit
    • No return for reading
    • Unaffected by BCG vaccination
    • Higher specificity than TST

Specimen Collection

  • Collection Protocol:
    • 1mL blood per tube
    • Proper tube order
    • Immediate mixing (10 times)
    • Temperature control (17-25°C)
  • Critical Steps:
    • Proper patient identification
    • Aseptic technique
    • Accurate volume collection
    • Proper tube labeling
    • Transport timing considerations

Processing Requirements

  • Time Constraints:
    • Incubation within 16 hours
    • 37°C ± 1°C incubation
    • 16-24 hour incubation period
    • Centrifugation parameters
  • Storage Conditions:
    • Room temperature transport
    • No refrigeration
    • Avoid extreme temperatures
    • Plasma storage requirements

Result Interpretation

  • Calculation:
    • TB Antigen minus Nil
    • Mitogen minus Nil
    • Cut-off values
    • Quality control criteria
  • Result Categories:
    • Positive: ≥0.35 IU/mL
    • Negative: <0.35 IU/mL
    • Indeterminate results
    • Invalid results

Clinical Considerations

  • Special Populations:
    • Immunocompromised patients
    • Infants and young children
    • Recent TB contacts
    • Healthcare workers
  • Limitations:
    • Cost considerations
    • Laboratory accessibility
    • Processing time constraints
    • Age limitations

Quality Assurance

  • Pre-analytical:
    • Proper storage of tubes
    • Collection technique
    • Transport conditions
    • Documentation accuracy
  • Analytical:
    • Internal controls
    • Temperature monitoring
    • Incubation timing
    • Equipment calibration

Documentation Requirements

  • Collection date and time
  • Collector identification
  • Transport conditions
  • Processing parameters
  • Result interpretation
  • Clinical correlation


Further Reading
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