Guidelines for Using the QuantiFERONTB Gold Test for Detecting M' tuberculosis Infection, United Sta - PowerPoint PPT Presentation

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Guidelines for Using the QuantiFERONTB Gold Test for Detecting M' tuberculosis Infection, United Sta

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Title: Guidelines for Using the QuantiFERONTB Gold Test for Detecting M' tuberculosis Infection, United Sta


1
Guidelines for Using the QuantiFERON-TB Gold
Test for Detecting M. tuberculosis Infection,
United States
  • May 11, 2006
  • Gerald Mazurek, M.D.

2
Headlines
3
Talk Objectives
  • Summarize guidelines
  • Describe the guideline development process
  • Encourage further evaluation

4
Guideline Summary
  • QFT-G may be used in all circumstances in which
    the TST is currently used
  • Further research is needed regarding use of
    QFT-G

5
Guideline Development Process
  • Establish guideline objectives
  • Identify representative experts
  • Review evidence on testing
  • Develop consensus
  • Publish guidelines

6
Guideline Objectives
  • Make recommendations from public health
    perspective
  • Address knowledge gaps
  • Encourage further evaluation
  • Provide reference for other guidelines

7
Representatives
  • Academic Institutions
  • Local Health Departments
  • Neil Schluger
  • Hank Blumberg
  • John Bernardo
  • Gail Woods
  • David Lewinsohn
  • Randall Reves
  • Jessie Wing
  • Esmaeil Porsa
  • Other Associations
  • Rachel Stricof (APIC)l
  • Ray Chinn (HICPAC)
  • Edward Ellis (Can. MOH)
  • Stephen Kralovic (VA)
  • Tanya Oemig (NTCA)
  • Nancy Warren (APHL)
  • (ACET)
  • Masae Kawamura
  • Mike Iseman
  • Chuck Daley
  • Dick Menzies
  • Frank Wilson
  • Ed Nardell
  • Madhu Pai
  • FDA
  • Roxanne Shively
  • CDC
  • Ken Castro
  • Andy Vernon
  • Michael Iademarco
  • John Jereb
  • Elsa Villarino
  • Rachael Albalak
  • Beverly Metchock
  • Jerry Mazurek
  • Phillip LoBue
  • David Weissman
  • Cellestis
  • Jim Rothel
  • Tony Catanzaro
  • Tony Radford

8
Review of Evidence
  • Literature search
  • Meeting at ATS (May 2005)
  • Unpublished studies
  • Consultation meeting at CDC (July 2005)

9
QFT-G vs. TST
  • in vitro
  • Specific TB antigens
  • Boosting not likely
  • 1 patient visit
  • Results in gt 1 day
  • Stimulate w/i 12 hrs
  • Unknown risk if
  • Includes Control
  • Minimal inter-reader variability
  • in vivo
  • Less specific PPD
  • Boosting
  • 2 patient visits
  • Results in 2 - 3 days
  • Read in 48 - 72 hrs
  • Increased TB risk if
  • No Control
  • Inter-reader variability

10
Limitations
  • Inadequate diagnostic standards
  • Unable to confirm clinical TB
  • Unable to confirm LTBI
  • Few reports using QFT-G or similar tests
  • Variations in antigens used
  • Variations in methods

11
Addressing Limitations
  • Sensitivity in people with culture TB
  • Sen positives / tested
  • Specificity in people at low risk for TB
    infection
  • Spec negative / tested
  • Test agreement in various populations
  • Agreement concordant / tested
  • Review both published unpublished data

12
Sensitivity Estimates
  • ? Subset of 118 tested by TST using Nippon PPD

1 of 5
13
Sensitivity Estimates
2 of 5
14
Sensitivity Estimates
3 of 5
15
Sensitivity Estimates
4 of 5
16
Sensitivity Estimates
  • 81 to 89 IFN excluding indeterminates

5 of 6
17
Sensitivity Estimates
  • 81 to 89 IFN excluding indeterminates
  • 71 to 88 IFN including indeterminates

6 of 6
18
Specificity Estimates
  • ? Subset of 213 tested by TST using Nippon PPD
  • Specificity 98

4 of 4
19
Specificity Estimates
4 of 4
20
Specificity Estimates
4 of 4
21
Specificity Estimates
  • 96 to 99.8 specificity w/o indeterminates
  • 96 to 98.9 specificity including indeterminates

4 of 4
22
Assessments of TST QFT-GAgreement
23
Test Agreement in Korea
  • Increase agreement with increased chance of
    infection

(n 273)
Percent positive
Kang 2005
24
Test Agreement in US
  • Good agreement for low-risk and TB patients
  • Less agreement with risk for LTBI for contacts

(n 1,500)
Percent positive
CDC Unpublished
25
Test Agreement in US Navy Recruits
  • Greater association of TST with risk than QFT-G

(n 810)
Percent positive
TB cases/100K in the recruits country of birth
CDC Unpublished
26
Test Agreement in Contacts US
  • Greater TST association with exposure than QFT-G

(n 446 exposed to AFB Respiratory TB)
Percent positive
CDC Unpublished
27
Test Agreement in Inmate US
  • 474 Harris Co. Jail inmates
  • Factors associated with TST / QFT-G negative
    discord
  • African-American race
  • Foreign birth
  • Prior incarceration

Porsa 2006
28
Test Agreement in Contacts Denmark
  • Good agreement between TST QFT-RD1

No BCG
BCG
Percent positive
Brock, 2004
29
Other Unpublished Studies
  • QFT-GIT in a Dutch investigation - S. Arend
  • QFT-G in Australian HCWs - P. Vinton
  • QFT-G in Japanese HCWs - N. Harada
  • QFT-G in hospitalized persons in Italy - L.
    Richeldi
  • Other studies - J. Rothel

30
Develop Consensus
  • Available evidence
  • Expert opinion
  • Guidelines

31
Guideline Summary
  • QFT-G may be used in all circumstances in which
    the TST is currently used
  • Further research is needed regarding use of
    QFT-G

32
Examples of Research Need
  • Risk of future TB if QFT-G
  • Reproducibility (conversions, reversions)
  • Effect of treatment on QFT-G
  • Performance in special populations
  • Threshold for IFN-? response
  • Timing of QFT-G conversion after infection
  • Programmatic use - PPV NPV - costs
  • Implementation - Rx completion rates

33
Published Guidelines
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