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CDC Guidelines for Use of QuantiFERON®-TB Gold Test
Philip LoBue, MD
Centers for Disease Control and Prevention
Division of Tuberculosis Elimination
Outline• Background and purpose
• Where to find guidelines
• Methods for developing guidelines
• Recommendations for QFT-G use
• Guidance for follow up of– Positive test result– Negative test result– Indeterminate test result
• Special situations– Contact investigation– Serial testing (e.g., occupational)
• Future research needs
• Future guidelines
Background and Purpose
• QFT-G received final approval from FDA as an aid for diagnosing M. tuberculosis infection in May 2005
• CDC statement (published December 2005) meant to provide interim guidance for use and interpretation of QFT-G
Where Can You Find the Guidelines?
• Print: Guidelines for Using the QuantiFERON®-TB Gold Test for Detecting Mycobacterium tuberculosis Infection, United States, MMWR, December 16, 2005 / Vol. 54 / No. RR-15, pp. 49-54.
• Internet: http://www.cdc.gov/nchstp/tb/pubs/mmwrhtml/maj_guide.htm
Methods for Developing Guidelines
• Panel of expert consultants convened July 2005
• Reviewed published and unpublished data
• In developing guidelines, CDC reviewed scientific evidence independently and considered opinion of consultants
Recommendations for Use of QFT-G
• Contact investigations
• Evaluation of recent immigrants who have had BCG vaccination
• TB screening of health-care workers and others undergoing serial evaluation for M. tuberculosis infection
QFT-G can be used in all circumstances in which
the TST is used, including
QFT-G usually can be used in place of (and usually not in addition to) the TST
Follow up of Positive QFT-G
• No reason exists to follow a positive QFT-G with a TST
• Persons with a positive QFT-G result should be evaluated for TB disease before LTBI is diagnosed
• After TB has been excluded, treatment of LTBI should be considered
A positive QFT-G should prompt the same health and medical interventions as a
positive TST result
Follow up of Negative QFT-G
The majority of healthy adults who have negative QFT-G results are unlikely to
have M. tuberculosis infection and do not require further evaluation
Cautions and Limitations• As with a negative TST result, negative QFT-G results
should not be used alone to exclude M. tuberculosis infection in persons with symptoms or signs suggestive of TB disease
• The performance of QFT-G has not been determined in persons who, because of impaired immune function (e.g., HIV infection), are at increased risk for M. tuberculosis infection progressing to TB disease
• As with a negative TST result, negative QFT-G results alone might not be sufficient to exclude M. tuberculosis infection in immunocompromised persons
• Limited published data document the performance of QFT-G in children aged <17 years
Follow up of Indeterminate QFT-G
An indeterminate QFT-G result does not provide useful information regarding the
likelihood of M. tuberculosis infection
• Optimal follow up of persons with indeterminate QFT-G results has not been determined
• Options are to repeat QFT-G with a new blood sample, administer a TST, or do neither
• Decision should be based on pre-test likelihood of M. tuberculosis infection
Contact Investigations
For persons with recent contact to an infectious TB patient, negative QFT-G
results should be confirmed with a repeat test 8-10 weeks after exposure (end of
window period) as is recommended for a negative TST
When “window prophylaxis” has been started for high-risk contacts exposed to an infectious
TB patient, a negative QFT-G result at the end of the window period should be interpreted in light
of all other clinical and epidemiologic data
• A full course of LTBI treatment should be considered even with a negative result when the rate of M. tuberculosis transmission to other contacts is high or when a false-negative result is suspected because of an immunocompromising medical condition
Serial Testing (e.g., Healthcare Workers)
In situations with serial testing for M. tuberculosis infection (e.g.,
health-care workers), initial two-step testing (necessary for TST) is
not necessary for QFT-G
• In contrast to TST, there is no boosting with QFT-G
Future Research Needs
• Performance of QFT-G in young children
• Performance of QFT-G in persons with impaired immunity (e.g., HIV)
• Performance and practicality of QFT-G in substantial numbers of persons who undergo periodic screening
• Determination of subsequent incidence of TB disease after LTBI has been either diagnosed or excluded with QFT-G
• Length of time between exposure, establishment of infection, and emergence of a positive QFT-G test result
• Economic evaluation and decision analysis comparing QFT-G with TST
• Changes in QFT-G results with therapy for TB disease and LTBI
• Ability of QFT-G to detect re-infection after treatment for LTBI and TB disease
• Performance of QFT-G in targeted testing programs (e.g., recent immigrants from high-incidence countries)
Future Guidelines
• Current guidelines will be modified or new guidelines developed as
– Additional studies on QFT-G are published
– New versions of QFT and other interferon-gamma release assays become available