QuantiFERON

QuantiFERON is the registered trademark of two tests for tuberculosis or latent tuberculosis, manufactured by Cellestis Limited, Carnegie, Victoria, Australia. These are interferon-γ release assays used in tuberculosis diagnosis.

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QuantiFERON-TB

According to the U.S. Centers for Disease Control,^[1]:

In 2001, the QuantiFERON®-TB test (QFT) was approved by the Food and Drug Administration (FDA) as an aid for detecting latent Mycobacterium tuberculosis infection (1). This test is an in vitro diagnostic aid that measures a component of cell-mediated immune reactivity to M. tuberculosis. The test is based on the quantification of interferon-gamma (IFN-γ) released from sensitized lymphocytes in whole blood incubated overnight with purified protein derivative (PPD) from M. tuberculosis and control antigens.

Tuberculin skin testing (TST) has been used for years as an aid in diagnosing latent tuberculosis infection (LTBI) and includes measurement of the delayed type hypersensitivity response 48--72 hours after intradermal injection of PPD. TST and QFT do not measure the same components of the immunologic response and are not interchangeable. Assessment of the accuracy of these tests is limited by lack of a standard for confirming LTBI.

As a diagnostic test, QFT 1) requires phlebotomy, 2) can be accomplished after a single patient visit, 3) assesses responses to multiple antigens simultaneously, and 4) does not boost anamnestic immune responses. Compared with TST, QFT results are less subject to reader bias and error. In a CDC-sponsored multicenter trial, QFT and TST results were moderately concordant (overall kappa value = 0.60). The level of concordance was adversely affected by prior bacille Calmette-Guérin (BCG) vaccination, immune reactivity to nontuberculous mycobacteria (NTM), and a prior positive TST (2). In addition to the multicenter study, two other published studies have demonstrated moderate concordance between TST and QFT (3,4). However, one of the five sites involved in the CDC study reported less agreement (5).

Limitations of QFT include the need to draw blood and process it within 12 hours after collection and limited laboratory and clinical experience with the assay. The utility of QFT in predicting the progression to active tuberculosis has not been evaluated.

QuantiFERON-TB Gold

According to the U.S. Centers for Disease Control,^[2]

The QuantiFERON®-TB Gold test (QFT-G) is a whole-blood test for use as an aid in diagnosing Mycobacterium tuberculosis infection, including latent tuberculosis infection (LTBI) and tuberculosis (TB) disease. This test was approved by the U.S. Food and Drug Administration (FDA) in 2005.

Blood samples are mixed with antigens (substances that can produce an immune response) and controls. For QFT-G, the antigens include mixtures of synthetic peptides representing two M. tuberculosis proteins, ESAT-6 and CFP-10. After incubation of the blood with antigens for 16 to 24 hours, the amount of interferon-gamma (IFN-gamma) is measured.

If the patient is infected with M. tuberculosis, their white blood cells will release IFN-gamma in response to contact with the TB antigens. The QFT-G results are based on the amount of IFN-gamma that is released in response to the antigens.

Clinical evaluation and additional tests (such as a chest radiograph, sputum smear, and culture) are needed to confirm the diagnosis of LTBI or TB disease.

Advantages of the test are:

• Requires a single patient visit to draw a blood sample.
• Results can be available within 24 hours.
• Does not boost responses measured by subsequent tests, which can happen with tuberculin skin tests (TST).
• Is not subject to reader bias that can occur with TST.
• Is not affected by prior BCG (bacille Calmette-Guérin) vaccination.

Disadvantages and limitations of the test are:

• Blood samples must be processed within 12 hours after collection while white blood cells are still viable.
• There are limited data on the use of QFT-G in children younger than 17 years of age, among persons recently exposed to M. tuberculosis, and in immunocompromised persons (e.g., impaired immune function caused by HIV infection or acquired immunodeficiency syndrome [AIDS], current treatment with immunosuppressive drugs, selected hematological disorders, specific malignancies, diabetes, silicosis, and chronic renal failure).
• Errors in collecting or transporting blood specimens or in running and interpreting the assay can decrease the accuracy of QFT-G.
• Limited data on the use of QFT-G to determine who is at risk for developing TB disease.

References

1. ^ Gerald H. Mazurek, M.D., Margarita E. Villarino, M.D.. Guidelines for Using the QuantiFERON®-TB Test for Diagnosing Latent Mycobacterium tuberculosis Infection. Retrieved on 2007-06-01.
2. ^ Division of Tuberculosis Elimination (2004-04-18). QuantiFERON®-TB Gold Test. Retrieved on 2007-06-01.