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Notice regarding indeterminate results with the QuantiFERON-TB Gold testThis is an archived document. The links and content are no longer being updated. October 11, 2006 CDC has received several calls and e-mails regarding a higher than expected number of indeterminate results with the QuantiFERON-TB Gold test (QFT-G, manufactured by Cellestis Limited, Carnegie, Australia). It is not currently possible to provide a specific percentage of indeterminate results in excess of which one should become concerned. The percentage of indeterminate results varies based on the population tested. In a study conducted in United States Navy recruits, the number of indeterminate QFT-G results was approximately 2%; however, rates in some immune suppressed populations may be substantially higher (13-20%). We have contacted Cellestis, and the company believes that the unexpectedly high number of indeterminate results is related to the use of some sodium heparin blood collection tubes. To address this potential problem, Cellestis is recommending the use of lithium heparin tubes in place of sodium heparin tubes for the collection of blood for QFT-G testing. In addition to reports of higher than expected indeterminate QFT-G results, CDC has received two reports of higher than expected positive test results. In general, the percentage of people with positive QFT-G results is not expected to exceed the percentage with positive TST results based on historical data. Cellestis has indicated that they have not received any reports of higher than expected positive test results. Facilities experiencing unexpectedly high rates of indeterminate results or positive results with QFT-G should contact Cellestis Technical Services at (800) 519-4627. After contacting Cellestis, if you wish to notify CDC of new or unresolved issues regarding QFT-G, you may contact Dr. Gerald Mazurek at (404) 639-8174 or by e-mail at GYM6@cdc.gov. CDC requests this information only so we can remain aware of issues that arise as QFT-G is implemented. Cellestis is responsible for providing direct technical assistance for any problems related to performing QFT-G, and has been working diligently to address these concerns.
Last Reviewed: 05/18/2008 |
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Centers for Disease Control & Prevention |