False Positive TB TestOur office is currently representing clients that were tested for TB using the QuantiFERON® -TB Gold test between January 6, 2012 and December 1, 2012 that resulted in a false positive test result.

False positive test results mean that the test showed that the person being tested had TB when they did not have TB.  The false positive test result may have caused re-testing,  additional unnecessary medical treatment, medical expenses along with fear and anxiety.

The QuantiFERON® -TB Gold test is a blood test used to detect the presence of a Tuberculosis (TB) infection.  It is considered a modern alternative and more effective that the Tuberculin Skin Test (TST) also known as the Mantoux test.

QUIGEN the manufacturer of the QuantiFERON® -TB Gold test issued a voluntary recall notice on September 27, 2012.  The recall notice can be found at http://public.health.oregon.gov/LaboratoryServices/Documents/qft-notice.pdf . QUIGEN issued the voluntary recall after finding that test tubes used in the testing process were contaminated causing false positive test results.

The possibility of contamination resulting in false positive test results was first reported by a team of physicians in the Department of Medicine, Stanford University School of Medicine. The abstract of their published article can be found at http://www.ncbi.nlm.nih.gov/pubmed/22785197 or the article can be obtained through the medical journal, Journal of Clinical Microbiology website at http://jcm.asm.org/content/early/2012/07/05/JCM.00730-12.full.pdf .

A number of private laboratories and institutions also issued recall notices after QUIGEN issued its recall notice triggering retesting of patients that may have been subjected to a false positive TB test result because of the contaminated QuantiFERON® -TB Gold test tubes.  Additional information can be found at:

http://www.clpct.com/portals/14/images/1/Quantiferon_False_Positive_100112.pdf

http://public.health.oregon.gov/LaboratoryServices/Documents/qft-memo.pdf

http://public.health.oregon.gov/LaboratoryServices/Documents/qft-qa.pdf

https://www.healthcare.uiowa.edu/Path_Handbook/lab_bulletins/Quantiferon.html

http://www.facebook.com/PeaceHealthLabs/posts/277104512406342

http://www.peacehealthlabs.org/publications/Physician%20Updates%20%20Laboratory%20Alerts/RECALL%20QuantiFERON-TB%20Gold%20TB-Antigen%20Collection%20Tubes.pdf

It appears the QUIGEN may have had a similar problem with tests distributed outside of the United States in 2009.  http://www.mhra.gov.uk/home/groups/dts-bi/documents/fieldsafetynotice/con054657.pdf

If you were the victim of a false positive TB test caused by a contaminated test tube manufactured and used by Cellestis a QIAGEN Company in its QuantiFERON® -TB Gold test contact attorney Al Baker at abaker@solberglaw.com or call toll free 1-877-237-3166 or local at 701-237-3166.