Quanti FERON - QuantiFERON-TB Gold In-Tube

QuantiFERON-TB Gold In-Tube

On 10/10/2007 the US FDA gave approval for the Quantiferon TB Gold In Tube to be marketed in the US

The FDA state:

Approval for a modification of the quantiferon-tb gold to an in-tube collection system that consists of three blood collection tubes, nil, tb antigen, and mitogen. The device, as modified, will be marketed under the trade name quantiferon-tb gold in-tube and is indicated for use as an in vitro diagnostic test using a peptide cocktail simulating esat-6, cfp-10 and tb 7.7(p4) proteins to stimulate cells in heparinized whole blood drawn directly into specialized blood collection tubes. Detection of interferon-y by enzyme-linked immunosorbent assay (elisa) is used to identify in vitro responses to these peptide antigens that are associated with mycobacterium tuberculosis infection.

According to the FDA approved package insert Quantiferon TB Gold In Tube has a consistent specificity of >99% in low risk individuals and a sensitivity as high as 92% in individuals with active disease, depending on setting and extent of disease. The specificity in two studies of a few hundred people is 96-98% in a health immunised population.

The package insert also advises that the kit provides three collection tubes which have had antigens dried onto their walls and that these tubes must be transferred to an incubator within 16 hours of blood collection.

On 25 June 2010, the US Centers for Disease Control and Prevention (CDC) updated the tuberculosis (TB) testing guidelines (MMWR June 2010, http://www.cdc.gov/mmwr/pdf/rr/rr5905.pdf) providing guidance to US public health officials, clinicians, and laboratory workers regarding screening for and diagnosis of TB infection. The updated guidelines provide new direction for TB control in the US.

Previously, QuantiFERON®-TB Gold was able to be used in any situation in which the Tuberculin Skin Test (TST) was used, without preference. The 2010 guidelines establish a new benchmark because they recommend IGRAs as the preferred TB testing method in many patients, including those who are BCG vaccinated or are unlikely to return for TST reading.

Medical facilities in the US using QFT can be found at http://www.cellestis.com/IRM/content/usa/contact_quantiferon.html. {Clicking on their column heading "State" twice will sort listings alphabetically by state. Likely more useful than their current default listing by alphabetical order of "Testing Facility" names}