CMV Test Product Brochure
QuantiFERON-CMV is an in vitro diagnostic test using a peptide cocktail simulating human cytomegalovirus proteins (CMV) to stimulate cells in heparinised whole blood. Detection of interferon-gamma (IFN-) by Enzyme-Linked Immunosorbent Assay (ELISA) is used to identify in vitro responses to these peptide antigens that are associated with CMV infection. Loss of this immune function may be associated with development of CMV disease. The intended use of QuantiFERON-CMV is to monitor the level of anti-CMV immunity in persons at risk of developing CMV disease.
QuantiFERON-CMV is not a test for determining CMV infection and should not be used to exclude CMV infection.
The QuantiFERON-CMV test system uses specialised blood collection tubes, which are used to collect whole blood. Incubation of the blood occurs in the tubes for 16 to 24 hours, after which, plasma is harvested and tested for the presence of IFN- produced in response to the peptide antigens.
The QuantiFERON-CMV test is performed in two stages.
First, whole blood is collected into each of the QuantiFERON-CMV blood collection tubes, which include a Nil Control tube, CMV Antigen tube and a Mitogen tube. The Mitogen tube is used in the QuantiFERON-CMV test as a positive control. This may be especially warranted where there is doubt as to the individual's immune status, such as with transplant patients. The Mitogen tube may also serve as a control for correct blood handling and incubation.
Second, the tubes are incubated at 37 degrees Celsius as soon as possible, and within 16 hours of collection. Following a 16 to 24 hour incubation period, the tubes are centrifuged, the plasma is removed and the amount of IFN- (IU/mL) measured by QuantiFERON ELISA.
The amount of IFN- in plasma samples is used to assess the level of anti-CMV immunity in patients at risk of developing CMV disease.
QuantiFERON-CMV is CE Marked for use in Europe. Click here to view product information for residents outside the USA.