The ImmunoDOT Coxiella burnetii (Q Fever) test is an enzyme immunoassay for the qualitative detection of antibodies to Coxiella burnetii in serum specimens and is used as an aid in the diagnosis of Coxiella burnetii (Q fever) infection.
The test is used as an aid for diagnosis of C. burnetii (Q fever) infection in subjects suspected with consistent signs and symptoms to suspect the infection.
Q fever is a zoonosis caused by Coxiella burnetii, an obligate gram-negative intracellular bacterium. C. burnetii infects various hosts, including humans, ruminants (cattle, sheep, goats), and pets—and, in rare cases, reptiles, birds, and ticks. This bacterium is excreted in urine, milk, feces, and birth products. These products, especially the latter, contain large numbers of bacteria that become aerosolized after drying. C. burnetii is highly infectious, and only a few organisms can cause disease.
Because of its sporelike life cycle, C. burnetii can remain viable and virulent for months. Infection can be acquired via inhalation or skin contact, and direct exposure to a ruminant is not necessary for infection. Rare human-to-human transmissions involving exposure to the placenta of an infected woman and blood transfusions have been reported. Sexual transmission is also possible.
C. burnetii infection in livestock often goes unnoticed. In humans, acute C. burnetii infection is often asymptomatic or mistaken for an influenzalike illness or atypical pneumonia (see the following image). In rare cases, C. burnetii infection becomes chronic, with devastating results, especially in patients with preexisting valvular heart disease. Because of its highly infectious nature and has an inhalational route of transmission, C. burnetii is recognized as a potential agent of bioterrorism. The Centers for Disease Control and Prevention (CDC) classifies Q fever as a Category B agent.
The ImmunoDOT assay utilizes an enzyme-linked immunoassay (EIA) dot technique for the detection of IgG and IgM antibodies to C. burnetii. The antigens are dispensed as discrete dots onto a solid membrane. After adding specimen to a reaction cuvette, an assay strip is inserted, allowing patient antibodies reactive with the test antigen to bind to the strip’s solid support membrane. In the second stage, the reaction is enhanced by removal of non-specifically bound materials. During the third stage, alkaline phosphatase-conjugated anti-human antibodies are allowed to react with bound patient antibodies. Finally, the strip is transferred to enzyme substrate reagent, which reacts with bound alkaline phosphate to produce an easily seen, distinct spot.
INTERPRETATION:
Single Specimen, Interpretation: If Phase 1 dot is reactive, and if all three Phase 2 dots are reactive, report as positive. Otherwise, report as negative.
Equivocal: If only Phase 1 or Phase 2 is positive, the result should be cautiously interpreted. Report as Equivocal or Phase 1 positive associated with consistent symptomatology may indicate chronic infection.
Initially weakly reactive: Weakly reactive specimens (1 or 2 dots) should be cautiously interpreted. Collection of convalescent specimen is recommended.
Seroconversion: Seroconversion occurs when the first serum pair (acute) reports negative and the convalescent specimen result is positive.
The ImmunoDOT Coxiella burnetii (Q Fever) test is available directly from GenBio (www.genbio.com <http://www.genbio.com> ) and is another kit offered in the extensive line of GenBio products for infectious diseases. 858-592-9300
Dear editor, yes it is FDA cleared and registered as confirmable online under company name Innominata dba GenBio, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm and attached Certificate to Foreign Government. If you have any questions, please contact me. You are the ONLY press release on this product. It was just added to our product registrations with FDA with new data available on request.
