Pre-Biologic Screening Profile

Serum and/or plasma and whole blood

Two 10 mL gel-barrier tubes (preferred), one serum transfer tube (4.5 mL), and 1 mL x four tubes in QuantiFERON-TB Gold Plus kit

Two 10 mL gel-barrier tubes (preferred), one serum transfer tube (4.5 mL), and 1 mL x four tubes in QuantiFERON-TB Gold Plus kit

Two 10 mLgel-barrier tubes and one serum transfer tube and QuantiFERON-TB Gold Plus kit.

Biologic therapies can be used to treat many different autoimmune diseases, such as Inflammatory Bowel Disease, Rheumatoid Arthritis, and Psoriasis. Biologic therapies can be life-changing drugs but they can also suppress the immune system and put the patient at risk of infection. Because of this risk, it is recommended by the American Academy of Dermatology (AAD), American College of Gastroenterology (ACG) and the American College of Rheumatology (ACR) to screen patients for certain infectious diseases, including hepatitis B, hepatitis C and tuberculosis.^1-3

Patients who are negative for HBsAg may still have acute type B viral hepatitis. There is sometimes a "core window" stage when HBsAg has become negative and the patient has not yet developed the antibody (anti-HBs). On such occasions, both tests for anti-HBc are usually positive and anti-HBc, IgM is the only specific marker for the diagnosis of acute infection with hepatitis B. In cases with strong clinical suspicion of viral hepatitis, serologic testing should not be limited to detecting HBsAg, but should include a battery of tests to evaluate different stages of acute and convalescent hepatitis.

Presence of anti-HBs is not an absolute indicator of resolved hepatitis infection nor of protection from future infection. Since there are different serologic subtypes of hepatitis B virus, it is possible (and has been reported) for a patient to have antibody to one surface antigen type and to be acutely infected with a virus of a different subtype. Thus, a patient may have coexisting HBsAg and anti-HBs. Transfused individuals or hemophiliacs receiving plasma components may give false-positive tests for antibody to hepatitis B surface antigen.

A negative QFT-Plus result does not preclude the possibility of M. tuberculosis infection or tuberculosis disease: false negative results can be due to stage of infection, co-morbid conditions that affect immune function, incorrect handling of the blood collection tubes following venipuncture, incorrect performance of the assay, or other individual immunological variables. Heterophile antibodies on non-specific interferon-gamma production from other inflammatory conditions may mask specific responses to CD4+ and CD*+ T cell antigens. A positive QFT-Plus result should not be the sole or definitive basis for determining infection with M. tuberculosis. Incorrect performance of the assay may cause false-positive results. A positive QFT-Plus result should be followed by further medical evaluation for active tuberculosis disease.

See individual tests.