Pre-Biologic Screening Profile

Also known as: Humira; Adalimumab; Remicade; Infliximab; Entyvio; Vedolizumab; Enbrel; Etanercept; Cimzia; Certolizumab; Simponi; Golimumab; Rituxan; Rituximab; Stelara; Ustekinumab; Inflectra; Infliximab-dyyb; Renflexis; Infliximab-abda

Clinical Use

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Use

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

Special Instructions

Not provided.

Limitations

Patients negative for HBsAg may still have hepatitis B during the window period. False negatives for M. tuberculosis infection can occur due to incorrect assay performance or other individual immunological variables. Serologic testing should include multiple markers to avoid misinterpretation due to serologic subtypes and other complicating factors.

Test Details

Methodology

Other

Biomarkers

3 components

Hepatitis B Testing • ELISAHepatitis C Testing • PCRQuantiFERON-TB Gold Plus • PCR

LOINC Codes

Order Codes

144441

Result Codes

5196-1 - HBV surface Ag SerPl Ql IA
13952-7 - HBV core Ab SerPl Ql IA
16935-9 - HBV surface Ab Ser-aCnc
13955-0 - HCV Ab SerPl Ql IA
8251-1 - Service Cmnt-Imp
71773-6 - M TB IFN-g Bld-Imp

Result Turnaround Time

3-5 days

Specimen

Serum

Volume

Two 10 mL gel-barrier tubes

Minimum Volume

Two 10 mL gel-barrier tubes

Container

Two 10 mL gel-barrier tubes

Storage Instructions

Refrigerate 1 gel-barrier tube; maintain 1 gel-barrier tube at room temperature; freeze 4.5 mL serum transfer tube; maintain QuantiFERON-TB Gold Plus kit at room temperature.