Pre-biologic/biosimilar Screen Panel, HCV/HBV with Reflexes and QFT 1 Tube

Test Code
37616


CPT Codes
86480, 87340, 86317, 86704, 86803

Includes
The Centers for Disease Control and Prevention (CDC) has provided guidance on clinical considerations for tuberculosis (TB) testing such as QuantiFERON®-TB Gold Plus in conjunction with COVID-19 mRNA vaccines. Please refer to the QuantiFERON®-TB Gold Plus FAQ link under Test Resources for more detailed information on the latest CDC guidelines regarding TB testing and COVID-19 vaccines.

QuantiFERON®-TB Gold Plus, 1 Tube
Hepatitis B Surface Antigen with Reflex Confirmation
Hepatitis B Surface Antibody Immunity, Quantitative
Hepatitis B Core Antibody, Total, with Reflex to IgM
Hepatitis C Antibody with Reflex to HCV RNA,PCR w/Reflex to Genotype, LiPA

Hepatitis B Surface Antigen: Reactive samples will be confirmed based on the manufacturer's FDA approved recommendations at an additional charge (CPT code(s): 87341).

If Hepatitis B Core Antibody Total is reactive, then Hepatitis B Core IgM Antibody will be performed at an additional charge (CPT code(s): 86705).

If Hepatitis C Antibody is reactive or borderline, then Hepatitis C Viral RNA, Quantitative, Real-Time PCR will be performed at an additional charge (CPT code(s): 87522).
If Hepatitis C Viral RNA, Quantitative, Real-Time PCR is ≥300 IU/mL, then Hepatitis C Viral RNA Genotype, LiPA will be performed at an additional charge (CPT code(s): 87902).


Preferred Specimen
6 mL whole blood collected in a no-gel lithium heparin (green-top) tube and
2.5 mL serum collected in each of two separate serum separator tubes (SST) and
2.5 mL serum collected in a red-top tube (no gel)


Minimum Volume
6 mL whole blood • 2.5 mL serum in each of two separate Serum Separator Tubes (SST®) • 2.5 mL serum


Instructions
Collect 6 mL of blood by venipuncture into a lithium heparin (green-top) tube. Hold tube at room temperature (17-25° C.) for between 15 minutes and 3 hours after blood collection. Refrigerate at 2-8° C.

Note: The Centers for Disease Control and Prevention (CDC) has provided guidance on clinical considerations for tuberculosis (TB) testing such as QuantiFERON®-TB Gold Plus in conjunction with COVID-19 mRNA vaccines. Please refer to the QuantiFERON®-TB Gold Plus FAQ link (https://education.questdiagnostics.com/faq/FAQ204) for more detailed information on the latest CDC guidelines regarding TB testing and COVID-19 vaccines.


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Whole blood in no gel lithium (green-top) tube
Room temperature: Unacceptable
Refrigerated: 48 hours
Frozen: Unacceptable

Serum in serum separator tube
Room temperature: 72 hours
Refrigerated: 14 days
Frozen: 30 days

Serum in red-top tube no gel
Room temperature: 7 days
Refrigerated: 14 days
Frozen: 30 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
See individual tests


Methodology
See individual tests

Setup Schedule
Set up and Report available: See individual tests


Reference Range
See individual tests


Clinical Significance
For patients diagnosed with any of a number of chronic autoimmune disorders (such as rheumatoid arthritis, plaque psoriasis, IBD and others), this panel combines screening for HCV, HBV and latent TB, all of which are required before initiating therapy with biologics and/or biosimilars. It is important to identify whether latent infections are present as they can rapidly manifest themselves in an immunosuppressed patient.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.