Pre-biologic/biosimilar Screen Panel, HCV/HBV with Reflexes and QFT 4 Tubes
Test Code
Clinical Significance
Pre-biologic/biosimilar Screen Panel, HCV/HBV with Reflexes and QFT 4 Tubes - 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.
Test Resources
Test FAQ
QuantiFERON®-TB Gold PlusTest Details
QuantiFERON®-TB Gold Plus, 4 Tubes, Draw Site Incubated
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 ≥2000 IU/mL, then Hepatitis C Virus RNA Genotype will be performed at an additional charge (CPT code(s): 87902).
Methodology
Reference Range(s)
Alternative Name(s)
Preferred Specimen(s)
1 mL whole blood collected in each of the following tubes:
QFT-Nil control (gray cap, white or gold ring) tube
QFT-TB1 antigen (green cap, white or gold ring) tube
QFT-TB2 antigen (yellow cap, white or gold ring) tube
QFT-Mitogen control (purple cap, white or gold ring) tube
and
2.5 mL serum collected in each of two separate serum separator tubes (SST) and
2.5 mL serum
Minimum Volume
0.8 mL whole blood in each tube • 2.5 mL serum in each of two separate serum separator tubes (SST) • 2.5 mL serum
Collection Instructions
Note: Specimen collection locations >3350 feet above sea level should use the QuantiFERON® collection kit designed for "High Altitude" (tubes with a gold ring on tube top)
For each patient, collect 1 mL of blood by venipuncture directly into each of the 4 QFT-PLUS blood collection tubes. These tubes should be at 17-25° C at the time of draw.
If a "butterfly needle" is being used, a "purge" tube should be used to ensure that the tubing is filled with blood prior to the QFT-Plus tubes being used.
Immediately after filling the tubes, shake them 10 times just firmly enough to ensure the entire surface of the tube is coated with blood, to solubilize antigens on tube walls.
Each of the four tubes must be transferred to a 37° C plus or minus 1° C incubator as soon as possible and within 16 hours of collection for 16-24 hours. If the blood is not incubated immediately after collection, re-mixing of the tubes by inverting 10 times must be performed immediately prior to incubation. The specimen rack should sit off the floor of the incubator and the tubes should be upright.
Following incubation either:
A. Centrifuge each of the 4 incubated collection tubes for 15 minutes at 2000-3000 RCF(G). Label with patient name, identification number, and date of collection. Deliver to Quest Diagnostics at 2-8° C. Samples will be stable for 28 days at 2-8° C (refrigerated).
*OR*
B. Immediately transport the 4 collection tubes to Quest Diagnostics between 4 and 27° C. Samples will be stable for 72 hours at 4-27° C (refrigerated or at room temperature).
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.
Dietary supplements containing biotin may interfere in assays and may skew analyte results to be either falsely high or falsely low. For patients receiving the recommended daily doses of biotin, draw samples at least 8 hours following the last biotin supplementation. For patients on mega-doses of biotin supplements, draw samples at least 72 hours following the last biotin supplementation.
Transport Container
See Preferred Specimen(s)
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
- See individual tests
Reject Criteria
See individual tests
Setup Schedule
QFT-Nil control (gray cap, white or gold ring) tube
QFT-TB1 antigen (green cap, white or gold ring) tube
QFT-TB2 antigen (yellow cap, white or gold ring) tube
QFT-Mitogen control (purple cap, white or gold ring) tube
and
2.5 mL serum collected in each of two separate serum separator tubes (SST) and
2.5 mL serum
Note: Specimen collection locations >3350 feet above sea level should use the QuantiFERON® collection kit designed for "High Altitude" (tubes with a gold ring on tube top)
For each patient, collect 1 mL of blood by venipuncture directly into each of the 4 QFT-PLUS blood collection tubes. These tubes should be at 17-25° C at the time of draw.
If a "butterfly needle" is being used, a "purge" tube should be used to ensure that the tubing is filled with blood prior to the QFT-Plus tubes being used.
Immediately after filling the tubes, shake them 10 times just firmly enough to ensure the entire surface of the tube is coated with blood, to solubilize antigens on tube walls.
Each of the four tubes must be transferred to a 37° C plus or minus 1° C incubator as soon as possible and within 16 hours of collection for 16-24 hours. If the blood is not incubated immediately after collection, re-mixing of the tubes by inverting 10 times must be performed immediately prior to incubation. The specimen rack should sit off the floor of the incubator and the tubes should be upright.
Following incubation either:
A. Centrifuge each of the 4 incubated collection tubes for 15 minutes at 2000-3000 RCF(G). Label with patient name, identification number, and date of collection. Deliver to Quest Diagnostics at 2-8° C. Samples will be stable for 28 days at 2-8° C (refrigerated).
*OR*
B. Immediately transport the 4 collection tubes to Quest Diagnostics between 4 and 27° C. Samples will be stable for 72 hours at 4-27° C (refrigerated or at room temperature).
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.
Dietary supplements containing biotin may interfere in assays and may skew analyte results to be either falsely high or falsely low. For patients receiving the recommended daily doses of biotin, draw samples at least 8 hours following the last biotin supplementation. For patients on mega-doses of biotin supplements, draw samples at least 72 hours following the last biotin supplementation.