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Pre-Biologic Screening Profile

Test Number 144441
Test number copied
CPT 86317; 86480; 86704; 86803; 87340
Synonyms
  • Humira; Adalimumab; Remicade; Infliximab; Entyvio; Vedolizumab; Enbrel; Etanercept; Cimzia; Certolizumab; Simponi; Golimumab; Rituxan; Rituximab; Stelara; Ustekinumab; Inflectra; Infliximab-dyyb; Renflexis; Infliximab-abda

Test Details

Methodology

See individual tests.

Result Turnaround Time

3 - 5 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Documents

For more information, please view the literature below.

Therapeutic Drug Monitoring Options for Rheumatoid Arthritis Flyer

Rheumatic Diseases Biologics (DoseASSURE™) Flyer

Rheumatoid Arthritis (RA) Comprehensive Testing Brochure

Test Includes

Hepatitis C Virus (HCV) Antibody Cascade to Quantitative PCR and Genotyping; Hepatitis B Surface Antigen (HBsAg) Screen, Qualitative; Hepatitis B Surface Antibody, Quantitative: Hepatitis B Core Antibody with Reflex; QuantiFERON®-TB Gold Plus

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

For HCV Antibody Cascade (PCR/Geno) [144127]: Submit two samples, preferably one refrigerated unopened gel-barrier tube and one frozen serum/plasma pour off tube.

If reflex test is performed, additional charges/CPT code(s) may apply.

One or more of these tests may exhibit interference when a sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to collection of a sample.

Limitations

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.

Footnotes

1. Farraye FA, Melmed GY, Lichtenstein GR, Kane SV. ACG clinical guideline: preventive care in inflammatory bowel disease. Am J Gastroenterol. 2017 Feb;112(2):241-258.28534523
2. Menter A, Strober BE, Kaplan DH, et al. Joint ADD-NPF Guidelines of Care for the Management and Treatment of Psoriasis with Biologics. J Am Acad Dermatol. 2019 Apr;80(4):1029-1072.30772098
3. Singh JA, Furst DE, Bharat A, et al. 2012 Update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012 May;64(5):625-639.22473917

Specimen Requirements

Specimen

Serum and/or plasma and whole blood

Volume

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

Minimum Volume

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

Container

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

Collection Instructions

QuantiFERON-TB Gold Plus kit: Blood collection tubes should be at room temperature at the time of collection. Refer to collection instructions included with draw kit. Special specimen collection kit contains four gel-barrier tubes as noted above. All four tubes are required for a single test result. Each tube is designed to draw only 1 mL and fill time may be longer than other blood collection tubes. Because of the limited vacuum in these tubes, use a needle and holder (not a butterfly) to collect QuantiFERON® specimens. If a butterfly is required, first collect other required tubes or use another Vacutainer® tube to purge the butterfly line of air and then proceed with drawing the QuantiFERON® tubes. Fill tubes to the black fill line on the tube. If tubes are underfilled or overfilled (see kit insert), immediately collect a replacement tube.

Following proper fill, label the tubes appropriately and shake tubes 10 times firmly enough to ensure the entire surface of the tube is coated with blood cells to solubilize the antigen on the tube walls. After shaking, the volume may fall below the fill line. Do not centrifuge or refrigerate specimens.

Return each of the four properly filled, labeled, and shaken tubes to the box labeled "QFT kit." Seal the top by removing tape from the adhesive. To preserve cellular viability, specimens should be collected and sent the same day, at room temperature, so as to arrive at the lab as soon as possible and within 14 hours of collection.

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 (must be incubated witin 16 hours of collection).

Causes for Rejection

QuantiFERON-TB Gold Plus kit: Expired collection tubes. Four-tube QuantiFERON collection kit: Specimen centrifuged, refrigerated, or frozen; specimen more than 14 hours old on receipt by lab; receipt of three tube collection kit.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
144441 Pre-Biologic Screening Profile 006510 HBsAg Screen 5196-1
144441 Pre-Biologic Screening Profile 006718 Hep B Core Ab, Tot 13952-7
144441 Pre-Biologic Screening Profile 006531 Hepatitis B Surf Ab Quant mIU/mL 16935-9
144441 Pre-Biologic Screening Profile 144035 HCV Ab 40726-2
144441 Pre-Biologic Screening Profile 182889 QuantiFERON Incubation N/A
144441 Pre-Biologic Screening Profile 182890 QuantiFERON-TB Gold Plus 71773-6
Order Code144441
Order Code NamePre-Biologic Screening Profile
Order Loinc
Result Code006510
Result Code NameHBsAg Screen
UofM
Result LOINC5196-1
Order Code144441
Order Code NamePre-Biologic Screening Profile
Order Loinc
Result Code006718
Result Code NameHep B Core Ab, Tot
UofM
Result LOINC13952-7
Order Code144441
Order Code NamePre-Biologic Screening Profile
Order Loinc
Result Code006531
Result Code NameHepatitis B Surf Ab Quant
UofMmIU/mL
Result LOINC16935-9
Order Code144441
Order Code NamePre-Biologic Screening Profile
Order Loinc
Result Code144035
Result Code NameHCV Ab
UofM
Result LOINC40726-2
Order Code144441
Order Code NamePre-Biologic Screening Profile
Order Loinc
Result Code182889
Result Code NameQuantiFERON Incubation
UofM
Result LOINCN/A
Order Code144441
Order Code NamePre-Biologic Screening Profile
Order Loinc
Result Code182890
Result Code NameQuantiFERON-TB Gold Plus
UofM
Result LOINC71773-6
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 016105 HBsAg Confirmation 016105 HBsAg Confirmation 7905-3
Reflex 1
Order Code016105
Order NameHBsAg Confirmation
Result Code016105
Result NameHBsAg Confirmation
UofM
Result LOINC7905-3
Reflex Table for Hep B Core Ab, Tot
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 126881 HBcIgM 016881 Hep B Core Ab, IgM 24113-3
Reflex 1
Order Code126881
Order NameHBcIgM
Result Code016881
Result NameHep B Core Ab, IgM
UofM
Result LOINC24113-3
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 144030 Interpretation: 144030 Interpretation: 13955-0
Reflex 1
Order Code144030
Order NameInterpretation:
Result Code144030
Result NameInterpretation:
UofM
Result LOINC13955-0
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550553 HCV RT-PCR, Quant (Non-Graph) 550338 Hepatitis C Quantitation IU/mL 11011-4
Reflex 1
Order Code550553
Order NameHCV RT-PCR, Quant (Non-Graph)
Result Code550338
Result NameHepatitis C Quantitation
UofMIU/mL
Result LOINC11011-4
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550553 HCV RT-PCR, Quant (Non-Graph) 550338 Hepatitis C Quantitation IU/mL 11011-4
Reflex 1
Order Code550553
Order NameHCV RT-PCR, Quant (Non-Graph)
Result Code550338
Result NameHepatitis C Quantitation
UofMIU/mL
Result LOINC11011-4
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550553 HCV RT-PCR, Quant (Non-Graph) 550339 HCV log10 log10 IU/mL 38180-6
Reflex 1
Order Code550553
Order NameHCV RT-PCR, Quant (Non-Graph)
Result Code550339
Result NameHCV log10
UofMlog10 IU/mL
Result LOINC38180-6
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550553 HCV RT-PCR, Quant (Non-Graph) 550314 Test Information: 19147-8
Reflex 1
Order Code550553
Order NameHCV RT-PCR, Quant (Non-Graph)
Result Code550314
Result NameTest Information:
UofM
Result LOINC19147-8
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550553 HCV RT-PCR, Quant (Non-Graph) 550396 Interpretation: 62365-2
Reflex 1
Order Code550553
Order NameHCV RT-PCR, Quant (Non-Graph)
Result Code550396
Result NameInterpretation:
UofM
Result LOINC62365-2
Reflex Table for HCV Ab
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550553 HCV RT-PCR, Quant (Non-Graph) 550394 HCV Genotype N/A
Reflex 1
Order Code550553
Order NameHCV RT-PCR, Quant (Non-Graph)
Result Code550394
Result NameHCV Genotype
UofM
Result LOINCN/A
Reflex Table for QuantiFERON Incubation
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 182880 QuantiFERON-TB Gold Plus 182885 QuantiFERON Criteria 8251-1
Reflex 1
Order Code182880
Order NameQuantiFERON-TB Gold Plus
Result Code182885
Result NameQuantiFERON Criteria
UofM
Result LOINC8251-1
Reflex Table for QuantiFERON Incubation
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 182880 QuantiFERON-TB Gold Plus 182886 QuantiFERON TB1 Ag Value IU/mL 64084-7
Reflex 1
Order Code182880
Order NameQuantiFERON-TB Gold Plus
Result Code182886
Result NameQuantiFERON TB1 Ag Value
UofMIU/mL
Result LOINC64084-7
Reflex Table for QuantiFERON Incubation
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 182880 QuantiFERON-TB Gold Plus 182887 QuantiFERON TB2 Ag Value IU/mL 88517-8
Reflex 1
Order Code182880
Order NameQuantiFERON-TB Gold Plus
Result Code182887
Result NameQuantiFERON TB2 Ag Value
UofMIU/mL
Result LOINC88517-8
Reflex Table for QuantiFERON Incubation
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 182880 QuantiFERON-TB Gold Plus 182891 QuantiFERON Nil Value IU/mL 71776-9
Reflex 1
Order Code182880
Order NameQuantiFERON-TB Gold Plus
Result Code182891
Result NameQuantiFERON Nil Value
UofMIU/mL
Result LOINC71776-9
Reflex Table for QuantiFERON Incubation
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 182880 QuantiFERON-TB Gold Plus 182892 QuantiFERON Mitogen Value IU/mL 71774-4
Reflex 1
Order Code182880
Order NameQuantiFERON-TB Gold Plus
Result Code182892
Result NameQuantiFERON Mitogen Value
UofMIU/mL
Result LOINC71774-4