T-SPOT®.TB

Test Code
37737


CPT Codes
86481 <br><strong>This test is not available for New York patient testing.</strong>

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


Preferred Specimen
Adults and children ≥10 years: 6 mL whole blood collected in a Greiner 9 mL lithium heparin (green-top) tube

Pediatric 2-9 years of age: 4 mL whole blood collected in a Greiner 9 mL lithium heparin (green-top) tube

Pediatric <2 years of age: 2 mL whole blood collected in a Greiner 9 mL lithium heparin (green-top) tube

Immunocompromised individuals
Adults and children ≥10 years: 9 mL whole blood collected in a Greiner 9 mL lithium heparin (green-top) tube


Minimum Volume
Adults and children ≥10 years: 6 mL • Pediatric 2-9 years: 4 mL • Pediatric <2 years: 2 mL • Immunocompromised ≥10 years: 9 mL


Other Acceptable Specimens
Sodium heparin (green-top) tube


Instructions
The Centers for Disease Control and Prevention (CDC) has provided guidance on clinical considerations for tuberculosis (TB) testing such as T-SPOT®.TB in conjunction with COVID-19 mRNA vaccines. Please refer to the T-SPOT®.TB FAQ (https://education.questdiagnostics.com/faq/FAQ215) for more detailed information on the latest CDC guidelines regarding TB testing and COVID-19 vaccines.

*** This is a short stability test and requires special handling. ***
If you have any questions, please contact the Customer Service Department at 866-MYQUEST (866-697-8378).

Please contact Quest at tspot@questdiagnostics.com or work with your Quest Representative to obtain shipping materials(s) and discuss transportation options. This test will be handled separately from your standard Quest logistics courier pick-ups.

Patient Service Centers (PSCs) are available to collect Monday-Friday.

Collect blood by venipuncture into a Quest-provided Greiner 9 mL lithium heparin (green-top) tube. The tube contents must be inverted (8-10 times) to ensure that the whole blood is mixed thoroughly with the anticoagulant. Date and time of draw are required and must be provided.

Specimens must be packed for transport in a Quest supplied shipping container or sleeve that has been validated to maintain sample stability. Do not draw the day before a FedEx limited service day, which may include holidays or inclement weather events.

Transporting via FedEx
1. A daily FedEx Pickup must be arranged prior to your initial order by calling 1-800-GO-FEDEX (1-800-463-3339).
2. Place sample tube in the sealable plastic specimen bag with the absorbent pad.
3. Include the requisition in the outside pocket of the specimen bag.
4. Place the liquid pack into the bottom of the metallic color shipping container
5. Place the sealed specimen bags into the metallic color shipping container above the liquid pack. Up to 12 specimen bags may be included in a single shipping container.
6. Place the solid pack on top of the packed specimen bags.
7. Close and securely tape shut the corrugated box.
8. Place the entire box in the FedEx UN3373 clinical pack.
9. Affix the FedEx return label or air waybill onto the clinical pack in the specified location.
10. Please provide packed shipping containers directly to a FedEx courier and do not leave in the FedEx drop-off box or location.
11. Quest Diagnostics will track each customer’s usage of shipping containers and will automatically resupply as needed

Transporting via Quest Logistics
1. Using Quest Logistics must be coordinated with your Quest Representative prior to initial order.
2. Your Quest Representative will provide guidance on packing specimens to ensure temperature requirements are met.
3. Packed specimens must be stored at room temperature and made available for the next scheduled transportation pickup.


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 39 hours
Refrigerated: Unacceptable
Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Hemolysis • Anticoagulants other than lithium or sodium heparin • Centrifuged • Samples not received in T-SPOT insulated shipper/sleeve


Methodology
Enzyme-Linked Immunosorbent (ELISPOT) Assay

Setup Schedule
Set up: Daily; Report available: 2 days


Clinical Significance
The T-SPOT®.TB test is an in vitro diagnostic test for the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP 10 by capturing interferon gamma (IFN-g) in the vicinity of T cells in human whole blood collected in lithium heparin. It is intended for use as an aid in the diagnosis of M.tuberculosis infection. The T-SPOT®.TB test is an indirect test for M.tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography and other medical and diagnostic evaluations.




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.