FAQ

What does CLIA certification mean?

CLIA stands for Clinical Laboratory Improvement Amendments. The Centers for Medicaid and Medicare Services (CMS) regulates laboratory testing through the CLIA certification program. The objective of CLIA is to ensure the accuracy, reliability and timeliness of patient test results through quality laboratory standards. CLIA certification indicates that the laboratory has been inspected and has met all of the requirements to be certified to perform laboratory testing.

What is your CLIA registration number?

The CLIA registration number for Oxford Diagnostic Laboratories is 22D1099017.

How can I start to send samples to the lab?

Getting started is a simple, easy process. Contact our Client Services team at 1-877-59 TBLAB and they will review the process with you and send you all of the materials that you need to get started.

How long will it take to get results reported?

T-SPOT®.TBTB test results will be reported within 36-48 hours upon receipt of the blood specimen.

When can I send specimens to Oxford Diagnostic Laboratories?

Specimens are accepted Monday through Saturday.

Do I have to collect the blood specimen in a special collection tube?

No, only a standard lithium or sodium heparin tube is required.

How much blood do you need for the T-SPOT^®.TB test?

The guidelines for the volume of blood are:
• Adults and children 10 years old and over: 6mL
• Children 2 to 9 years old: 4 mL
• Children up to 2 years old: 2mL
Note: For immunosuppressed individuals collect two tubes

Do you accept other types of specimens beside blood?

No, we only accept whole blood specimens collected in lithium or sodium heparin tubes.

What information needs to be on the blood collection tube?

The tube should be labeled with the following information:
• Patient name
• Unique patient identifier
• Date of birth
• Date and time of specimen collection

How do I store specimens prior to sending them to the lab?

Blood specimens must be stored at room temperature, 64-77°F (18-25°C), until packaged for transport.

After collecting a blood specimen how long do I have to send it to the lab?

Blood specimens must be shipped the same day they are collected.

Which requisition form should I use?

You have two options, the Oxford Diagnostic Laboratories T-SPOT.TB test requisition form or your own laboratory's requisition form.

What is a Cryopak^® pouch?

Cryopak pouches incorporate Phase 22 phase change material (PCM).  PCM is a material that uses phase changes (e.g. melting or freezing) to absorb or release heat at constant temperatures.  These pouches will maintain the blood specimens at room temperature during transit to Oxford Diagnostic Laboratories.

How many Croypak pouches are used in one shipping container?

Two Cryopak pouches are used for each shipping container.

Can I use the Cryopak pouches immediately after removal from the refrigerator or 37°C incubator?

The Cryopak pouches should be left at room temperature for 30 minutes which will ensure that the pouches are at the appropriate temperature for transit.  The pouches are then ready to be placed in the shipping container.

The shipping instructions indicate that I should store some of my Cryopaks in the refrigerator to keep them solid.  If they are already solid do I need to do this?

Yes, because Cryopaks turn from solid to liquid at 72°F on a day when the room is warmer than 72°F.  To ensure that on those days when the Cryopak pouches must be in a solid state for shipping, it is recommended that several pouches are stored in a refrigerator.

The shipping instructions indicate that I should store some of my Cryopaks in an incubator to keep them liquid.  If they are already liquid do I need to do this?

Yes, because Cryopaks turn from liquid to solid at 72°F on a day when the room is 71°F.  To ensure that on those days when the Cryropak pouches must be liquid state for shipping, it is recommended that several pouches are stored in a 37°C incubator. 

How will I ship specimens to the lab?

Oxford Diagnostic Laboratories will provide shipping containers and packing materials at no additional cost to the customer. State-of-the-art phase change material ensures that the temperature range of the blood specimens is maintained during transit.

How many specimens will fit into one shipping container?

Four blood specimens will fit into one foam specimen tray.  Two trays, containing up to 8 specimens, will fit in one shipping container.

What if I have more than 8 specimens to ship?

You will need to ship your specimens in two different shipping containers. Oxford Diagnostic Laboratories is currently developing a larger shipping container which will be available in the near future.

Can I ship specimens in my own containers?

Please contact Client Services at 1-877-59 TBLAB so we can determine if your shipping containers meet the appropriate requirements.

Can I ship specimens using my own carrier?

Oxford Diagnostic Laboratories has established an agreement with Federal Express. If you have questions concerning this carrier please contact Client Services at 1-877-59 TBLAB.

When would a blood specimen be rejected?

A blood specimens would be rejected if:

• Received more than 32 hours from the time of collection
• Blood collection tube is not labeled
• Blood collection tube has been centrifuged prior to shipping
• Received refrigerated or frozen
• Specimen is collected in tubes that do not contain lithium or sodium heparin
• Blood collection tube is leaking or broken
• Blood collection tube is under-filled
• Blood specimens are not received in an Oxford Diagnostic Laboratories shipping container

How will T-SPOT.TB test results be reported?

T-SPOT.TB test results will be reported as positive, negative, borderline or invalid. Spot counts will also be reported. It is recommended that borderline and invalid results be retested with a new patient specimen.

How will I receive T-SPOT.TB test results?

T-SPOT.TB test results will be faxed to the designated person identified in the Oxford Diagnostic Laboratories Customer Agreement.  A hard copy report will follow in the mail.

How can I order additional supplies (e.g., requisition forms)?

To order supplies contact Client Services at 1-877-59 TBLAB or complete the reorder form found in the section "Order Supplies" located in the Client Services tab.