T-SPOT

TSPOT

TB; T spot

• Negative control
• Panel A
• Panel B
• Positive control

***WHOLE BLOOD SAMPLE TUBE MUST BE FULL***
1 Green tube Lithium Heparin ONLY; Sodium Heparin has not been validated for this assay
Do NOT use gel separator tube; DO NOT CENTRIFUGE

5 mL

None

• Sample tube must be full
• Lithium heparin is the only heparin choice for this test; sodium heparin cannot be used
• Do not use gel separator tubes
• Do not centrifuge
• Must be maintained at room temperature

Lthium heparin whole blood tube

Room temperature

32 hours from the time of draw

The following conditions will result in a rejected sample:

• Sodium heparin tube
• Serum sample
• Plasma sample
• Refrigerated sample
• Gel separator tube
• Frozen sample
• QNS <6 mL

M, Tu, W, Th, F, Sa, Su

This test requires at 16-20 hour incubation step.  Final report available within 48 hours after set up.

Negative	<4 spots
Borderline	5-7 spots
Positive	>8 spots

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Invalid results are due to either a spot count below 20 in the positive control or a spot count above 10 in the negative control. These instances do not meet performance expectations and are not clinically interpretable. Retesting with a new sample is recommended.

Upon retesting, if the test result remains Invalid, other diagnostic tests and/or epidemiologic information should be used to help determine the TB infection status of the patient.  Invalid results are uncommon and may be related to factors such as the immune status of the patient, inappropriate blood storage conditions, or delay in sample transport.

The T-SPOT^®.TB test is now the only IGRA cleared by the FDA for patients two and older

The T-SPOT assay is preferred for patients that have impaired immune status. The assay includes concentration of WBC and has improved sensitivity in patient populations with low white cell counts. This test is useful when Quantiferon Gold TB testing yields indeterminant results.

The T-Spot 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. This test is an in vitro diagnostic test based on an enzyme-linked immunospot (ELISPOT) method. The T-Spot test can be used in screening risk groups for TB infection and as a diagnostic aid when evaluating patients suspected of having active TB disease.