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T-SPOT.TB FLYER

Product catalog summary

Overview of T-SPOT.TB Test:
The T-SPOT.TB test is a highly sensitive and specific interferon-gamma release assay (IGRA) used for detecting tuberculosis (TB) infection. It boasts a sensitivity of 98.8% and specificity above 99%, minimizing false positives and unnecessary follow-ups. The test is unaffected by BCG vaccination and common non-tuberculous mycobacteria, making it suitable for all patient groups, including those with weakened immune systems, pregnant individuals, and young children.

Key Features:

Sample collection is straightforward, using routine phlebotomy techniques and standard blood collection tubes.
Sample stability is maintained for up to 32 hours, allowing for overnight shipment, and processing can be completed within 24 hours.
The test has low indeterminate results (1.1%) and includes a borderline result category to reduce false positives and negatives.
Requires only one patient visit, unlike the TST test which requires two visits.
Approved for use in over 50 countries, including the USA, Europe, Japan, and China.

Testing Procedure:

Blood is collected, and peripheral blood mononuclear cells (PBMCs) are isolated, washed, counted, and normalized.
Cells are added to plates and stimulated with TB-specific antigens (ESAT-6 and CFP10).
Interferon-gamma released by cells is captured using antibodies, followed by a secondary labelled antibody.
A detection reagent produces spots indicating interferon-gamma release, which are then counted.

Applications:

Testing patients with conditions that increase the risk of latent TB reactivation, such as HIV, immunosuppressant treatment, chronic renal disease, and cancer chemotherapy.
Targeted testing of high-risk populations, including close contacts, migrants, prisoners, and suspected TB patients.
Pre-employment and regular screening of healthcare professionals.

Catalog excerpts

How the T-SPOT.TB test helps you1 How the T-SPOT.TB test works based on the proprietary T-SPOT technology1 • Identifies a high percentage of infected subjects and is the only interferon- gamma release assay (IGRA) with sensitivity of 98.8%. • The only IGRA that separates cells from whole blood and standardises the number of these cells used in each patient test, reducing the risk of false- negative and indeterminate test results. • Specificity above 99%. False-positives are rare with the T-SPOT.TB test, so unnecessary chemoprophylaxis and follow-up is minimized. • Is unaffected by BCG vaccination...

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Testing of patients with conditions that weaken the immune system and increase the risk for latent TB reactivation, including: HIV infection, treatment with immunosuppressants, including anti-TNF-α therapy and high-dose steroids, chronic renal disease and cancer chemotherapy. • Targeted testing of high-risk populations including: Close contacts, migrants, prisoners and patients suspected of TB. • Pre-employment and regular screening of healthcare professionals. REFERENCES 1 T-SPOT.TB Package Insert (PI-TB-IVD-UK-V3) 2 Year to date (1/12/15) 2015 data at Oxford Diagnostic Laboratories, UK T-SPOT...

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