Validation of Interferon Gamma Release Assays (IGRA) using frozen Peripheral Blood Mononuclear Cells (PBMC)

Validation of Interferon Gamma Release Assays (IGRA) using frozen Peripheral Blood Mononuclear Cells (PBMC) - VIP study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34928

Enrollment

Registered

2010-05-19

Start date

2010-03-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Latent or active tuberculosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: presence/absence tuberculosis infection (in the past)

Exclusion criteria

Exclusion criteria: Age

Design outcomes

Primary

Measure	Time frame
THE QFT measures the level of interferon gamma and reports a test index with respect to the negative control. According to the guidelines of the manufacturer a test index >0.35 will be regarded positive. As the number of PBMC's in the teted aliquot is not determined, we will repeat the test with a counted number of fresh PBMC's (±600.000 cells). This enables us to compare the QFT index with the T-spot TB test which will be tested with a identical number of cells. Comparison of fresh versus frozen PBMC's: - If the index of positive samples, before and after freezing, will differ more than 40%, but both samples are positive we regard it as a minor error - A difference of the index which influences the test result qualitatively will be evaluated as major error T-spot TB: The T-spot visualises the level of interferon as spots on a white background. Conform the guidelines of the manufacturer a test with >6 spotsis regarded positive. Comparison of fresh versus frozen PBMC's: - A deviation in spots >30% that do not lead to another qualitative interpretation will be evaluated as minor error - A deviation in spots which influences the test result qualitatively will be evaluated as major error	—

Measure

Time frame

THE QFT measures the level of interferon gamma and reports a test index with respect to the negative control. According to the guidelines of the manufacturer a test index >0.35 will be regarded positive. As the number of PBMC's in the teted aliquot is not determined, we will repeat the test with a counted number of fresh PBMC's (±600.000 cells). This enables us to compare the QFT index with the T-spot TB test which will be tested with a identical number of cells. Comparison of fresh versus frozen PBMC's: - If the index of positive samples, before and after freezing, will differ more than 40%, but both samples are positive we regard it as a minor error - A difference of the index which influences the test result qualitatively will be evaluated as major error T-spot TB: The T-spot visualises the level of interferon as spots on a white background. Conform the guidelines of the manufacturer a test with >6 spotsis regarded positive. Comparison of fresh versus frozen PBMC's: - A deviation in spots >30% that do not lead to another qualitative interpretation will be evaluated as minor error - A deviation in spots which influences the test result qualitatively will be evaluated as major error

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Countries

Netherlands

Outcome results