Viability of lymphocytes at day 0: > or =75.0%
Maximum proliferation of Candida albicans as % CD45: > or =5.7%
Maximum proliferation of Candida albicans as % CD3: > or =3.0%
Maximum proliferation of tetanus toxoid as % CD45: > or =5.2%
Maximum proliferation of tetanus toxoid as % CD3: > or =3.3%
Abnormal antigen stimulation test results are indicative of impaired T-cell function if T-cell counts are normal or only modestly decreased. If there is profound T-cell lymphopenia, there could be a dilution effect with underrepresentation of T cells within the peripheral blood mononuclear cell population that could result in lower T-cell proliferative responses. However, this is not a significant concern in the flow cytometry assay, since acquisition of additional cellular events during analysis can compensate for artificial reduction in proliferation due to lower T-cell counts.
In the case of antigen-specific T-cell responses to tetanus toxoid (TT), there can be absent responses due to natural waning of cellular immunity, if the interval between vaccinations has exceeded the recommended period, especially in adults. In such circumstances, it would be appropriate to measure TT-specific T-cell responses 4 to 6 weeks after a booster vaccination.
There is no absolute correlation between T-cell proliferation in vitro and a clinically significant immunodeficiency, whether primary or secondary, since T-cell proliferation in response to activation is necessary, but not sufficient, for an effective immune response. Therefore, the proliferative response to antigens can be regarded as a more sensitive, but less specific, test for the diagnosis of infection susceptibility.
No single laboratory test can identify or define impaired cellular immunity on its own.
Controls in this laboratory and most clinical laboratories are healthy adults. Since this test is used for screening and evaluating cellular immune dysfunction in infants and children, it is reasonable to question the comparability of proliferative responses between healthy infants, children, and adults. It is reasonable to expect robust T-cell-specific responses to TT in children without cellular immune compromise, as a result of repeated childhood vaccinations. The response to Candida albicans can be more variable depending on the extent of exposure and age of exposure. A comment will be provided in the report documenting the comparison of pediatric results with an adult reference range and correlation with clinical context for appropriate interpretation.
Without obtaining formal pediatric reference values, it remains a possibility that the response in infants and children can be underestimated. However, the practical challenges of generating a pediatric range for this assay necessitate comparison of pediatric data with adult reference values or controls.