Document 0010
 DOCN  M9480010
 TI    [Validity of an ELISA test for CD4+ T lymphocyte count and validity of
       total lymphocyte count in the assessment of immunodeficiency status in
       HIV infection]
 DT    9410
 AU    Loua A; Kestens L; Vanham G; Boel L; Colebunders R; Gigase P;
       Departement de Biologie Clinique, CHU Ignace DEEN, Conakry,; Guinee.
 SO    Ann Soc Belg Med Trop. 1994 Mar;74(1):61-8. Unique Identifier : AIDSLINE
       MED/94296163
 AB    A newly available commercial ELISA (TRAx CD4, T Cell Diagnostics USA)
       for enumerating CD4+ T lymphocytes has been evaluated with blood samples
       of 105 HIV seropositive and 6 seronegative subjects. Results from the
       flow cytometric analysis were used as reference. The sensitivity and
       specificity of the ELISA to identify HIV seropositive subjects having
       less than 200 CD4+ T lymphocytes/microliters were assessed and studied
       using the ROC curve. The reproducibility of the ELISA test was analyzed
       on 40 samples. The results of the ELISA correlated well with these of
       the flow cytometric analysis (r = 0.79, p < 0.001). However, the ELISA
       test tends to overestimate the true CD4 count in HIV seropositives. This
       overestimation could not be explained by the aspecific contribution of
       monocytic CD4. The threshold for identifying HIV seropositive subjects
       with less than 200 CD4+ T lymphocytes with a maximum sensitivity and
       specificity was determined with ROC curve and equalled 400 cell
       equivalents with the ELISA (sensitivity and specificity were equal to
       80%) and 1,450 lymphocytes/microliters with the total absolute
       lymphocyte count (sensitivity and specificity were equal to 75%). Using
       this curve, a threshold of 300 cell equivalents for the ELISA test and
       of 1,100 lymphocytes/microliters for the absolute lymphocyte count was
       shown to maximize the specificity (> 95%) without a significant loss of
       sensitivity.
 DE    Comparative Study  English Abstract  *Enzyme-Linked Immunosorbent Assay
       Flow Cytometry  Human  HIV Infections/*BLOOD  *Leukocyte Count
       Reproducibility of Results  ROC Curve  Sensitivity and Specificity  *T4
       Lymphocytes  JOURNAL ARTICLE

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