【INTENDED USE】
  Anti-HIV1+2 is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of antibodies to human immunodeficiency virus type 1 and/or 2 in human serum or plasma.

【SPECIFIC PERFORMANCE CHARACTERISTICS】

1.  Sensitivity

   The sensitivity studies have been made on a panel of 156 positive samples including 135 HIV-1 (with 3 group O), 21 HIV-2 and seroconversion panels. The HIV 1+2 Antibody ELISA has presented a 100% sensitivity on true HIV positive and seroconversion panels.

2. Specificity

  The specificity has been determinated on blood donors samples (10063 samples tested) and on hospitalized patients (170 samples tested). The specificity calculated is respectively 100% and 100%. Additional studies of potentially interfering diseases (rheumatoid arthritis, auto-immune or viral diseases: 53 samples tested) have shown no cross-reactions.

3. Precision

  Assay reproducibility was determined by assaying 3 specimens in replicates of 10 on 2 consecutive runs using the same production lot. The Intra-assay and Inter-assay standard deviation (S.D.) and the coefficient of variation (%CV) were calculated (Table I). The mean signal to cut-off ratio (S/CO) is defined as the Mean Sample Absorbance divided by the calculated Cut-Off value.

Table 1: Table shows reproducibility of assay results performed on DaAn HIV 

                            Intra-assay Precision                              Inter-assay Precision

Sample             S/CO        S.D       CV%                        S/CO          S.D          CV%

     1                  11.005      0.186     9.4                          11.067        0.175         8.8

     2                  4.800      0.080     9.3                           4.867         0.078         8.9

     3                  2.822      0.042     8.3                           2.894          0.048        9.2

                         Intra-assay Precision                                Inter-assay Precision

Control Mean    Mean     S.D.     CV%                         Mean           S.D.           CV%

PC                    2.258     0.135    6.0                            2.336         0.121          5.2

NC                    0.051     0.005    —                             0.055         0.006           —