Pitfalls in HIV serology: reagent-dependent changes in sensitivity and specificity of ELISA kits.
Using confirmed positive and false-positive serum samples stored in deep frozen state we studied the reproducibility of the results obtained by different anti-HIV enzyme immunoassay (EIA) kits. Experiences obtained with 3 kits are presented. Two types of observations were made: (a) significant inter-lot, intra-lot and even inter-box sensitivity difference was found with some kits and (b) reactivity of the plates for true-positive and false-positive sera independently changed among different lots of the same kit: while reactivity for true positive sera was constant, a significant decrease or increase in reactivity for false-positive sera was found. These observations point to poor reproducibility of some commercial anti-HIV EIA kits that can cause serious difficulties in screening laboratories.
Ujhelyi
E
E
National Institute of Haematology and Blood Transfusion, Budapest, Hungary.
Füst
G
G
Katonka
M
M
Héjjas
M
M
Hollán
S R
SR
D004797:Enzyme-Linked Immunosorbent Assay; D005188:False Negative Reactions; D005189:False Positive Reactions; D015483:HIV Antibodies / Q000032:analysis*; D006801:Humans; D007202:Indicators and Reagents; D012680:Sensitivity and Specificity
D015483:HIV Antibodies; D007202:Indicators and Reagents