Levels of agreement between various serological and molecular tests for human immunodeficiency virus screening in blood donors

Objectives Many serological and molecular tests are available to reduce the spread of human immunodeficiency virus (HIV) transmission through blood transfusions. These include enzyme-linked immunosorbent assay (ELISA), rapid card tests, chemiluminescence, and nucleic acid testing. The level of agreement among all these test results has hardly been accessed. The aim of the present study was to evaluate the level of agreement among these commonly used tests. Material and Methods This is a cross-sectional study done from November 2021 to May 2023. Out of 5428 samples tested during the study period, 59 were reactive by fourth-generation ELISA. All these reactive samples were tested by another platform, that is, third-generation ELISA, enzyme-linked fluorescence assay (ELFA), polymerase chain reaction (PCR), and rapid card tests. An equal number of negative samples (i.e., 59) were also tested by all platforms. Results Out of all 59 samples that were reactive in 4 th generation ELISA, only 17 came in 3 rd generation ELISA. Of these, 13 only came to be positive in PCR. Similarly, 14 samples came to be positive in the ELFA test and rapid card test. Our study found the agreement to be 0.18, a fair agreement between third- and fourth-generation ELISA. Conclusion The present study has shown that although fourth-generation HIV ELISA has more sensitivity, false positives are present compared to third-generation ELISA. This study reflects the burden of HIV in the local population, and this result can be considered a preliminary step in quantifying the risk of Transfusion-Transmitted HIV and implementing different tests in blood donors.