Evaluation of the Efficacy of the HIV Ab/Ag Combi Chemiluminescence Immunoassay (CLIA) Method in the Diagnosis and Follow-up of HIV Infections

Diagnosis of human immunodeficiency virus (HIV) infection is important in detection of infected individuals and treatment planning. Serological methods, especially fourth-generation tests are used for screening and can detect both HIV-specific antibodies and p24 antigen. This study was investigated the efficacy of Maglumi-HIV Chemiluminescence Immunoassay test for detection of HIV Ab/Ag in patients’ plasma samples having low/high positive and negative HIV-RNA. Plasma samples of 179 patients were collected between January 2023 and June 2024. HIV-RNA Rt-PCR (Abbott,USA) and Maglumi-HIV assay (Snibe Diagnostics, Shenzhen, China) were performed simultaneously in the same plasma samples of patient. By Rt-PCR 54 high positive (10²-10⁷ IU/mL) and 32 low positive (40-10² IU/mL) HIV-RNA results were obtained. HIV-RNA was not detected in 93 samples by Rt-PCR. All of low positive samples and 53 high positive samples were also detected as positive by CLIA. Only one sample with high HIV-RNA positivity was found to be negative by CLIA. HIV Ab/Ag was found to be positive in the 20 samples out of 93 HIV-RNA negative samples. In the clinical analysis of these 20 patients, it was found out that all of them were diagnosed with HIV and were in remission being on anti-retroviral therapy which significantly reduced viral load (Table 1). In screening of HIV infections, the HIV Ab/Ag CLIA and HIV-RNA Rt-PCR along with a thorough evaluation of the patient's clinical findings should be used together. The Maglumi-HIV Ab/Ag assay may be used as an alternative screening method for the detection of HIV infection.