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  • This study has some limitations The

    2021-10-18

    This study has some limitations. The RDS technique was not effective for the population of MSM from Natal, as it has not reached the sample size initially calculated. Few seeds had enough waves to disperse the sample and make it closer to a probabilistic sample, even with all efforts from the research team to improve recruitment. Similar difficulties have been reported with the use of RDS technique by researches in Singapore. We ended up analyzing our entire group as a non-probabilistic sample as a consequence of these difficulties. Therefore, these results may not be representative of the entire Natal MSM population. Some of the results that did not show statistical significance may have been influenced by the sample size that may have not been sufficient to show associations. However, there is relevance to the study because it represents a population that is difficult to access in a location where no similar study had been performed previously.
    Conclusion
    Sources of support
    Conflicts of interest
    Background HIV continues to be a major public health concern, with more than 36 million people worldwide living with HIV [1]. HIV can be transmitted through certain bodily fluids, for example via sexual intercourse, sharing injection drug equipment, or from mother to child during pregnancy or breastfeeding [2]. It is estimated that only 70% of people living with HIV know their status and, as such, there is a need for patients to have access to effective testing [1]. HIV can also be transmitted via blood transfusion; therefore, sensitive screening assays are vitally important [2]. HIV p24 antigen is one of the earliest markers of HIV infection and typically appears around the first 2 weeks post infection [3,4]. Antibodies to HIV are usually detected later, with IgM and IgG BTS supplier mg detected approximately 3 and 6 weeks post infection, respectively [5]. In hospitals and routine laboratories HIV screening is usually performed using antigen/antibody test, unless a person is at high risk of exposure and a nucleic acid test (NAT) might be requested, although this is region specific. In blood donation centres, serological and NAT screening are performed in parallel in most countries [[6], [7], [8]]. Fourth generation HIV assays detect both HIV p24 antigen and antibodies to HIV-1 and HIV-2, decreasing the negative test window to 11–14 days post exposure, compared with assays that detected antibodies alone [3]. Fourth generation tests have been shown to improve the detection rate of HIV in real-world situations and to reduce the turnaround time of results reporting [[9], [10], [11], [12]]. The Elecsys® HIV Duo assay is a new fourth generation assay which provides a result for both the HIV antigen and the HIV antibody modules, in addition to an overall test result. This information can be used to aid in the selection of the confirmation test for reactive samples.
    Objectives The objective of this multicentre study was to evaluate the sensitivity and specificity of the Elecsys® HIV Duo assay using blood donor samples, and samples from routine diagnosis, comparing it with other commercially available fourth generation assays.
    Study design
    Results
    Discussion The results of the Elecsys® HIV Duo assay in more than 13,300 blood donation samples, assessed at four different test sites, demonstrates a comparable specificity (99.87%) to the routine assays used at each centre. There is a potential for selection bias when comparing a new assay to an established, in-house assay at a blood donation centre; the routine assay tends to be positively biased as reactive donations are rejected, ruling out potentially false positive donors over the time. The specificity of the Elecsys® HIV Duo assay in 1000 routine diagnostic samples was 100% and slightly better than the specificity of the Elecsys® HIV combi PT, ABBOTT ARCHITECT® HIV Ag/Ab Combo, LIAISON® XL murex HIV Ab/Ag and ADVIA Centaur® CHIV assays; however, the difference was not significant.