Laboratory confirmation of HIV : a literature review

Background: Early and accurate diagnosis of HIV is important for treatment, follow up and decrease the transmission of HIV. CLSI M53-A guideline no longer recommends using Western Blot for confirmation of HIV reactive results due to the number of false-negative and indeterminate results it yields. The objective of this literature review is to systematically review the performance and operational characteristics of HIV confirmatory assays that meet the CLSI M53-A guidelines. Method: “PubMed” and “EMBASE” databases were used to conduct a systematic literature review and identified the potential relevant publications after June 2011. Publications related to the performance and operational characteristics of HIV confirmatory assays applicable to the CLS M53-A guideline were retrieved, evidence were compelled and synthesized. Findings: Performance characteristics: sensitivity analysis for individual confirmatory assays were as follow: 100% for recomLine HIV-1/HIV-2; 100% for INNO-LIA HIV I/II; 95.3%-100% for Geenius HIV 1/2; 100% for RIBA HIV-1/2; and 98.3%-100% for Multispot. Specificity analysis for individual confirmatory assays: 98.1% for recomLine HIV-1/HIV-2; 91%-100% for INNO-LIA HIV I/II; 93.4%-100% for Geenius HIV 1/2; 100% for RIBA HIV-1/2; 99.1% for Multispot. Operational characteristics: INNO-LIA HIV I/II, recomLine HIV-1/HIV-2 and RIBA HIV-1/2 did not offer much advantage against rapid WB from the operational perspective. Geenius HIV-1/2 and Multispot are much faster and user friendly assay with the same performance as compared to Western Blot and other HIV confirmatory assays. Conclusion Overall, the five confirmatory assays reviewed had excellent sensitivity, specificity and differentiation ability when compared to WB. Geenius HIV 1/2 and Multispot exhibit operational advantages of fast processing time and simple testing procedure. Rapid confirmatory assays can be applied to both resource-limited and resource-rich setting for faster TAT and less indeterminate results to improve the overall quality of HIV diagnosis.published_or_final_versionPublic HealthMasterMaster of Public Healt