Rapid CD4 cell count determination and and antigen detection in people living with HIV: Implementation of a package of care strategy in a pilot study, Argentina.

OBJECTIVES

Despite advancements in HIV diagnosis and treatment, advanced HIV disease (AHD) is still a significant concern worldwide, especially in countries with a high percentage of undiagnosed cases and late-stage diagnoses.

METHODS

A prospective pilot study was conducted in Buenos Aires, Argentina to assess the feasibility of implementing a package for people living with HIV, integrating a point-of-care clusters of differentiation (CD4) test, followed by rapid and antigen (Ag) detection.

RESULTS

A total of 105 people living with HIV were enrolled, during June 2021 to October 2021. The VISITECT CD4 Advanced Disease Lateral Flow Assay (CD4-LFA) (Accubio) classified 98 (93%) patients with AHD. Compared with flow cytometry, the CD4-LFA performed with a high sensitivity (100%) but low specificity (19%) and limited accuracy (47%). In the 98 patients classified with AHD using the CD4-LFA, 16 tested positive for any of the rapid Ag used, including 12 patients positive for the Ag test and four positive for Ag; all four patients with positive Ag in sera and were diagnosed with meningitis. In the 30-day follow-up, one death was recorded.

CONCLUSIONS

The CD4-LFA correctly classified all patients with CD4 ≤200 cells/µL by flow cytometry, but a high frequency of patients misclassified with AHD was recorded. We also observed a high prevalence of opportunistic fungal infections, as previously observed in the hospital where this pilot study was conducted; however, in contrast with those previous reports, mortality was lower. The study underscores the importance of scaling up comprehensive care strategies and collaborating with governmental and non-governmental partners to enhance access to essential diagnostic tools and treatments for people living with HIV. Further research with larger sample sizes is needed to validate these findings.