The use of the GeeniusTM HIV-1/2 Rapid confirmatory test for the enrolment of patients and blood donors in the WHO Universal Test and Treat Strategy in Cameroon, Africa

Vox Sang. 2020 Nov;115(8):686-694. doi: 10.1111/vox.12942. Epub 2020 May 28.

Abstract

Background and objective: In the WHO Universal test and treat strategy, false-positive HIV blood donors and patients may be unnecessarily put under antiretroviral treatment and false-negative subjects may be lost to follow-up. This study assessed the false positivity rate of the Cameroonian national HIV screening testing algorithm and the benefit of a confirmation test in the enrolment of patients and donors in the HIV care programme.

Methods: We included initial HIV reactive blood donors and patients in a cross-sectional study conducted in two Cameroonian hospitals. Samples were retested according to the Cameroon national algorithm for HIV diagnosis. A positive or discordant sample was retested with the Geenius Bio-Rad HIV 1&2 (Bio-Rad, Marnes-la-Coquette, France) for confirmation. The Geenius HIV-1-positive results with 'poor' profiles were retested for RNA as well as the Geenius indeterminate results.

Results: Of the 356 participants, 190/225 (84·4%) patients and 76/131 (58%) blood donors were declared positive with the national algorithm; 257 participants (96·6%) were confirmed HIV-1-positive. The study revealed that about 34/1000 blood donors and patients are false-positive and unnecessarily put on treatment; 89/1000 blood donors and patients declared discordant could have been included immediately in the HIV care programme if confirmatory testing was performed. The second test of the algorithm had a false-negative rate of 3%. Eleven samples (3·1%) were Geenius poor positive and NAT negative.

Conclusion: The universal test and treat strategy may identify and refer more individuals to HIV care if a third rapid confirmatory test is performed for discordant cases.

Keywords: HIV; blood donor; donor care; epidemiology; serological testing.

MeSH terms

  • Adolescent
  • Adult
  • Algorithms
  • Blood Donors*
  • Cameroon
  • Cross-Sectional Studies
  • Female
  • HIV Antibodies / blood
  • HIV Infections / diagnosis*
  • HIV Seropositivity / diagnosis*
  • HIV-1 / immunology
  • HIV-2 / immunology
  • Humans
  • Male
  • Mass Screening
  • Middle Aged
  • Serologic Tests
  • World Health Organization
  • Young Adult

Substances

  • HIV Antibodies