Feasibility of performing multiple point of care testing for HIV anti-retroviral treatment initiation and monitoring from multiple or single fingersticks

PLoS One. 2013 Dec 20;8(12):e85265. doi: 10.1371/journal.pone.0085265. eCollection 2013.

Abstract

Background: Point of Care testing (POCT) provides on-site, rapid, accessible results. With current South African anti-retroviral treatment guidelines, up to 4 fingersticks /patient/clinic visit could be required if utilizing POC. We determined the feasibility and accuracy of a nurse performing multiple POCT on multiple fingersticks followed by simplification of the process by performance of multiple POC on a single fingerstick.

Method and findings: Random HIV positive adult patients presenting at a HIV treatment clinic in South Africa, for ART initiation/ monitoring, were approached to participate in the study between April-June 2012. Phase I: n=150 patients approached for multiple POCT on multiple fingersticks. Phase II: n=150 patients approached for multiple POCT on a single fingerstick. The following POC tests were performed by a dedicated nurse: PIMA (CD4), HemoCue (hemoglobin), Reflotron (alanine aminotransferase, creatinine). A venepuncture specimen was taken for predicate laboratory methodology. Normal laboratory ranges and Royal College of Pathologists Australasia (RCPA) allowable differences were used as guidelines for comparison. In 67% of participants, ≥3 tests were requested per visit. All POCT were accurate but ranged in variability. Phase I: Hemoglobin was accurate (3.2%CV) while CD4, alanine aminotransferase and creatinine showed increased variability (16.3%CV; 9.3%CV; 12.9%CV respectively). PIMA generated a misclassification of 12.4%. Phase II: Hemoglobin, alanine aminotransferase and creatinine showed good accuracy (3.2%CV, 8.7%CV, 6.4%CV respectively) with increased variability on CD4 (12.4%CV) but low clinical misclassification (4.1%). No trends were observed for the sequence in which POC was performed on a single fingerstick. Overall, PIMA CD4 generated the highest error rate (16-19%).

Conclusions: Multiple POCT for ART initiation and/or monitoring can be performed practically by a dedicated nurse on multiple fingersticks. The process is as accurate as predicate methodology and can be simplified using a single fingerstick.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Alanine Transaminase / blood
  • Blood Specimen Collection / methods*
  • CD4 Antigens / blood
  • Creatinine / blood
  • HIV Infections / diagnosis*
  • HIV Infections / drug therapy*
  • Hemoglobins / analysis
  • Humans
  • Medication Therapy Management
  • Point-of-Care Systems*
  • South Africa

Substances

  • CD4 Antigens
  • Hemoglobins
  • Creatinine
  • Alanine Transaminase

Grants and funding

This work was supported by Grand Challenges Canada [Grant number 0007-02-01-01]. Additional staff and logistical support was provided by the American people through the United States Agency for International Development [PEPFAR grant number 674-A-00-08-0005-00] and the National Health Laboratory Services, South Africa. The contents are the responsibility of the authors and do not necessarily reflect the views of United States Agency for International Development or the United States government. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.