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Performance verification of the new fully automated Aquios flow cytometer PanLeucogate (PLG) platform for CD4-T-lymphocyte enumeration in South Africa.
- Source :
- PLoS ONE; 11/03/2017, Vol. 12 Issue 11, p1-17, 17p
- Publication Year :
- 2017
-
Abstract
- Background: The National Health Laboratory Service (NHLS) offers wide-scale CD4 testing through a network of laboratories in South Africa. A new “load and go” cytometer (Aquios CL, Beckman Coulter), developed with a PLG protocol, was validated against the predicate PLG method on the Beckman Coulter FC500 MPL/CellMek platform. Methods: Remnant routine EDTA blood CD4 reference results were compared to results from two Aquios/PLG instruments (n = 205) and a further n = 1885 samples tested to assess daily testing capacity. Reproducibility was assessed using Immunotrol<superscript>TM</superscript> and patient samples with low, medium, high CD4 counts. Data was analyzed using GraphPad software for general statistics and Bland-Altman (BA) analyses. The percentage similarity (%Sim) was used to measure the level of agreement (accuracy) of the new platform versus the predicate and variance (%SimCV) reported to indicate precision of difference to predicate. Results: 205 samples were tested with a CD4 count range of 2–1228 cells/μl (median 365cells/μl). BA analysis revealed an overall -40.5±44.0cells/μl bias (LOA of 126.8 to 45.8cells/μl) and %Sim showing good agreement and tight precision to predicate results (94.83±5.39% with %SimCV = 5.69%). Workflow analysis (n = 1885) showed similar outcomes 94.9±8.9% (CV of 9.4%) and 120 samples/day capacity. Excellent intra-instrument reproducibility was noted (%Sim 98.7±2.8% and %SimCV of 2.8%). 5-day reproducibility using internal quality control material (Immunotrol™) showed tight precision (reported %CV of 4.69 and 7.62 for Normal and Low material respectively) and instrument stability. Conclusion: The Aquios/PLG CD4 testing platform showed clinically acceptable result reporting to existing predicate results, with good system stability and reproducibility with a slight negative but precise bias. This system can replace the faded XL cytometers in low- to medium volume CD4 testing laboratories, using the standardized testing protocol, with better staff utilization especially where technical skills are lacking. Central monitoring of on-board quality assessment data facilitates proactive maintenance and networked instrument performance monitoring. [ABSTRACT FROM AUTHOR]
- Subjects :
- T cells
BLAND-Altman plot
FLOW cytometry
ETHYLENEDIAMINETETRAACETIC acid
BLOOD
Subjects
Details
- Language :
- English
- ISSN :
- 19326203
- Volume :
- 12
- Issue :
- 11
- Database :
- Complementary Index
- Journal :
- PLoS ONE
- Publication Type :
- Academic Journal
- Accession number :
- 126045511
- Full Text :
- https://doi.org/10.1371/journal.pone.0187456