Establishment of a stable proficiency testing matrix in transfusion microbiology in South Africa.

Abstract

Background: All medical laboratories must participate in proficiency testing (PT) programmes to ensure high-quality results. Proficiency testing samples mimic clinical samples; however, PT programmes for detection of bacteria in blood products are not routinely performed due to unavailability of matrix-equivalent samples.

Objective: The aim of this study was to develop and test a matrix-equivalent PT programme using blood products as the basis matrix.

Methods: A prospective cross-sectional study was conducted from April 2021 until June 2021, using 52 blood products comprising 36 pooled platelet and 16 red blood cell products at the South African National Blood Service PT laboratory in Gauteng. Products were manipulated into matrix-equivalent PT samples by spiking 42 products with known bacterial strains at specific concentrations and treating the remaining 10 products with preserving fluid containing antibiotics. The level of agreement between the researcher results and participating laboratories' results was assessed.

Results: Of the prepared matrices, 568 out of 572 (99%) were stable for 30 days. Bacteria could correctly be identified in spiked samples for up to 23 days. Samples treated with preserving fluid remained negative until day 30. For spiked samples, an average of 98% agreement (153/156) was achieved between the three participating laboratories when compared with the researcher's results; 100% agreement was achieved for unspiked samples. The kappa scores obtained from all tested variables presented with scores between 0.856 and 1.000, and the p-value was < 0.001 throughout.

Conclusion: The developed PT matrix was therefore stable and suitable to be implemented in transfusion microbiology.

What this study adds: This study demonstrated that a stable microbiology PT programme using platelets and red blood cells can be developed for use on bacterial detection analysers and could help to close the gap presented by unavailability of a blood PT matrix for transfusion microbiology.