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Objective: To assess the inter-laboratory comparability and intra-assay reproducibility of full blood count (FBC) results.
Design: Exploratory cross-sectional study.
Setting: Three and two selected medical laboratories in the northern and southern zones, respectively.
Participants: Forty-nine individuals per zone; 16 type 2 diabetes mellitus, 16 with HbAS haemoglobin type and 17 normal samples
Intervention: Each sample was run eleven times through the analysers in the participating laboratories to evaluate intra-laboratory reproducibility and comparability of FBC results.
Main Outcome Measure: Intra-laboratory reproducibility was evaluated using %coefficient variation (%CV). Inter-laboratory comparisons were assessed through t-test or One-Way ANOVA for two-sample and three-sample tests. All statistical testing was undertaken using the two-tailed assumption.
Result: Statistically significantly different haemoglobin levels were estimated in both northern and southern zones (mean difference 0.00 g/dL to 3.75 g/dL vs 0.18 g/dL to 1.92 g/dL respectively). Also, total WBC counts significantly differed across laboratories in both northern and southern zones (mean difference 0.15 x109/L - 3.86 x109/L vs 0.02 x109/L to 1.39 x109/L respectively). Furthermore, platelet counts significantly differed across the participating laboratories in the northern and southern zones (mean difference 0.40 x109/L to 299.76 x109/L vs 5.7 x109/L to 76.9 x109/L respectively). Moreover, there was evidence of non-reproducibility of results within the respective laboratories in each zone as the respective %CV were outside the acceptable limits.
Conclusion: The intra-laboratory non-reproducibility and inter-laboratory non-comparability of FBC results highlight the need to establish a national quality assessment scheme to harmonise laboratory practices nationwide.