Field evaluation of BD FACSPrest for haemoglobin and CD4 measurement
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Background:Measurements of CD4 and haemoglobin are used to determine the immunological state and information about disease progression for HIV-infected patients. Use of BD FACS Presto™ point of care (POC) device for CD4 and haemoglobin (Hb) determination can significantly improve access, uptake and coverage of laboratory services and hence management of HIV-infected patients in resource-limited settings. This study evaluated the relative bias in CD4 and Hb measurements using BD FACSPresto™ system compared to BD FACSCalibur™ CD4 analyser and Mindray BC-5380 haematology analyser respectively based on venous and capillary blood samples in a clinical hospital setting. Methods:Venous and capillary blood samples were used to determine CD4 counts and Hb levels among HIV-1 infected patients. The samples were analysed on the BD FACSPresto™ and results compared against BD FACSCalibur™ and Mindray BC-5380 for CD4 and haematology analyser respectively. Results: Results for absolute CD4 counts in both venous and capillary blood showed a high correlation (R2 = 0.922, P< 0.001) when they were analysed on BD FACSPresto™ and BD FACSCalibur™ machines. Overall, the mean difference in absolute CD4 count was 77.16 cells/mL (95%CI: 49.89, 104.42, p<0.01) when analysed on two platforms. The BD FACSCalibur™ gave a higher mean of absolute CD4 count (834.38 cells/ml) compared to BD FACSPresto™ (757.23 cells/ml) when venous sample type is used. There was a significant mean difference of Hb levels at 0.31 (P <0.001) between the two sample types when analysed on BD FACSPresto™ and Mindray BC-5380 haematology analyser. In addition, there was a high correlation (R2 = 0.920, P< 0.001) of Hb level measurements between the BD FACSPresto™ and Mindray BC-5380 haematology analyser.Conclusion: The BD FACSPresto performed satisfactorily in comparison to the conventional reference standard technologies. Venous and capillary blood sample types showed a high correlation when analysed for absolute CD4 count and Hb using BD FACSPresto™, BD FACSCalibur™ and Mindray BC-5380 haematology analyser. BD FACSPresto capillary platform can be used interchangeably with BD FACSCalibur™ venous platform for CD4 and Mindray BC-5380 for Hb measurement in resource limited settings to increase access and uptake of laboratory services.