Study title: Quality Improvement and Assay Validation of Automated Platforms testing for Antimicrobial Resistance in Blood Culture Isolates

Lead Researcher(s): Katharina Kranzer

Funder(s): Foundation of Innovative Diagnostics

Partner(s): Sally Mugabe Central Hospital, Biomedical Research and Training Institute, Ministry of Health and Child Care

Background

Sepsis is a condition where potentially life-threatening organ dysregulation occurs as a result of a dysregulated host response to bloodstream infection. Detecting and adequately treating bacterial bloodstream infection (BSI) with appropriate antibiotics can both save lives and reduce the risk of serious sequelae to sepsis. The gold standard test for BSI is a blood culture followed by antimicrobial sensitivity testing which can take up to 72 hours, jeopardizing patients’ outcomes. Additionally, blood cultures may produce false negative or inaccurate results due to inadequate blood volumes collected and contamination.

Study aim(s)

To optimise the pre-analytic phase of the blood culture process via a quality improvement programme.

To validate an automated molecular platform for pathogen identification and detection of antimicrobial resistance, performed in parallel to standard techniques currently employed in the laboratories.

Study design

Optimisation of the pre-analytic phase was implemented through a plan-do-study-act (PDSA). Interventions included drafting of standard operating procedures endorsed by the clinical leads of the neonatal and paediatric department, regular training of clinical officers, stock checks and feedback of indicators such as blood volume taken and contamination rates.

The validation study compared the results of 780 positive blood cultures investigated by standard techniques with the results obtained by the automated molecular platform over a period of 10 months. Usability of the molecular platform was assessed using a 10-item system usability scale (SUS).

Duration

June 2022 - December 2025