Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples

Официальное название

Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast

Обзор

The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture. The objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.

Вмешательства

• Диагностический тест InfectID-BSI (Bloodstream Infection) qPCR Assay
  InfectID-BSI technology targets nucleic acid sequences unique to the target analyte. The qPCR raw data collected from InfectID-BSI's 9 assay tubes is analysed by Microbio's InfectID-Client (InfectID-BSI-associated software) and the result is reported as an analyte-detection if the unique target analyte is present or no result if the unique target analyte is absent. InfectID-BSI is carried out with whole blood from a venous puncture (EDTA). DNA is extracted from a sample of the collected blood u

Первичные конечные точки

• Determine the sensitivity and specificity of InfectID-BSI versus blood culture. [Срок оценки: Through study completion, an average of 1 year]
• Determine the efficacy of detection and identification of the 26-pathogen panel in the InfectID-BSI assay versus standard of care blood culture. Using qPCR - a new molecular technology to identify the top 20 bacterial and 6 yeast sepsis causing species. [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Male or female of neonates (less than 1 month of age), paediatrics (between 1 month and 17 years of age) or adults (≥18 years of age).
• Admitted to ICU, Emergency Department, or other medical wards for acute illness with medical decision to perform blood culture for suspicion of bloodstream Infection.
• Two additional EDTA blood sample/s collected from one anatomical site and at the same time as blood culture (two EDTA samples to be collected where possible).
• EDTA blood volume is ≥1mL.
• EDTA blood sample is stored according to Microbio's stability requirements.

Критерии исключения

• No suspicion of blood stream infection (BSI).
• Any inclusion criterion not met.
• Multiple EDTA blood samples from the same patient.
• EDTA blood sample not obtained from the same anatomical site and at the same time as the blood culture sample.
• Subject has had an antimicrobial drug administered through the same port or central line as is used to collect the specimen.
• EDTA blood samples that have not been stored according to Microbio's sample stability requirements.
• EDTA blood volume <1mL.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 5 центров

• Indiana University Hospital — Indianapolis
• University of Maryland — Baltimore
• TriCore Reference Laboratories — Albuquerque
• Vanderbilt University Medical Centre — Nashville
• Texas Children's Hospital — Houston

Австралия · 2 центра

• The Prince Charles Hospital — Chermside
• The Princess Alexandra Hospital — Woolloongabba

Великобритания · 1 центр

• Southwest Regional Laboratory, UK Health Security Agency, Bristol UK — Bristol

Идентификаторы

NCT: NCT06531031 · MB-CLA-PRT-0022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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