Which bacteria. Which antibiotic. From one specimen, in one shift.
RapidID identifies bacteria. RapidAST measures their response to antibiotics. The assays are designed to use the same urine specimen or positive blood culture on compatible Luminex instruments.
From specimen to decision in about five hours.
- 0 hSpecimen arrives
A urine sample, or a blood culture that has turned positive
The specimen enters the laboratory's normal intake. Bloodstream testing starts from the positive culture, not from the patient's blood draw.
- 2 to 3 hRapidID
Which bacteria are present?
Species-specific ribosomal RNA is detected directly, several species in one run, without waiting for a culture to grow.
- about 5 hRapidAST
Which antibiotics are the bacteria susceptible to?
The bacteria are exposed to a panel of antibiotics and their growth response is measured directly and used to assess susceptibility.
- Same shiftClinician decides
The prescription follows the result
The admitting clinician can target treatment before the shift ends, instead of adjusting the initial antibiotic days later.
Turnaround measured in the joint laboratory programme in Saskatchewan on the legacy instrument. Investigational; not licensed by Health Canada for clinical use.
Reading the bacteria's own ribosomal RNA.
Every bacterial cell carries thousands of copies of ribosomal RNA, and the sequence differs by species. That abundance is what makes a fast, direct test possible.
A molecular sandwich that lights up when the right bacteria are present.
The specimen is treated to release ribosomal RNA from the bacteria. DNA probes then capture and detect species-specific sequences, forming a DNA-rRNA-DNA "sandwich" that produces a measurable signal on the instrument. Because rRNA is so abundant, the bacteria can be identified directly from the specimen, several species in one run, without first growing a culture.
The same signal measures the bacteria's response to each antibiotic.
Bacteria from the specimen are incubated briefly with a panel of antibiotics. Where the bacteria keep growing, their rRNA signal rises; where an antibiotic suppresses growth, it does not. The result is phenotypic: it observes how the bacteria respond to each drug, rather than predicting susceptibility from the resistance genes they carry.
Identification and susceptibility guide treatment together.
Identification and susceptibility results together help clinicians select targeted treatment. The two assays are designed to use the same specimen and provide results within one shift.
Built for instruments already in the laboratory.
Kit-based assays
MicrobeDX is developing kit-based assays. The laboratory supplies a compatible instrument, its staff and the workflow it already runs.
Luminex xMAP instruments
The assays are designed for the Luminex xMAP family, including the LX200, an analyser already cleared for clinical laboratory use and installed in many laboratories worldwide. They are intended for laboratories with a compatible Luminex instrument.
Two specimen types
Urine, for suspected urinary tract infection, and positive blood cultures, for suspected bloodstream infection and sepsis.
Designed for central laboratories
Benchtop protocols suited to higher-throughput hospital and regional laboratories, where most urine and blood-culture testing is already done.
Programme results were generated on a legacy instrument and do not by themselves establish equivalent performance on another platform. Platform-specific validation and the applicable regulatory pathway are part of the development programme. Clearance of an instrument does not itself authorize MicrobeDX's assays for routine clinical use.
Investigational, with a defined next step.
Assays migrated to the Luminex LX200.
The chemistry evaluated in the Saskatchewan programme has been moved to the current platform, and validation on it is under way.
Platform validation and a prospective clinical study.
Formal method validation, planned under a quality-management framework, and a prospective emergency-department study to measure what a faster answer changes for patients and the health system.
Not licensed for clinical use.
MicrobeDX's assays are investigational and are not licensed by Health Canada for routine clinical use. No commercial availability date is stated.