PBD Biotech is to make components of its Actiphage diagnostic available for Research Use Only (RUO). Actiphage is able to detect mycobacteria belonging to the Mycobacterium tuberculosis complex (MTBC), including M. tuberculosis (Mtb), in a 2ml human blood sample.
Actiphage offers a rapid assay (24/48 hours to result) utilising patented bacteriophage technology to infect and lyse live mycobacteria and release its DNA, which can then be used as a target to detect Mtb by qPCR.
COMPONENTS
Instructions for use (IFU)
A comprehensive set of instructions describing the set up and interpretation of results using the Actiphage RUO components for detection of Mtb in human blood is provided.
White blood cells isolation reagents
Mtb are sequestered by peripheral blood mononuclear cells (PBMCs). PBD Biotech has validated a robust, reproducible method to isolate intact PBMCs from a fresh sample of human whole blood, for exposure to and infection by our phage technology – Actiphage.
Actiphage incubation reagents
Optimal amount of freeze-dried phage particles are provided for successful Mtb infection, lysis and recovery of released DNA.
DNA clean up reagents and spin columns
All the reagents required to remove any residual inhibitory substances from the phage infection assay and to purify and concentrate the DNA released from the Mtb ready for efficient downstream qPCR analysis are included.
Positive control
Freeze-dried attenuated M.bovis BCG strain is supplied as a positive control. A positive control determines whether the pre-PCR sample-processing and PCR reaction conditions are optimal. It allows assessment of any enzymatic inhibitors and/or technical issues that may interfere with the efficiency of the pre-PCR sample-processing steps and PCR, giving confidence that the test is performing to the technical specifications detailed in the IFU.
Internal positive control
Exogenous DNA template is supplied as an internal positive control (IPC). An IPC is added to each reaction to monitor the PCR assay performance and detect amplification inhibitors and false-negative results.
Negative control
Nuclease free water is supplied as a no-template control (NTC). An NTC omits any DNA template from the reaction and serves as a general control for extraneous nucleic acid contamination.
Internal positive control
Exogenous DNA template is supplied as an internal positive control (IPC). An IPC is added to each reaction to monitor the PCR assay performance and detect amplification inhibitors and false-negative results.
PCR assay reagents
Lyophilised PCR reaction beads containing polymerase enzyme, dNTPs, oligonucleotide primers and probes and PCR additives.
The primers and probes allow specific detection of DNA lysed from Mtb isolated from a human whole blood sample.
List of components coming shortly. In the meantime if you are interested in an RUO test please register below.
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