A clinical trial of Actiphage, a promising new diagnostic for tuberculosis infection, has shown for the first time that live...
ACTIPHAGE MTB COMPONENTS FOR RUO
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 2-5 ml 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.
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.
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.
Optimal amount of freeze-dried phage particles are provided for successful Mtb infection, lysis and recovery of released DNA.
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.
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.
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.
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.
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.
If you would like to find out more about how your lab could be meeting the requirement of the huge market for improved tuberculosis diagnostics then get in contact.
Researchers at Leicester Respiratory NIHR Biomedical Centre (2022) used Actiphage to screen high risk patients.
It was the first study to successfully isolate Mtb in the blood and to use this to distinguish between latent TBI and incipient TBI.
Showed bacteraemia (bacteria in the blood) can be used to provide early-stage diagnosis.
Demonstrated that Actiphage had potential for rapid blood test for screening vulnerable populations.
The research was presented at the 32nd European Congress of Clinical Microbiology & Infectious Diseases
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