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FastPlaqueTB™ and FastPlaque-Response™ Diagnostic Assays

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An innovative breakthrough for the detection of Tuberculosis

The new FastPlaqueTB™ system, developed by BIOTEC Laboratories Ltd and FIND (Foundation for Innovative New Diagnostics) and manufactured by BIOTEC Laboratories Ltd, is a novel application of phage amplifcation technology which allows the rapid detection of TB within 24 hours of sample preparation.

This technology has been further applied to produce the  FastPlaque-Response™ assay for drug resistance which provides results within 48 hours (see below)

Product	Code	Tests	Product Information	QA
FastPlaqueTB™	CB30/5100	50 tests	see details
FastPlaque-Response™	CB30/5200	25 tests	see details
NOA Antimicrobial Supplement	CB30/5250	5 vials (sufficient for one FastPlaque-Response)	see details

 

Summary of Assay Principle (View schematic flow diagram of FastPlaqueTB™Diagnostic Assay)

• A specific mycobacteriophage infects cells of MTB Complex present in the sample
• Following infection the sample is treated with a virucide to destroy phage not infecting a host cell
• Remaining intracellular phage undergo a replication cycle resulting in the release of phage from host cells
• During incubation, released phage are allowed to infect a lawn of non-pathogenic organisms within an agar plate
• The phage undergo further replication and lyse the non-pathogenic organisms, producing zones of clearing (plaques) on the surface of the agar. Appearance of plaques is indicative of a positive TB sample

The benefits of FastPlaqueTB™

• Rapid - assay results available within 24 hours of sample preparation
• Detects patient positive samples missed by smear
• No instrumentation required
• Safe - no culturing of pathogen required
• Sensitive - assay sensitivity 100 - 300 cells/ml
• Only detects live bacilli - reduces the possibility of false positives
• Technology can be extended for antibiotic susceptibility testing (see figure below)

 

The FastPlaque-Response™ assay allows the early detection of rifampicin resistance. This assay allows rapid screening of various patient populations, for example those who have failed or defaulted from the first-line treatment who are at an increased risk of multi-drug resistant tuberculosis (MDR-TB) and those who are not responding to therapy, despite good compliance.

 Summary of Assay Principle (View schematic flow diagram of FastPlaque-Response™Diagnostic Assay)

• Process smear positive sputum speciment. Incubate a sample with and without rifampicin overnight at 37^oC
• Add phage to processed specimen. Phage infection occurs
• Add virucide to destroy extra-cellular phage. TB bacilli and replicating phage within cells are unaffeted
• Neutralise virucide. Add Sensor cells for amplification of released phage
• Incorporate reaction mixture into agar in Petri dish and incubater overnight at 37^oC. Viable TB bacilli in the original specimen are reflected as clear zones (plaques) in a lawn of Sensor cell growth. Rifampicin resistant TB strains survive drug treatment and product plaques, whilst susceptible strains do not (see below)

 

FastPlaqueTB™ and FastPlaque-Response™ are manufactured by BIOTEC Laboratories Ltd. Please visit their website via this link www.biotec.com

Press Release: FIND and BIOTEC Announce Development of a New Test for Rapid Diagnosis of Multi-Drug Resistant TB

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