The novel assay has been assessed for detecting the bacteria responsible for many pharmaceutical product recalls, Burkholderia cepacia complex
Daddy Gaoh et al. have published an article in the journal Pathogens that lays out a novel colourimetric LAMP (Loop-Mediated Isothermal Amplification) assay method for detecting Burkholderia cepacia complex (BCC) bacteria. The 1$ per reaction test was investigated to see its feasibility for use in detecting BCC more cost-effectively.
As the responsible bacteria in many pharmaceutical product recalls, efficiently detecting and addressing these contamination events is key to avoiding damage to the consumer and the business.
The ribB-based method was able to detect BCC in autoclaved nuclease-free water after 361 days, and in both 10 μg/mL CHX solutions and 50 μg/mL BZK solutions after 184 days.
The cost-efficiency of LAMP assays is $1 per reaction and this "makes it acceptable to use even in resource-limited laboratories of smaller pharmaceutical manufacturers"
According to results from LAMP and qPCR used in this study, LAMP assays, combined with DNA extraction by boiling, can be used as effective methods to detect BCC strains found in drug ingredients, pharmaceutical-grade water, and finished pharmaceutical products.
Lead author, Soumana Daddy Gaoh, who works for the Division of Microbiology, National Center for Toxicological Research, at the US Food and Drug Administration, along with her six fellow authors, said that testing on the news assay proved the LAMP test to be less technically demanding, faster, and more cost-effective.
The article "Loop-Mediated Isothermal Amplification (LAMP) Assay for Detecting Burkholderia cepacia Complex in Non-Sterile Pharmaceutical Products", stated that the cost-efficiency of LAMP assays is $1 per reaction and this "makes it acceptable to use even in resource-limited laboratories of smaller pharmaceutical manufacturers".