CASE STUDY 3
Review of Optimal Performance of a Diagnostic Kit
Serosep is a laboratory diagnostics company that has evolved since 1997 to become an internationally successful clinical diagnostic manufacturing company.
One of Serosep's diagnostic kits is called EntericBio. Although this is a gold standard test, Serosep, as an enthusiastic, innovative company, wished to investigate whether the incubation time was optimal. This required expertise in handling of pathogenic organisms and access to standard microbiological techniques as well as molecular biology technology.
Solution through Shannon ABC
The diagnostics products market is becoming more and more competitive. There are many drivers of this including accuracy and precision of kits. However, the time taken to perform an assay will also have a considerable impact. The longer that the samples are incubated for in the EntericBio enrichment medium means a greater cell density and therefore more cells for the assay to detect, however this is balanced by the need for results to be delivered quickly.
Shannon ABC's development specialists worked with four representative pathogenic bacteria spiked into the EntericBio enrichment broth. Samples were incubated over various time points, including those of the recommended standard operating procedure. Both culture and molecular biology techniques (polymerase chain reaction, PCR) were used to determine the limit of detection in the enrichment broth. While culturing assessed the ability of the cells to grow on differential media, and the sensitivity thereof, PCR detected the DNA present of the target organisms, thus providing an increased sensitivity of detection. The results of this analysis indicated that reducing the incubation time would compromise the detection limit of the kit and therefore that the kit was working at optimal incubation time. As a result of this work, the company can be confident that their standard operating procedure is performing at peak levels and that their ethos of maintaining high standards is adhered to. As well as this, it is a clear demonstration to Serosep's clients that Serosep will continue to innovate and push back the boundaries of what can achieved in terms of diagnostic kits.