Analyzing the Performance of Lab-Developed, Commercial Assays

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Mark Espy, MS

According to data presented at Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2014, four different assays for the detection of norovirus in stool specimens performed comparably. Researchers from the Mayo Clinic compared the performance of a laboratory-developed real-time polymerase chain reaction (PCR [LDT]) and three commercial molecular assays (Luminex GPP [Waltham, MA], BioFire FilmArray [Salt Lake City, Utah] and Focus Simplexa [Cypress, CA]). Each methodology was used to test 169 stool specimens for norovirus, the results of which were compared to a “consensus result” obtained from at least three of the four PCR assays evaluated.

Mark Espy, MS, division of clinical microbiology, Mayo Clinic, told Healio.com/Gastroenterology, “Three of them have good specificity: the FilmArray, the Focus [Simplexa] and the ‘home brew assay’ [LDT] that we have. When we initially ran the samples with the Luminex, specificity was very poor; there were a lot of norovirus positives that just were not confirmed by any other assay. When we ran the specimens again with the new lot of reagents, then specificity was comparable to what we have seen with the other assays.”

Simplexa and LDT showed 100 percent sensitivity compared with 96 percent for BioFire and 94 percent for Luminex.

Accoriding to Espy, “They all have good sensitivity, and probably good specificity, but we are a little concerned about the Luminex. What we in the hospital are going to do in the future is just test in-house patients, and since we do not have a huge volume of them, we are going to go with the BioFire FilmArray. It is very easy to set up, it does multiple targets — close to 20. The only downfall is it is restricted to one specimen at a time, but we don’t see that many in house, so it will work well for us."

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Kelley Schreiber

Kelley Schreiber is a Marketing Channel Manager at Mayo Medical Laboratories. She is the principle editor and writer of Insights and leads social media and direct marketing strategy. Kelley has worked at Mayo Clinic since 2013. Outside of work, you can find Kelley running, traveling, playing with her new kitten, and exploring new foods.