Molecular testing for intestinal protozoa: how a laboratory developed test compares to one that is FDA-cleared
Presented by Dr Susan Madison-Antenucci
Lab Chief of Bloodborne and Parasitic Diseases, New York State Department of Health, Wadsworth Center
Assistant Professor - Biomedical Sciences. Assistant Professor - Environmental Health Sciences, College of Integrated Health Sciences, University at Albany.
Section Editor for PLOS Neglected Tropical Diseases
Infections with intestinal parasitic protozoa are frequently underdiagnosed. Contributing factors include lack of knowledge regarding the prevalence in economically developed countries, poor sensitivity for traditional microscopy-based testing algorithms and lack of ability to test for some parasites. Sensitive, comprehensive and efficient testing methods are key for detection of intestinal parasites in clinical and reference laboratories.
Here we will discuss the comparison of laboratory-developed multiplex real-time PCR tests with the FDA-cleared Genetic Signatures Gastrointestinal Parasite Detection test. Specimens submitted to a reference laboratory for confirmation testing were retrospectively tested using the Genetic Signatures assay. Overall, 225 specimens were tested by both methods and showed good concordance for detection of Cryptosporidium sp., Cyclospora cayetanensis, Giardia duodenalis, Dientamoeba fragilis, Blastocystis sp. and Entamoeba histolytica, which are included in both assays.
Dr. Madison-Antenucci's career has focussed on improving methods for identifying and characterizing pathogenic parasites, with a focus on those impacting the gastrointestinal tract. Dr Madison-Antenucci has driven the development of rapid and sensitive RT-PCR assays, providing many advantages compared to traditional diagnostic methods, to support rapid diagnostics, surveillance, and epidemiology studies.
Dr. Madison-Antenucci also had a keen interest in tropical diseases, including emerging diseases and emerging challenges for well-known diseases such as malaria, which has seen an increase in drug resistance. This work is supported by her role as Section Editor for PLOS Neglected Tropical Diseases.