Performance validation of the BD MAX Enteric Parasite Panel using simulated samples in low endemic regions

Area of Science:

• Molecular diagnostics
• Parasitology
• Clinical microbiology

Background:

• Detecting intestinal parasites is crucial but challenging in low-endemic regions.
• Molecular diagnostic tools require validation using clinical samples, which are scarce in low-incidence areas.

Purpose of the Study:

• To evaluate the performance of the BD MAX Enteric Parasite Panel for detecting Giardia lamblia, Cryptosporidium parvum, and Entamoeba histolytica.
• To assess the utility of simulated clinical samples for validating molecular diagnostic assays in regions with low parasite prevalence.

Main Methods:

• Simulated stool samples were prepared by spiking residual stool with known concentrations of G. lamblia, C. parvum, and E. histolytica standards.
• Limit of detection, repeatability, and accuracy were determined for the BD MAX Enteric Parasite Panel.
• Results were compared against intended results to evaluate diagnostic performance.

Main Results:

• The limit of detection was 781 cysts/ml for G. lamblia, 6,250 oocysts/ml for C. parvum, and 125 DNA copies/ml for E. histolytica.
• High concordance rates were observed for G. lamblia and E. histolytica.
• Cryptosporidium parvum showed variable concordance, improving with higher concentrations and retesting, resulting in an overall agreement of 95.2% and sensitivity of 87.8%.

Conclusions:

• The BD MAX Enteric Parasite Panel demonstrates good diagnostic performance for key intestinal protozoa, even with limited clinical samples.
• Simulated samples are a valuable tool for assessing molecular diagnostic assays in low-incidence regions.
• Further validation may be needed for Cryptosporidium parvum detection in specific scenarios.