4.0 Discussion
diarrhea
CNS INFECTIONS, CRYPTOSPORIDIOSIS
The CRYPTOFAZ trial was conducted in response to the unmet need for new Both RDTs and plate-based qPCR were used to screening potential participants, this was done to take advantage of the combined specificity of these methods to exclude those patients who were experiencing diarrhea for reasons excluding cryptosporidiosis. The use of qPCR for this purpose proved quite advantageous, owing to its increased sensitivity over rapid diagnostic tests for Both ELISA and plate-based qPCR were used to monitor daily oocyst shedding during the in-patient period and two follow-up visits to determine if those study participants receiving CFZ cleared The use of TAC allowed us to further confirm Given that our data demonstrates that our population all had multiple enteric infections in addition to Using both RDT and plate-based qPCR at screening (though study inclusion was based on the qPCR result) was advantageous for identifying potential trial participants. However, use of TAC on baseline samples allowed us to identify that only 7 of 22 participants had We employed Sanger sequencing to determine the We are mindful that CRYPTOFAZ was designed to test the efficacy of CFZ and not explicitly designed to test the robustness of the diagnostics. Because of this, the analysis presented in the current work has a few limitations. Samples collected during the inpatient and follow-up visits were frozen prior to batch processing and testing in ELISA and qPCR. Because these samples underwent a freeze-thaw cycle, it may be possible that this may have led to some loss in sensitivity in both diagnostics. In addition, single concentration positive controls were used in ELISA rather than fitted standard curves as were employed in qPCR. Having an oocyst standard curve for ELISA derived from the same oocyst source used for Cryptosporidium genomic DNA would have allowed us to perform more direct comparisons of sensitivity and detection between the diagnostics. Our analyses of the ELISA as presented in Figs 