Performance and operational feasibility of two diagnostic tests for cryptosporidiosis in children (CRYPTO-POC): a clinical, prospective, diagnostic accuracy study, 2018

Cryptosporidiosis is a common cause of diarrhoea in young children in resource-limited settings but is currently challenging to diagnose. Auramine-phenol (AP) staining and light-emitting diode fluorescence microscopy (LED-AP), recommended for tuberculosis testing, can also detect Cryptosporidium. A lateral-flow test not requiring fridge storage has recently been developed for Cryptosporidium detection. CRYPTO-POC evalueted the diagnostic accuracy and operational feasibility of both tests in a clinical, prospective, diagnostic accuracy study in an urban hospital and a rural health center in Southwest-Ethiopia. The project consists of data from 1618 children aged 0-5 years in Southwest Ethiopia, of which 912 cases with diarrhoea and 706 community controls without diarrhoea. In addition to questionnaires to caretakers and clinical assessment by study nurses. Stool samples were collected and tested for the presence of the Cryptosporidium spp parasite by the two index tests under evaluation, and by a panel of three reference tests.