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CrAg lateral flow assay - method. Serotype sensitivity of LFA for CrAg. EIA vs . LFA with patient samples. Paired samples from 62 patients with culture-proven cryptococcosis Samples assayed by quantitative EIA and titers by LFA. Method Comparison CDC Thai Study. CDC Retrospective Study
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EIA vs. LFA with patient samples • Paired samples from 62 patients with culture-proven cryptococcosis • Samples assayed by quantitative EIA and titers by LFA
Method Comparison CDC Thai Study • CDC Retrospective Study • Sera, HIV+, acute respiratory illness, Thailand, results @ 15 min Lateral flow vs EIA Lateral flow vs culture
IMMY CrAg LFA vs. IMMY CrAg LA • Serum and CSF from archived samples • Evaluated by lateral flow and latex agglutination Serum Specimens CSF Specimens
Diagnostics for the developing world: critical characteristics • The right diagnostic target • CrAg is a proven target • The LFA has high sensitivity for all serotypes • The right specimen type • CE Mark approved for serum and CSF (pending US FDA approval) • Phase II will target urine, plasma and whole fingerprick blood • The right assay platform • LFA meets all ASSURED criteria – extremely inexpensive, user-friendly, rapid, equipment-free, etc. • Next generation platform – Quantitative? 2 1 7.8 3.9 500 250 125 15.6 62.5 31.3 1000 CrAg (ng/ml)
Acknowledgments IMMYSt. Georges University of London Brandon Neary Thomas Harrison Joy Pelfrey Joseph Jarvis Brian Doherty Desmond Tutu Centre/GF Jooste Hospital University of Nevada, RenoCape Town, South Africa Ann Percival Graeme Mientjes Marcellene Gates-Hollingsworth G. Ntombomzi Williams Nicky Longley NIH/NIAID: AI014209