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Performance of the CrAg LFA Assay

Performance of the CrAg LFA Assay. Jeffrey D. Klausner, MD, MPH Professor of Medicine Division of Infectious Diseases and Program in Global Health David Geffen School of Medicine. Cryptococcal Antigen Lateral Flow Assay CrAg LFA. Qualitative Semi-Quantitative (titer).

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Performance of the CrAg LFA Assay

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  1. Performance of the CrAg LFA Assay Jeffrey D. Klausner, MD, MPH Professor of Medicine Division of Infectious Diseases and Program in Global Health David Geffen School of Medicine

  2. Cryptococcal Antigen Lateral Flow AssayCrAg LFA Qualitative Semi-Quantitative (titer) FDA-cleared for serum and CSF

  3. CrAg LFA test performance in serum

  4. CrAg LFA test performance in serum

  5. CrAg LFA test performance in plasma

  6. CrAg LFA test performance in urine

  7. CrAg LFA test performance in CSF

  8. CrAg Performance Summary • Serum: • Sensitivity: Median 100% (96.6%-100%) • Specificity: Median 98.0% (95.4%-100% • Plasma • Sensitivity: Median 100% (98.5%-100%) • Specificity: Median 95.8% (91.5%-100%) • Urine • Sensitivity: Median 98.0% (70.3-99%) • Specificity: Median 98.3% (98.3%-98.3%) • CSF • Sensitivity: Median 100% (96.2%-100%) • Specificity: Median 96.4% (93.5%-100%)

  9. Conclusions • CrAg LFA is both highly sensitive and specific in various body fluid specimens. FDA-cleared in serum and CSF. • “False positive” tests might reflect increased sensitivity of LFA vs. gold standard • Urine and plasma provide exciting potential alternative specimen types

  10. Acknowledgments • Tara Vijayan, MD, MPH Clinical ID Fellow, UCSF • Sean Bauman, Immy Diagnostics • Tom Chiller, CDC Mycotic Diseases Branch • Monika Roy, CDC Mycotic Diseases Branch • Various researchers who have shared their data

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