CrAg®

LFA

CRYPTOCOCCAL ANTIGEN


It's About

TIME

Cryptococcal meningitis is one of the most common opportunistic infections among HIV/AIDS patients, estimating more than 220,000 cases and 181,000 deaths worldwide each year. Early detection and treatment of infection are key to reducing the mortality associated with this disease.

The CrAg LFA is highly sensitive and specific, with a rapid turnaround time of just 10 minutes.

Whole Blood, Serum, Plasma & CSF
FDA: Serum, CSF
Results in just

10 MINUTES

Accuracy
Highly

SENSITIVE & SPECIFIC

No

PRETREATMENT REQUIRED


Clinical Relevancy

SERUM Positive % Agreement Negative % Agreement
CrAg EIA 100% 93%
1) IMMY CrAg LFA Domestic and International IFU
SERUM Positive % Agreement Negative % Agreement Total % Agreement
Meridian LA 100% 100% 99.8%
2) Binnicker MJ, et al. Comparison of Four Assays for the Detection of Cryptococcal Antigen. Clin and Vacc Immuno. 2012; 19(18):1988.

When tested against Meridian’s EIA, the CrAg LFA showed high diagnostic performance in 197 serum specimens. The Crag LFA agreed with 100% of the Meridian EIA positive test results, and 93% of the Meridian EIA negative test results.

Culture/India Ink SERUM1,2 CSF1,2 PLASMA2 WHOLE BLOOD2
Sensitivity 100% 100% 98.9% 99.3%
Specificity 100% 100% 100% 94.4%
1) IMMY CrAg LFA Domestic IFU
2) IMMY CrAg LFA International IFU

When tested against culture and India ink, the CrAg LFA showed high diagnostic performance in all specimen types.

From the table above, we can conclude that the CrAg LFA will correctly generate a positive result for 100% of patients with Cryptococcus in serum and CSF samples, and 98% in Plasma and Whole Blood samples.

The CrAg LFA will correctly generate a negative result for 100% of patients without Cryptococcus in serum, CSF, and Plasma samples, and 94% in Whole Blood samples.


Cryptococcal Meningitis Diagnostics and Screening in the Era of Point-of-Care Laboratory Testing
Rajasingham R, Wake RM, Beyene T, Katende A, Letang E, Boulware DR. Cryptococcal Meningitis Diagnostics and Screening in the Era of Point-of-Care Laboratory Testing. J Clin Microbiol. 2019 Jan 2;57(1).
Point-of-Care Diagnosis and Prognostication of Cryptococcal Meningitis With the Cryptococcal Antigen Lateral Flow Assay on Cerebrospinal Fluid
Kabanda T, Siedner MJ, Klausner JD, Muzoora C, Boulware DR. Point-of-care diagnosis and prognostication of cryptococcal meningitis with the cryptococcal antigen lateral flow assay on cerebrospinal fluid. Clin Infect Dis. 2014;58(1):113–116.
Large-scale clinical validation of a lateral flow immunoassay for detection of cryptococcal antigen in serum and cerebrospinal fluid specimens
Suwantarat N, Dalton JB, Lee R, Green R, Memon W, Carroll KC, Riedel S, Zhang SX. Large-scale clinical validation of a lateral flow immunoassay for detection of cryptococcal antigen in serum and cerebrospinal fluid specimens. Diagn Microbiol Infect Dis. 2015 May;82(1):54-6.
CrAg lateral flow assay for cryptococcosis.
Kozel TR, Bauman SK. CrAg lateral flow assay for cryptococcosis. Expert Opin Med Diagn. 2012;6(3):245–251.
5) Performance of the Cryptococcal Antigen Lateral Flow Assay in Non-HIV-Related Cryptococcosis
Jitmuang A, Panackal AA, Williamson PR, Bennett JE, Dekker JP, Zelazny AM. Performance of the Cryptococcal Antigen Lateral Flow Assay in Non-HIV-Related Cryptococcosis. J Clin Microbiol. 2016;54(2):460–463.
Cryptococcus Antigen LFA 50 tests CR2003