CDIA™ Cryptococcus Rapid Test - Creative Diagnostics

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CDIATM Cryptococcus Rapid test  (DTSXYZ25)

Intended Use

The Cryptococcal (Whole Blood, Plasma, Serum and Cerebral Spinal Fluid) Rapid test Device is a rapid immunechromatographic assay for the detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum, plasma, whole blood and cerebral spinal fluid (CSF). The assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.
  • Whole Blood, Plasma, Serum, Cerebral Spinal Fluid
  • Strip
  • Whole blood: Relative Specificity: 99.07%(96.68%-99.89%) Serum: Relative Specificity: 99.47%(97.11%-99.99%) Plasma: Relative Specificity: 98.83%(96.63

Product Introduction

General Description

The Cryptococcal (Whole Blood, Plasma, Serum and Cerebral Spinal Fluid) Rapid test Device has been designed to detect Cryptococcus species complex through visual interpretation of color development in the internal strip. The membrane was immobilized with anti Cryptococcal monoclonal antibody on the test region. During the test, the specimen is allowed to react with monoclonal anti-Cryptococcal antibody colored particals conjugates, which were precoated on the conjugate pad of the test. The mixture then moves on the membrane by capillary action, and interact with reagents on the membrane. If there were enough Cryptococcal antigens in specimens, a colored band will form at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.

Principle

Cryptococcosis is caused by both species of the Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii). Individuals with impaired cell-mediated immunity are at greatest risk of infection. Cryptococcosis is one of the most common opportunistic infections in AIDS patients. Detection of cryptococcal antigen in serum and CSF has been extensively utilized with very high sensitivity and specificity.

Reagents And Materials Provided

1. 20 Individually packed test devices: Each device contains a strip with colored conjugates and reactive reagents prespreaded at the corresponding regions. 

2. 3 ml Titration Buffer: Glycine-buffered saline containing a preservative.

3. 20 Disposable pipettes: For adding specimens. 

4. 1 Package insert: For operation instruction. 

5. 1 Positive control(on request only): Contain inactived Cryptococcal Antigen and sodium azide. For External control. 

6. 1 Negative control(on request only): Not contain Cryptococcal Antigen. For external control.

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