Infectious disease testing Cryptococcus Antigen Rapid Test Cassette

【SUMMARY】
Cryptococcosis is a cosmopolitan infectious disease of man which begins as a primary infection of the lungs and which may spread to the central nervous system in susceptible subjects. Cryptococcal meningitis (CM), a late and disseminated form of cryptococcal disease, results in substantial morbidity and mortality among HIV-infected individuals. The disease is encountered more frequently in patients with Hodgkin's disease, lymphosarcoma, leukemia and diabetes, and in those receiving prolonged therapy with steroids. WHO recommended (LFA) for the diagnosis and screening of infection with cryptococcal antigen.

【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum, Plasma or CSF specimen:
Hold the dropper vertically and transfer 1 drop of serum, plasma or CSF (approximately 40 ul) to the specimen well,then add 1 drop of buffer (approximately 40 ul), and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80 ul) to the specimen well, then add 1 drop of buffer (approximately 40 ul), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 80 ul of fingerstick whole blood specimen to the specimen well of test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.

【INTERPRETATION OF RESULTS】

(Please refer to the illustration above)

POSITIVE:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the

concentration of cryptococcal antigen present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.

NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.