Cryptococcus Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma/
Cerebral Spinal Fluid (CSF))
| Product features | Parameters |
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | WB/S/P/CSF |
| Certificate | CE |
| Reading Time | 10 minutes |
| Pack | 10 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
Application
The Cryptococcus Antigen Rapid Test is for the qualitative
detection of the capsular polysaccharide antigen of Cryptococcus
species complex (Cryptococcus neoformans and Cryptococcus gattii)
in specimen to aid in the diagnosis of cryptococcosis.
A rapid test for the qualitative detection of the capsular
polysaccharide antigen in whole blood, serum, plasma or cerebral
spinal fluid (CSF). For professional in vitro diagnostic use only.
INTENTED USE
The Cryptococcus Antigen Rapid Test Cassette (Whole
Blood/Serum/Plasma/CSF) is a rapid chromatographic immunoassay for
the qualitative detection of the capsular polysaccharide antigen of
Cryptococcus species complex (Cryptococcus neoformans and
Cryptococcus gattii) in whole blood, serum, plasma or cerebral
spinal fluid (CSF) to aid in the diagnosis of cryptococcosis.
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. (1)
Cryptococcal meningitis (CM), a late and disseminated form of
cryptococcal disease, results in substantial morbidity and
mortality among HIV-infected individuals.(2) The disease is
encountered more frequently in patients with Hodgkin's disease,
lymphosarcoma, leukemia and diabetes, and in those receiving prolonged therapy with ste/roids.(1) WHO
recommended (LFA) for the diagnosis and screening of infection with cryptococcal antigen.(3)
PRINCIPLE
The Cryptococcus Antigen Rapid Test Cassette (Whole
Blood/Serum/Plasma/CSF) is a qualitative membrane based immunoassay for the detection of
cryptococcus antigens in whole blood, serum, plasma or CSF. In this test procedure,
anti-cryptococcal antigen monoclonal antibodies are immobilized in the test line region of the test.
After specimen is added to the
specimen well of the cassette, it reacts with cryptococcal antibody
coated colloid gold particles in the test. This mixture migrates chromatographically along the
length of the test and interacts with the immobilized anti-cryptococcal antigen monoclonal antibodies. If
the specimen contains cryptococcal antigens, a colored line will appear in the test line
region indicating a positive result.
If the specimen does not contain cryptococcal antigens, a colored
line will not appear in this region indicating a negative result. To serve as a procedural
control, a colored line will always appear in the control line region, indicating that proper volume of
specimen has been added and membrane wicking has occurred.
REAGENTS
The test contains cryptococcusl antibody coated particles and
anti-cryptococcus antigen monoclonal antibodies coated on the membrane.
SPECIMEN COLLECTION AND PREPARATION
The Cryptococcus Antigen Rapid Test Cassette can be performed using
whole blood (from venipuncture or fingerstick) serum, plasma or
CSF.
To collect Fingerstick Whole Blood specimens:
Wash the patient’s hand with soap and warm water or clean with an
alcohol swab. Allow to dry.
Massage the hand without touching the puncture site by rubbing down
the hand towards the fingertip of the middle or ring finger.
Puncture the skin with a sterile lancet. Wipe away the first sign
of blood.
Gently rub the hand from wrist to palm to finger to form a rounded
drop of blood over the puncture site.
Add the Fingerstick Whole Blood specimen to the test by using a
capillary tube:
Touch the end of the capillary tube to the blood until filled to
approximately 80 uL. Avoid air bubbles.
Place the bulb onto the top end of the capillary tube, then squeeze
the bulb to dispense the whole blood to the specimen well of the
test cassette.
Separate serum or plasma from blood as soon as possible to avoid
hemolysis. Use only clear non-hemolyzed specimens.
Testing should be performed immediately after the specimens have
been collected. Do not leave the specimens at room temperature for
prolonged periods. Serum, plasma and CSF specimens may be stored at
2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should
be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole
blood specimens. Whole blood collected by fingerstick should be tested immediately.
Bring specimens to room temperature prior to testing. Frozen
specimens must be completely thawed and mixed well prior to testing. Specimens should not be
frozen and thawed repeatedly.
If specimens are to be shipped, they should be packed in compliance
with local regulations covering the transportation of etiologic agents.
EDTA K2, Heparin sodium, Citrate sodium and Potassium Oxalate can
be used as the anticoagulant for collecting the specimen.
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 80uL 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.
Order Information
| Cat. No. | Product | Specimen | Pack |
| ICRG-402 | Cryptococcus Antigen Rapid Test Cassette | WB/S/P/CSF | 10T |
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