Candida albicans Antigen Rapid Test
Canidia albicans, also known as Candida albicans, is an opportunistic pathogen that usually exists in the oral cavity, upper respiratory tract, intestinal tract and vagina of normal people. It is generally small in the normal body and does not cause disease. When the immune function or general defense of the body declines or the mutual restriction of normal bacteria is disregulated, it is easy to grow and multiply locally, causing skin, mucosa and even systemic Candida albicans infection. Candida albicans can cause vulva and vaginal inflammation in women, mainly manifested as sticky vaginal discharge, yellow or cheese like spots, vulva/vaginal itching or burning, bean dreg-like leucorrhea and other clinical symptoms. Male patients are rare, more sexual contact transmission, causing male candida balanitis and prepuce balanitis. In recent years, the prevalence of candida vaginitis remains high, which is related to the abuse of antibiotics, unclean and improper contraceptive tools and sanitary products. It is estimated that 75% of women will have vulvovaginal candidiasis at least once in their lifetime, and 5%~10% of women will have it twice a year. The infection rate varies is from 0.65%~39% across the country, and Candidiasis albicans is the main pathogen of vaginal candidiasis. Clinical drug resistance of fungi has always been one of the major problems at home and abroad. Due to the extensive or irregular application of antifungal drugs in clinical practice, drug-resistant strains of Candida have increased significantly. If the pathogen is uncertain, the treatment effect is often not ideal, and result to the high recurrence rate, and can induce drug resistance and bacterial imbalance. So this rapid, sensitive and accurate differential diagnosis of Candida albicans is very important for clinical treatment.
Candida albicans Antigen Rapid Test is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of diluted sample is added to the sample well of the test cassette. The sample flows through a pad containing antibodies against Candida albicans coupled to red-colored colloidal gold. If the sample contains Candida albicans antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region on which Candida albicans antibodies are immobilized separately. As the complexes reach the test line, they will bind to the antibody corresponding to the bacteria on the membrane to form of a line. A red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If bacteria is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.
· Individually packed test devices
· Dropper tips
· Disposable sampling swabs (Female Cervical)
· Extraction Tubes
· Package insert
Materials Required but Not provided
· Sterile Male Urethral Swabs
Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
- Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
- Extract the Candida albicans antigen according to the specimen type.
- For Female Cervical or Male Urethral Swab Specimen:
- Hold the buffer bottle vertically and add 10 drops of buffer (approx. 300μl) to the extraction tube. Immediately insert the swab, compress the bottom of tube and rotate swab 15 times. Let stand for 2 minutes.
- Press the swab against the side of tube and withdraw the swab while squeezing the tube. Keep as much liquid in the tube as possible. Fit the dropper tip on top of extraction tube.
- Place the test cassette on a clean and level surface. Add 4 full drops of the extracted solution (approx. 100μl) to each specimen wells of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well.
- Wait for the colored line(s) to appear. Read the result at 10 minutes; do not interpret the result after 20 minutes.
Note: It is recommended to use the buffer within 6 months after opening the vial.
INTERPRETATION OF RESULTS
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
- The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
- Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
Relative Sensitivity: 97.66% (95%CI: 93.30%～99.51%)
Relative Specificity: 94.69% (95%CI: 88.80%～98.03%)
Accuracy: 96.27% (95%CI: 93.03%～98.28%)