Fast reading High Sensitive Accurate One Step CA-125 Rapid Test Cassette Disposable for Diagnosis with CE
| Product features |
Parameters |
| Principle |
Chromatographic Immunoassay |
| Format |
Cassette |
| Specimen |
WB/S/P |
| Certificate |
CE |
| Reading Time |
10 minutes |
| Pack |
10 T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
| Sensitivity |
94.80% |
| Specificity |
98.00% |
| Accuracy |
97.40% |
| Cut-Off |
40 U/mL |
Applications:
The CA125 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of CA125 in human’s whole blood, serum or plasma.
Description:
CA-125 is the most frequently used prognostic biomarker for ovarian cancer detection. Around 90% of women with advanced ovarian cancer have elevated levels of CA-125 in their blood serum, making CA-125 a useful tool for detecting ovarian cancer after the onset of symptoms. Monitoring CA-125 blood serum levels is also useful for determining how ovarian cancer is responding to treatment (with the duration of disease-free survival correlating with the rate of fall of CA-125) and for predicting a patient’s prognosis after treatment.
This is because the persistence of high levels of CA-125 during therapy is associated with poor survival rates in patients. Also, an increase in CA-125 levels within individuals in a remission is a strong predictor of the recurrence of ovarian cancer.
How to use?
Allow test cassette, specimen, buffer and/or controls to equilibrate to room temperature (15-30℃) prior to testing.
1. Remove the test cassette from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test cassette on a clean and level surface.
For Serum or Plasma specimens:
Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 ul) to the specimen well (S) of the test cassette, then start the timer. See illustration below.
For Venipuncture Whole Blood specimens:
Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 ul) to the specimen well (S) of the test cassette, and add 1 drop of buffer (approximately 40 ul), then start the timer. See illustration below.
For Fingerstick Whole Blood specimens:
To use a capillary tube: Fill the capillary tube and transfer approximately 75 ul of fingerstick whole blood specimen to the specimen well (S) of the test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer. See illustration below.
3. Wait for the colored line is appeared. The result should be read 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 CA125 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 cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
| Cat. No. |
Product Description |
Specimen |
Format |
Kit Size |
Cut-Off |
Status |
| T125-402 |
CA125 Rapid Test Cassette |
WB/S/P |
Cassette |
10 T |
40U/mL |
CE
|
