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 |
