| 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 | 96.90% |
| Specificity | 98.70% |
| Accuracy | 98.30% |
| Cut-Off | 40 U/mL |
Fast Reading Convenient Rapid Test Kit CE Certificate For
Carbohydrate Antigen 19-9
Applications:
The CA19-9 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a
rapid chromatographic immunoassay for the qualitative detection of
CA 19-9 in human’s whole blood, serum or plasma.
Description:
CA19-9 (carbohydrate antigen 19-9, also called cancer antigen 19-9
1 or sialylated Lewis(a) antigen) is a tumor marker that is used
primarily in the management of pancreatic cancer. CA19-9 is an
antigen defined by monoclonal antibody binding to CA19-9, the tumor
surface marker Sialyl-Lewis A . CA19-9 was discovered in the serum
of patients with colon cancer and pancreatic cancer in 1981. The
main use of CA19-9 is to see whether a pancreatic tumor is
secreting it; if that is the case, then the levels should fall when
the tumor is treated, and they may rise again if the disease
recurs. In people with pancreatic masses, CA19-9 can be useful in
distinguishing between cancer and other diseases of the gland.
Because of its rising and falling levels with treatment, CA 19-9 is
used as a prognostic marker for pancreatic 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 CA19-9 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 |
|
| T199-402 | CA19-9 Rapid Test Cassette | WB/S/P | Cassette | 10 T | 40U/mL | CE |
