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Convenient Oncology Rapid Diagnostic Test kits
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Convenient Rapid Assay Test CE Marked For Carcinoma Antigen 15-3 With High Sensitivity

Convenient Rapid Assay Test CE Marked For Carcinoma Antigen 15-3 With High Sensitivity

Brand Name: AllTest
Model Number: Cassette(T153-402)
MOQ: N/A
Price: negotiation
Payment Terms: Ex works
Supply Ability: 10 M tests/month
Detail Information
Place of Origin:
China
Certification:
CE, ISO13485
Format:
Cassette
Specimen:
Whole Blood/Serum/Plasma
Certificate:
CE,ISO 13485
Storage:
2-30℃
Shelf Time:
24months
Cut-off:
30U/ml
Packaging Details:
10PC x 1/kit
Supply Ability:
10 M tests/month
Highlight:

rapid diagnostic test kits

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cancer diagnostic tests

Product Description

 

Convenient Rapid CE Certificate  for Carcinoma Antigen 15-3 Test Kit with high sensitivity

 

Applications:

 

The CA15-3 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of CA15-3 in human’s whole blood, serum or plasma.

 

Description:

 

CA15-3, for Carcinoma Antigen 15-3, is a tumor marker for many types of cancer, most notably breast cancer. It is derived from MUC1. CA15-3 and associated CA 27-29 are different epitopes on the same protein antigen product of the breast cancer-associated MUC1 gene.
Elevated CA15-3, in conjunction with alkaline phosphatase (ALP), was found to be associated with an increased chance of early recurrence in breast cancer. Both CA15-3 and CA 27-29 may be elevated in patients with benign ovarian cysts, benign breast disease, and benign liver disease. Elevations may also be seen in cirrhosis, sarcoidosis and lupus. CA 15-3 is now being regarded as a reliable prognostic marker for breast 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.

 

Convenient Rapid Assay Test CE Marked For Carcinoma Antigen 15-3 With High Sensitivity 0

 

 

 

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 CA15-3 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 line 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.