Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
CATALOG
INTENDED USE
CATALOG
Catalog No. Product Name Note
ABT-STD-A17 Anti-Syphilis Serum Strip CE
ABT-STD-B17 Anti-Syphilis Serum Cassette CE
ABT-STD-A60 Anti-Syphilis Whole Blood Strip CE
ABT-STD-B60 Anti-Syphilis Whole Blood Cassette CE
Accu-Tell ® Rapid Anti-TP (Treponema Pallidum / Syphilis) Test is a rapid, serological, immunochromatographic assay for the detection of antibodies to syphilis antigen in human serum or plasma(whole blood). The test is used to obtain a visual, qualitative result and is intended for healthcare professional use. Applications of the test include: screen test for sex transmitted diseases (STD’s) among high-risk group of people, regular health examinations, and field screen test for blood bank.
Accu-Tell ® Rapid Anti-TP (Treponema Pallidum /Syphilis) Test uses a double antigens “sandwich principle”1 for the detection of Syphilis antibody in human whole blood, serum or plasma. A recombinant syphilis antigen (TP Ag 2) was immobilized on the test band region, and an antibody to syphilis on the control band region of nitrocellulose membrane. Another syphilis antigen (TP Ag 1), coupled with colloidal gold particles, is dried on a conjugate pad. During the assay, the specimen is allowed to react with the colored conjugate (antigen-colloid gold conjugate); the mixture then migrates chromatographically along the membrane by capillary action. If the specimen contains syphilis antibody, the recombinant antigen immobilized on the membrane will capture the antibody-antigen-colloidal gold complex and form a colored test band on the membrane, indicating a positive result. Absence of the test band suggests a negative result. To serve as a procedural control, a colored band at control region always appears in the test area.
It is recommended that all specimens be handled in accordance with Biosafety Level 2 practices as described in the CDC NIH Publication, Biosafety in Microbiological and Biomedical Laboratories2, or other equivalent guidelines.3-4
1. For in vitro diagnostic use only.
2. All serum or plasma specimens should be treated as infectious material. Do not contact the test card without wearing safety gloves.
3. Clean and disinfect all spills of specimens and reagents using a suitable disinfectant,5 such as 1% Sodium Hypochlorite for nonradioactive material6 or 2% Glutaraldehyde for spills containing radioactive material7.
4. Devices used for the assay should be sterilized before being disposed.
5. Do not use beyond expiration date.
Read the entire procedure carefully prior to performing any tests.
For Test Cassette:
1. Bring all reagents and specimens to room temperature.
2. Remove the test cassette from the foil pouch and place on a clean dry surface.
3. Identify the test cassette for each specimen or control.
4. Dispense 100μl (3 drops)of the specimen or control into the circular sample well on the cassette.
5. Interpret the test results at 15 minutes.
For Test Strip:
1. Bring all reagents and specimens to room temperature.
2. Remove the test strip from the foil pouch and place on a clean dry surface.
3. Identify the test strip for each specimen or control.
4. Apply at least 80μl of specimen to the sample pad behind the ( ↓↓↓ ) mark at the bottom of test strip.
5. Interpret the test results at 15 minutes
INTERPRETATION OF RESULTS
Positive: In addition to the control band, a distinct colored band also appears on the test region (T).
Negative: Only one colored band appears in the control region (C). No apparent band on the test region (T).
Invalid: A total absence of color bands in both regions is an indication of procedure error and/or that test reagent deterioration has occurred.
A procedural control is included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is also required.
The test kit can be stored at room temperature (2 to 30℃) in the sealed pouch for duration of shelf life. The test kit should be kept away from direct sunlight, moisture and heat.
1. The assay should be performed in normal room temperature.
2. Test cards/strips should be used immediately after being taken from the package. Avoid exposing the test strips in the air for too long before use.
3. The test cards/strips may be stored under room temperature and dry condition. If refrigerated, the strips should be brought to room temperature before testing.
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.
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