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
PRINCIPLE OF THE PROCEDURE
CATALOG
Catalog No. Product Name
ABT-FT-A90 Tox IgG Whole Blood Strip
ABT-FT-B90 Tox IgG Whole Blood Cassette
INTENDED USE
Accu-Tell ® Rapid Tox IgG test is a colloidal gold enhanced, rapid immunochromatographic assay for the qualitative detection of IgG type antibodies to toxophasma gondii antigen detection (ToxIgG) in human whole blood, serum or plasma. This test is a screening test, and all positives must be confirmed using an alternate test such as western blot. The test is intended for healthcare professional use only.
PRINCIPLE OF THE PROCEDURE
Accu-Tell ® Rapid Tox IgG test is a colloidal gold enhanced immunoassay for the determination of IgG anti-TOX antigen (anti-TOX-IgG) in human whole blood, serum, or plasma. The nitrocellulose membrane was immobilized with TOX antigen on the test region. During the assay, the specimen is allowed to react with the colored conjugate mixture, and then migrates chromatographically on the membrane by the capillary action. For a positive result, a colored band with the specific immuno-complex will form on the membrane. Absence of this colored band in the test region suggests a negative result. A colored band always appears in the control region serving as procedural control regardless of the test result.
The test kits must be stored at 2-30℃in the sealed pouch and under dry conditions.
1. All positive results must be confirmed by an alternate method.
2. Treat all specimens as though potentially infectious. Wear gloves and protective clothing when handling specimens.
3. Devices used for testing should be autoclaved before disposal.
4. Do not use kit materials beyond their expiration dates.
5. Do not interchange reagents from one kit lot to another.
SAMPLE COLLECTION AND STORAGE
Whole Blood:
1. Collect whole blood specimens following regular clinical laboratory procedures.
2. Heparinized capillary tubes treated with anticoagulant must be used for collecting blood samples.
3. Whole blood specimens should be used immediately after collection.
Serum or Plasma:
1. Collect serum or plasma specimens following regular clinical laboratory procedures.
2. Only those specimens that are clean, clear and with good fluidity can be used for the assay.
3. Those specimens that are apparently hemolyzed, extremely thickened or with very high fat level are NOT suitable for the assay.
Storage: A specimen should be refrigerated if not used the same day of collection. Specimens should be frozen if not used within 3 days of collecting. 0.1% of sodium azide can be added to specimen as preservative without affecting the results of the assay.
Do not open pouch until you are ready to test the sample.
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 10μl of specimen to the sample well on the cassette , then add two drops (100μl) of sample diluent into the same well.
5. Interpret 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. Dispense 10μl of whole blood, serum or plasma to the upper edge of the sample pad of the test strip .
5. Add two drops (100μl) of Sample Diluent to the lower edge of the sample pad immediately after the specimen is added.
6. Interpret test results at 15 minutes.
Caution: Use a clean pipette or tip for every sample to avoid cross-contamination.
NOTE: Applying sufficient amount of sample diluent is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of diluent to sample well. Read the result between 1-15 minutes. Do not interpret the result after 20 minutes.
Positive: Both purplish red test band and purplish red control band appear on the membrane. The lower the antibody concentration, the weaker the test band.
Negative: Only the purplish red control band appears on the membrane. The absence of a test band indicates a negative result.
Invalid: There should always be a purplish red control band in the control region regardless of test result. If control band is not seen, the test is considered invalid. Repeat the test using a new test device.
PERFORMANCE CHARACTERISTICS
Accu-Tell ® Rapid Tox IgG test showed equivalent detectability to EIA immunoassay for TOX-IgG. A result of 99% correlation to EIA test was determined by a clinical study of 400 specimens.
Accu-Tell ® Rapid Tox IgG test is a screening test, the test procedure is limited to the detection of TOX-IgG in whole blood, serum or plasma. It is recognized that presently available methods for TOX-IgG detection may not detect all potential infectious units of blood or possible cases of TOX. False reactive results may be obtained with any diagnostic test.
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.
Recent Comments