Accu-Tell® Chagas Ab Cassette (Whole Blood/Serum/Plasma)
Product Description
CATALOG
Product Name | Specimen | Catalog No. | Quantity per box | Certificate |
Chagas Cassette | Whole Blood/Serum/Plasma | ABT-IDT-B219 | 25T | CE |
KEY POINTS
Detection for: IgG anti-Trypanosoma cruzi (T. cruzi) in human whole blood,serum or plasma
Reading time: 15minutes
Relative Sensitivity: 94.7%
Relative Specificity: 99.1%
Overall Agreement: 98.7%
INTRODUCTION
Chagas disease is an insect-borne, zoonotic infection by the protozoan T. cruzi, which causes a systemic infection of humans with acute manifestations and long term sequelae. It is estimated that 16-18 million individuals are infected worldwide, and roughly 50,000 people die each year from chronic Chagas disease (World Health Organization).
INTENDED USE
ACCU-TELL® Chagas Ab Cassette (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human whole blood,serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with T. cruzi. Any reactive specimen with the Chagas Ab Rapid Test Cassette must be confirmed with alternative testing method(s) and clinical findings.
TEST PROCEDURE
Allow the test cassette, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed 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 device on a clean and level surface
For Serum or Plasma Specimens: Hold the dropper vertically and transfer 1 drop of serum or plasma (approx. 15μL) to the specimen well (S) of the test cassette, then add 2 drops of buffer(approx. 80μL)and start the timer. Avoid trapping air bubbles in the specimen well (S). Please see the illustration below.
For Whole Blood Specimens: Hold the dropper vertically and transfer 2.drops of whole blood (approx. 30μL) to the specimen well (S) of the test cassette, then add 2 drops of buffer(approx. 80μL)and start the timer. Avoid trapping air bubbles in the specimen well (S). Please see the illustration below.
3.Wait for the colored line(S) to appear. Read results in 15minutes. Do not interpret the result after 15 minutes
PERFORMANCE CHARACTERISTICS
A total of 235 samples from susceptible subjects were tested by ACCU-TELL® Chagas Ab Cassette (Whole Blood/Serum/Plasma) and by a commercial IgG EIA test. Comparison for all subjects is showed in the following table:
Method | EIA | Total Results | ||
ACCU-TELL® Chagas Ab Cassette(Whole Blood/Serum/Plasma) | Results | Positive | Negative | |
Positive | 18 | 2 | 20 | |
Negative | 1 | 214 | 215 | |
Total Results | 19 | 216 | 235 |
Relative Sensitivity: 94.7%
Relative Specificity: 99.1%
Overall Agreement: 98.7%
LIMITATIONS
1. The Assay Procedure and the Assay Result Interpretation must be followed closely when testing the presence of anti -T. cruzi antibody in whole blood, serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.
2. ACCU-TELL® Chagas Ab Cassette (Whole Blood/Serum/Plasma) is limited to the qualitative detection of anti -T. cruzi antibody in human whole blood, serum or plasma. The intensity of the test band does not have linear correlation with the antibody titer in the specimen.
3. A negative result for an individual subject indicates absence of detectable anti -T. cruzi antibody. However, a negative test result does not preclude the possibility of exposure to or infection with T. cruzi.
4. A negative result can occur if the quantity of the anti -T. cruzi antibody present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.
5. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.
6. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.
Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.