InstaTest Chagas Serum/Whole Blood/Plasma/Saliva Cat. No. 174105-50,Page1
Atlas Link
InstaTest Chagas
Trypanosoma cruzi
Serum/Whole Blood
Cat. No. 174105-50 (50 Tests)
Description:
The Atlas Link Chagas InstaTest is used for the diagnosis of infection due to Trypanosoma cruzi. The test uses a unique combination of highly specific recombinant peptides which mimic the organism and provide a highly specific and sensitive antigen which captures an antibody when present in the test sample.
Summary and Explanation:
Trypanosoma cruzi is a parasite which is indicated as the etiological agent of Chagas disease. Chagas can be acute, latent or chronic. The acute phase can produce fever and enlargement of the liver, spleen and lymph glands; this disease is fatal in up to 10% of those infected. In the latent phase, there are no symptoms, but patients can transmit the disease. Chronic Chagas causes heart muscle damage, cardiac arrhythmia and in some cases gastrointestinal disease. Chagas has been defined as the fourth most-serious health problem after respiratory illnesses, diarrhea and AIDS in Latin America. Recent studies estimate that up to 370,000 U.S. residents are infected with the disease.
Trypanosoma cruzi is a protozoan of the Kinetoplantidia family and is parasitic in both insects and a wide variety of mammals. Blood-sucking reduviids serve as the principle vector by the passage of the infected feces into bite wounds or mucosal surfaces. Transfusion of infected blood is another important means of transmission. A highly sensitive and specific method to detect an infection with Trypanosoma cruzi detects antibodies (immunoglobulins) developed against the organism. Many techniques have been employed to detect the antibodies formed including indirect immunofluorescence, hemmagglutination, complement fixation, radioimmuno-assay and ELISA.
The Atlas Link Chagas InstaTest is an immunochromatographic, point-of-care test which provides rapid screening and detection of antibodies to Trypanosoma cruzi. The test requires no equipment, none of the test components need refrigeration and requires no technical training or experience to effectively perform the test.
Principle:
The Atlas Link Chagas InstaTest is a rapid immunochromatographic screening test for the detection of antibodies developed to Trypanosoma cruzi. The test can be used with whole blood and serum. The test is based on a unique combination of antibody binding proteins conjugated to dye materials which help visualize the reaction of antibody to the differentiating test antigens bound to the test membrane. The colored conjugate-antibody complex not only enhances the visibility but improves specificity of the reaction.
The initial addition of a drop of diluent activates/solubilizes the conjugate reagent; then as the test sample and the additional diluent flows laterally through the membrane, antibody/dye conjugate forms with all immunoglobulins present in the test sample. The colored immunoglobulins then move toward and through the antigen forming the test line.
If antibody/dye conjugate contains antibody against the antigens in the test line, a pink/purple line will form in the test area. If the test sample contains no reactive antibody to the test antigens then no pink/purple line will form in the test area. The antibody/dye conjugate continues to flow through the test line along the membrane and reacts with the components in the control line demonstrating that the reagents of the test device are functioning properly and that the test has been performed effectively. The visual confirmation provided by the control line is a clear-cut indication of the validity of the test and its proper use.
Test Components:
Each test package contains a complete test and all materials needed to perform the test:
1. One (1) test device packaged in a sealed package with “dry pack”.
2. One (1) diluent vial with dropping spout.
3. Instruction sheet.
Storage and Stability:
The Atlas Link Chagas InstaTest can be stored at any temperature between 4-30o C in the original sealed pouch.
DO NOT FREEZE THE TEST KIT
The Atlas Link Chagas InstaTest is stable for eighteen (18) months after the date of manufacture when stored at 4-30o C.
Precautions:
1. This test is designed for in vitro diagnostic use only.
2. Do not pipet any material by mouth. Do not smoke, eat or drink in areas were specimens or the kit and reagents are handled.
3. Do not use the kit beyond the expiration date which appears on the package label.
4. Wear disposable gloves throughout the test procedure. Dispose of gloves in the biohazard waste. Thoroughly wash hands after removing gloves.
5.The buffer/diluent in this test kit contain sodium azide as a preservative. Azides are reported to react with lead and copper in plumbing or form compounds that may detonate on percussion. When disposing of solutions containing azide, flush drains with large volumes of water to minimize the build-up of metal-azide compounds.
Caution: Handle test device, samples and controls, and the materials that contact them as potential biohazards. Each donor unit used to produce the controls has been found negative for Hepatitis B surface antigen and HIV antibody. Positive controls have been inactivated by heat treatment and shown to be negative for Hepatitis B surface antigen. However, no known test method can offer assurance that materials derived from human blood will not transmit infectious agents. These test materials should be handled at the BIOSAFETY LEVEL 2 as recommended for any potentially infectious serum or blood specimen in the Centers for Disease Control/National Institutes of Health Manual “Biosafety in Microbiological and Biomedical Laboratories”, 1984.
Specimen Collection:
The Atlas Link Chagas InstaTest can be performed on whole blood and serum.
Test samples are best evaluated immediately after they are collected. Samples should be refrigerated immediately at 2-8o C if they are not tested immediately and can be stored refrigerated for up to three (3) days. If samples cannot be tested in three days they should be stored frozen (-20o C or cooler).
Test Procedure:
1. Remove the test device from its sealed pouch and place on a level surface. Label the test device with the subject’s name or identification number.
2. Add one (1) drop of diluent buffer from the dropping bottle to the sample well. Let the buffer absorb completely (ten [10] seconds).
3. Add the sample to the sample well using the pipette provided with the kit. Be careful that no bubbles are added to the sample well and that a single drop of serum is added to the sample well. Allow to absorb completely.
a) Serum: One (1) drop (20µL)
b) Whole Blood: Two (2) drops (40µL)
4. Add six (6) drops of diluent buffer to the sample well using the dropper bottle. DO NOT OVERFILL the well. Add 4 drops, let absorb, then an additional 2 drops.
5. Read the test result fifteen (15) minutes after addition of the diluent buffer.
6. If the dye has not cleared the test area and a slight pink or color is apparent add 2 additional drops of diluent buffer
Interpretation of Test Results:
SEE DIAGRAM (Following Page).
NON-REACTIVE:
Only one pink/purple band appears on the control area and no band is visible in the test area.
REACTIVE:
Two bands are visible; one in the control area and the second in the test area.
INCONCLUSIVE:
No band is visible in the control area and the test is inconclusive. The test should be repeated with a new test device.
Quality Control Procedures:
Good laboratory practice requires the use of control materials to ensure the correct performance of the test and the validity of test components. A positive control is available on request from Atlas Link. The positive control should be used in the same manner as a patient specimen.
Limitations:
The Atlas Link Chagas InstaTest procedure and the interpretation of the results must be followed closely. This assay is designed for detecting antibodies against Trypanosoma cruzi. The test uses serum or whole blood; using other body fluids or testing pooled serum or blood may not provide correct results. This test is recommended for use only with Whole Blood or serum.
Performance of the Atlas Link Chagas InstaTest:
With limited testing the initial sensitivity was 98.7%, with positive specificity at 97.7% and negative specificity at 100.0%. The range of results obtained with any test depends on the experience, training, supervision and monitoring of the test procedures and specimen collection and handling.
References:
1. Anthony, R.L., Johnson, C. and Souda, O., Use of micro elisa for quantitative antibody detection to T. cruzi and rangell, Am. J. Trop. Med. Hyg., 1979, 28:969-973.
2. Cerrasco, H.A., Barboza, J.S., Inglessis, G., Fuenmayor, A, and Molina, C., Left ventricle cineanglography in Chagas’ disease: Detection of early myocardial damage, Am. Heart J. 1982, 104:565-602.
3. Chagas, C., Villela, E., Forma Cardiaca de trpanosomiasis Americana. Reimpreso dos mem lust Oswaldo Cruz. Rio de Janiero: Menguinhos, 1922:5-61.
4. Martin, S., Cetron, R.H., Stuart, K., Eisen, H. and Van Voortis, W.C., Evaluation of recombinant trypomastigote surface antigens of T. cruzi in screening sera from a population in rual northeastern Brazil endemic for Chagas’ disease. Am. J. Trop. Med. Hyg., 1992, 50:259-266.
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664