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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:
One (1) test device packaged in a sealed
package with “dry pack”.
2. One (1) diluent vial with dropping spout.
3. Instruction sheet.
1.
Storage and Stability:
The Atlas Link Chagas InstaTest can be stored at any
temperature between 4-30o C in the original sealed
pouch.
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]
InstaTest Chagas Serum/Whole Blood/Plasma/Saliva Cat. No. 174105-50,Page2
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 buildup 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.
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]
InstaTest Chagas Serum/Whole Blood/Plasma/Saliva Cat. No. 174105-50,Page3
3.
4.
Detection of early myocardial damage, Am. Heart J. 1982,
104:565-602.
Chagas, C., Villela, E., Forma Cardiaca de trpanosomiasis
Americana. Reimpreso dos mem lust Oswaldo Cruz. Rio de
Janiero: Menguinhos, 1922:5-61.
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.
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.
2.
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.
Cerrasco, H.A., Barboza, J.S., Inglessis, G., Fuenmayor, A, and
Molina, C., Left ventricle cineanglography in Chagas’ disease:
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]