One Step Fatty Acid Binding Protein/Troponin I Combo Cassette Test
Rapid Fatty Acid Binding Protein/Troponin I test for the in vitro Diagnosis of Myocardial Infarction in
human serum or plasma
INTENDED USE
One Step Fatty Acid Binding Protein/Troponin I Combo Test is a rapid and sensitive, in vitro diagnostic
device for the qualitative determination of two cardiac markers, namely Fatty Acid Binding Protein
(FABP) and Troponin I (TPI) in human serum or plasma. This kit acts as an aid in early detection or rule
out of acute myocardial infarction (AMI) in emergency room, critical care, and point of care and hospital
laboratory use.
One Step FABP/Troponin I Combo Test kit is intended as a qualitative test assay and does not provide
information about the actual concentration of each individual cardiac marker at a given time. It may
however allow visual detection of the changes in test band intensity, indicating the rise or fall in each
marker’s concentration over a given period of time through serial sample testing. To obtain a quantitative
result for confirmation of AMI, it is recommended that a quantitative assay be carried out. A physician
exercising appropriate professional judgment should make interpretation of test results using the One Step
FABP/Troponin I Combo test with other clinical information.
SUMMARY AND EXPLANATION
Following AMI, several cardiac proteins are released from damaged heart tissue into circulation.
Among these proteins, FABP and Myoglobin are released at an early stage (1-3 hours after AMI). This is
followed by CKMB and Troponin I(about 4-6 hours after AMI). Myoglobin and CKMB are relatively
non-specific to cardiac tissue, since the injury of skeletal muscle and other non-cardiac tissues will also
result in elevations of these two markers. FABP has the kinetics of release into blood circulation similar
to that of myoglobin. Because of a significantly lower FABP concentration in skeletal muscle compared
to myoglobin, the concentration of FABP in the blood of healthy donors is also considerably lower (6-10
ng/ml FABP vs. 60-100 ng/ml myoglobin). This makes FABP the more sensitive and reliable early
marker for myocardial tissue damage. Although Troponin I is present in skeletal muscle fibers and
cardiac muscles, the cardiac Troponin I isoform is uniquely located in the myocardium tissue of the heart.
Antibody made against this cardiac isoform is immunologically distinct from antibodies made against the
skeletal muscle Troponin I isoform. Because high specificity of cardiac Troponin I to heart tissue, its
elevations occur only in the case of AMI and other heart-related diseases. One Step Fatty Acid Binding
Protein/ Troponin I Combo Cassette Test allows quick detection of these two relatively specific cardiac
markers in serum or plasma and rapid diagnosis regarding the onset of AMI.
PRINCIPLE
One Step FABP/Troponin I Combo Cassette Test is a rapid immunochromatographic assay for rapid
detection of cardiac FABP & Troponin I as early as 1-3 hours after AMI. When a serum/plasma sample is
placed in a sample well, marker-specific antibodies conjugated to colloidal gold can capture any of these
marker molecules in the specimen. Through capillary action, the antigen-antibody-gold complexes are
migrated along the nitrocellulose membrane and then captured by the marker-specific antibodies
immobilized on the membrane through sandwich formations. Red color lines will appear on the test zone
designated as FABP and TPI depending on the presence of FABP and Troponin I, respectively in the
specimen. Antibody-gold complexes will be captured in the control zone (C) where goat anti-mouse IgG
is immobilized. The appearance of red control line is independent of the presence of markers in the
specimen and serves as the validity of the test
MATERIALS PROVIDED
Each individual sealed pouched kit contains:
One Step FABP/Troponin I Combo Cassette test
Desiccant
MATERIALS REQUIRED BUT NOT PROVIDED
Issued droppers or Micropipette (0-200 uL range) with disposable pipette tips.
Positive and negative controls (for comparison of concentration values of each marker)
Timer
WARNINGS AND PRECAUTIONS
Handling should preclude any pipetting by mouth.
Do not allow smoking or eating where specimens and reagents are being handled.
Wear disposable gloves while handling kit reagents or specimens. Wash hands thoroughly afterwards.
Avoid splashing or aerosol formation.
Clean up spills thoroughly using an appropriate intermediate-to high level disinfectant.
Decontaminate and dispose of all specimens and potentially contaminated materials as if they were
infectious.
Do not use reagents after the expiration date.
For in vitro diagnostic use only.
STORAGE AND STABILITY
The One Step FABP/Troponin I Combo Cassette test kit is stable until the expiration date marked on the
sealed pouched if unopened. The test kit should not be used after this date. This device should be stored
at 4 – 30 degrees Celsius.
SPECIMEN COLLECTION AND PREPARATON
This test may be used with human samples of serum or plasma. Both require collection of human
blood. If serum testing is intended, collect blood in a tube without anticoagulant and allow clotting. For
plasma samples, collect blood in a tube containing heparin or EDTA as anticoagulant. Specimens should
be run as soon as possible. Heat inactivation of samples may cause protein denaturation and affect test
results. If samples are to be stored for short periods, serum or plasma should be refrigerated at 2- 8
degrees Celsius.
TEST PROCEDURE
Procedural Notes
If a large amount of particulate matter is present in a serum sample, centrifuge the sample.
Fresh samples should be run as soon as possible, however samples that have been frozen or stored for a
long period of time may give inaccurate results, caution should be taken. Samples should not be
repeatedly thawed and re-frozen.
Consider each material that comes in contact with the specimen, potentially infectious. Disposing of
these materials should be made following good laboratory practices.
Once the test kit is opened, lay the device on a level surface.
Actual Test Procedure
1) Remove the cassette from the foil pouch.
2) Label the cassette with the patient's name or control number.
3) Add 100uL or 3 drops of serum or plasma into the sample well.
4) Wait 15 minutes and then read the test results.
Do not interpret results after 15 minutes.
Diagram for Explanation of Test Results *,**
* Maximum Values of Normal Healthy Individuals:
FABP: 10 ng/ml
TPI: 1.5 ng/mL (free TPI)
~5 ng/mL (complex TPI)
**It is recommended that the appropriate standards with the above reference values be used to calibrate
the test results when performing any test on a patient or patients; in order to judge if the test results of
any marker are positive or negative.
Interpretation of Results
A)FABP-positive/TPI-positive.
If After 15 mins these are your results, this indicates that myocardial cell necrosis within the past 12
hours. (FABP  10 ng/ml, TPI  1.5ng/mL).
B)FABP-positive/TPI-negative.
If After 15 mins these are your results, this suggests early muscle or cardiac injury. Serial Troponin I
testing is suggested in 4 & 8 hrs to rule in acute coronary syndrome. (FABP  10 ng/ml , TPI 
1.5ng/mL).
C)FABP-negative/TPI-positive.
If After 15 mins these are your results, this suggests a pattern of acute myocardial infarction post 12 - 24
hours from the onset of early symptoms. (FABP  10 ng/ml, TPI  1.5ng/mL).
D)FABP-negative/TPI-negative
If After 15 mins these are your results, this indicates that it is not consistent with acute myocardial
infarction. If the cardiac injury is suspected, retest in 2 – 4 hours. (FABP  10ng/mL, TPI  1.5ng/mL).
E) Invalid Test
If the control line is absent after 15 minutes, the test is invalid, and it is recommended that the specimen
be retested.