User Manual

Cardiac Troponin I Rapid Test Cassette
(Whole Blood /Serum/Plasma)
Package Insert
REF CTI-402
English
A rapid test for the diagnosis of myocardial infarction (MI) to detect cardiac Troponin I(cTnI)
qualitatively in whole blood, serum or plasma. For professional in vitro diagnostic use only.
【INTENDED USE】
The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic
immunoassay for the qualitative detection of human cardiac Troponin I in whole blood, serum or
plasma as an aid in the diagnosis of myocardial infarction (MI).
【SUMMARY】
Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5 kDa.
1
Troponin I is part of a three subunit complex comprising of Troponin T and Troponin C. Along with
tropomyosin, this structural complex forms the main component that regulates the calcium sensitive
ATPase activity of actomyosin in striated skeletal and cardiac muscle.
2
After cardiac injury occurs,
Troponin I is released into the blood 4-6 hours after the onset of pain. The release pattern of cTnI is
similar to CK-MB, but while CK-MB levels return to normal after 72 hours, Troponin I remains elevated
for 6-10 days, thus providing for a longer window of detection for cardiac injury. The high specificity of
cTnI measurements for the identification of myocardial damage has been demonstrated in conditions
such as the perioperative period, after marathon runs, and blunt chest trauma.
3
cTnI release has also
been documented in cardiac conditions other than acute myocardial infarction (AMI) such as
unstable angina, congestive heart failure, and ischemic damage due to coronary artery
bypass surgery.
4
Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has
recently become the most preferred biomarker for myocardial infarction.
5
The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is a simple test that
utilizes a combination of anti-cTnI antibody coated particles and capture reagent to detect cTnI in
whole blood, serum or plasma. The minimum detection level is 0.5ng/mL.
【PRINCIPLE】
The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane
based immunoassay for the detection of cardiac Troponin I(cTnI) in whole blood, serum or plasma. In
this test procedure, capture reagent is immobilized in the test line region of the test. After specimen is
added to the specimen area of the cassette, it reacts with anti-cTnI antibody coated colloid gold
particles in the test. This mixture migrates chromatographically along the length of the test and
interacts with the immobilized capture reagent. The test format can detect cardiac Troponin I(cTnI)
in specimens. If the specimen contains cardiac Troponin I(cTnI), a colored line will appear in the test
line region, indicating a positive result. If the specimen does not contain cardiac Troponin I(cTnI), a
colored line will not appear in this region, indicating a negative result. To serve as a procedural control,
a colored line will always appear in the control line region, indicating that proper volume of specimen
has been added and membrane wicking has occurred.
【REAGENTS】
The test contains anti-cTnI antibody coated colloid gold particles and capture reagent coated on the
membrane.
【PRECAUTIONS】
• For professional in vitro diagnostic use only. Do not use after expiration date.
• Do not eat, drink or smoke in the area where the specimens or kits are handled.
• Do not use test if pouch is damaged.
• Handle all specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout all procedures and follow the standard procedures for proper
disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when
specimens are assayed.
• The used test should be discarded according to local regulations.
• Humidity and temperature can adversely affect results.
【STORAGE AND STABILITY】
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The
test is stable through the expiration date printed on the sealed pouch. The test must remain in the
sealed pouch until use. DO NOT FREEZE. Do not use after the expiration date.
【SPECIMEN COLLECTION AND PREPARATION】
• The Caridiac Troponin I (Whole Blood/Serum/Plasma) can be performed using whole blood (from
venipuncture or fingerstick), serum or plasma.
• To collect Fingerstick Whole Blood specimens:
• Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
• Massage the hand without touching the puncture site by rubbing down the hand towards the
fingertip of the middle or ring finger.
• Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
• Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the
puncture site.
• Add the Fingerstick Whole Blood specimen to the test by using a capillary tube:
• Touch the end of the capillary tube to the blood until filled to approximately 75L. Avoid air
bubbles.
• Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense the
whole blood to the specimen area of the test cassette.
• Add the Fingerstick Whole Blood specimen to the test by using hanging drops:
• Position the patient’s finger so that the drop of blood is just above the specimen area of the
test cassette.
• Allow 3 hanging drops of fingerstick whole blood to fall into the center of the specimen area
on the test cassette, or move the patient’s finger so that the hanging drop touches the center
of the specimen area. Avoid touching the finger directly to the specimen area.
• Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear
non-hemolyzed specimens.
• Testing should be performed immediately after the specimens have been collected. Do not leave
the specimens at room temperature for prolonged periods. Serum and plasma specimens may be
stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.
Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 1 day
of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be
tested immediately.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely
thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
• If specimens are to be shipped, they sho uld be packed in compliance with local regulations
covering the transportation of etiologic agents.
【MATERIALS】
Materials provided
• Test Cassettes
• Droppers
• Buffer
• Package insert
Materials required but not provided
• Specimen collection Containers
• Centrifuge
• Timer
For fingerstick whole blood
• Lancets
• Heparinized capillary tubes and dispensing bulb
【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior
to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed
pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
• Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 L) to
the specimen area, then add 1 drops of buffer (approximately 40 L), and start the timer. See
illustration below.
For Venipuncture Whole Blood specimen:
• Hold the dropper vertically and transfer 3 drops of w hole blood (approximately 75 L) to the
specimen area, then add 1 drops of buffer (approximately 40 L), and start the timer. See
illustration below.
For Fingerstick Whole Blood specimen:
• To use a capillary tube: Fill the capillary tube and transfer approximately 75 L of fingerstick
whole blood specimen to the specimen area of test cassette, then add 1 drop of buffer
(approximately 40 L) and start the timer. See illustration below.
• To use hanging drops: Allow 3 hanging drops of fingerstick whole blood specimen
(approximately 75 L) to fall into the specimen area of test cassette, then add 1 drop of buffer
(approximately 40 L) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after
20 minutes.
【INTERPRETATION OF RESULTS】
(Please refer to the illustration above)
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another
apparent colored line should be in the test line region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of
cardiac Troponin I(cTnI) present in the specimen. Therefore, any shade of color in the test line region
(T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line
region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural
techniques are the most likely reasons for control line failure. Review the procedure and repeat the
test with a new test. If the problem persists, discontinue using the test kit immediately and contact
your local distributor.
【QUALITY CONTROL】
A procedural control is included in the test. A colored line appearing in the contro l line region(C) is
considered an internal procedural control. It confirms sufficient specimen volume, adequate
membrane wicking and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that positive and negative
controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test
performance.
【LIMITATIONS】
1. The Cardiac Troponin I Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use
only. This test should be used for the detection of Troponin I in whole blood, serum or plasma
specimens only. Neither the quantitative value nor the rate of increase in cTnI can be determined
by this qualitative test.
2. The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) will only indicate the
qualitative level of cTnI in the specimen and should not be used as the sole criteria for the
diagnosis of myocardial infarction.
3. The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) cannot detect less than
0.5ng/mL of cTnI in pecimens. A negative result at any time does not preclude the possibility of
myocardial infarction.
4. As with all diagnostic tests, all results must be interpreted together with other clinical information
available to the physician.
5. Some specimens containing unusually high titers of heterophile antibodies or rheumatoid factor
(RF) may affect expected results. Even if the test results are positive, further clinical evaluation
should be considered with other clinical information available to the physician.
6. There is a slight possibility that some whole blood specimens with very high viscosity or which have
been stored for more than 1 day may not run properly on the test cassette. Repeat the test with a
serum or plasma specimen from the same patient using a new test cassette.
【EXPECTED VALUES】
The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) has been compared with a
leading commercial cTnI EIA test, demonstrating an overall accuracy of 99.1%.
【PERFORMANCE CHARACTERISTICS】
Sensitivity and Specificity
The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) has been evaluated with a
leading commercial cTnI EIA test using clinical specimens. The results show that the sensitivity of the
Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) is 99.4% and the specificity is
99.0% relative to the leading EIA test.
Method
EIA
Total Result
Cardiac Troponin I Rapid
Test Cassette (Whole
Blood/Serum/Plasma)
Results
Positive
Negative
Positive
172
5
177
Negative
1
472
473
Total Result
173
477
650
Relative sensitivity: 172/173=99.4% (95%CI*: 96.8%~99.9%);
Relative specificity: 472/477=99.0% (95%CI*: 97.6%~99.7%);
Accuracy: (172+472)/(172+1+5+472)=99.1%(95%CI*: 98.0%~99.7%). *Confidence
Intervals
Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates of five specimens: a negative, cTnI
1.0ng/mL positive, cTnI 5.0ng/mL positive, cTnI 10ng/mL positive and cTnI 40ng/mL positive. The
negative, cTnI 1.0ng/mL positive, cTnI 5.0ng/mL positive, cTnI 10ng/mL positive and cTnI 40ng/mL
positive values were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 15 independent assays on the same five specimens:
a negative, cTnI 1.0ng/mL positive, cTnI 5.0ng/mL positive, cTnI 10ng/mL positive and cTnI 40ng/mL
positive specimens. Three different lots of the Cardiac Troponin I Rapid Test Cassette (Whole
Blood/Serum/Plasma) have been tested over a 3-day period using negative, cTnI 1.0ng/mL positive,
cTnI 5.0ng/mL positive, cTnI 10ng/mL positive and cTnI 40ng/mL positive specimens. The specimens
were correctly identified >99% of the time.
Cross-reactivity
The Cardiac Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested by
10,000ng/mL Skeletal Troponin I, 2,000ng/mL Troponin T, 20,000ng/mL Cardiac Myosin, HBsAg,
HBsAb, HBeAg, HBeAb, HBcAb, syphilis, anti-HIV, anti-H.pylori, MONO, anti-CMV, anti-Rubella and
anti-Toxoplasmosis positive specimens. The results showed no cross-reactivity.
Interfering Substances
The following potentially interfering substances were added to cTnI negative and positive specimens.
Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL
Acetylsalicylic Acid: 20 mg/dL Gentisic Acid: 20 mg/dL
Ascorbic Acid: 20mg/dL Albumin: 10,500mg/dL
Creatin: 200 mg/dL Hemoglobin 1,000 mg/dL
Bilirubin: 1,000mg/dL Oxalic Acid: 600mg/dL
Cholesterol: 800mg/dL Triglycerides: 1,600mg/dL
None of the substances at the concentration tested interfered in the assay.
【BIBLIOGRAPHY】
1. Adams,et al. Biochemical markers of myocardial injury, Immunoassay Circulation 88:750-763,
1993.
2. Mehegan JP, Tobacman LS. Cooperative interaction between troponin molecules bound to the
cardiac thin filament. J.Biol.Chem. 266:966, 1991.
3. Adams, et al. Diagnosis of Perioperative myocardial infarction with measurements of cardiac
troponin I. N.Eng.J.Med 330:670, 1994.
4. Hossein-Nia M, et al. Cardiac troponin I release in heart transplantation. Ann. Thorac. Surg. 61:
227, 1996.
5. Alpert JS, et al. Myocardial Infarction Redefined, Joint European Society of Cardiology American
College of Cardiology: J. Am. Coll. Cardio., 36(3):959, 2000
Index of Symbols
Attention, see
instructions for use
Tests per
kit
Authorized
Representative
For in vitro
diagnostic use only
Use by
Do not reuse
Store between 2-30°C
Lot
Number
REF
Catalog #
Do not use if package is
damaged
Number: 145021104
Effective date: 2015-09-07