ACCU-TELL CARDIAC WHOLE BLOOD TEST
Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Accu-Tell ® Rapid Myoglobin/CK-MB/Troponin I Whole Blood Test is an immunochromatography based rapid in vitro test. It is designed for qualitative determination of cardiac Myoglobin/CK-MB/Troponin I in human whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction.
Accu-Tell ® Myoglobin(MYO),Creatine kinase MB(CK-MB) and Cardiac Troponin I (cTnI) are proteins released into the bloodstream after cardiac injury. Myoglobin is a heme-proein normally found in skeletal and cardiac muscle with a molecular weight of 17.8 KDa.It constitutes abour 2 percent of total muscle protein and is responsible for transporting oxyen within muscle cells.1when muscle cells are damaged, Myoglobin is released into the blood rapidly due to its relatively small size.The level of Myoglobin increases measurably above baseline within 2-4 hours post-infarct,peaking at 9-12 hours, and returning to baseline within 24-36 hours.2,3 CK-MB is an enzyme also present in the cardiac muscle, with a molecular weight of 87.0 KDa.4 Creatine kinase is a dimeric molecule formed from two subunits designed as “M” and “B”, which combine to form three different isoenzymes,CK-MM,CK-BB and CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of catdiac muscle tissue.5 The release of CK-MB
Into the blood following an MI can be detected whin3-8 hours.after the onset of symptoms.It pesks within 9 to 30 hours, and returns to baselin levels within 48 to 72 hours.6 Cardiac Troponin I is a cardiac muscle protein found in cardiac muscle, with a molecular weight of 22.5 KDa.7Troponin I is a part of three subunit complex comprised 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.8 After cardiac injury occurs,Troponin I is released into the blood 4-6 hours after the onset of pain.The release pattern of Troponin I 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 Troponin I, CK-MB, Myoglobin Plasma/Serum/Whole blood Device utilizes a combination of antibody coated particles and capture reagents to qualitatively detect Myoglobin, CK-MB and Troponin I in whole blood, serum or plasma. The minimum detection level is 50 ng/mL Myoglobin, 5 ng/mL CK-MB and 0.5 ng/mL Troponin I.
Accu-Tell ® Rapid Myoglobin/CK-MB/Troponin I Whole Blood Test is a qualitative, Membrane based immunoassay for the detection of Troponin I, CK-MB and Myoglobin in Whole blood, serum or plasma. The membrane is pre-coated with specific capture antibodies in each of the test line regions of the test. During testing,the whole blood, serum or plasma specimen reacts with the particle coated with specific antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with specific capture reagents on the membrane and generate a colored line. The presence of this colored line in the specific test line region indicates a positive result, while its absence indicates 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.
1. For professional and IN VITRO diagnostic use only.
2. The test device must remain in the sealed pouch until use.
3. Do not use after the expiration date.
4. Do not use if pouch is damaged.
5. Do not eat, drink or smoke in the area where the specimens or kits are handled.
6. All serum or plasma specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
7. The test device should be discarded in a proper biohazard container after testing.
8. Avoid cross-contamination of serum samples by changing a new specimen pipette for each sample.
9. Humidity and temperature can adversely affect results.
Accu-Tell ® Rapid Myoglobin/CK-MB/Troponin I Whole Blood Test can be performed using whole blood (from venipuncture or fingerstick), serum or plasma.
1. Collect whole blood specimens following regular clinical laboratory procedures.
2. Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.
3. Testing should be performed immediately after specimen collection. 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 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.
4. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed an d mixed well prior to testing. Specimens should not be frozen and thawed repeatedly
5. If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
Read package insert carefully before testing. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
1. Place the test cassette on a clean and level surface. Dispense 80ul of specimen and one drop of diluent to the specimen well (S) in the test device.
2. Wait for the red line(s) to appear. The result should be read at 15 minutes. Do not read the result after 20 minutes.
POSITIVE: A colored line in the control line region (C) and the presence of one or more colored lines in the test line regions indicates a positive result. This indicates that the concentration of Myoglobin, CK-MB and/or Troponin I is above the minimum detection level.
NOTE: The intensity of the color in the test line region(s) will vary depending on the concentration of Myoglobin,CK-MB and/or Troponin I present in the specimen. Therefore, any shade of color in the test line regions should be considered positive.
NEGATIVE: One colored line appears in the control(C). No apparent colored lines appear in any of the test line region(s). This indicates that the concentration of Myoglobin, CK-MB and Troponin I are below the minimum detection levels.
INVALID: Control line (C) 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.
A procedural control is included in the test. A line appearing in the control region (C) is considered as internal positive procedural control. A clear background in the result window is considered as internal negative procedural control.
1. Accu-Tell ® Rapid Myoglobin/CK-MB/Troponin I Whole Blood Test is for in vitro diagnostic use only.This test should be used for the detection of Myoglobin, CK-MB, and Troponin I in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Myoglobin, CK-MB and Troponin I can be determined by this qualitative test.
2. Accu-Tell ® Rapid Myoglobin/CK-MB/Troponin I Whole Blood Test will only indicate the qualitative level of Myoglobin, CK-MB and Troponin I in the specimen and should not be used as the sole criteria for the diagnosis of myocardial infarction.
3. Accu-Tell ® Rapid Myoglobin/CK-MB/Troponin I Whole Blood Test cannot detect less than 50 ng/mLMyoglobin, 5 ng/mL CK-MB and 0.5 ng/mL Troponin I in specimens. 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. Unusually high titers of heterophile antibodies or rheumatoid factor (RF) may affect the results. Even if test results are positive, further clinical evaluation should be considered with other clinical information available to the physician.
Store as packaged in the sealed pouch at room temperature (2-30°C) for duration of shelf life. The test cassette should be kept away from direct sunlight, moisture and heat. DO NOT FREEZE.
Accu-Tell ® Rapid Myoglobin/CK-MB/Troponin I Whole Blood Test has been compared with a leading commercial Myoglobin/CK-MB/Troponin I EIA test, demonstrating an overall accuracy of 98.0% with Myoglobin, 99.8% with CK-MB, and 98.5% with Troponin I.
Sensitivity and Specificity Accu-Tell ® Rapid Myoglobin/CK-MB/Troponin I Whole Blood Test has been evaluated with a leading commercial Myoglobin/CK-MB/Troponin I EIA test using clinical specimens. The results show that relative to leading EIA tests, Accu-Tell ® Rapid Myoglobin/CK-MB/Troponin I Whole Blood Test exhibits 100% sensitivity and 97.7% specificity for Myoglobin, 100% sensitivity and 99.8% specificity for CK-MB, and 98.7% sensitivity and 98.4% specificity for troponin I.
Accu-Tell ® Rapid Myoglobin/CK-MB/Troponin I Whole Blood Test vs. EIA
|
Method
|
EIA
|
Total
Results
|
||
|
Myoglobin
Test
|
Results
|
Positive
|
Negative
|
|
|
Positive
|
60
|
9
|
69
|
|
|
Negative
|
0
|
374
|
374
|
|
|
Total Results
|
60
|
383
|
443
|
|
Relative Sensitivity: 100% (94.0%-100%)*
Relative Specificity: 97.7% (95.6%-98.9%)*
Accuracy: 98.0% (96.2%-99.1%)* 95% Confidence Interval
Accu-Tell ® Rapid Myoglobin/CK-MB/Troponin I Whole Blood Test vs. EIA
|
Method
|
EIA
|
Total
Results
|
||
|
CK-MB
Test
|
Results
|
Positive
|
Negative
|
|
|
Positive
|
54
|
1
|
55
|
|
|
Negative
|
0
|
422
|
422
|
|
|
Total Results
|
54
|
423
|
477
|
|
Relative Sensitivity: 98.7% (96.2%- 99.7%)*
Relative Specificity: 98.4% (97.0%-99.3%)*
Accuracy: 98.5% (97.4%-99.3%)*
* 95% Confidence Interval
Precision
Intra-Assay
Within-run precision has been determined by using replicates of 10 tests for each of three lots using Myoglobin specimen levels at 0 ng/mL, 50 ng/mL, 100 ng/mL, 200ng/mL and 400 ng/mL, CK-MB specimen levels at 0 ng/mL, 5 ng/mL,10 ng/mL, 20 ng/mL and 40 ng/mL and Troponin I specimen levels at 0ng/mL, 2 ng/mL, 5 ng/mL, 10 ng/mL and 20ng/mL. The specimens were correctly identified > 99% of thetime.
Inter-Assay
Between-run precision has been determined by 3 independent assays on the same fifteen specimens: 0 ng/mL, 50 ng/mL, 100ng/mL, 200 ng/mL and 400 ng/mL of Myoglobin, 0 ng/mL, 5 ng/mL, 10 ng/mL, 20 ng/mL, and 40 ng/mL of CK-MB and 0 ng/mL, 2 ng/mL, 5 ng/mL, 10 ng/mL and 20 ng/mL of Troponin I. Three different lots of the Troponin I, CK-MB, Myoglobin Plasma/Serum/ Whole blood Device have been tested using these specimens. The specimens were correctly identified > 99% of the time.
Interfering Substances
The following substances were added to the negative control. No interference was found with any of the substances at the following concentrations:
|
substance
|
concentration
|
|
Bilirubin
|
10 mg/ml
|
|
Cholesterol
|
800 mg/ml
|
|
Hemoglobin
|
250 mg/ml
|
|
Triglyceride
|
250 mg/ml
|
|
sTnI
|
1000ng/ml
|
|
cTnT
|
1000ng/ml
|
|
cTnC
|
1000ng/ml
|
|
CK-MM
|
1390ng/ml
|
|
CK-BB
|
1000ng/ml
|
|
Cardiac Myosin
|
2000ng/ml
|
1. Wong SS. Strategic utilization of cardiac markers for diagnosis of acute myocardial infarction. Ann Clin Lab Sci, 26:301-12, 1996.
2. Kagen LJ. Myoglobin methods and diagnostic uses. CRC Crit. Rev. Clin. Lab. Sci., 2:273, 1978.
3. Chapelle JP. et al. Serum myoglobin determinations in the assessment of acute myocardial infarction. Eur. Heart Journal, 3:122, 1982.
4. Apple FS, Preese LM. Creatine kinase-MB: detection of myocardial infarction and monitoring reperfusion. J Clin Immunoassay, 17:24-9, 1994.
5. Lee TH, Goldman L. Serum enzyme assays in the diagnosis of acute myocardial infarction. Ann Intern Med, 105:221-233, 1986.
6. Kallner A, Sylven C, Brodin. U, et al. Early diagnosis of acute myocardial infarction; a comparison between chemical predictors. Scand J Clin Lab Invest, 49:633-9, 1989.
7. Adams, et al. Biochemical markers of myocardial injury, Immunoassay Circulation 88: 750-763, 1993.
8. Mehegan JP, Tobacman LS. Cooperative interaction between troponin molecules bound to the cardiac thin filament. J.Biol.Chem. 266:966, 1991.
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.
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