Myo-ckmb-tro

One Step Myoglobin/CK-MB/Troponin I Combo Test Device
Blood/Serum/Plasma) can be performed using whole blood (from venipuncture or *NOTE: The intensity of the color in the test line region(s) will vary depending on the
(Whole Blood/Serum/Plasma)
concentration of Myoglobin, CK-MB and/or Troponin I present in the specimen. One Step Troponin I
To collect Fingerstick Whole Blood specimens:
Therefore, any shade of color in the test line regions should be considered positive. A rapid, one step test for the qualitative detection of Myoglobin, CK-MB, and Troponin I Wash the patient’s hand with soap and warm water or clean with an alcohol swab. NEGATIVE: One colored line appears in the control line region (C). No apparent
For professional in vitro diagnostic use only. colored lines appear in any of the test line region(s). This indicates that the concentration of Total Results
• Massage the hand without touching the puncture site by rubbing down the hand Relative Sensitivity: 98.7% (96.2%-99.7%)* Relative Specificity: 98.4% (97.0%-99.3%)* INTENDED USE
Myoglobin, CK-MB and Troponin I are below the minimum detection levels. towards the fingertip of the middle or ring finger. The One Step Myoglobin/CK-MB/Troponin I Combo Test Device (Whole INVALID: Control line (C) fails to appear. Insufficient specimen volume or incorrect
Puncture the skin with a sterile lancet. Wipe away the first sign of blood. procedural techniques are the most likely reasons for control line failure. Review the Precision
Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative • Gently rub the hand from wrist to palm to finger to form a rounded drop of blood procedure and repeat the test with a new test. If the problem persists, discontinue using Intra-Assay
detection of human Myoglobin, CK-MB and cardiac Troponin I in whole blood, serum or the test kit immediately and contact your local distributor. Within-run precision has been determined by using replicates of 10 tests for each of plasma as an aid in the diagnosis of myocardial infarction (MI). • Position the patient’s finger so that the drop of blood is just above the specimen well QUALITY CONTROL
three lots using Myoglobin specimen levels at 0 ng/mL, 50 ng/mL, 100 ng/mL, 200 ng/mL and 400 ng/mL, CK-MB specimen levels at 0 ng/mL, 5 ng/mL, 10 ng/mL, 20 Allow 3 hanging drops of fingerstick whole blood to fall into the specimen well (S) of An internal procedural control is included in the test. A colored line appearing in the Myoglobin (MYO), Creatine Kinase MB (CK-MB) and cardiac Troponin I (cTnI) are ng/mL and 40 ng/mL and Troponin I specimen levels at 0 ng/mL, 2 ng/mL, 5 ng/mL, 10 the test device, or move the patient’s finger so that the hanging drop touches the control line region (C) is an internal procedural control. It confirms sufficient specimen proteins released into the bloodstream after cardiac injury. Myoglobin is a heme- ng/mL and 20 ng/mL. The specimens were correctly identified >99% of the time. specimen well (S). Avoid touching the finger directly to the specimen well (S). volume, adequate membrane wicking and correct procedural technique. protein normally found in skeletal and cardiac muscle with a molecular weight of 17.8 Inter-Assay
Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use Control standards are not supplied with this kit; however it is recommended that positive kDa. It constitutes about 2 percent of total muscle protein and is responsible for Between-run precision has been determined by 3 independent assays on the same and negative controls be tested as a good laboratory practice to confirm the test transporting oxygen within muscle cells.1 When muscle cells are damaged, fifteen specimens: 0 ng/mL, 50 ng/mL, 100 ng/mL, 200 ng/mL and 400 ng/mL of Testing should be performed immediately after specimen collection. Do not leave the procedure and to verify proper test performance. Myoglobin is released into the blood rapidly due to its relatively small size. The level Myoglobin, 0 ng/mL, 5 ng/mL, 10 ng/mL, 20 ng/mL, and 40 ng/mL of CK-MB and specimens at room temperature for prolonged periods. Serum and plasma specimens of Myoglobin increases measurably above baseline within 2-4 hours post-infarct, LIMITATIONS
0 ng/mL, 2 ng/mL, 5 ng/mL, 10 ng/mL and 20 ng/mL of Troponin I. Three different lots of may be stored at 2-8°C for up to 3 days. For long-term storage, specimens should be peaking at 9-12 hours, and returning to baseline within 24-36 hours.2,3 CK-MB is an 1. The One Step Myoglobin/CK-MB/Troponin I Combo Test Device (Whole the One Step Myoglobin/CK-MB/ Troponin I Combo Test Device (Whole kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if enzyme also present in the cardiac muscle, with a molecular weight of 87.0 kDa.4 Blood/Serum/ Plasma) is for in vitro diagnostic use only. This test should be used Blood/Serum/Plasma) have been tested using these specimens. The specimens were the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Creatine Kinase is a dimeric molecule formed from two subunits designated as “M” for the detection of Myoglobin, CK-MB, and Troponin I in whole blood, serum or correctly identified >99% of the time. Whole blood collected by fingerstick should be tested immediately. and “B”, which combine to form three different isoenzymes, CK-MM, CK-BB and plasma specimens only. Neither the quantitative value nor the rate of increase in Bring specimens to room temperature prior to testing. Frozen specimens must be Cross-Reactivity
CK-MB. CK-MB is the isoenzyme of Creatine Kinase most involved in the Myoglobin, CK-MB and Troponin I can be determined by this qualitative test. Sera containing known amounts of antibodies to Myoglobin, CK-MB and Troponin I completely thawed and mixed well prior to testing. Specimens should not be frozen metabolism of cardiac muscle tissue.5 The release of CK-MB into the blood following 2. The One Step Myoglobin/CK-MB/Troponin I Combo Test Device (Whole have been tested with 10,000 ng/mL Skeletal Troponin I, 2,000 ng/mL Troponin T, an MI can be detected within 3-8 hours after the onset of symptoms. It peaks within 9 Blood/Serum/Plasma) will only indicate the qualitative level of Myoglobin, CK-MB 1,390 ng/mL CK-MM, 1,000 ng/mL CK-BB and 20,000 ng/mL Cardiac Myosin. No If specimens are to be shipped, they should be packed in compliance with local to 30 hours, and returns to baseline levels within 48 to 72 hours.6 Cardiac Troponin I and Troponin I in the specimen and should not be used as the sole criteria for the cross-reactivity was observed, indicating that the One Step Myoglobin/CK-MB/Troponin regulations covering the transportation of etiologic agents. is a protein found in cardiac muscle, with a molecular weight of 22.5 kDa.7 Troponin I I Combo Test Device (Whole Blood/ Serum/Plasma) has a high degree of specificity for is part of a three subunit complex comprised of Troponin T and Troponin C. Along MATERIALS
3. The One Step Myoglobin/CK-MB/Troponin I Combo Test Device (Whole with tropomyosin, this structural complex forms the main component that regulates Materials Provided
Blood/Serum/ Plasma) cannot detect less than 50 ng/mL Myoglobin, 5 ng/mL CK- Interfering Substances
the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac MB and 0.5 ng/mL Troponin I in specimens. A negative result at any time does not The One Step Myoglobin/CK-MB/Troponin I Combo Test Device (Whole muscle.8 After cardiac injury occurs, Troponin I is released into the blood 4-6 hours preclude the possibility of myocardial infarction. Blood/Serum/Plasma) has been tested and no interference was observed in specimens after the onset of pain. The release pattern of Troponin I is similar to CK-MB, but Materials Required But Not Provided
4. As with all diagnostic tests, all results must be interpreted together with other clinical containing 110 mg/mL human albumin, 6 mg/mL bilirubin, 10 mg/mL hemoglobin, while CK-MB levels return to normal after 72 hours, Troponin I remains elevated for 5 mg/mL cholesterol and 15 mg/mL triglycerides. 6-10 days, thus providing for a longer window of detection for cardiac injury. • Lancets (for fingerstick whole blood only) 5. Unusually high titers of heterophile antibodies or rheumatoid factor (RF) may affect The following compounds have also been tested using the One Step The One Step Myoglobin/CK-MB/Troponin I Combo Test Device (Whole the results. Even if test results are positive, further clinical evaluation should be Myoglobin/CK-MB/Troponin I Combo Test Device (Whole Blood/Serum/Plasma) and no Blood/Serum/Plasma) utilizes a combination of antibody coated particles and capture DIRECTIONS FOR USE
considered with other clinical information available to the physician. reagents to qualitatively detect Myoglobin, CK-MB and Troponin I in whole blood, serum Allow the test, specimen and/or controls to reach room temperature (15-30°C)
6. There is a slight possibility that some whole blood specimens with very high Acetaminophen or plasma. The minimum detection level is 50 ng/mL Myoglobin, 5 ng/mL CK-MB and prior to testing.
viscosity or which have been stored for more than 2 days may not run properly on Acetoacetic Acid 1. Bring the pouch to room temperature before opening it. Remove the test device the test device. Repeat the test with a serum or plasma specimen from the same Acetylsalicylic acid PRINCIPLE
from the sealed pouch and use it as soon as possible. Best results will be obtained The One Step Myoglobin/CK-MB/Troponin I Combo Test Device (Whole if the test is performed immediately after opening the foil pouch. EXPECTED VALUES
Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection 2. Place the test device on a clean and level surface. The One Step Myoglobin/CK-MB/Troponin I Combo Test Device (Whole Atorvastatin Calcium of Myoglobin, CK-MB and Troponin I in whole blood, serum or plasma. The membrane For Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops
Blood/Serum/Plasma) has been compared with a leading commercial Myoglobin/CK- is pre-coated with specific capture antibodies in each of the test line regions of the test. of serum or plasma (approximately 50 µL) to the specimen well (S) of the test
MB/T EIA test, demonstrating an overall accuracy of 98.0% with Myoglobin, 99.8% with During testing, the whole blood, serum or plasma specimen reacts with the particle device, then start the timer. See illustration below. BIBLIOGRAPHY
coated with specific antibodies. The mixture migrates upward on the membrane For Venipuncture Whole Blood specimens: Hold the dropper vertically and
PERFORMANCE CHARACTERISTICS
1. Wong SS. Strategic utilization of cardiac markers for diagnosis of acute myocardial chromatographically by capillary action to react with specific capture reagents on the transfer 3 drops of venipuncture whole blood (approximately 75 µL) to the
infarction. Ann Clin Lab Sci, 26:301-12, 1996. membrane and generate a colored line. The presence of this colored line in the specific specimen well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) Sensitivity and Specificity
2. Kagen LJ. Myoglobin methods and diagnostic uses. CRC Crit. Rev. Clin. Lab. Sci., test line region indicates a positive result, while its absence indicates a negative result. and start the timer. See illustration below. The One Step Myoglobin/CK-MB/Troponin I Combo Test Device (Whole To serve as a procedural control, a colored line will always appear in the control line For Fingerstick Whole Blood specimens: Allow 3 hanging drops of fingerstick
Blood/Serum/Plasma) has been evaluated with a leading commercial Myoglobin/CK- 3. Chapelle JP. et al. Serum myoglobin determinations in the assessment of acute region indicating that proper volume of specimen has been added and membrane whole blood specimen (approximately 75 µL) to fall into the center of the
MB/Troponin I EIA test using clinical specimens. The results show that relative to myocardial infarction. Eur. Heart Journal, 3:122, 1982. specimen well (S) on the test device, then add 1 drop of buffer (approximately leading EIA tests, the One Step Myoglobin/CK-MB/Troponin I Combo Test Device 4. Apple FS, Preese LM. Creatine kinase-MB: detection of myocardial infarction and 40 µL) and start the timer. See illustration below. REAGENTS
(Whole Blood/Serum/Plasma) exhibits 100% sensitivity and 97.7% specificity for monitoring reperfusion. J Clin Immunoassay, 17:24-9, 1994. 3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret
Myoglobin, 100% sensitivity and 99.8% specificity for CK-MB, and 98.7% sensitivity and 5. Lee TH, Goldman L. Serum enzyme assays in the diagnosis of acute myocardial The test contains anti-Myoglobin antibody coated particles, anti-CK-MB antibody coated infarction. Ann Intern Med, 105:221-233, 1986. particles, anti-Troponin I antibody coated particles, and capture reagents coated on the One Step Myoglobin Test vs. EIA
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, PRECAUTIONS
• For professional in vitro diagnostic use only. Do not use after expiration date. 7. Adams, et al. Biochemical markers of myocardial injury, Immunoassay Circulation One Step Myoglobin
• The test must remain in the sealed pouch until use. • Do not eat, drink or smoke in the area where the specimens or kits are handled. 8. Mehegan JP, Tobacman LS. Cooperative interaction between troponin molecules bound to the cardiac thin filament. J.Biol.Chem. 266:966, 1991. Total Results
Handle all specimens as if they contain infectious agents. Observe established Relative Sensitivity: 100% (94.0%-100.0%)*Relative Specificity: 97.7% (95.6%-98.9%)* precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. • Wear protective clothing such as laboratory coats, disposable gloves and eye One Step CK-MB Test vs. EIA
protection when specimens are being tested. • Humidity and temperature can adversely affect results. • The used test should be discarded according to local regulations. One Step CK-MB Test
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 INTERPRETATION OF RESULTS
Total Results
test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond
Relative Sensitivity: 100% (93.4%-100.0%)*Relative Specificity: 99.8% (98.7%-99.9%)* (Please refer to the illustration above) POSITIVE:* A colored line in the control line region (C) and the presence of one or
SPECIMEN COLLECTION AND PREPARATION
more colored lines in the test line regions indicates a positive result. This indicates
One Step Troponin I Test vs. EIA
• The One Step Myoglobin/CK-MB/Troponin I Combo Test Device (Whole that the concentration of Myoglobin, CK-MB and/or Troponin I is above the minimum

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