One Step 3 in 1 Cardiac Combo cardiac blood Tests , gold colloidal method,quickly and easily, multiple cassette

Accessories:

Instruction for use, Specimens dilution tube with buffer

Intended Use:

The Cardiac Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human Myoglobin, CK-MB and cardiac Troponin I in whole blood, serum or plasma as an aid in the determination of myocardial infarction (MI).

Summary:

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-protein normally found in skeletal and cardiac muscle with a molecular weight of 17.8 kDa. It constitutes about 2 percent of total muscle protein and is responsible for transporting oxygen within muscle cells.1 When 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 designated as “M” and “B”, which combine to form three different isoenzymes, CK-MM, CK-BB and CK-MB. CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac muscle tissue.5 The release of CK-MB into the blood following an MI can be detected within 3-8 hours after the onset of symptoms. It peaks within 9 to 30 hours, and returns to baseline levels within 48 to 72 hours.6 Cardiac Troponin I is a protein found in cardiac muscle, with a molecular weight of 22.5 kDa.7 Troponin I is part of a 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 Cardiac Combo Rapid Test 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.

Test Principle:

The One Step Myoglobin/CK-MB/Troponin I Combo Test Single Use Kit (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of Myoglobin, CK-MB and Troponin I in whole blood, serum or plasma. The membrane is precoated 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.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready

to begin testing.

2. Remove the device from the sealed pouch and lay it on a flat and dry surface.

3. Using the provided pipette, add one drop of fresh specimen to the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Read the result between 15-20minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

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 TP antibodies 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.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

The Cardiac Combo Rapid Test Card 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, the Cardiac Combo Rapid 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.

Myoglobin Test vs. EIA

Troponin I Test vs. EIA

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)