Check4® Myoglobin

Check4® Myoglobin is a qualitative rapid test assay for the detection of human myoglobin in serum, plasma or whole blood. The method employs a unique combination of monoclonal-dye conjugate and polyclonal solid phase antibodies to identify myoglobin in the test samples with a high degree of specificity.

As the sample flows through the absorbent device, the labelled antibody-dye conjugate binds to the myoglobin forming an antibody antigen complex. This complex binds to the anti-myoglobin antibody in the positive reaction zone (B) and produces a pink-rose colour band when myoglobin concentration is higher than 100 ng/mL.

In the absence of myoglobin, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and control zone. Unbound conjugate binds to the reagents in the control zone (C) producing a pink-rose colour band, demonstrating that the reagents are functioning correctly.

Myoglobin is an intra cellular heme protein involved in the storage and transfer of oxygen to muscle tissues. In humans myoglobin is one of the major proteins found in the myocardium and therefore it is not surprising that injury to cardiac muscle results in the release of myoglobin into the bloodstream.

1. This test is designed for in vitro diagnostic use and for healthcare professional use only.
2. Handle all specimens as if they contained infectious agents. When the assay procedure is completed, dispose of specimens carefully after autoclaving them for at least one hour. Alternatively, they can be treated with 0.5% to 1% solution of sodium hypochlorite for one hour before disposal.
3. Wear protective clothing such as laboratory coats and disposable gloves while assaying samples.
4. Do not eat, drink or smoke in the area where specimens and kit reagents are handled.
5. Avoid any contact between hands and eyes or nose during specimens collection and testing.
6. Do not use beyond the expiry date stated on the package label.
7. Do not use a test from a damaged protective wrapper.

1. As for any diagnostic procedure, the physician should confirm the data obtained using this test by other clinical methods.
2. Check4® Myoglobin is designed to yield a positive result for myoglobin concentration at 100 ng/mL or higher.
3. The time required for blood myoglobin level to reach the upper limit of normal has been found to be 2-4 hours after the onset. Therefore, a negative result within the first hours of the onset of symptoms does not rule out AMI with certainty. If suspected, repeat the test at appropriate intervals.
4. Check4® Myoglobin is only for providing qualitative results.
5. Use only fresh whole blood samples (< 4 hours) when test is performed with blood samples.
6. Some serum specimens with high rheumatoid factor concentration (RF) may yield non specific positive results during testing. Such cases should be discriminated before testing.
7. The test is designed to eliminate the potential interference of human antibodies to murine IgG (HAMA). However high level of HAMA could give falsely positive results.

If there is no distinct coloured band visible in the control zone, the test is invalid. It is recommended that the test be repeated immediately or within 4 hours after first collection.

Results should be read after five to ten minutes.

A. Sensitivity

The analytical sensitivity of the test is 100 ng/mL. Concentrations below 100 ng/mL may also be detected occasionally.

B. Specificity

54 patients with suspected clinical and/or ECG signs of AMI were examined, mean ages 54 +9.5 years. All patients were admitted in coronary care unit between 2 to 8 hours of onset. Blood samples were taken immediately and qualitative immunochromatographic tests were performed. At the same time, we performed a quantitative assay in order to evaluate the myoglobin blood level. When compared to the clinical status of the patient both diagnostic sensitivity and specificity are 100 %.
When compared to the quantitative method, the specificity was 100 %.