The CK-MB Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human CK-MB in serum, plasma or whole blood, as an aid in the diagnosis of myocardial infarction (MI).
| Product Description | Specimen | Catalog No. | Format | Cut-off Value | Kit Size | Regulatory Clearance |
|---|---|---|---|---|---|---|
| CK-MB Rapid Test Cassette | S/P | GDCKM-302a√ | Cassette | 5 ng/mL | 25 Tests/Kit | EU CE-IVDD |
| CK-MB Rapid Test Cassette | WB/S/P | GDCKM-402a√ | Cassette | 5 ng/mL | 25 Tests/Kit | EU CE-IVDD |
The C-Reactive Protein Semi-Quantitative Rapid Test is a rapid chromatographic immunoassay for semi-quantitative detection of C-Reactive Protein in serum, plasma or whole blood specimens to aid in evaluating risks of cardiovascular disease. C-Reactive Protein (CRP) is a marker of acute phase response to inflammatory disorder. A high level of CRP in the blood is a sign that there may be an inflammatory process occurring in the body. CRP measurements have been used for many years in the management of a variety of clinical situations, such as bacterial infections, ischemic necrosis of tissue, and active inflammatory conditions. Recent studies suggest that CRP is a strong predictor of future coronary events in apparently healthy subjects and a prognostic value in patients with acute coronary syndromes.
| Product Description | Specimen | Catalog No. | Format | Cut-off Value | Kit Size | Regulatory Clearance |
|---|---|---|---|---|---|---|
| C-Reactive Protein Semi-Quantitative Rapid Test Cassette | WB/S/P | GDCRP-402a√ | Cassette | 1~3~10 mg/L | 25 Tests/Kit | EU CE-IVDD |
| C-Reactive Protein Semi-Quantitative Rapid Test Cassette | WB/S/P | GDCRP-T402b√ | Cassette | 10~40~80 mg/L | 25 Tests/Kit | EU CE-IVDD |
The D-Dimer Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of D-dimer in human whole blood or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT). Any reactive specimen with the D-Dimer Rapid Test Cassette (Whole Blood/Plasma) must be confirmed with alternative testing method(s) and clinical findings.
Acute cardiac ailments can be catastrophic to patient health and warrant urgent diagnosis and intervention. Timely detection of cardiac markers, which are released into the bloodstream after cardiac injury such as a myocardial infarction (MI), can help clinicians in making treatment choices. However, these markers are released within a certain time frame after a MI, thus requiring rapid and sensitive technologies to detect their presence.
D-dimer is a protein fragment from the breakdown of a blood clot. Blood clots generally start to slowly break down after they are formed, and this process releases D-dimer into the blood. An elevated D-dimer level is not normal. If you are having significant formation and breakdown of blood clot in your body, D-dimer may be elevated.
| Product Description | Specimen | Catalog No. | Format | Cut-off Value | Kit Size | Regulatory Clearance |
|---|---|---|---|---|---|---|
| D-dimer Rapid Test Cassette | WB/P | GDDDI-402b√ | Cassette | 500 ng/mL | 25 Tests/Kit | EU CE-IVDD |
The Troponin I Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human cardiac Troponin I in serum, plasma or whole blood, as an aid in the diagnosis of myocardial infarction (MI).
| Product Description | Specimen | Catalog No. | Format | Cut-off Value | Kit Size | Regulatory Clearance |
|---|---|---|---|---|---|---|
| Troponin I Rapid Test Cassette | S/P | GDTRO-302a√ | Cassette | 0.5 ng/mL | 25 Tests/Kit | EU CE-IVDD |
| Troponin I Rapid Test Cassette | WB/S/P | GDTRO-402a√ | Cassette | 0.5 ng/mL | 25 Tests/Kit | EU CE-IVDD |
| Troponin I Rapid Test Cassette | WB/S/P | GDTRO-402b√ | Cassette | 0.5 ng/mL | 25 Tests/Kit | EU CE-IVDD |
| Product Description | Specimen | Catalog No. | Format | Cut-off Value | Kit Size | Regulatory Clearance |
|---|---|---|---|---|---|---|
| Procalcitonin Semi-Quantitative Rapid Test Cassette | WB/S/P | GDPCT-T402a√ | Cassette | 0.5~2~10 ng/mL | 25 Tests/Kit | EU CE-IVDD |
| Product Description | Specimen | Catalog No. | Format | Cut-off Value | Kit Size | Regulatory Clearance |
|---|---|---|---|---|---|---|
| Procalcitonin Semi-Quantitative Rapid Test Cassette | WB/S/P | GDPCT-T402a√ | Cassette | 0.5~2~10 ng/mL | 25 Tests/Kit | EU CE-IVDD |
The Myoglobin/CK-MB/Troponin I Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human Myoglobin, CK-MB and cardiac Troponin I in serum, plasma or whole blood, as an aid in the diagnosis of myocardial infarction (MI). 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. 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.
CK-MB is an enzyme also present in the cardiac muscle, with a molecular weight of 87.0 kDa. 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. 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.
Cardiac Troponin I is a protein found in cardiac muscle, with a molecular weight of 22.5 kDa. 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. 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.
| Product Description | Specimen | Catalog No. | Format | Cut-off Value | Kit Size | Regulatory Clearance |
|---|---|---|---|---|---|---|
| Cardiac Myoglobin/CK - MB/cTnl Combo Test | S/P | GDCAR-335a√ | Cassette | 50/5/0.5 ng/mL | 25 Tests/Kit | EU CE-IVDD |
| Cardiac Myoglobin/CK - MB/cTnl Combo Test | WB/S/P | GDCAR-435a√ | Cassette | 50/5/0.5 ng/mL | 25 Tests/Kit | EU CE-IVDD |
| Cardiac Myoglobin/CK - MB/cTnl Combo Test | WB/S/P | GDCAR-W435a√ | Cassette | 50/5/0.5 ng/mL | 20 Tests/Kit | EU CE-IVDD |