CHEST PAIN ANALYZER +
Fast chest pain Combo diagnostic device h-FABP & cTnl biomarker in one IVD device
Signs of illness, that are symptoms characteristic of a disease. With the CHEST PAIN ANALYZER + we want to make sure that your symptoms are really a heart attack, in 15 minutes without the use of expensive laboratories. Time is the most terrible enemy of a heart attack because if you lose time, the heart muscle will quickly be permanently damaged.
But what if the patient doesn't have a heart attack - despite the typical symptoms. These include back pain between the shoulder blades, chest and left arm pain, and numbness in the left palm.
In this case the patient is under extreme stress, the emergency service treats him like a heart attack patient and he has to stay in the emergency room for up to 6-8 hours until the actual result is available - yes or no!
The CHEST PAIN ANALYZER + is the safe rapid answer within 10 minutes, without unnecessarily burdening the patient or the health system, because these test reduces the operating coast of the emergency departments.
It's the best rapid diagnostic Method to exclude or to detect an Acute Myocardial Infarction (AMI) plus a silent infarction in the past
It's the In-vitro-Diagnostikum Qualitative rapid test for the detection of cardiac troponin I and heart-specific FABP in human whole blood, serum or plasma.
WEAKNESSES IN INFARM DIAGNOSTICS
The highly specific myocardial infarction biomarker troponin I can only be detected in the blood 8 hours after an ischemic event due to the delayed release. Other biomarkers such as myoglobin are not sufficiently reliable because they are non-specific in the body. Even a 12-lead ECG remains normal in about 25% of infarct patients. In some cases, an acute infarct could not be clearly diagnosed.
CONCEPT CARDIO COMBO RAPID TEST
In order to improve the sensitivity in acute infarcts and weak NSTEMI, the Cardio Combo Rapid Test determines not only troponin I but also the early phase protein hFABP. Due to its biochemical properties and physiological function, this protein is particularly suitable for detecting myocardial infarction within the first 12 hours after the onset of symptoms
Figure 1) Detection of h-FABP and troponin I in time
BACKGROUD INFORMATION
Cardiac troponin I (cTnl) is a protein that occurs as a complex with troponin T and troponin C in the heart muscle. Together with tropomyosin, this structural unit regulates the calcium-sensitive ATPase activity of actomyosin in the striated skeletal and cardiac muscles. In the event of myocardial damage, the complex disintegrates. The components are released into the bloodstream and can be detected there several hours after the onset of the infarction. The troponin | The level remains elevated for 8 days after the release. This results in a larger time window for the detection of cardiac damage. Because of its high specificity and sensitivity in myocardial tissue, troponin I has become the preferred biomarker for myocardial infarction. The analytical sensitivity is 0.6 ng / ml.
HFABP, the heart-specific fatty acid-binding protein, is involved in the active fatty acid metabolism, in which it transports fatty acids from the cell membrane of the mitochondria for metabolic conversion. The cytoplasmic protein is rapidly released into the blood by the heart muscle cells after an ischemic event. Its clinical detection limit is 7.0 ng / ml. It is released just 20 minutes after the infarction. The increased concentration persists for about 24 hours and then falls back to the natural level.
STRUCTURE AND FUNCTION OF A QUICK TEST
Immunological lateral flow rapid tests consist of various membranes that are arranged overlapping one another on a carrier (backing card): The sample pad is used to collect samples. From there, the sample flows through the conjugate pad, where antibodies coupled with gold colloid are released which are directed against epitopes of the biomarker to be detected. The pre-incubate that has now formed flows over the nitrocellulose membrane (NC) to the wicking pad.
Quality Check
QUALITY CONTROL
The test contains an internal quality control. The appearance of a control line in the control region serves as an internal positive procedural control. It confirms sufficient sample volume and correct test execution. The test does not include any external control solutions. It is recommended that positive and negative controls be run according to good laboratory practice to confirm the testing procedure. Please note that this test is a qualitative test. The test cannot determine the concentration of the analytes in the blood sample. Insufficient sample material, incorrect test execution or the expiry date of the CARDIO COMBO RAPID test cassette are the most common reasons for the control line not to appear.
TEST ACCESSORIES AND STORAGE
Included: Each CARDIO COMBO RAPID TEST pack contains the test cassette, a self-filling minivette (with an orange plunger) for handling blood samples from the fingertip, a dropper, an ampoule with buffer solution and a user manual.
Materials required: stopwatch, sample collection container and centrifuge (only for plasma / serum).
Storage and stability The test can be stored at +2 to +30 ° C until the expiry date printed on it. Do not freeze the test. The test must remain in the sealed package until use. Please protect the test components from contamination and moisture.