One Step multiple cassette H-FABP/Cardiac Troponin I Combo cardiac blood Tests , gold colloidal method, quickly and easily

Intended Use:

The H-FABP/Cardiac Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human H-FABP and cardiac Troponin I (cTnI) in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (MI).

Summary:

FABP is a newly introduced plasma marker of acute myocardial infarction (AMI). The plasma kinetics of FABP (15 kD) closely resemble those of myoglobin in that elevated plasma concentrations are found within 2 hours after AMI and return to normal generally within 18 to 24 hours. But the concentration of FABP in the skeletal muscle is 20 times lower than in cardiac tissue (for myoglobin the same content for cardiac and skeletal tissue), that makes FABP to be more cardiac specific than myoglobin. This makes FABP a useful biochemical marker for the early assessment or exclusion of AMI. FABP also appears to be a useful plasma marker for the estimation of myocardial infarct size. FABP is suitable for use as a standard in immunoassay for early detection of acute myocardial infarction, immunogen for antisera production, mass FABP standard, FABP biochemical and immunochemical studies, tracer for iodination. Cardiac Troponin I (cTnI) is a protein found in cardiac muscle with a molecular weight of 22.5 kDa.1 Troponin I is part of a three subunit complex comprising 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 cTnI 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 high specificity of cTnI measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative period, after marathon runs, and blunt chest trauma. cTnI release has also been documented in cardiac conditions other than acute myocardial infarction (AMI) such as unstable angina, congestive heart failure, and ischemic damage due to coronary artery bypass surgery. Because of its high specificity and sensitivity in the myocardial tissue, Troponin I has recently become the most preferred biomarker for myocardial infarction. The H-FABP/Cardiac Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of antibody coated particles and capture reagents to qualitatively detect H-FABP and cardiac Troponin I (cTnI) in whole blood, serum or plasma. The minimum detection level is 8 ng/mL H-FABP and 0.5 ng/mL Troponin I.

Test Principle:

The H-FABP/Cardiac Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of H-FABP and cardiac Troponin I (cTnI) in whole blood, serum or plasma. The membrane is pre-coated 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.

Limitation

1. The H-FABP/Cardiac Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/ Plasma) is for in vitro diagnostic use only. This test should be used for the detection of H-FABP, and cardiac Troponin I (cTnI) in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in H-FABP and cardiac Troponin I can be determined by this qualitative test.
2. The H-FABP/Cardiac Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/ Plasma) will only indicate the qualitative level of H-FABP and Troponin I in the specimen and should not be used as the sole criteria for the diagnosis of myocardial infarction.
3. The H-FABP/Cardiac Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) cannot detect less than 8ng/mL H-FABP and 0.5ng/mL cardiac Troponin I (cTnI) in specimens. A negative result at any time does not preclude the possibility of myocardial infarction.
4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
5. Some specimens containing unusually high titers of heterophile antibodies or rheumatoid factor (RF) may affect expected results. Even if the test results are positive, further clinical evaluation should be considered with other clinical information available to the physician.
6. There is a slight possibility that some whole blood specimens with very high viscosity or which have been stored for more than 2 days may not run properly on the test cassette. Repeat the test with a serum or plasma specimen from the same patient using a new test cassette.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

The Cardiac Combo Rapid Test Card has been evaluated with a leading commercial H-FABP/Troponin I EIA test using clinical specimens. The results show that relative to leading EIA test.

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)

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.