A CLIA test kit for the quantitative determination of Heart-fatty acid-binding protein (H-FABP) in human whole blood, serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Heart-fatty Acid-binding Protein (H-FABP) is intended for quantitative determination of the Heart-fatty acid-binding protein (H-FABP) in human whole blood, serum and plasma, as an aid in the auxiliary diagnosis of acute myocardial infarction in clinical practice. For professional in vitro diagnostic use only.
【SUMMARY】
The molecular weight of the heart-shaped fatty acid binding protein (H-FABP) is 15 kDa and composed of 132 amino acids. It is a new type of small cytoplasmic protein rich in the heart with a high degree of cardiac specificity and is mainly distributed in tissues with active fatty acid metabolism, such as the heart, liver and intestines.1 Studies have found that H-FABP has high specificity and sensitivity for early diagnosis of early myocardial injury. Due to the low molecular weight of H-FABP, its release
into the blood after myocardial injury occurs earlier than troponin (cTnI), myoglobin (MYO) and creatine kinase isoenzyme (CK-MB). Therefore, H-FABP in the blood can be used as an early detection marker of myocardial infarction injury.
【PRINCIPLE】
This product adopts double antibody sandwich method. The first step is to mix the sample with an alkaline phosphatase-labeled H-FABP antibody and magnetic particles coated with h-FABP antibody. After incubation, the H-FABP in the sample forms an immune complex with corresponding antibodies. In the second step, magnetic separation and cleaning were carried out to remove free enzyme-labeled antibodies.
The third step is to add chemiluminescent substrate solution to the immune complex. The luminescence signal generated by the enzyme reaction was detected by automatic chemiluminescence immunoanalyzer. The detected luminescence intensity was related to the concentration of H-FABP in the sample, and the concentration of H-FABP in the sample could be calculated by automatic chemiluminescence immunoanalyzer.
【REAGENTS】
The reagent strip includes H-FABP antibody coated with magnetic particles, Alkaline phosphatase labeled H-FABP antibody, wash buffer, substrate solution.
【STORAGE AND STABILITY】
1. Unopened test kits should be stored at 2-8 °C. When stored and handled as required, all unopened reagents are stable through the expiration date printed on the label.
2. Do not freeze. Do not turn the reagent strips over.
3. Store the test kit upright. Do not expose reagents to strong light during storage. Care should be taken to protect the components of the test from contamination.
4. Remaining reagents in the kit should be stored at 2-8°C immediately.
5. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment,
containers or reagents may lead to false results.
6. Calibrator and Control Materials: Unopened:
Stable until the expiration date when stored at 2-8 °C.
Opened: Undissolved: Stable for 1 week at 2-8 °C, avoid deliquescence
Dissolved: Stable for 1 week at 2-8 °C.
【EXPECTED RESULTS】
According to the nonparametric method, the reagent performed 90% median analysis of h-fabp detection results of 332 healthy population samples at 95% confidence level, with 95% percentile concentration values less than 10ng/mL.
Due to differences in geography, race, gender and age, it is suggested that each laboratory establish its own reference value (range).
【PERFORMANCE CHARACTERISTICS】
1.Method comparison
lt was compared with commercial CLIA test kit, 70 specimens were tested and the correlation coefficient (R2 ) is 0.9954.
2.Accuracy
The test deviation is≤±15%.
3.Assay Range and Detection Limit
Assay Range: 0.2-300ng/mL
Blank limit: 0.2 ng/mL
4.Linearity range
0.2~300 ng/mL , R≥0.990
5.Precision
Intra-lot precision
Within-run precision has been determined by using 10 replicates of 2 specimens containing 20 ng/mL, 120 ng/mL of H-FABP. The C.V. is ≤8%.
Inter-lot precision
Between-run precision has been determined by using 10 replicates for each of three lots using 2 specimens containing 20 ng/mL, 120 ng/mL of H-FABP. The C.V. is ≤15%.
6.Interfering Substances
The following potentially interfering substances were added to 2.45 ng/mL
and 92.42 ng/mL of H-FABP specimens.
Triglyceride: 10 mg/mL
Bilirubin: 0.1 mg/mL
Biotin: 100 ng/mL
Albumin: 2 mg/mL
Hemoglobin 5 mg/mL
None of the substances at the concentration tested interfered in the assay.
