Author(s)

Zhang Lei ¹, Yang Feng ², Zhu Junzhe ³

Affiliation(s)

¹ Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
² Community Health Service Center, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Zhang Lei

ABSTRACT

The H-FABP and Myoglobin/CK-MB/Cardiac Troponin I Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) is a chromatographic immunoassay designed for the qualitative detection of human heart-type fatty acid-binding protein (H-FABP), myoglobin (MYO), creatine kinase MB (CK-MB) and cardiac troponin I (cTnI) in whole blood, serum, or plasma, thereby aiding in the diagnosis of acute myocardial infarction (AMI); this study aimed to evaluate both the consistency between the test results of CITEST DIAGNOSTICS INC.'s combo rapid test and the reference device, as well as its clinical applicability, so it conducted tests on representative specimens, analyzed the results using scientific statistical methods, and adopted enzyme-linked immunosorbent assay (ELISA) as the reference method, specifically testing 281 H-FABP specimens, 514 myoglobin specimens, 887 cTnI specimens, and 797 CK-MB specimens, which showed the test had high sensitivity (89.9% for H-FABP, 98.7% for myoglobin, 98.1% for cTnI, 98.2% for CK-MB), specificity (91.0% for H-FABP, 97.2% for myoglobin, 98.5% for cTnI, 99.2% for CK-MB), and accuracy (90.7% for H-FABP, 97.5% for myoglobin, 98.4% for cTnI, 99.1% for CK-MB), with Kappa values ranging from 0.76 to 0.97 (indicating good to excellent consistency with the reference method) and additionally, the test exhibited no cross-reactivity with common interfering substances and remained stable under the recommended storage conditions (2-30°C), confirming it as a reliable, rapid, and practical tool for the simultaneous detection of key cardiac biomarkers and facilitating timely AMI assessment.

KEYWORDS

H-FABP; Myoglobin; CK-MB; Cardiac Troponin I; Rapid Test; Myocardial Infarction; Chromatographic Immunoassay

CITE THIS PAPER

Zhang Lei, Yang Feng, Zhu Junzhe, Performance Evaluation of H-FABP and Myoglobin/CK-MB/Cardiac Troponin I Combo Rapid Test Cassette (CMA-445) via Clinical Validation. MEDS Clinical Medicine (2025) Vol. 6: 32-37. DOI: http://dx.doi.org/10.23977/medsc.2025.060505.

REFERENCES

[1] Wong SS. Strategic utilization of cardiac markers for diagnosis of acute myocardial infarction. Ann Clin Lab Sci, 26:301-312, 1996.
[2] Kagen LJ. Myoglobin methods and diagnostic uses. CRC Crit. Rev. Clin. Lab. Sci., 2:273, 1978.
[3] Chapelle JP, et al. Serum myoglobin determinations in the assessment of acute myocardial infarction. Eur. Heart J, 3:122, 1982.
[4] Apple FS, Preese LM. Creatine kinase-MB: detection of myocardial infarction and monitoring reperfusion. J Clin Immunoassay, 17:24-29, 1994.
[5] Lee TH, Goldman L. Serum enzyme assays in the diagnosis of acute myocardial infarction. Ann Intern Med, 105:221-233, 1986.
[6] Kallner A, Sylven C, Brodin U, et al. Early diagnosis of acute myocardial infarction; a comparison between chemical predictors. Scand J Clin Lab Invest, 49:633-639, 1989.
[7] Adams, et al. Biochemical markers of myocardial injury. Circulation, 88:750-763, 1993.
[8] Mehegan JP, Tobacman LS. Cooperative interaction between troponin molecules bound to the cardiac thin filament. J Biol Chem, 266:966, 1991.
[9] Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. Eur Heart J, 32: 2551-2567, 2011.
[10] van der Wall EE, de Boer MJ, Hamm CW, et al. Heart-type fatty acid-binding protein as an early marker of myocardial infarction. Lancet, 352:1041-1042, 1998.
[11] Jaffe AS, Babuin L, Apple FS. Biomarkers in acute cardiac disease: the present and the future. J Am Coll Cardiol, 52:1725-1739, 2008.

Sponsors, Associates, and Links

---

• Journal of Neurobiology and Genetics
  
  
• Medical Imaging and Nuclear Medicine
  
  
• Bacterial Genetics and Ecology
  
  
• Transactions on Cancer
  
  
• Journal of Biophysics and Ecology
  
  
• Journal of Animal Science and Veterinary
  
  
• Academic Journal of Biochemistry and Molecular Biology
  
  
• Transactions on Cell and Developmental Biology
  
  
• Rehabilitation Engineering & Assistive Technology
  
  
• Orthopaedics and Sports Medicine
  
  
• Hematology and Stem Cell
  
  
• Journal of Intelligent Informatics and Biomedical Engineering
  
  
• MEDS Basic Medicine
  
  
• MEDS Stomatology
  
  
• MEDS Public Health and Preventive Medicine
  
  
• MEDS Chinese Medicine
  
  
• Journal of Enzyme Engineering
  
  
• Advances in Industrial Pharmacy and Pharmaceutical Sciences
  
  
• Bacteriology and Microbiology
  
  
• Advances in Physiology and Pathophysiology
  
  
• Journal of Vision and Ophthalmology
  
  
• Frontiers of Obstetrics and Gynecology
  
  
• Digestive Disease and Diabetes
  
  
• Advances in Immunology and Vaccines
  
  
• Nanomedicine and Drug Delivery
  
  
• Cardiology and Vascular System
  
  
• Pediatrics and Child Health
  
  
• Journal of Reproductive Medicine and Contraception
  
  
• Journal of Respiratory and Lung Disease
  
  
• Journal of Bioinformatics and Biomedicine