The first experience of clinical implementation of express-test for the qualitative simultaneous evaluation of cardiac protein, binding fatty acids, and cardiac troponin I in patients with suspected acute coronary syndrome


DOI: https://dx.doi.org/10.18565/therapy.2019.1.36-42

Kokorin V.A., Arefiev M.N., Levchouk N.N., Goncharova A.Ya., Yakovtsova A.A.

1 Pirogov Russian National Research Medical University, Moscow; 2 Municipal Clinical Hospital № 15 named after O.M. Filatov, Moscow; 3 Alliance of Competences «Park of Active Molecules» Scientific Research Center, Kaluga Region, Obninsk
Summary. The simultaneous evaluation of several markers of myocardial damage and necrosis (a multi-marker approach) may allow to exclude or to confirm the diagnosis of myocardial infarction (MI) more quickly and precise than the serial measurement of cardiac troponins. The aim was to assess the diagnostic efficacy of the new express-test «CARD-INFO 1+1» («CARDIO-Plus», Russia) for the qualitative simultaneous evaluation of the concentration of heart type fatty acid binding protein (H-FABP) and cardiac troponin I (cTnI) in patients with acute coronary syndrome (ACS). Material and methods. 118 patients admitted to the hospital with the referral diagnosis of «ACS», typical angina duration at least 20 min in the interval 1-24 h since the beginning of the pain syndrome were enrolled into the study. A qualitative evaluation of H-FABP and cTnI concentrations was performed in all patients at admission by the immunochromatographic rapid test «CARD-INFO 1+1» in addition to the standard diagnostic procedures. Results. The sensitivity of «CARD-INFO 1+1» was 85,9% (95% CI: 77,7–91,8%), specificity – 77,5% (95% CI: 64,4–87,3%), diagnostic accuracy – 83,1% (95% CI: 76,0–88,6%), positive prognostic value – 88,2% (95% CI: 80,3–93,5%), negative prognostic value – 73,8% (95% CI: 60,5–84,3%). A diagnostic efficiency of the test in patients with ACS with and without ST-segment elevation was not significantly different (p>0.05). A sensitivity of the express-test «CARD-INFO 1+1» reached a maximum in the period between 3 and 6 hours from the pain onset. The application of the test «CARD-INFO 1+1» in addition to the first measurement of hsTnI performed at admission revealed a 17,5% more cases of MI. Conclusion. The first results on the clinical application of the express-test «CARD-INFO 1+1» has demonstrated its high efficiency in the diagnosis of MI, which was not inferior to the evaluation of hsTnI. Further studies are required to confirm the data obtained and to clarify the diagnostic significance of the above test in ACS.

Literature



  1. Здравоохранение в России. 2017: Стат. сб. Росстат. М., 2017. 170 с.

  2. https://www.factograph.info/a/29104480.html

  3. Thygesen K., Alpert J.S., Jaffe A.S., Chaitman B.R., Bax J.J. et al. Fourth universal definition of myocardial infarction. European Heart Journal. 2018. https://doi.org/10.1093/eurheartj/ehy462.

  4. Odqvist M., Andersson P. O., Tygesen H., Eggers K. M., Holzmann M. J. High-sensitivity troponins and outcomes after myocardial infarction. J Am Coll Cardiol. 2018; 71(23): 2616–24.

  5. Shah A.S.V., Anand A., Strachan F.E., Ferry A.V., Lee K.K. et al. High-sensitivity troponin in the evaluation of patients with suspected acute coronary syndrome: a stepped-wedge, cluster-randomised controlled trial. Lancet. 2018; 392(10151): 919–28.

  6. Kleine A.H., Glatz J.F., van Nieuwenhoven F.A. et al. Release of heart fatty acid-binding protein after acute myocardial infarction in man. Mol Cell Biochem 1992; 116: 155–62.

  7. Hamm C.W., Bassand J.-P., Agewall S. et al. Guidelines for the management of acute coronary syndromes (ACS) in patients presenting without peristent ST segment elevation. Eur Heart J. 2011; 32: 2999–3054.

  8. Кокорин В.А. Сердечный белок, связывающий жирные кислоты, в диагностике и прогнозировании течения острого коронарного синдрома: новые возможности или утраченные иллюзии? Терапия. 2018; 3(21): 125–33.

  9. Dupuy A.M., Cristol J.P., Kuster N. et al. Performances of the heart fatty acid protein assay for the rapid diagnosis of acute myocardial infarction in ED patients. Am J Emerg Med. 2015; 33(3): 326–30.

  10. Young J.M., Pickering J.W., George P.M. et al. Heart fatty acid binding protein and cardiac troponin: development of an optimal rule-out strategy for acute myocardial infarction. BMC Emerg Med. 2016; 16(1): 34.

  11. Body R., Dixon D., Burrows G. et al. Economic evaluation of a heart-type fatty acid binding protein based protocol for rapid chest pain assessment. 14th International Conference on Emergency Medicine. Acad Emerg Med. 2012; 19(6): 746–47.

  12. Body R., McDowell G., Carley S. et al. A FABP-ulous ‘rule out’ strategy? Heart fatty acid binding protein and troponin for rapid exclusion of acute myocardial infarction. Resuscitation. 2011; 82(8): 1041–46.

  13. McMahon C.G., Lamont J.V., Curtin E. et al. Diagnostic accuracy of heart-type fatty acid-binding protein for the early diagnosis of acute myocardial infarction. Am J Emerg Med. 2012; 30(2): 267–74.

  14. Jacobs L.H., van Borren M., Gemen E. et al. Rapidly rule out acute myocardial infarction by combining copeptin and heart-type fatty acid-binding protein with cardiac troponin. Ann Clin Biochem. 2015; 52(Pt 5): 550–61.

  15. Батурина О.В. Сочетанное применение тестов на биомаркеры для ранней диагностики острого инфаркта миокарда: автореферат дис. канд. мед. наук. Москва, 2015. 25 с.

  16. Banu S., Tanveer S., Manjunath C.N. Comparative study of high sensitivity troponin T and heart-type fatty acid-binding protein in STEMI patients. Saudi J Biol Sci. 2015; 22(1): 56–61.

  17. Collinson P.O., Gaze D.C., Thokala P. et al. Randomised assessment of treatment using panel assay of cardiac markers – contemporary biomarker evaluation (RATPAC CBE). Health Technol Assess. 2013; 17(15): V–VI, 1–122.

  18. Gami B.N., Patel D.S., Haridas N. et al. Utility of heart-type fatty acid binding protein as a new biochemical marker for the early diagnosis of acute coronary syndrome. J Clin Diagn Res. 2015; 9(1): BC22–24.

  19. Schoenenberger A.W., Stallone F., Walz B. et al. Incremental value of heart-type fatty acid-binding protein in suspected acute myocardial infarction early after symptom onset. Eur Heart J Acute Cardiovasc Care. 2016; 5(2): 185–92.

  20. Liou K., Ho S., Ooi S.Y. Heart-type fatty acid binding protein in early diagnosis of myocardial infarction in the era of high-sensitivity troponin: a systematic review and meta-analysis. Ann Clin Biochem. 2015; 52(Pt 3): 370–81.

  21. Шалмиев Г. Диагностическое значение быстрого экспресс-анализа SensAheart (Новамед, Израиль) у пациентов с установленным или возможным острым коронарным синдромом (ОКС). Главный врач Юга России. 2017; 2(54): 12–14.

  22. Thygesen K., Alpert J.S., Jaffe A.S. et al. Third Universal Definition of Myocardial Infarction. Eur Heart J. 2012; 33: 2551–67.


About the Autors


Valentin A. Kokorin, MD, PhD, associate professor of the Hospital therapy №1 Department of Pirogov Russian National research medical University of the Ministry of Healthcare of Russia. Address: 117997, Moscow, 1 Ostrovityanova str. Tel.: +79161329606. E-mail: valentinkokorin@yahoo.com
Mikhail N. Arefiev, MD, head of department of anesthesiology and intensive care № 9, Municipal clinical hospital №15 named after O.M. Filatov, Department of Health of Moscow. Address: 111539, Moscow, 23 Veshnyakovskaya str.
Tel.: +79037908058. e-mail: ar839mn@yandex.ru, http://orcid.org/ 0000-0002-6675-5794
Nina N. Levchouk, MD, PhD, head of clinical and diagnostic laboratory, Municipal clinical hospital №15 named after O.M. Filatov, Department of Health of Moscow. Address: 111539, Moscow, 23 Veshnyakovskaya str. Tel.: +79035627459. E-mail: krumina64@rambler.ru
Anna Ya. Goncharova, PhD, Director of Alliance of competences «Park of Active Molecules» Scientific research center. Address: 249030, Kaluga region, Obninsk, 3 Kievskoe shosse; tel.: +79109135766. E-mail: goncharova@pam-alliance.ru
Anna A. Yakovtsova, Chief of test production Department, Alliance of competences «Park of Active Molecules» Scientific research center. Address: 249030, Kaluga region, Obninsk, 3 Kievskoe shosse. Tel.: +79109166306.
E-mail: utp@pam-alliance.ru


Similar Articles


Бионика Медиа