Aim: Measurement of B-type natriuretic peptide (BNP) is widely used as a
diagnostic and risk assessment tool for cardiovascular disease. Recent studies
have demonstrated that BNP-32 and its precursor proBNP circulate in the blood stream, and that most commercial BNP immunoassays
measure both forms. However, recombinant or synthetic BNP-32 is used as the
standard for those BNP immunoassays. This gap between clinical samples and the
standard might be a potential source of variation in BNP measurements among
assays. The purpose of this study is to validate a more suitable calibrator for
BNP immunoassays.Methods: External BNP calibrators containing both BNP-32 and glycosylated proBNP
were prepared at two concentration levels. Target BNP concentrations of the low
and high levels were 40 and 160 pg/mL, respectively. And to reflect clinical
samples, the molar ratios of BNP-32 to glycosylated proBNP in these
concentration levels were adjusted to 50:50 and 25:75, respectively. BNP
concentrations of plasma samples along with the external BNP calibrators were
measured at two commercial labs and using an automated analyzer MI02 Shionogi® BNP
(MI02). These samples and the calibrators were also measured using an
immunoradiometric assay (IRMA) as a standard assay procedure. Concentrations of
the plasma samples measured at the labs or using the MI02 were adjusted
according to a comparison of the measured concentrations of the external BNP
calibrators with the IRMA.Results: After measured concentrations of the plasma samples were adjusted using
the external BNP calibrators, the correlation between each measurement and the
IRMA was improved. The range of the slopes according to Passing-Bablok
regression analysis narrowed from 0.628-0.955 to
0.911-
References
[1]
Sudoh, T., Maekawa, K., Kojima, M., Minamino, N., Kangawa, K. and Matsuo, H. (1989) Cloning and Sequence Analysis of cDNA Encoding a Precursor for Human Brain Natriuretic Peptide. Biochemical and Biophysical Research Communications, 159, 1427-1434. https://doi.org/10.1016/0006-291X(89)92269-9
[2]
Mukoyama, M., Nakao, K., Saito, Y., Ogawa, Y., Hosoda, K., Suga, S., Shirakami, G., Jougasaki, M. and Imura, H. (1990) Human Brain Natriuretic Peptide, a Novel Cardiac Hormone. The Lancet, 335, 801-802.
https://doi.org/10.1016/0140-6736(90)90925-U
[3]
Mukoyama, M., Nakao, K., Saito, Y., Ogawa, Y., Hosoda, K., Suga, S., Shirakami, G., Jougasaki, M. and Imura, H. (1990) Increased Human Brain Natriuretic Peptide in Congestive Heart Failure. The New England Journal of Medicine, 323, 757-758.
https://doi.org/10.1056/NEJM199009133231114
[4]
Nakata, K., Komukai, K., Yoshii, Y., Miyanaga, S., Kubota, T., Kosuga, T., Suzuki, K., Yamada, T., Yoshida, J., Kimura, H., Takagi, M., Shimizu, M. and Yoshimura, M. (2015) The Optimal Cut-Off Value of Plasma BNP to Differentiate Heart Failure in the Emergency Department in Japanese Patients with Dyspnea. Internal Medicine, 54, 2975-2980.
[5]
Nakamura, M., Ishibashi, Y., Tanaka, F., Omama, S., Onoda, T., Takahashi, T., Takahashi, S., Tanno, K., Ohsawa, M., Sakata, K., Koshiyama, M., Ogasawara, K. and Okayama, A. (2018) Ability of B-Type Natriuretic Peptide Testing to Predict Cardioembolic Stroke in the General Population—Comparisons With C-Reactive Protein and Urinary Albumin. Circulation Journal, 82, 1017-1025.
[6]
Ponikowski, P., Voors, A.V., Anker, S.D., Bueno, H., Cleland, J.G.F., Coats, A.J.S., Falk, V., González-Juanatey, J.R., Harjola, V., Jankowska, E.A., Jessup, M., Linde, C., Nihoyannopoulos, P., Parissis, J.T., Pieske, B., Riley, J.P., Rosano, G.M.C., Ruilope, L.M., Ruschitzka, F., Rutten, F.H. and Meer, P. (2016) 2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. European Heart Journal, 37, 2129-2200. https://doi.org/10.1093/eurheartj/ehw128
[7]
Yancy, C.W., Jessup, M., Bozkurt, B., Butler, J., Casey Jr., D.E., Colvin, M.M., Drazner, M.H., Filippatos, G.S., Fonarow, G.C., Givertz, M.M., Hollenberg, S.M., Lindenfeld, J., Masoudi, F.A., McBride, P.E., Peterson, P.N., Stevenson, L.W. and Westlake, C. (2017) 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. Circulation, 136, e137-e161.
[8]
Tateyama, H., Hino, J., Minamino, N., Sakaki, K., Ogihara, T. and Matsuo, H. (1992) Concentration and Molecular Form of Human Nartiuretic Peptide in Plasma. Biochemical and Biophysical Research Communications, 185, 760-767.
https://doi.org/10.1016/0006-291X(92)91691-I
[9]
Yandle, T.G., Richards, A.M, Gilbert, A., Fisher, S., Holmes, S. and Espiner, E.A. (1993) Assay of Brain Natriuretic Peptide (BNP) in Human Plasma: Evidence for High Molecular Weight BNP as a Major Plasma Component in Heart Failure. The Journal of Clinical Endocrinology & Metabolism, 76, 832-838.
https://doi.org/10.1210/jcem.76.4.8473392
[10]
Shimizu, H., Masuta, K., Aono, K., Asada, H., Sasakura, K., Tamaki, M., Sugita, K. and Yamada, K. (2002) Molecular Forms of Human Brain Natriuretic Peptide in Plasma. Clinica Chimica Acta, 316, 129-135.
https://doi.org/10.1016/S0009-8981(01)00745-8
[11]
Giuliani, I., Rieunier, F., Larue. C., Delagneau, J.F., Granier, C., Pau, B., Ferrière, M., Saussine, M., Cristol, J.P., Dupuy, A.M., Merigeon, E., Merle, D. and Villard, S. (2006) Assay for Intact B-Type Natriuretic Peptide Prohormone in Blood. Clinical Chemistry, 52, 1054-1061. https://doi.org/10.1373/clinchem.2005.061770
[12]
Seferian, K.R., Tamm, N.N., Semenov, A.G., Mukharyamova, K.S., Tolstaya, A.A., Koshkina, E.V., Kara, A.N., Krasnoselsky, M.I., Apple, F.S., Esakova, Y.V., Filatov, V.L. and Katrukha, A.G. (2007) The Brain Natriuretic Peptide (BNP) Precursor Is the Major Immunoreactive Form of BNP in Patient with Heart Failure. Clinical Chemistry, 53, 866-873. https://doi.org/10.1373/clinchem.2006.076141
[13]
Tamm, N.N., Seferian, K.R., Semenov, A.G., Mukharyamova, K.S., Koshkina, E.V., Krasnoselsky, M.I., Postnikov, A.B., Serbryanaya, D.V., Apple, F.S., Murakami, M.M. and Katrukha, A.G. (2008) Novel Immunoassay for Quantification of Brain Natriuretic Peptide and Its Precursor in Human Blood. Clinical Chemistry, 54, 1511-1518. https://doi.org/10.1373/clinchem.2007.100545
[14]
Nishikimi, T., Minamino, N., Ikeda, M., Takeda, Y., Tadokoro, K., Shibasaki, I., Fukuda, H., Horiuchi, Y., Oikawa, S., Ieiri, T., Matsubara, M. and Ishimitsu, T. (2010) Diversity of Molecular Forms of Plasma Brain Natriuretic Peptide in Heart Failure—Different proBNP-108 to BNP-32 Ratios in Atrial and Ventricular Overload. Heart, 96, 432-439. https://doi.org/10.1136/hrt.2009.178392
[15]
Schellenberger, U., O’Rear, J., Guzzetta, A., Jue, R.A., Protter, A.A. and Pollitt, N.S. (2006) The Precursor to B-Type Natriuretic Peptide Is an O-Linked Glycoprotein. Archives of Biochemistry and Biophysics, 451, 160-166.
https://doi.org/10.1016/j.abb.2006.03.028
[16]
Halfinger, B., Hammerer-Lercher, A., Amplatz, B., Sarg, B., Kremser, L. and Lindner, H.H. (2017) Unraveling the Molecular Complexity of O-Glycosylated Endogenous (N-Terminal) pro-B-Type Natriuretic Peptide Forms in Blood Plasma of Patients with Severe Heart Failure. Clinical Chemistry, 63, 359-368.
https://doi.org/10.1373/clinchem.2016.265397
[17]
Semenov, A.G., Postnikov, A.B., Tamm, N.N., Seferian, K.R., Karpova, N.S., Bloshchitsyna, M.N., Koshkina, E.V., Krasnoselsky, M.I., Serebryanaya, D.V. and Katrukha, A.G. (2009) Processing of Pro-Brain Natriuretic Peptide Is Suppressed by O-Glycosylation in the Region Close to the Cleavage Site. Clinical Chemistry, 55, 489-498. https://doi.org/10.1373/clinchem.2008.113373
[18]
Semenov, A.G., Tamm, N.N., Seferian, K.R., Postnikov, A.B., Karpova, N.S., Serebryanaya, D.V., Koshkina, E.V., Krasnoselsky, M.I. and Katrukha, A.G. (2010) Processing of pro-B-Type Natriuretic Peptide: Furin and Corin as Candidate Convertases. Clinical Chemistry, 56, 1166-1176.
https://doi.org/10.1373/clinchem.2010.143883
[19]
Nishikimi, T., Nakagawa, Y., Minamino, N., Ikeda, M., Tabei, K., Fujishima, A., Takayama, K., Akimoto, K., Yamada, C., Nakao, K., Minami, T., Kuwabara, Y., Kinoshita, H., Tsutamoto, T., Ishimitsu, T., Kangawa, K., Kuwahara, K. and Nakao, K. (2015) Pro-B-Type Natriuretic Peptide Is Cleaved Intracellularly: Impact of Distance between O-Glycosylation and Cleavage Sites. The American Journal of Physiology-Regulatory, Integrative and Comparative Physiology, 309, R639-R649.
https://doi.org/10.1152/ajpregu.00074.2015
[20]
Nishikimi, T., Minamino, N., Horii, K. and Matsuoka, H. (2007) Do Commercially Available Kits for B-Type Natriuretic Peptide Measure Pro-BNP1-108, as Well as BNP1-32? Hypertension, 50, e163.
https://doi.org/10.1161/HYPERTENSIONAHA.107.098350
[21]
Luckenbill, K.N, Christenson, R.H., Jaffe, A.S., Mair, J., Ordonez-Llanos, J., Pagani, F., Tate, J., Wu, A.H.B, Ler, R. and Apple, F.S. (2008) Cross-Reactivity of BNP, NT-ProBNP and ProBNP in Commercial BNP and NT-ProBNP Assays: Preliminary Observations from the IFCC Committee for Standardization of Markers of Cardiac Damage. Clinical Chemistry, 54, 619-620.
https://doi.org/10.1373/clinchem.2007.097998
[22]
Cauliez, B, Santons, H., Bauer, F., Basuyau, J.P., Nadolny, A., Galpy, G. and Lavoinne, A. (2012) Cross-Reactivity with Endogenous ProBNP from Heart Failure Patients for Three Commercial BNP Immunoassays. Clinica Chimica Acta, 413, 337-338. https://doi.org/10.1016/j.cca.2011.09.022
[23]
Saenger, A.K., Rodriguez-Fraga, O., Ler, R., Ordonez-Llanos, J., Jaffe, A.S., Goetze, J.P. and Apple, F.S. (2017) Specificity of B-Type Natriuretic Peptide Assays: Cross-Reactivity with Different BNP, NT-proBNP, and proBNP Peptides. Clinical Chemistry, 63, 351-358. https://doi.org/10.1373/clinchem.2016.263749
[24]
Kono, M., Yamauchi, A., Tsuji, T., Misaki, A., Igano, K., Ueki, K., Fujishima, M., Ueda, A., Inouye, K., Nakao, K. and Imura, H. (1993) An Immunoradiometric Assay for Brain Natriuretic Peptide in Human Plasma. The Japanese Journal of Nuclear Medicine Technology, 13, 2-7.
[25]
Tsuju, T., Imagawa, K., Masuda, H., Haraikawa, M., Shibata, K., Kono, M., Inouye, K. and Uchida, H. (1994) Stabilization of Human Brain Natriuretic Peptide in Blood Samples. Clinical Chemistry, 40, 672-673.
[26]
Nishikimi, T., Okamoto, H., Nakamura, M., Ogawa, N., Horii, K., Nagata, K., Nakagawa, Y., Kinoshita, H., Yamada, C., Nakao, K., Minami, T., Kuwabara, Y., Kuwahara, K., Masuda, I., Kangawa, K., Minamino, N. and Nakao, K. (2013) Direct Immunochemiluminescent Assay for proBNP and Total BNP in Human Plasma proBNP and Total BNP Levels in Normal and Heart Failure. PLoS ONE, 8, e53233.
https://doi.org/10.1371/journal.pone.0053233
[27]
Shimosako, K., Takahashi, A., Saitou, T., Tanaka, H., Kaneshige, T. and Futana, T. (2005) Evaluation of Automated Chemiluminescent Immunoassay Analyzer Exclusive Kit “MI02 Shionogi? BNP”. Journal of Pharmaceutical Science and Technology, Japan, 53, 355-360.
[28]
Semenov, A.G., Tamm, N.N., Apple, F.S., Schulz, K.M., Love, S.A., Ler, R., Feygina, E.E. and Katrukha, A.G. (2017) Searching for a BNP Standard: Glycosylated proBNP as a Common Calibrator Enables Improved Comparability of Commercial BNP Immunoassays. Clinical Biochemistry, 50, 181-185.
https://doi.org/10.1016/j.clinbiochem.2016.11.003
[29]
Hammerer-Lercher, A., Halfinger, B., Sarg, B., Mair, I.J., Puschendorf, B., Griesmacher, A., Guzman, N.A. and Lindner, H.H. (2008) Analysis of Circulating Forms of proBNP and NT-proBNP in Patients with Severe Heart Failure. Clinical Chemistry, 54, 858-865. https://doi.org/10.1373/clinchem.2007.090266
[30]
Fischer, Y., Filzmaier, K., Stiegler, H., Graf, J., Fuhs, S., Franke, A., Janssens, U. and Gressner, A.M. (2001) Evaluation of a New, Rapid Bedside Test for Quantitative Determination of B-Type Natriuretic Peptide. Clinical Chemistry, 47, 591-594.
[31]
Clerico, A., Prontera, C., Emdin, M., Passino, C., Storti, S., Poletti, R., Zyw, L. and Zucchelli. G.C. (2005) Analytical Performance and Diagnostic Accuracy of Immunometric Assays for the Measurement of Plasma B-Type Natriuretic Peptide (BNP) and N-Terminal proBNP. Clinical Chemistry, 51, 445-447.
https://doi.org/10.1373/clinchem.2004.038281
