The 99th percentile values of six cardiac troponin assays established for a reference population using strict selection criteria.
BACKGROUND
Since the 99th percentile reference limit for cardiac troponin (Tn) can vary depending on the reference population, Sandoval et al. published systematic selection criteria. In this study, these systematic criteria were applied for the first time to obtain the 99th percentile reference limits for 6 Tn tests.


METHODS
The reference population was selected in accordance with the systematic criteria, and reference limits were set with respect to the six types of Tn assays. The coefficient of variation (CV) at the reference limit was determined using 3-4 concentrations of frozen serum.


RESULTS
In total, 641 South Koreans (303 males, 338 females) were selected as the reference population. The 99th percentile reference limit of Tn in the six assays ranged from 13.4 to 34.2pg/ml. The measurable fractions among the reference population ranged from 1.3% to 80.5%. The CVs at the reference limit ranged from 5.3% to 43.0%, and three were <10%.


CONCLUSIONS
In this study, a reference population was selected for the first time in accordance with the systematic criteria of Sandoval et al., and the reference limit for South Koreans was established. The values obtained in this study are different from those proposed by manufacturers, which confirms the importance of having a reference population. Four out of six assays did not fulfill the criteria for high-sensitivity tests.
Department of Laboratory Medicine, Hallym University College of Medicine, Dongtan Sacred Heart Hospital, Hwaseong, Republic of Korea.
Dae-Hyun
DH
Ko
Department of Laboratory Medicine, Ewha Womans University, School of Medicine, Seoul, Republic of Korea.
Tae-Dong
TD
Jeong
Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Eun-Jung
EJ
Cho
Department of Laboratory Medicine, Chungnam National University College of Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea.
Jinsook
J
Lim
Department of Laboratory Medicine, Konkuk University School of Medicine, Konkuk University Hospital, Seoul, Republic of Korea.
Misuk
M
Ji
Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Kyunghoon
K
Lee
Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Woochang
W
Lee
Department of Laboratory Medicine, Konkuk University School of Medicine, Konkuk University Hospital, Seoul, Republic of Korea.
Yeo-Min
YM
Yun
Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Sail
S
Chun
Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Junghan
J
Song
Department of Laboratory Medicine, Chungnam National University College of Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea.
Kye-Chul
KC
Kwon
Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea. Electronic address: wkmin@amc.seoul.kr.
Won-Ki
WK
Min
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001774:Blood Chemical Analysis / Q000592:standards*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009206:Myocardium / Q000378:metabolism*; D018579:Patient Selection; D012016:Reference Values; D014336:Troponin / Q000097:blood*; D055815:Young Adult
D014336:Troponin
99th percentile; Reference population; South Korean; Troponin