Establishing reference intervals of four routine coagulation indicators in healthy Chinese adults

doi:10.16150/j.1671-2870.2023.04.008

Abstract

Abstract:

Objective To establish four coagulation indicators suitable for Chinese adults, including activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT) and fibrinogen (FIB). Methods Representative medical institutions from East and North China were selected. A total of 668 Chinese healthy adults were enrolled from Shanghai Oriental Hospital (South Campus), Beijing Jishuitan Hospital and Linyi Hospital of Traditional Chinese Medicine in this study. The cobas t 711 platform was used to detect the four coagulation indicators, and reference intervals were established based on the results. Results The reference interval applicable to all enrolled population was established: APTT (s): 26.6-43.6 s, PT (s): 7.67-10.5, TT (s): 14.5-19.2, FIB (mg/dL): 193-419. The four coagulation indicators were statistically different in different regions, genders and ages. In the gender analysis, difference in PT was the most significant (P<0.001). PT and APTT were higher in the male group, and FIB was higher in the female group; Taking ≤50 years as the cut-off age, APTT, FIB were statistically higher in the elderly group (>50 years old); There were statistical differences in APTT, FIB, PT, and TT in different regions (Shanghai, Beijing, and Shandong) (P<0.001). The median APTT and FIB were highest in Shanghai (P<0.001), the median PT was highest in Beijing (P=0.001), and the median TT was highest in Shandong. Conclusions The reference interval of four coagulation indicators suitable for Chinese healthy adult population is established. Factors that influencing the reference intervals include region and age. Reference intervals between male and female overlaps,and reference intervals establishment depends on laboratory conditions, influencing factors (region, and age) on coagulation management.

Key words: Coagulation indicators, Reference intervals, Healthy Chinese adults, Gender, Age

CLC Number:

YAO Yong, DONG Zhenghua, FAN Houzhen, GAO Yunqin, LIU Qian, WU Jun. Establishing reference intervals of four routine coagulation indicators in healthy Chinese adults[J]. Journal of Diagnostics Concepts & Practice, 2023, 22(04): 379-384.

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Gender	Age (year)	Sample (n)
Male
Standard deviation	45.2 (18.8)	317
Interquartile range	40(30.0-61.0)
Female
Standard deviation	43.2 (16.5)	351
Interquartile range	40 (30.0-55.0)
P	0.145	/

Gender	PT (s)	APTT (s)	TT (s)	FIB (mg/dL)
Male
Standard deviation	9.3 (1.1)	33.7 (4.7)	16.4 (1.2)	269.2 (58.7)
Interquartile range	9.3 (8.9-9.6)	33.1 (30.8-36.2)	16.2 (15.4-17.1)	260.5 (231.7-293.0)
Reference interval	7.7-10.8	26.7-44.0	14.5-19.0	190.0-414.0
Female
Standard deviation	9.1 (0.9)	33.1 (4.3)	16.5 (1.3)	272.1 (42.3)
Interquartile range	9.1 (8.7-9.5)	32.4 (29.9-35.4)	16.2 (15.5-17.1)	272.5 (242.2-309.0)
Reference interval	7.7-10.4	26.6-41.8	14.7-19.3	202.0-422.0
P	<0.001	0.048	0.029	0.001
Reference interval of healthy Chinese adults	7.7-10.5	26.6-43.6	14.5-19.2	193.0-419.0

Gender	PT (s)	APTT (s)	TT (s)	FIB (mg/dL)
Young group ≤50 (year)
Standard deviation	9.2 （0.7）	33.1 （4.0）	16.3 （1.2）	263.6 （52.2）
Interquartile range	9.2 （8.8-9.6）	32.6 （30.3-34.8）	16.2 （15.4-17.0）	258.0 （231.0-285.0）
Reference interval	7.8-10.6	24.6-43.2	14.5-19.2	188.1-397.8
Elderly group >50 (year)
Standard deviation	9.2 （1.5）	34.0 （5.4）	16.4 （1.3）	298.2 （57.0）
Interquartile range	9.1 （8.7-9.5）	33.3 （30.3-37.0）	16.2 （15.4-17.2）	289.5 （255.0-326.3）
Reference interval	7.3-10.8	26.7-44.3	14.5-19.5	212.9-443.4
P	0.942	0.031	0.316	<0.001

Indice	Shanghai	Beijing	Shandong	P	Overall	Product Manual
APTT(s)	34.1 (27.7-43.9）	31.9 (25.9-39.1)	32.1 (26.2-44.5)	<0.001	26.6-43.6	23.9-33.2
FIB(mg/dL）	280.0 (206.0-397.0)	245.0 (186.0-337.0)	266.0 （203.0-461.0）	<0.001	193.0-419.0	193.0-412.0
PT(s)	9.3 （8.35-10.4）	9.3 （8.22-10.6）	8.8 （7.29-10.5）	<0.001	7.67-10.5	8.4-10.6
TT(s)	15.6 （14.5-17.1）	16.2 （14.5-17.8）	17.5 （14.6-19.8）	<0.001	14.5-19.2	16.1-19.7