Quality assurance and quality control of biospecimen

doi:10.3877/cma.j.issn.2095-5820.2017.01.009

Abstract

Abstract:

With the fast growth and increasing demands for translational research, collection of clinical research resources in biobanks around the world has brought us a big concern about sample quality and its usability. Quality assurance(QA) and quality control (QC) of biospecimen are the key factors of biobank quality and usability. The main factors influencing the quality of biospecimen are pre-analytical and analytical variables, including the donor′s biological and environmental factors, biospecimen collection, processing, transportation, storage, distribution, analysis and so on. Those factors such as personnel, equipment, material, method and environment, which could interact with pre-analytical and analytical variables, directly influence the quality of biospecimen, so it is difficult to guarantee quality samples in clinical translational research if only single factor is applied to sample quality management. We should develop a quality management system specific to quality control of biobank. The goal is to gradually develop international standardization and accreditation. Taking together, it would facilitate quality samples for quality research as clinical research resources in term of biomarker and drug discovery for both translational and personal medicine.

Key words: Clinical bio-bank, Quality control, Quality assurance, Translational medicine

Dan Guo, Anqi Wang, Jian Sun, Yingchun Xu. Quality assurance and quality control of biospecimen[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2017, 05(01): 36-45.

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References 50

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分析前变量								分析中变量
生物变量	环境变量	血液样本采集	组织样本采集	血液样本处理	组织样本处理	样本存储	样本运输	样本前处理
年龄	季节更替	采集时间点	采集时间点	离心温度	延迟处理时间	时间	时间	分析方法
性别	气温	采集方式	麻醉方式	离心力	冷冻效率	方式	方式	分析试剂
种族	湿度	采集姿势	麻醉持续时间	离心时间	样本大小	温度	温度	仪器
生理周期	地理位置	采集顺序	动脉夹闭时间	延迟处理时间	固定剂种类	冻融次数	路程远近	人员操作
怀孕/哺乳	海拔高度	麻醉方式	热缺血时间	样本状态	固定方式	样本浓度	样本包装	?
饮食/生活方式	日照强度	麻醉持续时间	冷缺血时间	?	固定时间	?	安全性	?
疾病/药物治疗	?	抗凝剂种类	手术方式	?	固定温度	?	?	?
吸烟/饮酒	?	?	?	?	固定及时性	?	?	?
锻炼	?	?	?	?	?	?	?	?
体态	?	?	?	?	?	?	?	?
昼夜节律变化	?	?	?	?	?	?	?	?

分析前变量								分析中变量
生物变量	环境变量	血液样本采集	组织样本采集	血液样本处理	组织样本处理	样本存储	样本运输	样本前处理
年龄	季节更替	采集时间点	采集时间点	离心温度	延迟处理时间	时间	时间	分析方法
性别	气温	采集方式	麻醉方式	离心力	冷冻效率	方式	方式	分析试剂
种族	湿度	采集姿势	麻醉持续时间	离心时间	样本大小	温度	温度	仪器
生理周期	地理位置	采集顺序	动脉夹闭时间	延迟处理时间	固定剂种类	冻融次数	路程远近	人员操作
怀孕/哺乳	海拔高度	麻醉方式	热缺血时间	样本状态	固定方式	样本浓度	样本包装	?
饮食/生活方式	日照强度	麻醉持续时间	冷缺血时间	?	固定时间	?	安全性	?
疾病/药物治疗	?	抗凝剂种类	手术方式	?	固定温度	?	?	?
吸烟/饮酒	?	?	?	?	固定及时性	?	?	?
锻炼	?	?	?	?	?	?	?	?
体态	?	?	?	?	?	?	?	?
昼夜节律变化	?	?	?	?	?	?	?	?

抗凝剂种类	适合分析	不适合分析
无/二氧化硅/凝血酶	大多数生化分析、激素分析代谢组学研究^[8]	?
EDTA	多数DNA和蛋白分析^[8,11]、游离核酸^[9]、外泌体^[9]、血液学分析^[8]	PCR分析^[11]、金属离子测定^[8,11]、细胞遗传学分析^[8]
枸橼酸盐	RNA/DNA分析^[8,11]、红细胞沉降率、凝血因子/血小板分析^[8,11]、淋巴细胞活性分析^[8,11]	?
肝素	激素分析^[9]、肾功能测定^[9]、肝脏酶学检测^[9]、代谢组学研究^[8]	PCR分析^[8,11,14]、DNA提取^[14]
氟化钠	血糖^[9]	?

抗凝剂种类	适合分析	不适合分析
无/二氧化硅/凝血酶	大多数生化分析、激素分析代谢组学研究^[8]	?
EDTA	多数DNA和蛋白分析^[8,11]、游离核酸^[9]、外泌体^[9]、血液学分析^[8]	PCR分析^[11]、金属离子测定^[8,11]、细胞遗传学分析^[8]
枸橼酸盐	RNA/DNA分析^[8,11]、红细胞沉降率、凝血因子/血小板分析^[8,11]、淋巴细胞活性分析^[8,11]	?
肝素	激素分析^[9]、肾功能测定^[9]、肝脏酶学检测^[9]、代谢组学研究^[8]	PCR分析^[8,11,14]、DNA提取^[14]
氟化钠	血糖^[9]	?

样本类型		原始采样管		离心延迟时间			第一次离心					第二次离心					离心后时间			长期存储
AMN	羊水	ACD	枸橼酸葡萄糖	A	常温	<2 h	A	常温	10 min	<3000g	无制动	A	常温	10 min	<3000g	无制动	A	3~7℃	<1 h	A	0.5~2 ml的PP管	-85 ~ -60℃
ASC	腹水	CPD	枸橼酸盐磷酸盐右旋糖	B	3~7℃	<2 h	B	常温	10 min	<3000g	制动	B	常温	10 min	<3000g	制动	B	常温	<1 h	B	0.5~2 ml的PP管	-35 ~ -18℃
BAL	支气管肺泡灌洗物	HEP	肝素锂	C	常温	2~4 h	C	3~7℃	10 min	<3000g	无制动	C	3~7℃	10 min	<3000g	无制动	C	3~7℃	1~2 h	C	1~2 ml冻存管	液氮
BLD	全血	HIR	水蛭素	D	3~7℃	2~4 h	D	3~7℃	10 min	<3000g	制动	D	3~7℃	10 min	<3000g	制动	D	常温	1~2 h	D	1~2 ml冻存管	-85 ~ -60℃
BMA	骨髓	ORG	Oragene或类似采集容器	E	常温	4~8 h	E	常温	10 min	3000~6000g	制动	E	常温	10 min	3000~6000g	制动	E	3~7℃	2~8 h	E	1~2 ml冻存管	程序冷冻到-135℃以下
BMK	母乳	PAX	血液RNA	F	3~7℃	4~8 h	F	3~7℃	10 min	3000~6000g	制动	F	3~7℃	10 min	3000~6000g	制动	F	常温	2~8 h	F	麦管	液氮
BUC	口腔细胞	PED	乙二胺四乙酸钾（依地酸钾）	G	常温	8~12 h	G	常温	10 min	6000~10 000g	制动	G	常温	10 min	6000~10 000g	制动	G	3~7℃	8~24 h	G	麦管	-85 ~ -60℃
BUF	活性非聚蔗糖离心棕黄层	PIX	蛋白酶抑制剂	H	3~7℃	8~12h	H	3~7℃	10 min	6000~10 000g	制动	H	3~7℃	10 min	6000~10 000g	制动	H	常温	8~24 h	H	麦管	-35 ~ -18℃
CEL	Ficoll液分离的活性单核细胞	PI1	S8820蛋白酶抑制剂或等价物	I	常温	12~24 h	I	常温	10 min	>10 000g	制动	I	常温	10 min	>10 000g	制动	I	3~7℃	>24 h	I	麦管	程序冷冻到-135℃以下
CEN	非血液新鲜细胞	PPS	聚丙烯无菌管	J	3~7℃	12~24 h	J	3~7℃	10 min	>10 000g	制动	J	3~7℃	10 min	>10 000g	制动	J	常温	>24 h	J	≥5 ml的PP管	-85 ~ -60℃
CLN	非血液活性细胞	PXD	血液DNA	K	常温	24~48 h	N	无离心	无离心	无离心	无离心	N	无离心	无离心	无离心	无离心	X	未知	未知	K	≥5 ml的PP管	-35 ~ -18℃
CRD	脐带血	PXR	骨髓RNA	L	3~7℃	24~48 h	X	未知	未知	未知	未知	X	未知	未知	未知	未知	Z	其他	其他	L	微孔板	-85 ~ -60℃
CSF	脑脊液	SCI	枸橼酸钠	M	常温	>48 h	Z	其他	其他	其他	其他	Z	其他	其他	其他	其他	?	?	?	M	微孔板	-35 ~ -18℃
NAS	鼻腔清洗物	SED	乙二胺四乙酸钠（依地酸钠）	N	3~7℃	>48 h	?	?	?	?	?	?	?	?	?	?	?	?	?	P	石蜡包埋	室温
PEL	Ficoll液分离的无活性单个核细胞	SPO	氟化钠/草酸钾	O	35~38℃	<2 h	?	?	?	?	?	?	?	?	?	?	?	?	?	X	未知	未知
PEN	非血液无活性细胞	SST	促凝血清分离管	X	未知	未知	?	?	?	?	?	?	?	?	?	?	?	?	?	Z	其他	其他
PFL	胸水	TEM	Tempus管	Z	其他	其他	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
PL1	单次离心血浆	TRC	微量元素管	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
PL2	二次离心血浆	XXX	未知	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
SAL	唾液	ZZZ	其他	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
SEM	精液	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
SER	血清	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
SPT	唾液	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
STL	大便	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
SYN	关节滑膜液	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
TER	泪液	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
U24	24h尿	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
URN	尿液	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?
ZZZ	其他	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?	?

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