6 Sigma 在临床生化检测的应用:
Architect c16000
• Kasal C, et al. Evaluation of general chemistry
assays on the Abbott Architect c16000 clinical
chemistry system. Clin Chem 2007;53(S);A175.
www,westgard, Alb BCG s
AlbuminBCG = s
Albumin BCP = s
Total Bilirubin = s
Calcium = s
Cholesterol = s
Creatinine = s
Glucose = s
Total Protein = s
Triglycerides = s
Lambert-Beer's Law
当一束平行的单色光通过一定均匀的某吸
收溶液时，该溶液对光的吸收程度 与吸光
物质的浓度c和光通过的液层厚度b的乘积
成正比。这种关系称为朗伯-比尔定律，其
数学表达式为 。
A = Kbc
c=A *1/kb
F=Kb
A称为吸光度，I0和I分别为入射光和透射
光的强度，b为光通过的液层厚度，c为吸
光物质的浓度，K为比例常数。b的单位为
cm, 若c的单位以mol/L表示，则用ε表示K
，ε称为摩尔吸光系数，单位为L/(mol·cm)
；若c的单位以g/L表示，则用a表示K， a
称为吸光系数，单位为L/(g·cm)。由于吸光
度与吸光物质浓度的关系最为重要，有时
又被简称比尔定律。
光学检测原理
• 光路系统为直接光检测，后分光，采用凹
面衍射光栅，有16个检测波长。光路系统
主要组成有：卤钨灯，隔热玻璃，凸镜，
Shutter，狭缝，反光镜，光栅，线性硅
二极管矩阵，前置放大板，数据处理板和
CPU板等。光路组件将光聚焦后射入反应
杯，当反应杯中的物质发生化学反应时，
其吸光度会发生变化。光经狭缝到光栅后
被分成不同的波长，线性硅二极管矩阵根
据不同波长进行检测。用单波长或双波长
测定每个读数点，一般分析项目都使用双
波长检测。
关于反应时间
• 反应时间包括反应杯
转盘的转动，转动的
时间和转盘周围组件
的位置
• 每次转动都发生在特
定的时间和到达特定
的位置
• 反应转盘按逆时针方
向每秒旋转近1/4
圈（41个反应杯的位
置）使反应杯到达特
定位置
• 每一次旋转，有41个
反应杯会经过光路系
统，每个反应杯中的
吸光度值都会被检测
到
关于反应的几个点
1.起始位置，样品探针将样品吸入反
应杯
2. R1位置，试剂探针1将1试剂
（或样品稀释液）加入反应杯
3.无动作
4.混匀位置1，样品和1试剂（或样品
稀释液）被混匀
4~5.反应杯经过光路系统被读取吸光度
值
5.以上总共转了4个1/4圈共164个反应
杯位置，此位置为起始1号位置的后
一个反应杯的位置（总共有165个反
应杯）。如果样品需稀释，在此位
置样品探针将稀释样品吸入放入1号
位置的反应杯。
31.如此样品进行ICT检测，在此位置
被ICT系统的探针从反应杯吸入稀释
样品进行检测
位置，试剂探针2将2试剂加入反
应杯（此前时间为分钟）
68.混匀位置2，样品/试剂1和试剂2被
混匀
6~135.为持续旋转孵育时间，当反应
杯每经过一次光路系统将被读取吸
光度值，总共最多33次读数
136~164.反应杯清洗系统对反应杯进
行8步清洗步骤
165.此位置为到重新使用的1号位置前
的最后一个循环位置（至此全部反
应时间为分钟）
REACTION TIME
TABLE
sa
m
pl
e
re ag en t 1
m
i
x s
a m pl e &
R 1
Cuvette position:
1 2 4 67 68 132 136
re ag en t 2
m
i
x
sa m pl e + R
1
+R 2
la st
o pt ic
re ad
w as h
st ar t
fir st
" 9" ' " '
Sample + R1 (blank reading) Reaction (sample + R1+ R2)
w as h st ar
t
18"
re ad
p oi nt
1 re ad p oi nt
17re ad p oi nt
18 re ad p o
i nt
33
blank read option react. readtime / flex rate read option
st ar
t
R 1
fir st
Total reaction time = min. (same for each assay)
- 10 -
读数点示意图
仪 器 详 述
è 分配组件加液量
è 光路
è 反应时间
è常见报警
- 6 -
雅培诊断
各分配组件加液量详述
范围 步进
Sample Volume 样本体积:
DS Vol = Diluted sample Volume:稀释样本
Reagent 1 Volume R1 试剂量:
Reagent 2 Volume R2 试剂量 :
Smartwash Volume 智能冲洗洗液量
Water/Diluent Vol for Conc. Reagent:
浓缩试剂使用水或稀释液的量Total Volume in Cuvette:
反应杯最小量及最大量
* Not including over aspiration volume
** Water- and reagent volume entered determine the
dilution ratio
- 7 -
Volume Tolerance:
Volume range Min/Max Range Precision
20 to 50 µL nominal +/- 5% </= 2 %
51 to 345 µL nominal +/- % </= %
2 to 35 µL µL steps
2 to 15 µL µL steps
20 to 345 µL µL steps
20 to 345 µl 1 µL steps
10 to 345 µL steps*
0 to 345 µL µL steps**
Min. 160 µl
Max. 360 µl
光路详述
波长
Specifications Options
光径
测量体积:
读数点:
吸光度范围
吸光度线性
- 8 -
16
340 – 380 – 404 – 412 – 444 –
476 –
500 – 524 – 548 – 572 – 604 –628
–
660 – 700 – 748 - 804
5 mm Mono-/Bichromatic(单或双)
Min. 160 µL
Max. 360 µL
Mono Reag.: 1 – 33 points
Bi Reag.: 1 – 16 (Blank)
17 – 33
(Reaction)
1 – 33 (每 18 秒)
- to Abs
Within +/- 2 % at 2
Abs
项目反应类型
- 11 -
终点法:
End – up
End – down
速率法 (Kinetik):
Rate – up
Rate - down
- 11 -
终点法:
反应达到平衡
单双试剂都可以使用
双试剂推荐使用Self blank
反应类型 –终点法1
反应类型–终点法2
TimeSample Dispense
+ R1 R2 addition
=Reaction Start
- 9 -
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33
A bs or ba nc e
Total Abs – Self blank Abs =
未知样本浓度= D Abs x cal Factor
D Abs
Total A
bs
D A
bs
Self blank Abs
self blank 可读点范围
A1
A2
A
bs
or
ba
nc
e
反应类型–终点法2
- 13 -
R2 addition
= Reaction Start
A1A1
A2A2
TimeTime
Sample Dispense
+ R1
t1t1 t2t2
待待测测物物浓浓度在定度在定标标的基的基础础上上进进行行计计算算
Conc. sample (unknown) = (A1 – A2) x cal factorConc. sample (unknown) = (A1 – A2) x cal factor
11 16 1716 17 3333
Abs reading pointsAbs reading points
反应类型– 速率法 1
- 11 -
酶类
- 使用因子
物质
- 定标曲线
- 未达到平衡时段
速率法 :
A
bs
or
ba
nc
e
Time
反应类型– 速率法 2
For Enzymes – 因子用于计算
- 12 -
Sample Dispense
+ R1
R2 addition
= Reaction Start
A1 A2
A3
A4
A5
A6
A7A8...
未知待测物浓度 = D Abs 变化 / min x Enzyme Factor or
D Abs 变化/ sec x Factor
D Abs change / min = U/L
D Abs change /sec = µkat/L
11 16 1716 17 3333
Abs reading pointsAbs reading points
è Flex Time Reading
酶的线性扩展
è 样本稀释
- 91 -
雅培诊断
速率法 - FLEX TIME READING 弹性速
率Absorbance
Photometric PointsS R1 R2
Flex Read Time Main Read Time
正常样本
高浓度或高活性样本
Abs Range
Substrate Depletion
- 92 -
样本稀释
加样本
( to µL)
用来稀释的
反应杯
用量反应的
反应杯
加入稀释液
(10 to 345 µL
s x 1 cycle
混匀100 µL
或 更多
加入稀释后的样本
( to µL)
s x 1 cycle
s x 2 cycles
- 94 -
- 42 -
样本稀释
CC Application Training
- 42 -
空 白 选 择
è Self - Blank
è Reagent Blank 试剂空白 (R1 + R2 + Water as Sample)
(R 1 and Sample)
- 43 -
终点法 /速率法 –试剂空白
Sample Dispense
first Reagent
Dispense
First Mix
è定标过程使用
è R1 + R2 + (Sample) = 水, 生理盐水或定标液 A
Photometric
Points
A
bs
or
ba
nc
e
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33
Second Reagent
Dispense
Second Mix
BLK Abs Range
- 44 -
错误代码 报警解释
Blank
Absorbance
Range
BLK
一个或多个空白定标的吸光度超出BLK
限定的范围
终点法 - SELF BLANK
A
bs
or
ba
nc
e
Photometric
Point
Sample Dispense first
Reagent Dispense
First Mix
Second Reagent
Dispense
Second Mix
1 5 10 16
Self-Blank
Main Read Time Option
DAbs
17 20 25 30 33
- 46 -
CC Application
Training
Flaggings定标
- 50 -
定 标 的 报 警 设 置
7个检测功能:
è试剂空白吸光度检测
è 定标重复次数间的离散度检测
è 斜率检测
è Factor Comparison Check *
è SD 检测
è Monotonic Check *
è Approximation Convergence Error *
- 51 -
终点法 /速率法 –试剂空白
Sample Dispense
first Reagent
Dispense
First Mix
è定标过程使用
è R1 + R2 + (Sample) = Water, Saline or Calibrator A
Photometric
Points
A
bs
or
ba
nc
e
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33
Second Reagent
Dispense
Second Mix
BLK Abs Range
- 44 -
错误代码 报警解释
Blank
Absorbance
Range
BLK
一个或多个空白定标的吸光度超出BLK
限定的范围
定标－离散度检测
Absorbance
ConcentrationC1 C2
calibrator deviation
- 54 -
代码 解释
Calibrator
absorbance
range
DEV 定标几次重复超出限定
定标－ 斜率检测
Absorbance
ConcentrationBlank
Calibrator 1 min. & max. allowed Span
. between Blank and Cal 1
x
x
- 56 -
错
误
代
码
解释
Slope
Chec
k
SP
N
空白与指定定标点
浓度间斜率超出范
围
定标方法
定标推荐:
è 在手册上没有官方的明确限定
è到定标周期或换批号时，建议全线定标
è换盒进行空白定标
选项:
è Blank
è 1-Point
è 2-Point
è Full
- 31 -
定标设置－ 体积 2
Print
Import
Update
Delete
OK
Cancel
Delete
Print
Update
Lot Change Ctg. Change Over Interval 2-Point 1-Point
BLK -
Export
C3
C4
C5
C6
C7
C8
Sample
BLK:
C1
C2
S. Vol
Water 0 W
Cocain2 150
Cocain3 300
Blank abs Range
Cal Deviation
Base CALIBRATION QC Smart Wash Rerun rulesOutline
Calib. Mode
Blank / Calib. Replication Extrapolation% Span
BLK.
Span abs Range
Interval (H)
/3 3
Linear
Cocain4
- 1
Assay Configuration - Cocain
Cocain5
500
1000
- 34 -
Prin
t
Import
Update
Delete
OK
Cancel
Delete
Print
Update
Lot Change Ctg. Change Over Interval 2-Point 1-Point
BLK -
Export
C3
C4
C5
C6
C7
C8
Sample
BLK:
C1
C2
S. Vol
Water 0 W
X908
X908
Blank abs Range
Cal Deviation
AssayConfiguration-OROSO
Base CALIBRATION QC Smart Wash Rerun rulesOutline
Calib. Mode
Blank / Calib. Replication Extrapolation% Span
BLK.
Span abs Range
Interval (H)
/3 3
0Spline
X908
- 1
X908
X908
155
150
90
定标设置－－ 自动稀释 2
- 37 -
CC Application Training
- 42 -
Flaggings分析结果确认
ASSAY RESULT FLAGGING
- 65 -
REACTION VALIDITY
CHECKS
è速率法
è非线性 & 终点法
-AbsMaxVar
检测最终吸光度的变异性
- Absorbance Limit
检测在读数窗内吸光度变化
的线性
-Colour Correction
-颜色矫正
-Reaction Check
-检测免疫反应的前代效应
（抗原过剩）
è终点法
- 66 -
终点法稳定性的检测
S R1 R2Blank Read option
point1 up to 17
A
bs
or
ba
nc
e
Photometric
Points
Main Read Time
End Stability = AbsMxVar
Main Read Time option point
18 upt to 33
- 67 -
代码 解释
Main
Read
Time
ABS Abs 超出 (－ – )
AbsMaxV
ar RF 读数波动
速率/终点－吸光度限定
Absorbance
Abs
Upper
limit
Abs
Lower
limit
S R1 R2 Photometric
Points
Main
ReadTime
Normal
Sample
High
Concentration/high
activity Sample
- 69 -
Error Interpretation
Abs
Limi
t
A#0
Main/Flex Read
time-none of the
read points
within defined
abs limits
A#1
Only 1 point
within defined
abs limits
A#2
Only two points
within defined
abs limits
ABS Abs OOR ( – )
速率法 -检测在读数窗内吸光度变化的线性
Absorbance
Photometric Points
DAf
DAb
DA
Reading Time
Calculation:
DAf - DAb
DA
x 100 % = rate of linearity %
- 71 -
代码 解释
Linearit
y RL %
Main/Flex Read 读数
窗口内的点超出了以
下限定：前三点与后
三点的速率之比的范
围
终点/速率 -颜色矫正
Calculation: (Abs Reagent 1 & Sample Blank) - (Abs Reagent Blank)
Sample
Dispense
Second
Reagent
Dispense
Abs Window
After Correction
Before Correction
First
Reagent
Dispense
Absorbance of
Sample Colour
Reagent
Blank Abs Abs. of
Sample
Colour
A bs or ba nc e
photometric points
Abs Limit
- 73 -
终点/速率 -颜色矫正
终点/速率 -颜色矫正
颜色矫正 – 例子
Lower abs
Higher abs
RBlk
R2
R1+S
Main Read Time
adj. Lower abs limit
+ =
adj. higher abs limit
+ =
R1+S - RBlk
Absorbance
photometric pointsR1+S
- 74 -
非线性 – 前带反应
- 79 -
A bs or ba nc e
Photometric Points
Read Time
A B
Erro
r
Cod
e
Interpretation
Reacti
on
Check
RCD 超出前带反应限定
Prozone
Normal
电解质系统的检测原理
• 电解质检测是测定样品中的电位。使用集成晶
片技术（ICT）来检测钠，钾和氯。ICT技术是
将固项的离子选择电极组合在一个单一的晶片
上，从而减少了在进行电极检测中所需要的保
养程序。ICT系统包括一个ICT的吸样针和一个
ICT的模块。ICT吸样针从反应杯中吸入稀释样
品并送入ICT模块进行检测（分析前先吸入经加
热的参比液，以提供一个参比浓度用于最后结
果的计算）
应 用 培 训
• 仪器详述
• 酶的线性扩展的设置和稀释的
设置
• 空白
• 定标
• 可靠性检测
• 常见报警代码
雅培诊断
ASSAY RESULT ERROR CODES 1
- 96 -
Error
Code Description
ABS Absorbance out of range ( – ) 超出吸光
度的范围
CAL A calibration error occured 定标出
现错误
INV Invalid result – occurs when the sytem is unable to calculate the
results and cannot identify the specific cause
无效结果－系统无法计算，且无法确认原因
NDC No data for calculation – an error occured for one of the assays
used to perform a calculation
PRM An assay parameter is defined incorrectly 项目参
数设置错误
SR Short reagent 试剂不足
SS Short sample 样本不足
SWR Smart Wash – Reagent probe wash – insufficient volume
aspirated of the solution used for washing the reagent probes
试剂探针Smart Wash 溶液用量不够
SWS Smart Wash – Sample probe wash – insufficient volume
aspirated of the solution used for washing the sample probe
样本探针Smart Wash 溶液用量不够
UTC Unable to calculate the result due to incorrect assay parameter
definition or an error occured during the run 无
法计算结果，由于不正确的参数限定或由运行引起的错误
HW Hardware error occured 硬件错
误
RESULT ERROR CODES 2
All Settings are in: ASSAY CONFIGURATION SCREEN
- 97 -
Error
Code Description
Instrument
Field Setting
A#0
A#1
A#2
None of the photometric reads during the Main or Flex Read Time
had a measured absorbance within the defined absorbance limit.
Only 1 read was within the above mentioned absorbance
limit
Only 2 reads were within the above mentioned absorbance
limit
读数点
不在吸光度范围
Base page
‚Absorbance
Limit‘
FLX The result was calculated using the read data in the Flex
Read Time – No indication for an error, just an alert
message 使用Flex计算结果
Base page
‚Flex Read
Time‘
RL % For Rate assays – the abs linearity was outside the defined
Linearity % range
吸光度线性出了
Linearity % 范围的限定
Base page
‚% Linearity‘
EXP Defined Calibration Interval has been exeeded
定标间隔过期
Calibration
page
‚Interval‘
RF Read Fluctuation – for endpoint assays, the abs reads for
the Main Read Time fluctuated more than the defined
‚MaxAbsVar‘_
读数波动－－终点法，吸光度主读数波动超过
MaxAbsVar‘_ 的限定
Base page
‚MaxAbsVar‘
RCD Reaction Check – Substrate Depletion: Reaction Check
value is outside the range defined to check for prozone
effect – nonlinear curves.
反应检测－－反应检测
出了带反应的限定
Base page
‚Reaction
Check‘
RESULT ERROR CODES 3
All Settings are in: ASSAY CONFIGURATION SCREEN
- 98 -
Error
Code Description
Instrument
Field Setting
LH Linear High – Out of the defined Linear Range (Dynamic
Range) 高出线性范围
Outline page
‚L – H‘
LL Linear Low – Out of the defined Linear Range (Dynamic
Range) 低于线性范围
See above
PSP Prev. Sample Panic Value – the previous sample was
outside the defined Panic Value Range
PVH Panic Value High – result outside the defined Panic Value
HI 结果高于危机值
Outline page
‚Panic High‘
PVL Panic Value Low – Result obtained outside the defined
Panic Value Low 结果低于危机值
Outline page
‚Panic Low‘
EXT The result measured is above the Extrapolation % defined
for the calibration curve
Calibration
page
‚Ext %‘
- 98 -
- 98 -
- 98 -
- 98 -
ARCHITECT 生化分析仪操作手册
- 98 -
- 98 -
- 98 -
- 98 -
- 98 -
7. c模块维护和保养
每日保养
6040 - Check 1mL. Syringes.
6028 - Check DI Water Purity.
6070 – Daily Maintenance
每周保养
6019 Check ICT Probe and Tubing.
6021 Clean Mixers.
6023 Clean Sample/Reagent Probes.
6056 Clean Cuvettes with Detergent.
6308 Check HC Waste Pump Tubing.
每月保养
6016 Check Dispense Components.
6018 Clean Cuvette Washer Nozzles.
6025 Check Wash Solution Trays.
Questions and CommentsQuestions and Comments
