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内毒素检测---LAL (Limulus amebocyte lysate)试剂
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内毒素检测---LAL (Limulus amebocyte lysate)试剂  

1956年,Bang 在研究鲎鱼(Limulus polyphemus,俗称马蹄蟹)的一种格兰氏阴性细菌性疾病时,发现该疾病会造成鲎鱼血液凝集。进一步的研究则说明这种血液凝集现像是一连串的酵素反应,这些酵素是存在鲎鱼的阿米巴细胞中(amebocytes),而诱导凝集的因子则是细菌细胞壁中的脂多醣(lipopolysaccharide,LPS,或称内毒素,endotoxin,亦是主要热源(pyrogen))。据此,发展出制造 LAL(Limulus amebocyte lysate)的方法及测试内毒素的最早方法-凝胶法。

※ 凝胶法操作

1. 取适当稀释的标准内毒素或样品 100μl + LAL试剂100μl

2. 于37±0.5℃非循环式水浴槽培育60±1分钟

3. 判定结果:内容物呈凝胶状则为凝集。内容物呈凝胶状但下滑,或呈浓稠状、维持液态,则为不凝集

【注意事项】
1. 本品为体外试验试剂,严禁用于人体。
2. 本品用于药品的细菌内毒素检查时,应遵循药典细菌内毒素检查法的规定。
3. 使用安瓿包装的鲎试剂在开启时,应防止玻璃屑落入瓶内,开启安瓿后应马上使用。
【规格】(1)0.2 ml (2)2 ml;1 (3)2.2 ml (4)5 ml;(5)5.2ml

【灵敏度】(1)0.03 Eu/ml; (2)0.06 Eu/ml (3)0.125 Eu/ml; (4)0.25 Eu/ml; (5)0.5 Eu/ml; (6)1.0 Eu/ml。
【贮藏】 遮光,在冷处保存。
【包装】 (1)0.2 ml小管; (2)2 ml安瓿;1 (3)2.2 ml安瓿 (4)5 ml安瓿;(5)5.2ml安瓿    (6)10支小管/盒; (7)10安瓿/盒;

※浊度法

浊度法:当有内素素存在的情况下, LAL 在形成凝胶前会先产生混浊,当内毒素含量愈高时,混浊愈快形成,混浊度可以由反应后读取 OD 360 测知,并据此对样品中的内毒素进行定量。理论上,浊度法可以有两种定量方法:(1) 终点法  (2) 动力学法

※呈色法

呈色法是最新开发的 LAL 内毒素检测方法。它仍以 LAL-endotoxin 反应为基础,但在反应的最后加入无色的人工多肽基质,当此基质 p-nitroaniline(pNA)被酵素裂解时呈现黄色,并吸收 405nm 的光。因此,呈色法和浊度法相似,以测量不同浓度的标准品及样品在反应后的 OD. 值,来定量样品中的内毒素含量;也同样有终点法及动力学法两种测量方式。

在终点法的使用上,若样品也会在 405 nm 吸光而造成干扰时,可在反应中加入溶有 nitrite 的 HCl 及 NEDA(N-(1-Naphthyl)-ethylenediamine),则形成 diazo 的洋红色衍生物,在 540-550nm 吸光。

   

PYROTELL® 凝胶法 :定性、半定量、更高的灵敏度

目录号

规格


Multitest ( 5 ml/vial)

G5003

0.03 EU/ml

G5006

0.06 EU/ml

G5125

0.125 EU/ml

G5250

0.25 EU/ml

Multitest (2 ml/vial)

G2003

0.03 EU/ml

G2006

0.06 EU/ml

G2125

0.125 EU/ml

G2250

0.25 EU/ml

Single Test Vial (STV) 0.2 ml/vial, 10 vials per pack

GS003

0.03 EU/ml

GS006

0.06 EU/ml

GS125

0.125 EU/ml

GS250

0.25 EU/ml

GS500

0.5 EU/ml

PYROTELL®-T浊度法:一步、经济、简单、较大范围内定量
 

目录号

规格


Multitest

T0051

5 ml/vial

 

 

 

 

三、 PYROCHROME®显色法:快速、简便、小范围内定量

目录号

   规格

 


C1500

60 Test Kit(带Buffer)

 

 

四、 CHROMO_LAL®显色法 :快速、稳定

目录号

规格


 

C0031

3.2 ml/vial

 

 

 

 

 

 

 

五、CONTROL STANDARD ENDOTOXIN (CSE)标准品

.目录号

规格

 

 


E0005

Escherichia coli O113:H10, 0.5 µg/vial

E0125

Escherichia coli O113:H10, 125 µg/vial

EC010

Escherichia coli O113:H10, 10 ng/vial, 5 vials per pack,
for use with Pyrochrome kits

PC010

Positive Control for Single Test Vial, 0.2 ml LAL and CSE,
10 vials per pack, CSE concentration is 0.1 ng/ml,
(for research use only)

 

 

美国ACC公司是世界上第一家获得FDA组织认可和批准生产内毒素--- LAL的厂家记录着LAL领域的发展和革新。其产品质量优秀种类齐全价格低廉,备受瞩目。

内毒素检测-------LAL (Limulus amebocyte lysate) 试剂
一 、PYROTELL® 凝胶法 :定性、半定量、更高的灵敏度
目录号 规格
Multitest ( 5 ml/vial)
G5003 0.03 EU/ml
G5006 0.06 EU/ml
G5125 0.125 EU/ml
G5250 0.25 EU/ml
Multitest (2 ml/vial)
G2003 0.03 EU/ml
G2006 0.06 EU/ml
G2125 0.125 EU/ml
G2250 0.25 EU/ml
Single Test Vial (STV) 0.2 ml/vial, 10 vials per pack
GS003 0.03 EU/ml
GS006 0.06 EU/ml
GS125 0.125 EU/ml
GS250 0.25 EU/ml
GS500 0.5 EU/ml
二 、 PYROTELL®-T浊度法: 一步、经济、简单、较大范围内定量

目录号 规格

Multitest
T0051 5 ml/vial


三、 PYROCHROME®显色法:快速、简便、小范围内定量
目录号 规格

C1500 60 Test Kit

目录号 规格

0.005 EU/m L
C0031 3.2 ml/vial

四、 CHROMO_LAL®显色法 :快速、稳定

五、CONTROL STANDARD ENDOTOXIN (CSE)标准品
.目录号 规格

E0005 Escherichia coli O113:H10, 0.5 µg/vial
E0125 Escherichia coli O113:H10, 125 µg/vial
EC010 Escherichia coli O113:H10, 10 ng/vial, 5 vials per pack,for use with Pyrochrome kits
PC010 Positive Control for Single Test Vial, 0.2 ml LAL and CSE,10 vials per pack, CSE concentration is 0.1 ng/ml,(for research use only)

六、PYROTROL® DEPYROGENATION CONTROL VIALS 热源去胶凝法
目录号 规格

DC011 Pyrotrol Depyrogenation Control Vials, contains >1,000 EU/vial, 10 vials per pack
DC015 Pyrotrol Depyrogenation Control Vials, contains >1,000 EU/vial, 50 vials per pack
DC201 Pyrotrol Depyrogenation Control Vials, contains >20,000 EU/vial, 10 vials per pack
DC205 Pyrotrol Depyrogenation Control Vials, contains >20,000 EU/vial, 50 vials per pack



七、LAL REAGENT WATER (LRW) 内毒素无热源水 (< 0.001 EU/ml)
目录号 规格

W0051 5.5 ml/bottle
W0201 20 ml/bottle
W020P 20 ml/bottle, 10 bottles/pk
W0504 50 ml/bottle
W050P 50 ml/bottle, 5 bottles/pk
W1004 100 ml/bottle
W100P 100 ml/bottle, 4 bottles/pk

八、PYROSOL® LAL RECONSTITUTION BUFFER 溶胶缓冲液
目录号 规格

BR051 Pyrosol with pH indicator (gel-clot method only), 5.5 ml/vial
BC051 Pyrosol without pH indicator, 5.5 ml/vial
BC554 Pyrosol without pH indicator, 55 ml/vial

内毒素检测-------LAL (Limulus amebocyte lysate) 耗材
一、PRECISION PIPETTES 精密移液器
目录号 规格

PPA01 Adjustable volume pipette 10-100 µL
PPA02 Adjustable volume pipette 100-1000 µL
PPR02 Repeating Pipette
PPM01 Pipette Mate
PPM02 Macro pipette bulb

二、TEST TUBE RACKS 试管架
目录号 规格

TTR01 Set of 2 clear acrylic test tube racks for 8 x 75 mm test tubes. Racks numbered 1-48 and 49-96.

三、PRECISION PIPETTE TIPS 无热源吸头
目录号 规格

PPT25 250 µL tips, 96 tips/box, 10 boxes/pack
PPT10 1000 µL tips, 96 tips/box, 8 boxes/pack

四、PYROTUBE® DEPYROGENATED TUBES 无热源试管
目录号 规格

TS050 10x75 mm soda lime glass for gel-clot method, 50/pk
TB050 10x75 mm borosilicate glass for turbidimetric method, 50/pk
TB240 12x75 mm borosilicate glass (for dilutions only), 40/pk
TB013 13x100 mm borosilicate glass (for dilutions only), 18/pk
TK100 8x75 mm borosilicate glass for Pyros Kinetix, 100/pk

美国ACC公司内毒素检测产品目录

内毒素检测-------LAL (Limulus amebocyte lysate) 试剂
一 、 PYROTELL® 凝胶法:定性、半定量、更高的灵敏度
目录号 规格

Multitest ( 5 ml/vial)
G5003 0.03 EU/ml
G5006 0.06 EU/ml
G5125 0.125 EU/ml
G5250 0.25 EU/ml
Multitest (2 ml/vial)
G2003 0.03 EU/ml
G2006 0.06 EU/ml
G2125 0.125 EU/ml
G2250 0.25 EU/ml
Single Test Vial (STV) 0.2 ml/vial, 10 vials per pack
GS003 0.03 EU/ml
GS006 0.06 EU/ml
GS125 0.125 EU/ml
GS250 0.25 EU/ml
GS500 0.5 EU/ml
二 、 PYROTELL®-T浊度法:一步、经济、简单、较大范围内定量

目录号 规格

Multitest
T0051 5 ml/vial

三、 PYROCHROME®显色法:快速、简便、小范围内定量
目录号 规格

C0060 60 Test Kit
C0120 120 Test Kit
C0180 180 Test Kit
CD060 60 Test Kit
(with Diazo-Coupling)

四、 CHROMO_LAL®显色法 :快速、稳定
目录号 规格

0.005 EU/m L
C0031 3.2 ml/vial


五、CONTROL STANDARD ENDOTOXIN (CSE)标准品
.目录号 规格

E0005 Escherichia coli O113:H10, 0.5 µg/vial
E0125 Escherichia coli O113:H10, 125 µg/vial
EC010 Escherichia coli O113:H10, 10 ng/vial, 5 vials per pack,for use with Pyrochrome kits
PC010 Positive Control for Single Test Vial, 0.2 ml LAL and CSE,10 vials per pack, CSE concentration is 0.1 ng/ml,(for research use only)

Reference Standard Endotoxins (RSE)

31000U Reference Standard Endotoxin Lot # G (USP) 10,000 EU / vial
31200F BRP-3 (Ph. Eur.) 10,000 I.U. / vial


六、PYROTROL® DEPYROGENATION CONTROL VIALS 热源去胶凝法

目录号 规格
DCV10 Depyrogenation Control Vials (>10,000 EU per vial, 10 vial / pack)

DC011 Pyrotrol Depyrogenation Control Vials, contains >1,000 EU/vial, 10 vials per pack
DC015 Pyrotrol Depyrogenation Control Vials, contains >1,000 EU/vial, 50 vials per pack
DC201 Pyrotrol Depyrogenation Control Vials, contains >20,000 EU/vial, 10 vials per pack
DC205 Pyrotrol Depyrogenation Control Vials, contains >20,000 EU/vial, 50 vials per pack



七、LAL REAGENT WATER (LRW) 内毒素无热源水 (< 0.001 EU/ml)
目录号 规格

W0051 5.5 ml/bottle
W0201 20 ml/bottle
W020P 20 ml/bottle, 10 bottles/pk
W0504 50 ml/bottle
W050P 50 ml/bottle, 5 bottles/pk
W1004 100 ml/bottle
W100P 100 ml/bottle, 4 bottles/pk

八、PYROSOL® LAL RECONSTITUTION BUFFER 溶胶缓冲液


BR051 Pyrosol with pH indicator (gel-clot method only), 5.5 ml/vial
BC051 Pyrosol without pH indicator, 5.5 ml/vial
BC554 Pyrosol without pH indicator, 55 ml/vial

3.1 GLUCATELL Reagent Kit for the Detection of (1-3)-ß-D-Glucans


GT001 Glucatell Endpoint Assay Kit with diazo-reagents 110 tests
GT002 Glucatell Kinetic Assay Kit without diazo-reagents 110 tests
GT003 Glucatell Endpoint Assay Kit with diazo-reagents 55 tests
GT004 Glucatell Kinetic Assay Kit without diazo-reagents 55 tests
GT005 Glucatell Serum Kinetic Assay Kit with serum 110 tests
treatment reagents


3.2 PYROTURB ES – an Endotoxin Specific Turbidimetric LAL Formulation


PT032 PYROTURB ES: 3.5 ml LAL/vial


3.3 Reagents for Endotoxin Removal

Endotoxin Affinity Resin
R0026 END-XB15 (removal capacity: 1 µg) six 2 ml tubes / pack
R0501 END-XB52 (removal capacity: 20 µg) one 50 ml tube / pack

Endotoxin Neutralizing Protein (ENP)
EPS01 (Recombinant ENP (Saccharomyces cerevisiae) 1 mg
ESP10 (Recombinant ENP (Saccharomyces cerevisiae) 10 mg
EPP01 Recombinant ENP (Pichia pastoris) 1 mg
EPP10 Recombinant ENP (Pichia pastoris) 10 mg
ENP01 (LALF) ENP (naturally derived), semi-pure 1 mg
ENP10 (LALF) ENP (naturally derived), semi-pure 10 mg


4 Water & Buffer for the Bacterial Endotoxin Test

4.1 Limulus Reagent Water (Sterile / Certified < 0.001 EU/ml)


W0504 LAL Reagent Water 50 ml bottle 10 bottles / pack

W1004 LAL Reagent Water 100 ml bottle 10 bottles / pack

W5004 LAL Reagent Water 500ml bottle 12 bottles / pack

W1000 LAL Reagent Water 1000 ml bottle 6 bottles / pack


4.2 PYROSOL LAL Reconstitution Buffer

BR051 PYROSOL® with pH indicator (for gel-clot method only) 5.5 ml / vial
BC051 PYROSOL® without pH indicator 5.5 ml / vial
BC554 PYROSOL® without pH indicator 55 ml / vial


4.3 GLUCASHIELD® : Glucan blocking LAL Reconstitution Buffer


GB051 GLUCASHIELD® 5.5ml / vial


4.4 Reagents for pH Adjustment (certified for LAL use)

PH100 Hydrochloric acid for pH adjustment (0.1 N) 100 ml / bottle
PH200 Sodium Hydroxide for pH adjustment (0.1 N) 100 ml / bottle


4.5 PYROSONIC Endotoxin Spike Recovery Aid

ESRA5 PYROSONIC 3 x 5 ml / vial


5.2 Plastic Dilution Tubes & Sample Containers

PL512 100 x 15mm Polystyrene tubes, certified 25 tubes / pack
AB128 30 ml sample container, certified approx 400 / box
AP185 100ml sample container, certified approx 200 / box

Please note that the 30ml & 100ml containers are available labelled for an additional surcharge.

5.3 Sample Containers (depyrogenated)

SP400 Glass containers, 100ml capacity, aluminium lid and 10 bottles / pack
individually labelled for non-liquid samples

内毒素检测-------LAL (Limulus amebocyte lysate) 耗材
一、PRECISION PIPETTES 精密移液器
目录号 规格

PPA01 Adjustable volume pipette 10-100 µL
PPA02 Adjustable volume pipette 100-1000 µL
PPR02 Repeating Pipette
PPM01 Pipette Mate
PPM02 Macro pipette bulb

二、TEST TUBE RACKS 试管架
目录号 规格

TTR01 Set of 2 clear acrylic test tube racks for 8 x 75 mm test tubes. Racks numbered 1-48 and 49-96.

三、PRECISION PIPETTE TIPS 无热源吸头
目录号 规格

PPT25 250 µL tips, 96 tips/box, 10 boxes/pack
PPT10 1000 µL tips, 96 tips/box, 8 boxes/pack

四、PYROTUBE® DEPYROGENATED TUBES 无热源试管
目录号 规格

TS050 10x75 mm soda lime glass for gel-clot method, 50/pk
TB050 10x75 mm borosilicate glass for turbidimetric method, 50/pk
TB240 12x75 mm borosilicate glass (for dilutions only), 40/pk
TB013 13x100 mm borosilicate glass (for dilutions only), 18/pk
TK100 8x75 mm borosilicate glass for Pyros Kinetix, 100/pk

五、PYROPLATE® (PYROCLEAR CERTIFIED)无热源微板
目录号 规格

CA961 96-well microplate
LAL

7 内毒素检测仪器
Instruments & Software for Automatic Endotoxin Determination

7.1 INSTRUMENTATION

PKX02 Pyros Kinetix 96 well incubating tube reader

PPS04 ELX808 Incubating Micro-plate Reader

TTD01 Pyrotrack™ Temperature Validation for Microplates

L5001 LAL-5000 Series 2 Master Module (New)
L5002 LAL-5000 Series 2 Expansion Module (New)

CA373 Micro –plate heating Block


TH120 Dry-bath Incubator (110 v)
TH240 Dry-bath Incubator (240v)
(includes NIST traceable thermometer & stop-clock)


7.2 SOFTWARE & RELATED PRODUCTS

Pyros Kinetix
SPS11 Pyrosoft-11 Software with Manual (21 CFR Part 11 Compliant)
VPPS1 Pyrosoft-11 Validation Protocol Package
PSV01 Pyrosoft-11 Verification Package


Micro-Plate Reader
KC411 KC4 Plate Reader Software (21CFR Compliant)
KC4NC KC4 Plate Reader Software (Non 21CFR)


LAL-5000 Series 2
SPS11 Pyrosoft-11 Software with Manual (21 CFR Part 11 Compliant)
VPPS1 Pyrosoft-11 Validation Protocol Package
PSV01 Pyrosoft-11 Verification Package

SPSNC Pyrosoft-NC (Non-Compliant Version) Software & Manual
VPNC1 Pyrosoft-NC Validation Protocol Package
PSVNC Pyrosoft-NC Verification Package




7.3 WARRANTIES, SERVICE & PARTS


WTMM1 Gold Plan Extended Warranty for LAL-5000
WTEM1 Gold Plan Extended Warranty for LAL-5000 Expansion Module
WPKX1 Gold Plan Extended Warranty for Pyros Kinetix

PT011 Bulb for LAL-5000 Series 1
PT021 Bulb for LAL-5000 Series 2
PT041 Bulb for ELX808 Plate-Reader
PT031 LAL-5000 PC Cable
74500UCP Universal Calibration plate for ELX Plate-reader
CAL01 Calibration for LAL5000 (per module)
CAL02 Calibration for Pyros Kinetix
CAL03 Plate Reader Calibration

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