bio-rad quality control products in dimension vista vials · 1 bio-rad quality control products in...

Bio-Rad Quality Control Products in Dimension Vista® Vials

Bio-Rad Laboratories Q U A L I T Y C O N T R O L

• Rely on Bio-Rad controls and QC performance • Take advantage of shared control lot numbers with existing product configurations

• Access extensive Unity™ peer group reports and comparisons

• Scan 2D barcodes to automatically set-up QC with Vista® assigned values to prevent transcription errors

• Alleviate manual pour-off tasks to minimize handling errors and reduce the cost of extra consumables

• Monitor analytes that are specific to the Dimension Vista® test menu

Our comprehensive line of liquid, multi-analyte quality controls are filled in Vista vials, ready for use on Dimension Vista® instruments . These assayed controls, with verified QC stability claims for on-board instrument storage, allow for routine quality control of Vista® assays .

Controls in Vista vials allow Dimension Vista® customers to:

Bio-Rad Controls in Dimension Vista® Vials

Siemens recommends the family of Bio-Rad Controls in Dimension Vista® vials for your Quality Control needs.

Bio-Rad Quality Control Products in Dimension Vista® Vials1

Bio-Rad Controls make using your Dimension Vista® Even More Efficient

2D barcodes are scanned from the product insert to automatically set-up QC with Dimension Vista® assigned values to prevent transcription errors .

QC vials are inserted into the vial carrier and loaded onto the instrument for automated scanning to identify the specific lot and catalog numbers .

QC vials are loaded and stored refrigerated on the Dimension Vista®, providing automated on board QC . Based on the number of analytes tested, an appropriate aliquot is taken from the vial and QC is automatically performed .

On board QC is automatically monitored and the Dimension Vista® alerts the technologist when new QC vials are required for analysis .

© 2014 Bio-Rad Laboratories, Inc. Page 1Generated15-Feb-2014 17:28:36

Worldwide ReportMultiqual 1, 2, 3 Unassayed • Lot 23456 • Exp 01-Jan-2016

January 2014

The statistics in this report are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to its customers. Such action does not imply support of reported analytes and test methods. Refer to the package insert for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories.

Abbott AEROSET/ARCHITECT (c, i, ci models)

Albumin Bromcresol Purple (BCP) g/dLMon CumLevel

1# Points

Mean

CV SD

# Labs

2.400.032

1.32346

2.400.050

2.148958

43 67

3 3.930.169

4.32346

3.880.086

2.248958

43 67

2 3.390.026

0.82270

3.330.057

1.744212

42 66

Mon Cum Mon Cum

Beckman Coulter LX20, LXi725, Chemistry Systems

Conventional Units

Level Level

1# Points

Mean

CV SD

# Labs

2.440.045

1.8436

2.440.054

2.216842

10 58

3 4.020.651.6

436

4.030.064

1.616842

10 58

2 3.420.059

1.7416

3.410.071

2.116540

9 54

Beckman Coulter UniCel DxC Series

1# Points

Mean

CV SD

# Labs

2.430.053

2.212556

2.430.069

2.8318K

225 390

3 4.020.084

2.112556

4.020.102

2.5318K

225 390

2 3.410.068

2.012412

3.410.107

3.1307K

222 373

Siemens Dimension Series

Method Group • Bromcresol Purple (BCP)

1# Points

Mean

CV SD

# Labs

2.400.072

3.033572

2.410.073

3.0818K

657 1248

3 3.970.129

3.233594

3.980.108

2.7818K

657 1248

2 3.400.071

2.132648

3.420.105

3.1796K

642 1195

Siemens Dimension Series

1# Points

Mean

CV SD

# Labs

2.370.080

3.412414

2.390.069

2.9306K

276 552

3 3.950.151

3.812412

3.960.096

2.4306K

276 552

2 3.340.067

2.012080

3.390.076

2.2304K

272 546

Siemens Dimension Vista

1# Points

Mean

CV SD

# Labs

2.440.061

2.55732

2.430.067

2.7121K

99 157

3 3.990.078

2.05732

3.950.093

2.4121K

99 157

2 3.420.072

2.15470

3.390.084

2.5120K

97 156

Beckman Coulter CX Series

1# Points

Mean

CV SD

# Labs

2.440.051

2.188

2.440.056

2.37108

4 24

3 4.060.062

1.5112

4.040.094

2.37356

4 24

2 ----

----

- -

© 2014 Bio-Rad Laboratories, Inc. Page 1Generated 15-Feb-2014 17:28:36

Laboratory Comparison ReportImmunoassay Plus • Lot 12345 • Exp 01-Jan-2016

January 2014 • Lab 12345

The statistics in this report are derived from user-supplied data and are provided by Bio-Rad Laboratories as a service to its customers. Such action does not imply support of reported analytes and test methods. Refer to the package insert for specific analyte claims and stability information. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories.

Siemens Dimension EXL

Associated Regional Laboratory 123 Main Street

Anytown, NY 12345-6789Attention: Lab Supervisor

Carbamazepine (Tegretol) Immunoturbidimetric ug/mLMon CumLevel Mon Cum Mon Cum Mon Cum

Your Lab Peer Group Method Group

3Peer CVR Method CVR

Peer SDI Method SDI

3 0.70.6

-0.21-0.09

1.41.2

-0.230.11 # Points

Mean

CV SD

# Labs

14.410.391

2.733

14.530.890

6.1294

14.540.588

4.0

2266794

14.680.661

4.5

30853336

14.470.640

4.4

67720382

14.450.730

5.1

925160K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

2 0.90.8

0.05-0.06

0.90.8

-0.55-0.21 # Points

Mean

CV SD

# Labs

8.750.314

3.634

8.660.366

4.2294

8.730.369

4.2

2226412

8.880.402

4.5

30350441

8.770.414

4.7

66619236

8.750.448

5.1

909151K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

1 0.90.8

0.100.45

1.81.7

-0.120.4 # Points

Mean

CV SD

# Labs

2.990.170

5.733

2.990.372

12.5316

2.970.196

6.6

2266794

3.010.209

7.0

30853336

2.900.201

6.9

67720382

2.900.219

7.6

925160K

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

3 1.10.6

0.220.37

1.20.8

-0.020.19 # Points

Mean

CV SD

# Labs

3.200.142

4.432

3.160.170

5.4300

3.170.132

4.2

31010978

3.170.141

4.5

41386299

0

2

-2

2

SDI

CVR

-1

1


Peer SDI Method SDI

1 0.60.4

-0.71-0.58

1.00.7

0.04-0.12 # Points

Mean

CV SD

# Labs

0.7140.038

5.331

0.7670.070

9.1308

0.7660.073

9.5

31010978

0.7640.068

8.9

41386299

0

2

-2

2

SDI

CVR

-1

1

Siemens Dimension EXL

Digoxin EIA ng/mLMon CumLevel Mon Cum Mon Cum

Your Lab Peer Group

SiemensDimension Series

Immunoturbidimetric

Mon CumMethod Group

3.120.219

7.0

62121956

3.120.213

6.8

826173K

0.7720.101

13.1

62121956

0.7790.105

13.4

826173K

EIASiemensDimension Series

The Unity™ Interlaboratory Program provides easily interpreted reports and worldwide peer group comparisons essential for more reliable patient test results .

www.bio-rad.com/qualitycontrol 2

Refer to the package insert of currently available lots for specific analyte and stability claims .

Liquichek™ Diabetes Control

A liquid, human whole blood based control to monitor the precision of Hemoglobin A1C . Available in three critical levels .

• 14 day open-vial (punctured) stability for all analytes when stored at 2–8ºC

• 3 year shelf life when stored at -10ºC to -50ºC

AnalytesHemoglobin A1C

Liquid Assayed Multiqual® Control

A trilevel control for monitoring general chemistry test procedures .

• Offers more than 60 analytes • 5 day open-vial (punctured) stability for all analytes when stored at 2–8ºC • 3 year shelf life when stored at -20ºC to -50ºC

Liquichek™ Cardiac Markers Plus Control LT

General ChemistryAlbuminAlkaline Phosphatase (ALP)ALT/SGPT AmylaseAST/SGOTBilirubin (Direct)Bilirubin (Total)Calcium (Total)ChlorideCholesterol (HDL)Cholesterol (LDL)Cholesterol (Total)CO2

Creatine KinaseCreatinineEthanol

GGTGlucoseIronIron (TIBC)Lactate (Lactic Acid)Lactate Dehydrogenase (LDH)LipaseMagnesiumPhosphorusPotassiumProtein (Total)PseudocholinesteraseSodiumTriglyceridesUrea NitrogenUric Acid

ImmunologyAlpha-1-AntitrypsinApolipoprotein A-1Apolipoprotein BCeruloplasminComplement C3Complement C4HaptoglobinImmunoglobulin A (IgA)Immunoglobulin G (IgG)Immunoglobulin M (IgM)PrealbuminTransferrin

Therapeutic Drug MonitoringAcetaminophenCarbamazepineDigoxin

GentamicinLithiumPhenobarbitalPhenytoinSalicylateTheophyllineTobramycinValproic Acid

ImmunoassayFerritinT3 (Total)T3 Uptake/T-UptakeT4 (Free)T4 (Total)TSHVitamin B12

Analytes

CK (Total)CK-MB IsoenzymeCRPDigitoxin

MyoglobinNT-proBNPTroponin I

AnalytesA comprehensive cardiac assessment control designed to monitor precision of Troponin I at lower levels .

• Offers 7 analytes • 10 day open-vial (punctured) stability for all analytes

when stored at 2–8ºC • 3 year shelf life when stored at -20ºC to -50ºC .



Liquichek™ Immunology Control

A liquid, trilevel control to monitor the precision of serum proteins and related analytes .

• Offers 31 analytes • 5 day open-vial (punctured) stability for all analytes when stored at 2–8ºC • 2 year shelf life when stored at -20ºC to -50ºC

α-1-Acid Glycoproteinα-1-Antitrypsin α-2-Macroglobulin β-2-MicroglobulinAlbuminAntistreptolysin O (ASO)Apolipoprotein A-1

Apolipoprotein BC1 Inhibitor Ceruloplasmin Complement C3Complement C4CRPCystatin C

Ferritin Haptoglobin Immunoglobulin A (IgA)Immunoglobulin E (IgE)Immunoglobulin G (IgG)Immunoglobulin G Subclasses 1-4Immunoglobulin M (IgM)

Kappa Light Chain Lambda Light ChainPrealbumin Protein (Total)Retinol Binding Protein Rheumatoid FactorTransferrin

Analytes

Liquichek™ Ethanol/Ammonia Control

Designed to monitor the precision of Ethanol and Ammonia test procedures across the clinical range .

• 20 day open-vial (punctured) stability for all analytes when stored at 2–8ºC

• 2 year shelf life when stored at 2-8ºC

AnalytesAmmonia Ethanol

Liquichek™ Immunoassay Plus Control

An efficient solution for QC of routine Immunoassay and Therapeutic Drug Monitoring analytes .

• Offers more than 40 analytes • 4 day open-vial (punctured) stability for all analytes when stored at 2–8ºC • 2 year shelf life when stored at -20ºC to -50ºC

Therapeutic Drug MonitoringAcetaminophenAmikacinCaffeine CarbamazepineDigoxinGentamicinLidocaineLithium N-Acetylprocainamide (NAPA)Phenobarbital Phenytoin Procainamide

Salicylate Theophylline Tobramycin Tricyclic Antidepressants (TCA) Screen Valproic Acid Vancomycin

ImmunologyImmunoglobulin A (IgA)Immunoglobulin E (IgE)Immunoglobulin G (IgG)Immunoglobulin M (IgM)

ImmunoassayAlphafetoprotein (AFP)CEAEstradiol FerritinFolate FSHHCG-β SubunitLHProlactin PSAPSA (Free)T3 (Free)

T3 (Total)T3 Uptake/T-Uptake T4 (Free)T4 (Total)TSH Vitamin B12

Cardiac CK-MB Isoenzyme

General ChemistryIron

Analytes



Liquichek™ Urine Chemistry Control

A liquid, bilevel human urine based control for monitoring urine chemistry test procedures .

• Offers 13 analytes • 30 day open-vial (punctured) stability for all analytes when

stored at 2–8ºC • 2 year shelf life when stored refrigerated at 2–8ºC

AmylaseCalciumChloride CreatinineGlucoseMagnesiumMicroalbumin

PhosphorusPotassium Protein (Total)SodiumUrea Nitrogen Uric Acid

Analytes

Liquichek™ Tumor Marker Control

A liquid, trilevel human based control designed to monitor the precision of tumor marker testing procedures .

• Offers 11 analytes, including CA 125, CA 15-3 and CA-19-9 • 10 day open-vial (punctured) stability for all analytes

when stored at 2–8ºC • 2 year shelf life when stored at -20ºC to -50ºC .

Alphafetoprotein (AFP)β-2-MicroglobulinCA 15-3CA 19-9CA 125Carcinoembryonic Antigen (CEA)

FerritinhCGProlactinPSA (Free)PSA (Total)

Analytes

Liquichek™ Pediatric Control

A liquid, bilevel control to monitor the precision of analytes important to neonatal testing . Four Bilirubin parameters are available at two clinically significant levels .


when stored at 2–8ºC • 3 year shelf life when stored at -20ºC to -50ºC

Bilirubin (Direct)Bilirubin (Total) Caffeine CalciumChloride

Glucose Magnesium PotassiumSodiumTheophylline

Analytes

Liquichek™ Spinal Fluid Control

A liquid, bilevel control to monitor the precision of assays for proteins and other critical analytes in cerebrospinal fluid .


when stored at 2–8ºC • 2 year shelf life at 2–8ºC

AlbuminChloride Glucose Immunoglobulin G (IgG)

Lactate (Lactic Acid)Lactate Dehydrogenase (LDH) Protein (Total)Sodium

Analytes


Unity Real Time®

Expert QC Data Management Solution for Desktop or Online Users

• Facilitate regulatory compliance under CLIA and ISO 15189

• Improve real-time bench and supervisor QC data review

• Implement best QC rules when used with Westgard Advisor™

• Run validation with comprehensive audit trails

• Advanced charts and reports for data analysis

• Reduce non-essential retests with Analytical Goal options

• Upload QC data points from an LIS, middleware or instrument (optional)

• RiLiBÄK Advisor™ module available to comply with German regulations

UnityWeb®

Entry-Level Online QC Data Management Solution

• No software to install and maintain

• Use basic QC rules, charts and reports

• Upgrade easily to Unity Real Time® online for more advanced tools and features

• Upload QC data points from an LIS, middleware or instrument (optional)

• Access UnityWeb® via mobile device

Unity™ Software SolutionsContact your local sales representative for more information about all of our QC Data Management Solutions.

Unity™ QC Data Management SolutionsBio-Rad Quality Controls are part of the Unity™ Program with its industry-leading features for benchmarking laboratory performance.

• Benefit from peer data generated from more than 40,000 instruments worldwide • Utilize real-time access to peer group comparisons to help with troubleshooting • Consolidate your entire laboratory into one QC system • Facilitate run-time decisions with optimized Westgard rules • Facilitate compliance with simple tools to review rule violations and document corrective actions

• Define your own quality requirements and track key quality performance indicators

You can consolidate your entire laboratory into one QC system through our Unity™ Program . This sophisticated software includes best-in-class tools to support releasing results, benchmarking laboratory performance, and designing your QC system .

Want to know more? Discover the power of Unity™ Solutions at www.bio-rad.com/qc-datamangement

Basic Advanced Desktop based Web based Mobile


Ordering InformationQ U A L I T Y C O N T R O L

Cat # Product Name Quantity

Liquid Assayed Multiqual® Control

337 Level 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 x 2 .5 mL 338 Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 x 2 .5 mL 339 Level 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 x 2 .5 mL 338X Trilevel MiniPak (1 of each level) . . . . . . . . . . 3 x 2 .5 mL

Liquichek™ Cardiac Markers Plus Control LT

297 Level 1C . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 298 Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 299 Level 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 298X Trilevel MiniPak (1 of each level) . . . . . . . . . . 3 x 2 .5 mL

Liquichek™ Diabetes Control

291 Level 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 x 2 mL 292 Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 x 2 mL 293 Level 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 x 2 mL 292X Trilevel MiniPak (1 of each level) . . . . . . . . . . . .3 x 2 mL

Liquichek™ Ethanol/Ammonia Control

271 Level 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 272 Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 273 Level 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 272X Trilevel MiniPak (1 of each level) . . . . . . . . . . 3 x 2 .5 mL

Liquichek™ Immunoassay Plus Control

267 Level 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 x 2 .5 mL 268 Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 x 2 .5 mL 269 Level 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 x 2 .5 mL 268X Trilevel MiniPak (1 of each level) . . . . . . . . . . 3 x 2 .5 mL

Cat # Product Name Quantity

Liquichek™ Immunology Control

281 Level 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 282 Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 283 Level 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 282X Trilevel MiniPak (1 of each level) . . . . . . . . . . 3 x 2 .5 mL

Liquichek™ Pediatric Control

176 Level 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 177 Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 178X Bilevel MiniPak (1 of each level) . . . . . . . . . . 2 x 2 .5 mL

Liquichek™ Spinal Fluid Control

303 Level 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 304 Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 x 2 .5 mL 302X Bilevel MiniPak (1 of each level) . . . . . . . . . . 2 x 2 .5 mL

Liquichek™ Tumor Marker Control

27114 Level 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 x 2 mL 27115 Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 x 2 mL 27116 Level 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 x 2 mL 27115X Trilevel MiniPak (1 of each level) . . . . . . . . . . . .3 x 2 mL

Liquichek™ Urine Chemistry Control

195 Level 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 x 2 .5 mL 196 Level 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 x 2 .5 mL 198X Bilevel MiniPak (1 of each level) . . . . . . . . . . 2 x 2 .5 mL

Quality Controls

Broad portfolio of independent controls provides an unbiased assessment of methods and system performance .

QC Data Management Solutions

Manage and interpret your QC results using the industry-leading Unity™ Interlaboratory Program and benefit from data generated by users worldwide .

Customer Support

Receive the backing of full-service technical and customer support trained to handle your inquiries in a prompt, knowledgeable manner .

Education

We offer the educational tools and resources to help improve your ability to produce reliable test results .

Efficiently manage your QC product inserts with My eInserts™. Visit www.myeinserts.com for more information.

Bio-Rad is Dedicated to Advancing QC Solutions Worldwide

For further information, please contact the Bio-Rad office nearest you or visit our website at www.bio-rad.com/qualitycontrol

Clinical Diagnostics Group

Website www.bio-rad.com/qualitycontrol Australia 61-2-9914-2800 Austria 43-1-877-8901 Belgium +32 (3)710-53-00 Brazil +55 (31)3689-6600 Canada 1-514-334-4372 China 86-21-61698500 Czech Republic 420-241-430-532 Denmark +45-4452-1000 Finland 358-9-804-22-00 France 33-1-47-95-60-00 Germany +49 (0)89-318-840 Greece 30-210-7774396 Hong Kong 852-2789-3300 Hungary +36-1-459-6100 India 1800-180-1224 Israel 972-3-9636050 Italy +39-02-216091 Japan 81-3-6361-7070 Korea 82-2-3473-4460 Mexico +52 (55)5488-7670 The Netherlands +31-318-540666 New Zealand 64-9-415-2280 Norway +47-23-38-41-30 Poland 48-22-3319999 Portugal 351-21-472-7700 Russia +7-495-721-1404 Singapore 65-6415-3170 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden +46-8-555-127-00 Switzerland +41 (0)26-674-55-05/06 Taiwan 886-2-2578-7189 Thailand 662-651-8311 United Kingdom +44 (0)20-8328-2000

© 2016 Bio-Rad Laboratories, Inc. Printed in USA QSD15-311 Q-1214 Rev. 01/2016 Printed on recycled paper with soy-based inks

Vista is a trademark of Siemens Healthcare.

bio-rad quality control products in dimension vista vials · 1 bio-rad quality control products in...

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