Infectious Disease Controls for Serology Testing - Infectious Disease Controls - Bio-Rad
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Infectious Disease Controls
Infectious Disease Controls for Serology Testing
A comprehensive guide for monitoring testing for Hepatitis, Retrovirus,
Respiratory, Sexually Transmitted and Congenital Diseases
Table of Contents
For Your Consideration
The Impact of Inaccurate Results to Patients and Your Laboratory. . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Why Choose Infectious Disease Quality Controls from Bio-Rad? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Assuring Quality in the Laboratory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Effective Document Control with Unity QC Data Management Systems . . . . . . . . . . . . . . . . . . . . . . 4
Important Differences Between Independent and In-kit Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Reference
List of Popular Instruments, Assays and Bio-Rad Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Quality Control Products and Services
Hepatitis and Retrovirus Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Congenital/Pediatric Disease Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Respiratory Disease Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Sexually Transmitted Disease Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Specialty Infectious Disease Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
QC Data Management Solutions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
www.bio-rad.com/idcontrols | 1
The Impact of Inaccurate Results to Patients
and Your Laboratory
Each year, approximately 16 to 22 million people in the United States are tested for HIV. The Centers for Disease Control and
Prevention (CDC) reports an estimated 39,000 new HIV infections annually. Around the world, the impact of all infectious diseases
is even greater. The role of the laboratory in providing accurate test results is a key component in controlling the spread of infection.
“Results of control materials must meet the laboratory’s and, as applicable, the manufacturer’s test system
criteria for acceptability before reporting patient test results.”
CLIA 493.1256 Standard: Control procedures (f)
The implications of reporting a false positive result are obvious, but the consequences of reporting a false negative can be just
as devastating in terms of necessary treatment and personal life style changes for the patient. Using Bio-Rad infectious disease
controls as an independent assessment of your testing systems helps to provide additional confidence in your test results.
Source: Centers for Disease Control and Prevention
2 | Infectious Disease Controls for Serology Testing
Why Choose Infectious Disease Quality Controls
from Bio-Rad?
We Speak From More Than 30 Years of Experience in Clinical Diagnostics
Bio-Rad Laboratories offers the most comprehensive line of infectious disease quality controls. Choose from over 25 infectious
disease control products that cover a wide-range of testing, including hepatitis and retrovirus, sexually transmitted diseases,
congenital diseases, panels and other specialty testing. Our infectious disease controls are used on a wide-range of test systems
and methods, which include automated immunoassay systems, EIA processors and manual EIA methods.
Where Can Our Controls Be Used? How Do Bio-Rad Infectious Disease Quality
■ Blood Banks Control Products and Services Stand Out
From the Competition?
■ Public Health Laboratories
■ Unbiased independent assessment of test systems
■ Virology Laboratories
■ Worldwide peer group comparisons available
■ Reference Laboratories
■ Liquid stable, ready-to-use, multi-analyte
■ Microbiology Departments
■ Basic to advanced QC data management solutions
■ Serology Departments
■ ssayed virology products available outside
A
■ Immunology Departments
the US only
■ Special Chemistry
www.bio-rad.com/idcontrols | 3Assuring Quality in the Laboratory
Regulations often provide plenty of general information on quality control, but may not always offer
specific information regarding quality control especially for infectious disease testing. “The laboratory shall
Without this specific direction, laboratories may unknowingly perform the minimum amount design quality control
of quality control, or use only the manufacturer provided (in-kit) controls. procedures that verify the
attainment of the intended
A responsible laboratory understands the critical nature of infectious disease testing. Establishing
quality of results.”
an internal QC system that incorporates independent controls and comprehensive data
management will help you assure the quality and reliability of your infectious disease testing. ISO 15189:2012 5.6.2.1
Effective Document Control With Unity
QC Data Management Systems
Laboratory inspectors often need to see documentation Unity Interlaboratory Program
of QC data as evidence of proper quality control procedures.
Participation in an interlaboratory program is extremely important
Yet documentation and monitoring of quality controls can become
for laboratories testing for hepatitis, retrovirus, STDs and other
a huge burden on a busy laboratory. Bio-Rad provides QC data
infectious diseases. Join the Unity Interlaboratory Program –
management solutions that allow you to optimize your laboratory
the world’s largest community of quality control users.
performance. Choose from basic to advanced statistical rules –
available as a web-based or desktop software solution. ompare to peer group data to increase confidence
C
in your patient test results.
▼ Example Unity Report
January 2020
Conventional Units
Worldwide Report
VIROTROL III • Lot 23456 • Exp 01-Jan-2022
Anti-HAV, IgM Chemiluminescence Sample/Cutoff (Index, ISR)
Level Mon Cum
Siemens Diagnostics Centaur/XP Series
Dedicated Reagent
Mean
SD 1 24.8
0.181
2.42
0.230
CV 7.3 9.51
# Points 792 5490
# Labs 24 35
Anti-HBc, IgM Chemiluminescence Sample/Cutoff (Index, ISR)
Level Mon Cum
Siemens Diagnostics Centaur/XP Series
Dedicated Reagent
Mean
SD 1 1.96
0.134
1.98
0.214
CV 6.8 10.8
# Points 642 4885
# Labs 18 30
4 | Infectious Disease Controls for Serology TestingImportant Differences Between Independent
and In-kit Controls
In-kit Controls
■ May be same material as calibrators ■ evels typically well above or below
L
■ Specific to each kit/reagent lot assay cut-off
■ ay not identify shifts between
M ■ requent lot changes don’t allow
F
reagent lots for long-term monitoring
■ Can be used to calculate assay cut-off ■ May not be similar to patient sample(s)
Independent Controls
■ Different from kit calibrators ■ ame control lot can be used across
S
■ Independent of kit/reagent lot multiple reagent lots allowing
■ Identify shifts between reagent lots long-term monitoring of assay
performance
■ esigned to monitor the precision
D
of the test system
■ ontrol may be treated the same
C
as a patient sample
■ evels are typically targeted to be
L
reactive within a relevant range
Shifts between reagent
lots could potentially alter
In-Kit Controls
patient test results.
Patient Samples
Independent Controls
POSITIVE
Cut Off
NEGATIVE
Reagent Lot 1 Reagent Lot 3
Reagent Lot 2
Controls should always be run with new reagent lots. In the illustration above, the in-kit controls matched
However, it’s important to be aware that in-kit controls to Reagent Lot 2, did not identify a change in sensitivity
are typically used as part of the process to determine assay that resulted in a shift in patient sample results and
cut-off, and are specific to each new lot of reagents. the independent controls.
Independent controls are independent of reagent lots,
Without independent controls, a situation like this could
and therefore, may detect shifts or changes that may
potentially result in reporting incorrect results.
not be identified by the in-kit controls.
www.bio-rad.com/idcontrols | 5List of Popular Instruments, Assays, Methods and Bio-Rad Controls
Please contact your Bio-Rad representative for additional details.
▼ Positive Controls ▼ Negative Controls
Liquichek ToRCH Plus (Negative)
Liquichek ToRCH Plus (Positive)
VIROCLEAR SARS CoV
VIROTROL SARS-CoV
VIROTROL ToRCH-M
VIROTROL HBc-IgM
VIROTROL HAV-IgM
VIROTROL HIV-1 gO
VIROTROL HIV-1 Ag
VIROCLEAR ToRCH
VIROTROL PLUS-R
VIROCLEAR MuMZ
VIROTROL Chagas
VIROTROL ToRCH
VIROTROL HBeAg
VIROTROL MuMZ
VIROCLEAR EBV
VIROTROL HIV-2
VIROTROL Lyme
VIROTROL EBV
VIROTROL IV
VIROTROL III
VIROTROL II
VIROCLEAR
VIROTROL I
PyloriTrol
Manufacturer/ Instrument/Assay/Method
Abbott Diagnostics
Alinity ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
Architect Series ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
ARCHITECT i System ● ●
PRISM ● ● ● ● ●
Beckman Coulter
Access Series/LXi/UniCel Dxl ● ● ● ● ● ● ● ● ● ●
BioMérieux
VIDAS ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
Bio-Rad Laboratories
BioPlex 2200 ● ● ● ● ● ● ● ● ● ● ●
Evolis/EIA (GS, Genscreen, Monolisa, Platella) ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
Geenius HIV 1/2 ● ● ●
Platelia SARS Screen ● ●
Cellex
Cellex Rapid Test ● ●
DiaSorin
LIAISON/ LIAISON XL ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
ETI-MAX Systems ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
Diesse
Chorus Line ● ● ● ●
EuroImmun
Anti-SARS-CoV-2 ELISA (IgG) ● ●
Ortho Clincal Diagnostics
VITROS ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
VITROS ECi/ECiQ/3600/5600/XT/7600 ● ●
Roche Diagnostics
cobas 4000/6000/8000 Series ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
Cobas e411/e601/e602/e801 ● ●
Elecsys Systems ● ● ● ● ● ● ● ● ● ● ●
Siemens
ADVIA Centaur Series ● ● ● ● ● ● ● ● ● ● ●
Atellica ● ● ● ● ● ● ● ● ● ●
IMMULITE Series ● ● ● ● ● ● ● ● ● ●
The controls listed here include analyte(s) that may be appropriate for use on the test systems noted.
Content is provided as a guide and for informational purposes only. Results and specific performance characteristics may vary with different
manufacturers’ test kits and assay procedures, different lots of the same test kit, and different lots of the control material. Please note that
not all products may be available in all countries. Refer to the product insert for current product claims.
Refer to myeInserts.com or the package insert of currently available lots for specific analyte and stability claims.
6 | Infectious Disease Controls for Serology TestingHepatitis & Retrovirus
VIROTROL I
■ An unassayed quality control Analytes
■ Human serum based Anti-CMV
■ 3 year shelf life at 2–8ºC Anti-HBc
■ 60 day open-vial stability at 2–8ºC Anti-HCV
■ Available in multiple configurations Anti-HIV-1
and fill sizes Anti-HTLV-I
HBsAg
Assayed VIROTROL I-C / Assayed VIROTROL I-E / Assayed VIROTROL I-F
■ ssayed quality controls
A Analytes
■ Human serum based Anti-CMV*
■ Values provided for popular automated methods Anti-HBc
■ 3 year shelf life at 2–8°C Anti-HCV
■ 60 day open-vial stability at 2–8°C Anti-HIV-1
Anti-HTLV-I*
Available outside the United States only. HBsAg
*Values not provided.
VIROTROL II Assayed VIROTROL II-B
■ An unassayed quality control ■ Assayed quality control
■ Human serum based ■ Human serum based
■ 3 year shelf life at 2–8ºC ■ 3 year shelf life at 2-8ºC
■ 60 day open-vial stability at 2–8ºC ■ 60 day open-vial stability at 2–8ºC
■ Available in multiple configurations Available outside the United States only.
and fill sizes
Analytes
Analytes
Anti-HAV
Anti-HAV Anti-HBs
Anti-HBs
VIROTROL III
■ An unassayed quality control Analytes
■ Human serum based Anti-HAV
■ 3 year shelf life at 2–8ºC HAV-IgM
■ 60 day open-vial stability at 2–8ºC HBc-IgM
Refer to myeInserts.com or the package insert of currently available lots for specific analyte and stability claims.
www.bio-rad.com/idcontrols | 7Hepatitis & Retrovirus
VIROTROL IV
■ n unassayed quality control
A Analyte
■ Human serum based Anti-HBe
■ 3 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
VIROTROL HIV-1 Ag
■ An unassayed quality control Analyte
■ Human serum based HIV-1 Ag
■ 2 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
VIROTROL PLUS-R
■ An unassayed quality control Analytes
■ Human serum based Anti-CMV
■ 2 year shelf life at 2–8ºC Anti-HBc
■ 60 day open-vial stability at 2–8ºC Anti-HCV
Anti-HIV 1/2
Anti HTLV I/II
Anti-Treponema pallidum (Syphilis)
HBsAg
VIROTROL HIV-2 VIROTROL HIV-1 gO
■ An unassayed quality control ■ n unassayed control used to detect
A
■ Human serum based antibodies to HIV-1 group O
■ 2 year shelf life at 2–8ºC ■ Human serum based
■ 60 day open-vial stability at 2–8ºC ■ 2 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
Analyte Analyte
Anti-HIV-2 Anti-HIV-1 group O
Refer to myeInserts.com or the package insert of currently available lots for specific analyte and stability claims.
8 | Infectious Disease Controls for Serology TestingHepatitis & Retrovirus
VIROCLEAR
■ An unassayed, non-reactive quality control
■ Human serum based
■ 3 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
■ Available in multiple configurations and fill sizes
Analytes
Non-reactive for:
Anti-CMV Anti-HCV HAV-IgM Non-treponemal Antibodies
Anti-HAV Anti-HIV-1 HBc-IgM (Syphilitic Reagin)
Anti-HBc Anti-HIV-2 HBeAg Treponema pallidum (Syphilis) IgG
Anti-HBe Anti-HTLV-I HBsAg Treponema pallidum (Syphilis) IgM
Anti-HBs Anti-HTLV-II HIV-1 Ag
VIROTROL HAV-IgM
■ An unassayed quality control Analyte
■ Human serum based HAV-IgM
■ 3 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
VIROTROL HBc-IgM
■ An unassayed quality control Analyte
■ Human serum based HBc-IgM
■ 3 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
VIROTROL HBeAg
■ An unassayed quality control Analyte
■ Human serum based HBeAg
■ 3 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
Refer to myeInserts.com or the package insert of currently available lots for specific analyte and stability claims.
www.bio-rad.com/idcontrols | 9Congenital/Pediatric Disease
VIROTROL ToRCH
■ An unassayed quality control Analytes
■ Human serum based Toxoplasma gondii IgG
■ 2 year shelf life at 2–8ºC Cytomegalovirus (CMV) IgG
■ 60 day open-vial stability at 2–8ºC Herpes Simplex Virus Type 1
(HSV-1) IgG
Herpes Simplex Virus Type 2
(HSV-2) IgG
Rubella Virus IgG
VIROTROL ToRCH-M
■ n unassayed quality control
A Analytes
■ Human serum based
■ 2 year shelf life at 2–8ºC (Cat #00117A) Toxoplasma gondii IgG Herpes Simplex Virus Type 2
or 18 month shelf life at 2–8ºC (Cat #00117B) Toxoplasma gondii IgM (HSV-2) IgG
Cytomegalovirus (CMV) IgG Rubella Virus IgG
■ 60 day open-vial stability at 2–8ºC
Cytomegalovirus (CMV) IgM Rubella Virus IgM
Herpes Simplex Virus Type 1
(HSV-1) IgG
VIROCLEAR ToRCH
■ An unassayed, non-reactive quality control Analytes
■ Human serum based
Non-reactive for:
■ 2 year shelf life at 2–8ºC Herpes Simplex Virus Type 2
Toxoplasma gondii IgG
■ 60 day open-vial stability at 2–8ºC (HSV-2) IgG
Toxoplasma gondii IgM
Cytomegalovirus (CMV) IgG Herpes Simplex Virus Type 2
Cytomegalovirus (CMV) IgM (HSV-2) IgM
Herpes Simplex Virus Type 1 Rubella Virus IgG
(HSV-1) IgG Rubella Virus IgM
Herpes Simplex Virus Type 1
(HSV-1) IgM
Liquichek ToRCH Plus Control
■ n unassayed, bilevel control used to monitor
A Analytes
the precision of the most widely used serology Helicobacter pylori IgG
test methods Toxoplasma gondii IgG
■ Liquid, human serum based Treponema pallidum (Syphilis) IgG
■ 3 year shelf life at 2–8ºC Cytomegalovirus (CMV) IgG
■ 60 day open-vial stability at 2–8ºC Epstein-Barr Virus (EBV) IgG
Herpes Simplex Virus Type 1 (HSV-1) IgG
■ Positive and negative levels
Herpes Simplex Virus Type 2 (HSV-2) IgG
packaged separately Rubella Virus IgG
Syphilis RPR
Varicella Zoster Virus (VZV) IgG
Refer to myeInserts.com or the package insert of currently available lots for specific analyte and stability claims.
10 | Infectious Disease Controls for Serology TestingCongenital/Pediatric Disease
VIROTROL MuMZ and VIROCLEAR MuMZ
■ Unassayed quality controls Analytes
■ Use VIROTROL MuMZ as a reactive control and Mumps Virus IgG
VIROCLEAR MuMZ as a non-reactive control for Rubeola Virus (Measles) IgG
the analytes listed at right Varicella Zoster Virus (VZV) IgG
■ Human serum based
■ 2 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
Respiratory
VIROTROL SARS-CoV
■ An unassayed reactive control Analytes
■ Human plasma based SARS-CoV-2 (Total)
■ 1 year shelf life at 2-8ºC SARS-CoV-2 (IgG)
■ 15 day open-vial stability at 2-8ºC
For research use only.
Not for use in diagnostic procedures.
VIROCLEAR SARS-CoV
■ An unassayed negative control Analytes
■ Human plasma based SARS-CoV-2 (Total)
■ 1 year shelf life at 2-8ºC SARS-CoV-2 (IgG)
■ 15 day open-vial stability at 2-8ºC
For research use only.
Not for use in diagnostic procedures.
PneumoTrol
■ An unassayed quality control Analytes
■ Human serum based Chlamydia trachomatis IgG
■ 2 year shelf life at 2–8ºC Mycoplasma pneumoniae IgG
■ 60 day open-vial stability at 2–8ºC Mycoplasma pneumoniae IgM
Refer to myeInserts.com or the package insert of currently available lots for specific analyte and stability claims.
www.bio-rad.com/idcontrols | 11Sexually Transmitted Disease
VIROTROL Syphilis LR-A
■ A low reactive (LR), unassayed quality control Analyte
■ Human serum based Anti-Treponema pallidum (Syphilis)
■ 3 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
VIROTROL RPR Panel
■ An unassayed quality control Analyte
■ VIROTROL RPR Panel consists of one Non-treponemal Antibodies (Syphilitic Reagin)
non-reactive member, one minimally
reactive member, and one moderately
to highly reactive titerable member
■ Human serum based
■ 2 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
Specialty Infectious Disease
VIROTROL EBV
■ n unassayed quality control
A Analytes
■ Human serum based EBNA IgG
■ 2 year shelf life at 2–8ºC Epstein-Barr Virus (VCA) IgG
■ 60 day open-vial stability at 2–8ºC Epstein-Barr Virus (VCA) IgM
VIROCLEAR EBV
■ n unassayed, non-reactive quality control
A Analytes
■ Human serum based Non-reactive for:
■ 2 year shelf life at 2–8ºC EBNA IgG
■ 60 day open-vial stability at 2–8ºC EBV EA IgG
Epstein-Barr Virus (VCA) IgG
Epstein-Barr Virus (VCA) IgM
Refer to myeInserts.com or the package insert of currently available lots for specific analyte and stability claims.
12 | Infectious Disease Controls for Serology TestingSpecialty Infectious Disease
PyloriTrol
■ An unassayed quality control Analyte
■ Human serum based Helicobacter pylori IgG
■ 2 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
VIROTROL Chagas
■ An unassayed, reactive quality control Analyte
■ Human serum based Trypanosoma cruzi (T. cruzi)
■ 2 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
VIROTROL Lyme
■ An unassayed quality control Analyte
■ Human serum based Borrelia burgdorferi IgG
■ 2 year shelf life at 2–8ºC
■ 60 day open-vial stability at 2–8ºC
VIROTROL WNV
■ An unassayed quality control Analytes
■ Human serum based West Nile Virus IgG
■ 2 year shelf life at 2–8ºC West Nile Virus IgM
■ 60 day open-vial stability at 2–8ºC
Refer to myeInserts.com or the package insert of currently available lots for specific analyte and stability claims.
www.bio-rad.com/idcontrols | 13QC Data Management Solutions
Join over 29,000 of your peers who already use the Unity Interlaboratory Program,
the most robust program for clinical labs
Bio-Rad Quality Controls are part of the Unity Program with ■ Facilitate run-time decisions with optimized Westgard rules
industry-leading features for benchmarking laboratory performance. ■ acilitate compliance with simple tools to review rule violations
F
Whether a lab produces five hundred or five million results a year, and document corrective actions
the lab director bears ultimate responsibility for the accuracy and ■ efine your own quality requirements and track key quality
D
timeliness of each test result.1 performance indicators
A patient risk approach to QC means planning your QC based ■ utomate QC data from Instruments, Middleware and/or LIS
A
on the type or method of the test and its impact on patient systems with Unity Connectivity
outcomes when a failure is detected. As the world’s leader in clinical
This sophisticated software includes best-in-class tools to support
laboratory QC, we’ve established the foundation to help you make
releasing results, benchmarking laboratory performance, and
the transition to patient-focused QC.
designing your QC system. Unity enables you to work smarter,
■ enefit from peer data generated from more than 50,000
B making it possible to achieve optimum lab practice for your QC
instruments worldwide workflow. Reducing manual QC data management tasks with
■ tilize real-time access to peer group comparisons
U software automation frees your staff to focus on more critical tasks.
to help with troubleshooting Unity ultimately helps your team deliver objectives more efficiently
■ Consolidate your entire laboratory into one QC system and with greater ease.
Choose From Four Unity Solutions
Bio-Rad Laboratories offers several options for participation in the Unity Interlaboratory Program. Refer to the product comparison grid below to help
determine which solution is the most appropriate for your laboratory.
Basic User Options Advanced User Options
UnityWeb Unity Real Time LT Unity Real Time online Unity Real Time
Type of Solution
Web Service (Web-based) X X
Desktop Software X X
Unity Interlaboratory Reports
Monthly Reports X X X X
InstantQC Reports X X X X
Basic Intralaboratory Charts & Reports
Westgard Rules X X X X
Various Charts and Reports X X X X
Additional Features
Westgard Advisor (Subscription sold separately) X X X
Bench Review with Data Review Report X X X X
Supervisor Data Review with Data Review Report X X
Analytical Goals X X
Dynamic Data Set Comparisons X X
Database Platform
Bio-Rad Hosted X X
Installed on Local Laboratory PC X X
Connectivity (Sold separately)
WebConnect X X
UnityConnect X X X X
Want to know more? Discover the power of Unity Solutions at www.qcnet.com/datamanagement/
Malone B. A New Approach to Quality Control. AACC. 2011;37:11. Available at: http://www.aacc.org/publications/cln/2011/november/Pages/ANewApproachtoQualityControl.aspx#.
1
Accessed June 14, 2013.
14 | Infectious Disease Controls for Serology TestingBasic Advanced Desktop based Web based Mobile
Premier Unity Software Solutions
Unity Real Time UnityWeb
Expert QC Data Management Solution for Desktop Users Entry-Level Online QC Data Management Solution
■ Facilitate compliance under CLIA and ISO 15189 ■ No software to install and maintain
■ Improve real-time bench and supervisor QC data review ■ Use basic QC rules, charts and reports
■ Implement best QC rules when used with Westgard Advisor ■ Upgrade easily to Unity Real Time online for more
■ Run validation with comprehensive audit trails advanced tools and features
■ Advanced charts and reports for data analysis ■ Upload QC data points from an LIS, middleware
■ Reduce non-essential retests with Analytical Goal options or instrument (optional)
■ Upload QC data points from an LIS, middleware
or instrument (optional)
■ RiLiBÄK module available to comply with German regulations
■ GOST module available to comply with Russian regulations
Connectivity Solutions for Automated Uploads to Unity Software
Simple automated uploading of your data from your instruments, middleware and LIS to Unity software solutions
LIS
Middleware
Connectivity Unity
Instrument
UnityConnect WebConnect
A connectivity solution that allows QC data from LIS
A web-based connectivity solution that allows laboratories
systems, middleware and/or instruments to be quickly
to easily upload QC data from LIS systems, middleware and/or
and easily imported into Unity software, enabling
instruments directly into Unity Real Time online or UnityWeb
interlaboratory program comparison
■ liminate manual keying of data
E
■ Eliminate manual keying of QC data ■ Standard LIS QC reports can be used
■ Standard LIS QC reports can be used ■ No software to install
■ Automatic data import and real-time connection
■ Transparent to the flow of data to the LIS
Hardware solutions available for serial and network devices. Contact your Bio-Rad sales
■ Capture and analyze QC data economically from representative for recommendation.
laboratory instruments not connected to the LIS
■ Easy-to-install optional interface hardware
■ Choose from soft, serial and ethernet connections
Regulatory Requirements
“The laboratory shall design quality control procedures that verify the attainment of the
intended quality of results.”
– ISO 15189:2012(E), Subclause 5.6.2.1
www.bio-rad.com/idcontrols | 15Unity Interlaboratory Reports
There has never been a better time to be a member of the List of Available Reports
world’s largest QC peer group program ■ Monthly Evaluation
■ Laboratory Performance Overview
Bio-Rad drives innovation in the development of Quality Control ■ Laboratory Comparison Report
for the clinical laboratory and we’re raising the bar again. ■ Laboratory Histogram
It’s time to take a fresh look at your Unity peer reports. ■ Bias & Imprecision Histogram
Redesigned formats make reports easier than ever to read. ■ Worldwide Report
The addition of color, graphics and statistical information allows ■ Statistical Profile Report
you to interpret your data with ease, enabling prompt action ■ Affiliated Laboratory Comparison Report
to potential problems. Condensed report formats require fewer ■ Affiliated Laboratory Comparison Report:
pages and view equally well printed in color or black and white.
Abbreviated Summary
Unity Interlaboratory Program Reports Feature: ■ Affiliated Data Exception Report
■ Urinalysis Reports
■ ogical arrangement of data provides a quick and
L ■ Qualitative Worldwide Report
intuitive read ■ Blood Typing/Serum Indices Report
■ Data consolidation and imagery simplifies interpretation ■ InstantQC Report
of lab data
Contact your Bio-Rad Sales Representative or visit
QCNet.com for more information.
January 2019 • Lab 12345 January 2019 • Lab 12345
Associated Regional Laboratory Associated Regional Laboratory
Monthly Evaluation 123 Main Street Laboratory Comparison Report 123 Main Street
Immunoassay Plus • Lot 12345 • Exp 01-Jan-2021 Anytown, NY 12345-6789 Immunoassay Plus • Lot 12345 • Exp 01-Jan-2021 Anytown, NY 12345-6789
Attention: Lab Supervisor Attention: Lab Supervisor
Please review your QC reports for January 2019.
Carbamazepine (Tegretol) Immunoturbidimetric ug/mL Your Lab Peer Group Method Group
Level Mon Cum Mon Cum Mon Cum Mon Cum
! The tests listed below may require investigation or review ! Siemens Immunoturbidimetric
Siemens Dimension EXL Dimension Series
0.9
1 1.8 Mean
1 2.99 2.99 2.97 3.01 2.90
2
Gentamicin Immunoturbidimetric ug/mL Peer CVR 2.90
Level Level Lab Peer Method Method CVR 0.8 1.7 1 SD 0.170 0.372 0.196 0.209 0.201 0.219
Peer SDI 0.10 -0.12 CVR CV 5.7 12.5 6.6 7.0 6.9 7.6
Siemens Dimension RXL Method SDI 0.45 0.4
0 2
# Points 33 316 6794 53336 20382 160K
1 1
-1
Data Exclusion: Lab Mean = 2.15 Mean 2.15 2.80 3.00 # Labs 226 308 677 925
SDI -2
SD 0.14 0.170 0.253
!
Acceptable values are 2.1841 to 3.5306
2 0.9 0.9 Mean
2 8.75 8.66 8.73 8.88 8.75
2
CV 6.5 6.0 8.4 Peer CVR 8.77
This data was not used as part of the Unity 6797 20391 Method CVR 0.8 0.8 SD 0.314 0.366 0.369 0.402 0.414 0.448
# Points 31 1
worldwide statistical database. # Labs 223 670 Peer SDI 0.05 -0.55 0
CVR
2
CV 3.6 4.2 4.2 4.5 4.7 5.1
Method SDI -0.06 -0.21 # Points 34 294 6412 50441 19236 151K
2 0.9 -1
2
Peer CVR Mean 5.54 5.98 6.31 # Labs 222 303 666 909
Method CVR 0.4 SD 0.171 0.209 0.469
SDI -2
-2.1 Warning: Acceptable values are above -2.0, below 2.0
3 0.7 1.4 Mean
3 14.41 14.53 14.54 14.68 14.45
2
Peer SDI CV 3.1 3.5 7.4 Peer CVR 14.47
Method SDI -1.6 # Points 32 6588 19764 Method CVR 0.6 1.2 1 SD 0.391 0.890 0.588 0.661 0.640 0.730
# Labs 220 659 Peer SDI -0.21 -0.23 0
CVR
2
CV 2.7 6.1 4.0 4.5 4.4 5.1
Method SDI -0.09 0.11 # Points 33 294 6794 53336 20382 160K
Peer CVR
Method CVR 3 0.8
0.4
This level is within established parameters Mean
SD 3 7.94
0.215
7.87
0.273
8.13
0.575
-1
SDI -2
# Labs 226 308 677 925
Peer SDI 0.25 CV 2.7 3.5 7.1
Method SDI -0.33 # Points 33 6797 20391
# Labs 223 670
Digoxin EIA ng/mL Your Lab Peer Group Method Group
Level Mon Cum Mon Cum Mon Cum Mon Cum
Siemens EIA
Siemens Dimension EXL Dimension Series
0.6
1 1.0 Mean
1 0.714 0.767 0.766 0.764
2
Peer CVR 0.772 0.779
Method CVR 0.4 0.7 1 SD 0.038 0.070 0.073 0.068 0.101 0.105
Peer SDI -0.71 0.04 0
CVR
2
CV 5.3 9.1 9.5 8.9 13.1 13.4
Method SDI -0.58 -0.12 # Points 31 308 10978 86299 21956 173K
-1
# Labs 310 413 621 826
SDI -2
Receive on-demand InstantQC Reports via QCNet today! 3 1.1 1.2 Mean
3 3.20 3.16 3.17 3.17
2
Peer CVR 3.12 3.12
Method CVR 0.6 0.8 1 SD 0.142 0.170 0.132 0.141 0.219 0.213
Peer SDI 0.22 -0.02 0
CVR
2
CV 4.4 5.4 4.2 4.5 7.0 6.8
Method SDI 0.37 0.19 # Points 32 300 10978 86299 21956 173K
InstantQC Reports allow you to compare your QC results to other laboratories at any time, with real-time peer information.
-1
# Labs 310 413 621 826
SDI -2
On-demand reports are particularly useful for troubleshooting problems with test system performance.
Customers agree:
“The documentation “To compare our data with “The reports are clean and easy
of Bio-Rad Controls using a substantial peer group to read and understand. For each
the Unity QC Program has ensures that we are turning test, Unity Reports for our lab
been well accepted by CAP out reliable patient data.” show a summary of our data, our
inspectors. Worry-free QC.” — Laboratory Supervisor, instrument group, and our method
— Laboratory Director, School of Medicine group—reports are simple.”
Health Center
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 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.
Generated 15 Feb-2014 17:28:36 Page 1
— Clinical Chemist,
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.
© 2014 Bio-Rad Laboratories, Inc. © 2014 Bio-Rad Laboratories, Inc. Generated 15-Feb-2014 17:28:36 Page 1
Hospital Laboratory
16 | Infectious Disease Controls for Serology TestingOrdering Information
Cat # Description Cat # Description
Hepatitis & Retrovirus Congenital Disease (continued)
VIROTROL I VIROCLEAR ToRCH
00100A / 00100B / 00100C / 00100E / 00100F / 00100G / 00100H 00118 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
Liquichek ToRCH Plus Control
00101B / 00101C / 00101E / 00101F
239 Positive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 x 3 mL
Single Level/Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 x 4 mL
239X Positive MiniPak. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 3 mL
00102B / 00102C
227 Positive, Assayed* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 x 3 mL
Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 x 20 mL
227X Positive Assayed MiniPak*. . . . . . . . . . . . . . . . . . . . . . . . 1 x 3 mL
Assayed VIROTROL I-C* 228 Negative. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 x 3 mL
00164 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL 228X Negative MiniPak. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 3 mL
Assayed VIROTROL I-E* VIROTROL MuMZ
00166 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL 00119 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
Assayed VIROTROL I-F* VIROCLEAR MuMZ
00168 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL 00133 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
VIROTROL II Respiratory
00104A / 00104B VIROTROL SARS-CoV
Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL 12013881 Single Level/Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 4 mL
00115A / 00115B
Single Level/Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 x 4 mL VIROCLEAR SARS-CoV
12013883 Single Level/Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 4 mL
Assayed VIROTROL II-B
00152 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL PneumoTrol
00129 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
VIROTROL III
00110A / 00110C Sexually Transmitted Disease
Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL VIROTROL Syphilis LR-A
00171 Single Level/Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 x 4 mL
VIROTROL IV
00171X Single Level/Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 4 mL
00111 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
VIROTROL RPR Panel
VIROTROL HIV-1 Ag
01400 Three Levels/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . 3 x 1.5 mL
00108A / 00108B
Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL Specialty Infectious Disease
VIROTROL PLUS-R VIROTROL EBV
12000538 Single Level/Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 x 4 mL 00128A Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
12000539 Single Level/Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 4 mL VIROCLEAR EBV
VIROTROL HIV-2 00131 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
00105A / 00105B / 00105C PyloriTrol
Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL 00121 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
VIROTROL HIV-1 gO VIROTROL Chagas
00113 Single Level/Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 x 4 mL 00125 Single Level/Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 x 4 mL
00113X Single Level/Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 4 mL 00125X Single Level MiniPak. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 x 4 mL
VIROCLEAR VIROTROL Lyme
00106 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL 00132 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
00107 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . 2 x 20 mL
00112 Single Level/Tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 x 4 mL VIROTROL WNV
00116 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
VIROTROL HAV-IgM
00142A Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL QC Data Management Solutions
Unity Real Time
VIROTROL HBc-IgM
804 Installation Package. . . . . . . . . . . . . . . . . . . . . . . . . . . . Single use
00143 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL
804-1 Unity Real Time . . . . . . . . . . . . . . . . . . . . . . . Annual subscription
VIROTROL HBeAg 825i Unity Remote Installation & Training. . . . . . . . . . . . . . . . Single use
00144 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL 858i Additional Software Training. . . . . . . . . . . . . . . . . . . . . . Single use
Congenital Disease Unity Web
VIROTROL ToRCH 870-1 UnityWeb. . . . . . . . . . . . . . . . . . . . . . . . . . . . Annual subscription
00109 Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL 825i Unity Remote Installation & Training. . . . . . . . . . . . . . . . Single use
VIROTROL ToRCH-M UnityConnect
00117A Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL 820-1 UnityConnect Software . . . . . . . . . . . . . . . . . Annual subscription
00117B Single Level/Dropper Bottle. . . . . . . . . . . . . . . . . . . . . . . 1 x 5 mL 858i Additional Software Training. . . . . . . . . . . . . . . . . . . . . . Single use
WebConnect
870-W1 WebConnect 2.0 . . . . . . . . . . . . . . . . . . . . . . Annual subscription
858i Additional Software Training. . . . . . . . . . . . . . . . . . . . . . Single use
825i Unity Remote Installation & Training. . . . . . . . . . . . . . . . Single use
*Available outside the United States only.
Please note that not all products may be available in all countries.EQAS Independent QC Unity
An independent, external assessment Ongoing, proactive, unbiased daily QC that QC Data Management tools that help you create
of performance in comparison to your peers. helps identify errors as they occur or begin to trend. a strategy to reduce risk and streamline QC workflow.
QCNet.com/eqas QCNet.com/independentqc QCNet.com/datamanagement
Bio-Rad For further information, please contact the Bio-Rad office nearest
Laboratories, Inc. you or visit our website at www.bio-rad.com/idcontrols
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