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Product Catalogue

Independent Quality Controls and


QC Software Solutions

S USTA I N A B I L I TY

A C C R E D I T AT I O N

A U T O M AT I O N
2 | Independent Quality Controls and QC Software Solutions

Navigating this Catalogue


This interactive document is designed to provide quick and easy access to all product information, both in this
catalogue and on our website, www.technopathcd.com.

Hyperlinks are provided throughout and are highlighted in bold text.

Other navigation tools include:

The Home icon on each section The Menu icon on the side of
contents page links back to each product page links back to
the main cotents page. contents page for that section.

The visit website icon links to the Then LGC Clinical Diagnostics logo at the
corresponding product web page. top of each page provides a quick link
to www.lgcclinicaldiagnostics.com.

Ordering Products
Multichem Independent QC for all major platforms
To order Technopath's Multichem® QC products and IAMQC® software solutions please contact:
technopath.info@lgcgroup.com.

Independent QC for Abbott Alinity and Architect systems


For independent QC and IAMQC software solutions for Alinity and Architect systems, please contact your local
Abbott representative.

Independent QC for Roche cobas® systems


For independent QC and IAMQC software solutions for Roche cobas, please contact your local Roche
representative.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 3

Introduction.................................................................... 4
Enhance Laboratory Efficiencies............................... 5
Advancing Quality Control in the Clinical
Laboratory...................................................................... 5
QC Data Management Solutions............................... 6
Quality Matters.............................................................. 7
Technical Support Services......................................... 7
Multichem® QC Product Analyte Guide.................... 8

Multichem Independent QC for

all Major Platforms.....................................................11

Multichem Independent QC for Abbott Alinity &


ARCHITECT ci Systems..............................................29

Multichem Independent QC for Roche cobas®......42

QC Data Management Solutions.............................48

technopathcd.com
4 | Independent Quality Controls and QC Software Solutions

Introduction

"Technopath Clinical Diagnostics mission is to provide clinical diagnostics solutions


which positively impact the quality of people's lives by improving healthcare."

Technopath Clinical Diagnostics is now part of LGC and antibodies:


Clinical Diagnostics.

LGC Diagnostics is a leading in vitro diagnostic (IVD)


manufacturer of clinical diagnostic quality solutions
and test components to the extended life science
industry. We partner with In Vitro Diagnostics (IVD)
Instrument Manufacturers, Healthcare System Labs,
Reference Labs, clinical research organizations (CROs)
and academic institutions in commercialization Maine Standards Company
activities across the entire diagnostic pipeline - from Calibration verification materials, validation &
concept and early-stage research, through expedited qualification panels, calibrators, and OEM PT/EQA
product development and onwards into routine clinical samples
use. Laboratories and diagnostic professionals across
SeraCare Quality Controls,
disciplines of clinical chemistry, immunochemistry,
Reference Materials, Biological Materials, reagent
serology, molecular diagnostics, and clinical genomics
components
rely on LGC’s products to achieve accurate and
reliable diagnostic results. Technopath Clinical Diagnostics
Independent Quality Controls & QC Software Solutions
Our combined and ever-growing capabilities mean
we are better positioned to support the needs of the The Native Antigen Company
clinical diagnostics industry, from early feasibility and Viral and bacterial antigens/antibodies
research to commercial & laboratory development
test (LDT) assay development, installation, validation Together, our brands serve over 7,500 customers in
and ongoing performance monitoring support. over 120 countries, providing products for more than
LGC Clinical Diagnostics Quality Management and 20 clinical application areas, including infectious
reagent component manufacturing facilities are FDA- diseases, NIPT, diabetes, cardiac disease and oncology.
registered, and ISO 13485 and ISO 9001 certified. We are passionately committed to go beyond. In
collaboration with our customers, our people and with
Our brands include three IVD manufacturers of QMTs absolute quality, we make the exploration of science
and one manufacturer of viral and bacterial antigens our mission to create a safer world.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 5

Enhance Laboratory Efficiencies


with Multichem® Independent Quality Controls and
IAMQC® QC data management software

CONSOLIDATION AUTOMATION QUALITY


Fewer products required to Load and go barcoded Independent, 3rd party,
meet your core laboratory controls for greater human based controls with
control needs, leading throughput, reduced manual analytes targeted at clinical
to increased operational errors and automated decision points supporting
efficiencies, and reduced waste. QC data reporting. clinician quality goals.

Internal Laboratory Quality Control (IQC) is important Technopath’s Independent quality control solution,
in ensuring confidence in patient test results and in Multichem QC and IAMQC software, provides clinical
meeting accreditation requirements including CLIA, laboratories with significant cost, handling and
CLSI, CAP, RiliBÄK and ISO. time savings, whilst delivering higher confidence in
analytical testing methods.
Increasingly Laboratories seek objective assessment
and comparison of analytical methods and
instrumentation performance, to meet their quality
goals.

Advancing Quality Control


in the Clinical Laboratory so
lidated Con
t ar
co
ded Cont
ro
n

ro

ls
B
Co

ls

ore
Re

St

y
By utilising Multichem barcoded QC
ad

to d
Load an

materials*, laboratories can optimise


their QC workflow and minimise handling to D
ownlo
ad -Ti
me Peer D
Au al
errors. It is supported and complemented
at
Re

with IAMQC® data management system.


Q
Learn more here: QC
Ta r g e t s om
ated C Rep Au
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https://www.technopathclinicaldiagnostics.
or
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com/why-technopath/
Si

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| L J | Yo
*Platform dependent

technopathcd.com
6 | Independent Quality Controls and QC Software Solutions

QC Data Management Software

IAMQC Infinity Daily QC software, and Interlaboratory


Peer software, support laboratory IQC while
achieving greater efficiency and reducing costs.
Early identification of trends enable corrections
before results are compromised. IAMQC Infinity
helps facilitate compliance under CLIA, ISO 15189
and RiliBÄK. Featuring real-time supervisor QC data
review, validation with comprehensive audit trails, and
comprehensive QC charts and reports for laboratory
data analysis.

ISO, CAP, CLIA, RiliBÄK guidelines QC data automatically Realtime QC data review,
for laboratory testing support collected and processed peer analysis, automated
confidence in patient results. in a secure workflow. compliance reports and
expert support & service.

Technical Support Services


Our technical support team comprises of experienced Laboratory Technologists, who are available to offer
support for Multichem QC products and IAMQC informatics.

For support please contact:


technopath.qcsupport@LGCGroup.com for Multichem quality control products.
technopath.iamqcsupport@LGCGroup.com, for IAMQC data management solutions.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 7

Quality Matters
Every day we are committed to delivering high quality,
safe and effective clinical diagnostic products to
achieve maximum customer satisfaction; by complying
with the appropriate regulatory requirements
supported by our Quality Management System.

Technopath Clinical Diagnostics is certified and has


successfully achieved international regulatory market
approvals for example:

• IVD Regulation (EU) 2017/746

• IVD 98/79/EC (CE Marked)

• HPRA (Health Products Regulatory Authority)


Our products are manufactured using fresh frozen
• MHRA plasma and urine. Having direct access to high
quality fresh frozen plasma ensures that our products
• US FDA (previously 510k approved)
mimic the performance of patient samples as closely
• Health Canada as possible, giving increased commutability. We
maintain particular expertise in the stabilisation of
• China NMPA
labile analytes (i.e Troponin, Bilirubin, etc.) and we
• Brazil ANVISA also use Human matrix based lipid additions to ensure
commutability across testing systems.
• Australia TGA
The combination of these high quality raw materials
Multichem is manufactured to the highest quality and our proprietary process gives Technopath a
standards in our ISO 13485 accredited facility. significant competitive advantage over key global
Our proprietary manufacturing processes allow competitors.
incorporation of greater numbers of analytes in to
a single matrix, which enables extensive test menu
consolidation.

technopathcd.com
8 | Independent Quality Controls and QC Software Solutions

Multichem® QC Analyte Guide*

Multichem ID-COVID19Neg
Multichem ID-COVID19 G
Multichem IA Speciality
Analytes

Multichem ID-HIV p24**

Multichem ID-SeroNeg
Multichem D-Dimer
● Claimed Analytes

Multichem IA Plus
Multichem S Plus

Multichem hsTn
Multichem AMH

Multichem WBT

Multichem ID-B
Multichem CSF

Multichem A1c
Listed Analytes

Multichem NB

Multichem AE
Multichem IA

Multichem U
Multichem P
Multichem S
(No Claims on performance)

17 Hydroxyprogesterone ⃝ ⃝

A
Acetaminophen ● ● ● ●
Acid Phosphatase ● ●
ACTH ● ● ●
ADNase B ⃝ ⃝ ⃝

Alanine Aminotransferase (ALT) ● ●


Albumin ● ● ⃝

Aldosterone ⃝ ⃝

Alkaline Phosphatase ● ●
Alpha Fetoprotein (AFP) ● ●
Alpha-hydroxybutyrate Dehydrogenase (α-HBDH) ⃝ ⃝

Alpha-1-acid Glycoprotein ● ● ●
Alpha-1-Antitrypsin (A1AT) ● ● ●
Alpha 2-macroglobulin ⃝ ⃝ ⃝

Amikacin ● ● ● ●
Ammonia ●
Amylase, Pancreatic ● ●
Amylase, Total ● ● ●
Androstenedione ⃝ ⃝

Angiotensin Converting Enzyme ⃝ ⃝ ⃝ ⃝ ⃝

Anti-HBc IgG ● ●
Anti-HCV IgG ● ●
Anti-HIV 1 ● ●
Anti-HTLV I IgG ● ●
Antistreptolysin O ⃝ ⃝ ⃝

Anti-Treponema Pallidum IgG ● ●


Anti-Thyroglobulin ● ● ⃝

Anti-Mullerian Hormone ●
Antithrombin III ⃝ ⃝ ⃝

Anti-TPO ● ●
Apolipoprotein A1 (APO A1) ● ● ●
Apolipoprotein B (APO B) ● ● ●
AST ● ●
B
Beta-hydroxybutyrate Dehydrogenase ⃝ ⃝

Beta-2-Microglobulin ● ● ●
Beta-HCG ● ● ●
Bile Acids ● ●
Bilirubin, Direct ● ● ●
Bilirubin, Indirect ⃝ ⃝

Bilirubin, Total ● ● ●
BNP ● ● ●
C
C1 Inhibitor ⃝ ⃝ ⃝

C3 ● ● ●
C4 ● ● ●
CA 125 ●
CA 15-3 ●
CA 19-9 ●
Caffeine ⃝ ⃝ ⃝ ⃝ ⃝

Calcitonin ● ● ●
Calcium ● ● ●
Calcium, Ionized ⃝ ⃝

Carbamazepine, Free ⃝ ⃝

Carbamazepine, Total ● ● ● ●
Carbon Dioxide (CO2) ● ●
CEA ● ●
Ceruloplasmin ● ● ●
CH50 (Total hemolytic Complement) ⃝ ⃝ ⃝

Chloramphenicol ⃝ ⃝

Chloride ● ● ●
Cholesterol, HDL ● ●
Cholesterol, LDL ● ●
Cholesterol, Total ● ●
Cholinesterase (CHE) ● ●
Creatine Kinase (CK) ● ●
CK-MB ⃝ ⃝ ● ●
Copper ⃝ ⃝

Cortisol ● ● ● ● ●
C-Peptide ● ●

*Please refer to lot specific package inserts for stability and performance claims.
**Coming Soon

technopathcd.com
Independent Quality Controls and QC Software Solutions | 9

Multichem® QC Analyte Guide*

Multichem ID-COVID19Neg
Multichem ID-COVID19 G
Multichem IA Speciality
Analytes

Multichem ID-HIV p24**

Multichem ID-SeroNeg
Multichem D-Dimer
● Claimed Analytes

Multichem IA Plus
Multichem S Plus

Multichem hsTn
Multichem AMH

Multichem WBT

Multichem ID-B
Multichem CSF

Multichem A1c
Listed Analytes

Multichem NB

Multichem AE
Multichem IA

Multichem U
Multichem P
Multichem S
(No Claims on performance)

C-Reactive Protein ● ●
Creatinine ● ● ●
CRP, Ultra-sensitive ⃝ ⃝

Cyclosporine ⃝ ⃝ ●
Cystatin C ⃝ ⃝ ⃝

D
D-Dimer ●
DHEA Sulfate ● ●
Digoxin ● ● ● ●
Disopyramide ⃝ ⃝

E
EPO ● ●
Estradiol ● ●
Estriol, Total ⃝ ⃝

Estriol. Free ● ●
Estrogen, Total ⃝ ⃝

Ethanol ● ● ●
Ethosuximide ⃝ ⃝

F
Ferritin ⃝ ⃝ ● ● ⃝

Folate ● ● ⃝

Fructosamine ⃝ ⃝

FSH ● ●
G
Gentamicin ● ● ● ●
GGT ● ●
Glucose ● ● ● ● ⃝

H
Haptoglobin ● ● ●
HBsAg ● ●
Hemopexin ⃝ ⃝ ⃝

HbA1c ●
HIV 1 p24 Antigen** ● ●
Homocysteine ● ●
Human Growth Hormone ● ●
I
Ibuprofen ⃝ ⃝

IgA ● ● ●
IgE ⃝ ⃝ ● ● ⃝

IGF-1 ⃝ ⃝

IgG ● ● ● ●
IgG1 Subclass ⃝ ⃝ ⃝

IgG2 Subclass ⃝ ⃝ ⃝

IgG3 Subclass ⃝ ⃝ ⃝

IgG4 Subclass ⃝ ⃝ ⃝

IgM ● ● ●
Insulin ● ●
Iron ● ●
K
Kappa Light Chain ⃝ ⃝ ⃝

L
Lactate (Lactic Acid) ● ● ●
Lambda Light Chain ⃝ ⃝ ⃝

LDH ● ●
LH ● ●
Lidocaine ⃝ ⃝

Lipase ● ●
Lipoprotein (a) ⃝ ⃝ ⃝

Lithium ● ● ● ●
M
Magnesium ● ● ●
Microalbumin ●
Myoglobin ● ●
N
N-Acetyl-Procainamide (NAPA) ⃝ ⃝

NT-proBNP ⃝ ⃝ ● ●
O
Osmolality ⃝ ⃝ ●
Ostase ⃝ ⃝

P
Phenobarbital ● ● ● ●

*Please refer to lot specific package inserts for stability and performance claims.
**Coming Soon
technopathcd.com
10 | Independent Quality Controls and QC Software Solutions

Multichem® QC Analyte Guide*

Multichem ID-COVID19Neg
Multichem ID-COVID19 G
Multichem IA Speciality
Analytes

Multichem ID-HIV p24**

Multichem ID-SeroNeg
Multichem D-Dimer
● Claimed Analytes

Multichem IA Plus
Multichem S Plus

Multichem hsTn
Multichem AMH

Multichem WBT

Multichem ID-B
Multichem CSF

Multichem A1c
Listed Analytes

Multichem NB

Multichem AE
Multichem IA

Multichem U
Multichem P
Multichem S
(No Claims on performance)

Phenytoin, Free ⃝ ⃝

Phenytoin, Total ● ● ● ●
Phospholipids ⃝ ⃝

Phosphorous ● ● ●
Potassium ● ● ●
Prealbumin ● ● ●
Primidone ⃝ ⃝

Procollagen type 1 (P1NP) ⃝ ⃝

Procainamide ⃝ ⃝

Procalcitonin ●
Progesterone ● ●
Prolactin ● ●
Properdin Factor B ⃝ ⃝ ⃝

Prostatic Acid Phosphatase ⃝ ⃝

Protein Electrophoresis ⃝ ⃝

Protein, Total ● ● ⃝ ●
PSA, Free ● ●
PSA, Total ● ●
PTH, Intact ● ● ●
Q
Quinidine ⃝ ⃝

R
Renin ⃝ ⃝

Retinol Binding Protein ⃝ ⃝ ⃝

Rheumatoid Factor (RF) ● ●


S
Salicylate ● ● ● ●
SARS-CoV-2 Positive ●
SARS-CoV-2 Negative ●
SHBG ● ●
Sirolimus ●
Sodium ● ● ●
Soluble Transferrin Receptor (sTfR) ⃝ ⃝ ⃝

Specific Gravity ⃝

T
T3, Free ● ●
T3, Total ⃝ ⃝ ● ●
T4, Free ● ●
T4, Total ● ● ● ●
Tacrolimus ●
TBG ⃝ ⃝

Testosterone, Total ● ●
Testosterone, Free ⃝ ⃝

Theophylline ● ● ● ● ●
Thyroglobulin ● ●
Tobramycin ● ● ● ●
Total Iron Binding Capacity (TIBC) ⃝ ⃝

Transferrin ● ● ●
Triglycerides ● ●
Troponin I ● ● ●
Troponin T ⃝ ⃝ ● ● ●
TSH ● ●
T-Uptake ● ●
U
UIBC ● ●
Urea Nitrogen ● ● ●
Uric Acid ● ● ●
Urinary Protein (Urine Total Protein) ●
V
Valproic Acid, Total ● ● ● ●
Valproic Acid, Free ⃝ ⃝

Vancomycin ● ● ● ●
Vitamin B12 ● ●
Vitamin D ● ●
Z
Zinc ⃝ ⃝

*Please refer to lot specific package inserts for stability and performance claims.
**Coming Soon

technopathcd.com
Independent Quality Controls and QC Software Solutions | 11

Multichem® Independent Quality Controls


Suitable
for use
for on
useall
onmajor
all major
platforms.
platforms.

Clinical Chemistry.............................................12 Fertility.......................................................... 23


Multichem S Plus......................................................... 13 Multichem AMH........................................................... 23
Multichem S................................................................. 14
Immunosuppressant........................................ 24
Multichem AE............................................................... 15
Multichem WBT........................................................... 24
Multichem CSF............................................................. 15
Multichem NB.............................................................. 15 Coagulation.................................................... 24
Multichem D-Dimer..................................................... 24
Immunology.....................................................16
Multichem P................................................................. 16 Infectious Disease............................................ 25
Multichem ID-B............................................................ 26
Urine Chemistry................................................17
Multichem ID-HIVp24................................................. 27
Multichem U ................................................................ 17
Multichem ID-SeroNeg............................................... 27
Immunoassay...................................................18
Infectious Disease QC Available in USA................ 28
Multichem IA Plus........................................................ 19
Multichem ID-COVID19 G.......................................... 28
Multichem IA................................................................ 20
Multichem ID-COVID19Neg....................................... 28
Multichem IA Speciality.............................................. 21
Multichem ID-B............................................................ 29
Cardiac........................................................... 22 Multichem ID-SeroNeg............................................... 29
Multichem hsTn........................................................... 22

Diabetes......................................................... 23
Multichem A1c............................................................. 23

technopathcd.com
12 | Independent Quality Controls and QC Software Solutions

Multichem® Chemistry Quality Controls


The Multichem Chemistry product range incorporates serum chemistry, immunology, lipid, TDM , enzymes and
esoterics. It includes liquid-only unassayed and assayed products based on human matrix formulations.

Our human based matrix facilitates unrivaled test consolidation and offers increased stability. Together, these
control characteristics offer greater quality control efficiencies without compromising compliance or confidence
in patient results.

Multichem Chemistry Quality Controls - Suitable for use on all major platforms
PRODUCT DESCRIPTION KIT CONFIGURATION PART CODE

Assayed Single Level (Level 1) 15 x 10mL CH101PLA

Assayed Single Level (Level 2) 15 x 10mL CH102PLA

Assayed Single Level (Level 3) 15 x 10mL CH103PLA

Multichem S Plus Unassayed Single Level (Level 1) 15 x 10mL CH101CRP

Unassayed Single Level (Level 2) 15 x 10mL CH102CRP

Unassayed Single Level (Level 3) 15 x 10mL CH103CRP

Mini Kit (Unassayed Tri-level) 3 x 1 x 10mL CH100MCRP

Assayed Single Level (Level 1) 15 x 10mL CH101A

Assayed Single Level (Level 2) 15 x 10mL CH102A

Assayed Single Level (Level 3) 15 x 10mL CH103A


Multichem S
Unassayed Single Level (Level 1) 15 x 10mL CH101X

Unassayed Single Level (Level 2) 15 x 10mL CH102X

Unassayed Single Level (Level 3) 15 x 10mL CH103X

Assayed Single Level (Level 1) 12 x 2mL AE611A

Assayed Single Level (Level 2) 12 x 2mL AE612A

Assayed Single Level (Level 3) 12 x 2mL AE613A

Unassayed Single Level (Level 1) 12 x 2mL AE611X

Unassayed Single Level (Level 2) 12 x 2mL AE612X


Multichem AE
Unassayed Single Level (Level 3) 12 x 2mL AE613X

Assayed Bi-Level 2 x 6 x 2mL AE600A

Unassayed Bi-Level 2 x 6 x 2mL AE600X

Assayed Tri-Level 3 x 4 x 2mL AE610A

Unassayed Tri-Level 3 x 4 x 2mL AE610X

Assayed Bi-Level 2 x 6 x 2mL CF100A


Multichem CSF
Unassayed Bi-Level 2 x 6 x 2mL CF100X

Assayed Single Level 12 x 2mL NB800A


Multichem NB
Unassayed Single Level 12 x 2mL NB800X

technopathcd.com
Independent Quality Controls and QC Software Solutions | 13

Multichem® S Plus Features


• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C.

Instruments
Multichem S Plus, independent clinical chemistry QC, is
Replace up to four competitor chemistry QC suitable for use on all major platforms.
products with Multichem S Plus
Order Information
Multichem S Plus Config. Part Code

Assayed Single Level (Level 1) 15 x 10mL CH101PLA


Corresponding Competitor Products Multichem Assayed Single Level (Level 2) 15 x 10mL CH102PLA
S Plus Assayed Single Level (Level 3) 15 x 10mL CH103PLA
Unassayed Single Level (Level 1) 15 x 10mL CH101CRP
Unassayed Single Level (Level 2) 15 x 10mL CH102CRP
2 3 2 3 2 3 2 3
1 1 1 1 Unassayed Single Level (Level 3) 15 x 10mL CH103CRP

Mini kit 3 x 1 x 10mL CH100MCRP


(contains one vial of each level)

Analyte List
Chemistry Immunoproteins Enzymes
Albumin Alpha-1 Aminoglycoprotein Acid Phosphatase
Bilirubin, Direct Alpha-1 Antitrypsin Alanine Aminotransferase (ALT)
Bilirubin, Total Alpha 2-macroglobulin* Alkaline Phosphatase (ALP)
Calcium ASO* Amylase (Pancreatic)
Carbon Dioxide (Bicarbonate) ADNase B (Anti-Streptococcal DNase B)* Amylase (Total)
Chloride Antithrombin III* Aspartate Aminotransferase (AST)
Creatinine Apolipoprotein A1 Alpha-hydroxybutyrate Dehydrogenase
Glucose Apolipoprotein B (α-HBDH)*
Iron Beta-2 Microglobulin Beta-hydroxybutyrate Dehydrogenase*
Lactic acid C1 Inhibitor* Cholinesterase
Magnesium CH5O (Total hemolytic Complement)* Creatine Phosphokinase
Phosphorous Cystatin C* CK-MB*
Potassium Complement C3 Gamma Glutamyltransferase
Protein, Total Complement C4 Lactate Dehydrogenase (L to P)
Sodium Ceruloplasmin Lipase
Total Iron Binding Capacity* C-Reactive Protein Prostactic Acid Phosphatase*
Unsaturated Iron Binding Capacity (UIBC) Ferritin*
Urea Haptoglobin Lipids
Uric Acid Hemopexin* Cholesterol, HDL
Immunoglobulin A Cholesterol, LDL
Esoterics Immunoglobulin G Cholesterol, Total
ACE* Immunoglobulin M Phospholipids*
Bile Acids IgE* Triglycerides
Bili, Indirect* IgG1, Subclass*
Caffeine* IgG2, Subclass* Therapeutic Drugs
Calcium, Ionized* IgG3, Subclass* Acetaminophen
Copper* IgG4, Subclass* Amikacin
Cortisol Kappa Light Chain* Carbamazepine
Ethanol Lambda Light Chain* Digoxin
Fructosamine* Lipoprotein (a)* Gentamicin
NT-proBNP* Prealbumin Lithium
Osmolality* Properdin Factor B* Phenobarbital
Protein Electrophoresis* Retinol Binding Protein* Phenytoin
Triiodothyronine* Rheumatoid Factor* Salicylic Acid
Thyroxine, (Total T4) Transferrin Theophylline
Troponin T* sTfR (Soluble Transferrin Receptor)* Tobramycin
Zinc* Valproic Acid
Vancomycin
*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
14 | Independent Quality Controls and QC Software Solutions

Multichem® S Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C.

Instruments
Multichem S, independent clinical chemistry QC, is suitable
for use on all major platforms.

Order Information
Multichem S Config. Part Code
Features
Assayed Single Level (Level 1) 15 x 10mL CH101A
• Human based matrix proprietary formulation. Assayed Single Level (Level 2) 15 x 10mL CH102A
• Mimics performance of patient samples. Assayed Single Level (Level 3) 15 x 10mL CH103A
• Targeted at key clinical decision points.
Unassayed Single Level (Level 1) 15 x 10mL CH101X
• Liquid for ease of use.
Unassayed Single Level (Level 2) 15 x 10mL CH102X
Unassayed Single Level (Level 3) 15 x 10mL CH103X

Multichem S contains 102 analytes, but excludes


CRP and RF, which are available in Multichem S Plus

Analyte List
Chemistry Immunoproteins Amylase (Pancreatic)
Albumin Alpha-1-acid glycoprotein Amylase (Total)
Bilirubin, Direct Alpha-1 Antitrypsin Aspartate Aminotransferase (AST)
Bilirubin, Total Alpha 2-macroglobulin* Alpha-hydroxybutyrate Dehydrogenase
Calcium Antistreptolysin O (ASO)* (α-HBDH)*
Carbon Dioxide (Bicarbonate) ADNase B (Anti-Streptococcal DNase Beta-hydroxybutyrate Dehydrogenase*
Chloride B)* Cholinesterase
Creatinine Antithrombin III* Creatine Kinase (CK)
Glucose Apolipoprotein A1 (APO A1) CK-MB*
Iron Apolipoprotein B (APO B) Gamma Glutamyltransferase
Lactate (Lactic acid) Beta -2 Microglobulin Lactate Dehydrogenase (LDH)
Magnesium C1 Inhibitor* Lipase
Phosphorous CH5O (Total hemolytic Complement)* Prostactic Acid Phosphatase*
Potassium Cystatin C*
Protein, Total Complement C3 Lipids
Sodium Complement C4 Cholesterol, HDL
Total Iron Binding Capacity (TIBC) Ceruloplasmin Cholesterol, LDL
Unsaturated Iron Binding Capacity Ferritin* Cholesterol, Total
(UIBC) Haptoglobin Phospholipids*
Urea Hemopexin* Triglycerides
Uric Acid Immunoglobulin A
Immunoglobulin G Therapeutic Drugs
Esoterics Immunoglobulin M Acetaminophen
ACE* IgE* Amikacin
Bile Acids IgG1, Subclass* Carbamazepine
Bilirubin, Indirect* IgG2, Subclass* Digoxin
Caffeine* IgG3, Subclass* Gentamicin
Calcium, Ionized* IgG4, Subclass* Lithium
Copper* Kappa Light Chain* Phenobarbital
Cortisol Lambda Light Chain* Phenytoin
Ethanol Lipoprotein (a)* Salicylate
Fructosamine* Prealbumin Theophylline
NT-proBNP* Properdin Factor B* Tobramycin
Osmolality* Retinol Binding Protein* Valproic Acid
Protein Electrophoresis* Transferrin Vancomycin
Triiodothyronine, (Total T3)* sTfR (Soluble Transferrin Receptor)*
Thyroxine, (Total T4)
Troponin T* Enzymes
Zinc* Acid Phosphatase
Alanine Aminotransferase (ALT)
Alkaline Phosphatase (ALP)

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 15

Multichem® AE Instruments
Multichem AE, independent Ammonia and Ethanol QC, is
suitable for use on all major platforms.

Order Information
Multichem AE Config. Part Code

Assayed Single Level (Level 1) 12 x 2mL AE611A


Assayed Single Level (Level 2) 12 x 2mL AE612A
Assayed Single Level (Level 3) 12 x 2mL AE613A

Unassayed Single Level (Level 1) 12 x 2mL AE611X


Features Unassayed Single Level (Level 2) 12 x 2mL AE612X
Unassayed Single Level (Level 3) 12 x 2mL AE613X
• Human based matrix proprietary formulation.
• Mimics performance of patient samples. Assayed Bi-Level 2 x 6 x 2mL AE600A
• Targeted at key clinical decision points.
Unassayed Bi-Level 2 x 6 x 2mL AE600X
• Liquid for ease of use.
Assayed Tri-Level 3 x 4 x 2mL AE610A

Unassayed Tri-Level 3 x 4 x 2mL AE610X


Specifications
• 36 month closed vial stability at -20°C to -80°C. Analyte List
• 14 day open vial stability at 2°C to 8°C.
Ammonia
Ethanol

Multichem® CSF Multichem® NB


Features Features
• Human based matrix proprietary • Human based matrix proprietary
formulation. formulation.
• Mimics performance of patient • Mimics performance of patient samples.
samples. • Targeted at key clinical decision points.
• Targeted at key clinical decision • Liquid for ease of use.
points.
• Liquid for ease of use.
Specifications
Specifications • 36 month closed vial stability at -20°C to -80°C.
• 14 day open vial stability at 2°C to 8°C.
• 36 month closed vial stability at -20°C to -80°C.
• 30 day open vial stability at 2°C to 8°C. Instruments
Instruments • Multichem NB, independent Neonatal Bilirubin QC, is
suitable for use on all major platforms.
Multichem CSF, independent Cerebral Spinal Fluid QC, is
suitable for use on all major platforms. Order Information
Multichem NB Config. Part Code
Order Information
Assayed Single Level 12 x 2mL NB800A
Multichem CSF Config. Part Code

Assayed Bi-Level 2 x 6 x 2mL CF100A Unassayed Single Level 12 x 2mL NB800X

Unassayed Bi-Level 2 x 6 x 2mL CF100X

Analyte List
Analyte List Bilirubin, Direct
Bilirubin, Total
Glucose Caffeine*
Lactate Theophylline
IgG
Protein

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
16 | Independent Quality Controls and QC Software Solutions

Multichem® Immunology Quality Controls


Multichem P (Protein) is specifically designed as a supplementary QC product for immunoproteins to be used
in conjunction with our clinical chemistry QC. This product offers elevated concentrations for immunoproteins.
Users can use this in conjunction with 1, 2 or 3 levels of Multichem S Plus or Multichem S, each of which already
include multiple concentrations for immunoproteins. The full list of products available are shown below.

Multichem® P Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 14 day open vial stability at 2°C to 8°C.

Instruments
Multichem P is suitable for use on all major platforms.

Order Information
Multichem P Config. Part Code
Features
Assayed Single Level 12 x 3mL SP41PA
• Human based matrix proprietary formulation.
• Mimics performance of patient samples. Unassayed Single Level 12 x 3mL SP40PX
• Targeted at key clinical decision points
• Key elevated protein concentration for key medical
relevance.
• Liquid for ease of use.

Analyte List
Immunoproteins Chemistry IgG4, Subclass*
Alpha-1-acid glycoprotein Albumin* Immunoglobulin A
Alpha-1 Antitrypsin Angiotensin Converting Enzyme* Immunoglobulin G
Alpha 2-macroglobulin* Ceruloplasmin Immunoglobulin M
Antistreptolysin O (ASO)* Complement C3 Kappa Light Chain*
ADNase B (Anti-Streptococcal DNase)* Complement C4 Lambda Light Chain*
Antithrombin III* C-Reactive Protein Lipoprotein (a)*
Apolipoprotein A1 (APO A1) Ferritin* Prealbumin
Apolipoprotein B (APO B) Haptoglobin Properdin Factor B*
Beta -2 Microglobulin Hemopexin* Retinol Binding Protein*
C1 Inhibitor* IgE* Rheumatoid Factor
CH50 (Total hemolytic Complement)* IgG1, Subclass* sTfR (Soluble Transferrin Receptor)*
Cystatin C* IgG2, Subclass* Total Protein*
IgG3, Subclass* Transferrin

*Please refer to lot specific package inserts for stability and performance claims.

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Independent Quality Controls and QC Software Solutions | 17

Multichem® Urine Chemistry Quality Control


Our leading urine chemistry control is Multichem U. This product provides a single product to cover the majority
of standard urine chemistry assays, including Microalbumin, which some competitors provide a separate QC
product for. The full list of products available are shown below.

Multichem® U Specifications
• 24 month closed vial stability at 2°C to 8°C.
• 30 day open vial stability at 2°C to 8°C.

Instruments
Multichem U is suitable for use on all major platforms.

Order Information
Multichem U Config. Part Code
Features Assayed Single Level (Level 1) 15 x 10mL UC201A.10
Assayed Single Level (Level 2) 15 x 10mL UC202A.10
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
Unassayed Single Level (Level 1) 15 x 10mL UC201X
• Targeted at key clinical decision points. Unassayed Single Level (Level 2) 15 x 10mL UC202X
• Liquid for ease of use.

Analyte List

Amylase Human Chorionic Gonadotropin Sodium


Calcium Magnesium Specific Gravity*
Chloride Microalbumin Urea Nitrogen
Cortisol Osmolality Uric Acid
Creatinine Phosphorous Urinary Protein
Glucose Potassium

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
18 | Independent Quality Controls and QC Software Solutions

Multichem® Immunoassay Quality Controls


Our flagship immunoassay product is Multichem IA Plus. Multichem IA Plus consolidates over 86 analytes into
a single product and can replace up to four competitor products in your lab. We also offer Multichem IA, which
omits CA 19-9, CA 15-3 and CA 125 from the consolidated list of analytes. In addition to the two consolidated
controls, we offer Multichem IA Speciality, providing extended open vial stability for peptide hormones, in addition
to tri-level utility for BNP, PTH, ACTH, PCT and CT.

Multichem Immunoassay Quality Controls - Suitable for use on all major platforms
KIT
PRODUCT DESCRIPTION PART CODE
CONFIGURATION

Assayed Tri-Level 3 x 4 x 5mL IA310A

Assayed Single Level (Level 1) 12 x 5mL IA311A

Assayed Single Level (Level 2) 12 x 5mL IA312A

Assayed Single Level (Level 3) 12 x 5mL IA313A

Multichem IA Plus Unassayed Tri-Level 3 x 4 x 5mL IA310X

Unassayed Single Level (Level 1) 12 x 5mL IA311X

Unassayed Single Level (Level 2) 12 x 5mL IA312X

Unassayed Single Level (Level 3) 12 x 5mL IA313X

Mini Kit (contains one vial of each level) 3 x 1 x 5mL IA310MX

Assayed Tri-Level 3 x 4 x 5mL IA300A

Assayed Single Level (Level 1) 12 x 5mL IA301A

Assayed Single Level (Level 2) 12 x 5mL IA302A

Assayed Single Level (Level 3) 12 x 5mL IA303A


Multichem IA
Unassayed Tri-Level 3 x 4 x 5mL IA300X

Unassayed Single Level (Level 1) 12 x 5mL IA301X

Unassayed Single Level (Level 2) 12 x 5mL IA302X

Unassayed Single Level (Level 3) 12 x 5mL IA303X

Assayed Tri-Level 3 x 4 x 2mL BP300A

Assayed Single Level (Level 1) 12 x 2mL BP301A

Assayed Single Level (Level 2) 12 x 2mL BP302A

Assayed Single Level (Level 3) 12 x 2mL BP303A

Multichem
Unassayed (Tri-Level) 3 x 4 x 2mL BP300X
IA Speciality

Unassayed Single Level (Level 1) 12 x 2mL BP301X

Unassayed Single Level (Level 2) 12 x2mL BP302X

Unassayed Single Level (Level 3) 12 x 2mL BP303X

Mini kit (contains one vial of each level) 3 x 1 x 2mL BP300MX

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Independent Quality Controls and QC Software Solutions | 19

Multichem® IA Plus Features


• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C*.

Instruments
Replace up to four competitor immunoassay QC Multichem IA Plus, independent immunoassay QC, is
products with Multichem IA Plus suitable for use on all major platforms.

Order Information
Multichem IA Plus Config. Part Code
Corresponding Competitor Products Multichem
Assayed Tri-Level 3 x 4 x 5mL IA310A
IA Plus
Assayed Single Level (Level 1) 12 x 5mL IA311A
Assayed Single Level (Level 2) 12 x 5mL IA312A
Assayed Single Level (Level 3) 12 x 5mL IA313A
2 3 2 3 2 3 2 3
1 1 1 1
Unassayed Tri-Level 3 x 4 x 5mL IA310X
Unassayed Single Level (Level 1) 12 x 5mL IA311X
Unassayed Single Level (Level 2) 12 x 5mL IA312X
Unassayed Single Level (Level 3) 12 x 5mL IA313X

Mini kit 3 x 1 x 5mL IA310MX


(contains one vial of each level)

Analyte List
Cancer Markers Thyroxine, Free (FT4) Ibuprofen* Estradiol
Alpha Fetoprotein Thyroxine, Total (TT4) Lidocaine* Follicle Stimulating Hormone
CA 125 Triiodothyronine, Free (FT3) Lithium Human Chorionic
CA 15-3 Triiodothyronine, Total (TT3) N-Acelyl procainamide* Gonadotropin
CA 19-9 T Uptake Phenobarbital 17-Hydroxyprogesterone*
Carcinogenic Embryonic Phenytoin Leutinizing Hormone
Antigen Anaemia Phenytoin, Free* Progesterone
Prostate Specific Antigen, Erythropoietin (EPO) Primidone* Prolactin
Free Ferritin Procainamide* Sex Hormone Binding
Prostate Specific Antigen, Folate Quinidine* Globulin (SHBG)
Total Vitamin B12 Salicylate Testosterone
Theophylline Testosterone, Free*
Cardiac Pituitary/Adrenal Tobramycin
BNP Adrenocorticotropic Valproic Acid Diabetes
CK-MB hormone (ACTH) Valproic Acid, Free* C-Peptide
Myoglobin Aldosterone* Vancomycin Insulin
NT-proBNP Androstenedione* Insulin-like Growth Factor
Renal (IGF-1)*
Troponin I Cortisol
Troponin T Human Growth Hormone Angiotensin*
Ultrasensitive CRP* Renin* Esoterics
Therapeutic Drugs 25 (OH) Vitamin D
Allergy Bone Metabolism Homocysteine
Acetaminophen
IgE Amikacin Ostase*
Caffeine* Parathyroid hormone (PTH)
Thyroid Carbamazepine Procollagen type 1 amino-
Anti-Thyroperoxidase Carbamazepine, Free* terminal propeptide (P1NP)*
Anti-Thyroglobulin Chloramphenicol*
Cyclosporine* Reproductive/Fertility
Calcitonin
Thyroglobulin Digoxin DHEA Sulfate
Thyroid Stimulating Disopyramide* Estriol, Free
Hormone Ethosuximide* Estriol, Total*
Thyroxine Binding Globulin* Gentamicin Estrogen, Total*

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
20 | Independent Quality Controls and QC Software Solutions

Multichem® IA Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C*.

Instruments
Multichem IA, independent immunoassay QC, is suitable for
use on all major platforms.

Order Information

Multichem IA Config. Part Code

Multichem IA contains 83 analytes, but excludes tumour Assayed Tri-Level 3 x 4 x 5mL IA300A
markers, which are available in Multichem IA Plus Assayed Single Level (Level 1) 12 x 5mL IA301A
Assayed Single Level (Level 2) 12 x 5mL IA302A
Assayed Single Level (Level 3) 12 x 5mL IA303A

Features Unassayed Tri-Level 3 x 4 x 5mL IA300X


Unassayed Single Level (Level 1) 12 x 5mL IA301X
• Human based matrix proprietary formulation. Unassayed Single Level (Level 2) 12 x 5mL IA302X
• Mimics performance of patient samples. Unassayed Single Level (Level 3) 12 x 5mL IA303X
• Targeted at key clinical decision points.
• Liquid for ease of use.

Analyte List
Cancer Markers Pituitary/Adrenal Renal
Alpha Fetoprotein Adrenocorticotropic hormone (ACTH) Angiotensin*
Carcinogenic Embryonic Antigen Aldosterone* Renin*
Prostate Specific Antigen, Free Androstenedione*
Prostate Specific Antigen, Total Cortisol Bone Metabolism
Human Growth Hormone Ostase*
Cardiac Parathyroid hormone (PTH)
Therapeutic Drugs Procollagen type 1 amino-terminal
BNP
CK-MB Acetaminophen propeptide (P1NP)*
Myoglobin Amikacin
NT-proBNP Caffeine* Reproductive/Fertility
Troponin I Carbamazepine DHEA Sulfate
Troponin T Carbamazepine, Free* Estriol, Free
Ultrasensitive CRP* Chloramphenicol* Estriol, Total*
Cyclosporine* Estrogen, Total*
Allergy Digoxin Estradiol
IgE Disopyramide* Follicle Stimulating Hormone
Thyroid Ethosuximide* Human Chorionic Gonadotropin
Anti-Thyroperoxidase Gentamicin 17-Hydroxyprogesterone*
Anti-Thyroglobulin Ibuprofen* Leutinizing Hormone
Calcitonin Lidocaine* Progesterone
Thyroglobulin Lithium Prolactin
Thyroid Stimulating Hormone N-Acetyl procainamide* Sex Hormone Binding Globulin (SHBG)
Thyroxine Binding Globulin* Phenobarbital Testosterone
Thyroxine, Free (FreeT4) Phenytoin Testosterone, Free*
Thyroxine, (Total T4) Phenytoin, Free*
Triiodothyronine, Free (FreeT3) Primidone* Diabetes
Triiodothyronine, (Total T3) Procainamide* C-Peptide
T Uptake Quinidine* Insulin
Salicylate Insulin-like Growth Factor (IGF-1)*
Anaemia Theophylline
Tobramycin Esoterics
Erythropoietin (EPO)
Valproic Acid
Ferritin 25 (OH) Vitamin D
Valproic Acid, Free*
Folate Homocysteine
Vancomycin
Vitamin B12

*Please refer to lot specific package inserts for stability and performance claims.

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Independent Quality Controls and QC Software Solutions | 21

Multichem® IA Speciality

Features
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 7 day open vial stability at 2°C to 8°C*.

Instruments
Multichem IA Speciality is suitable for use on all major
platforms.

Order Information

Multichem IA Speciality Config. Part Code

Assayed Tri-Level 3 x 4 x 2mL BP300A


Assayed Single Level (Level 1) 12 x 2mL BP301A
Assayed Single Level (Level 2) 12 x 2mL BP302A
Assayed Single Level (Level 3) 12 x 2mL BP303A

Unassayed Tri-Level 3 x 4 x 2mL BP300X


Unassayed Single Level (Level 1) 12 x 2mL BP301X
Unassayed Single Level (Level 2) 12 x 2mL BP302X
Unassayed Single Level (Level 3) 12 x 2mL BP303X

Mini kit 3 x 1 x 2mL BP300MX


(contains one vial of each level)

Analyte List
BNP
PTH Intact
ACTH
Calcitonin
Procalcitonin

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
22 | Independent Quality Controls and QC Software Solutions

Multichem® Cardiac Quality Control


Our core cardiac assessment product is the Multichem hsTn QC for high sensitive troponin assays. This product
provides a high level of stability and confidence in your testing at the low concentrations that are relevant for
today’s cardiac assessment strategies. This product can be used as a stand-alone product or in conjunction
with our consolidated immunoassay products; Multichem IA Plus or Multichem IA, that include a wide range of
cardiac markers.

Multichem® hsTn Instruments


Multichem hsTn is suitable for use on all major platforms.

Order Information
Multichem hsTn Config. Part Code

Assayed Single Level 12 x 3mL HS301A

Unassayed Single Level 12 x 3mL HS301X

Features Mini kit 3 x 3mL HS301MX


Unassayed Single Level
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points. Analyte List
• Liquid for ease of use.
Troponin I
Troponin T
Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C*.

Example of Multichem hsTn Targeted Concentration on a Sample Platform


Multichem® Multichem® Multichem® Multichem®
hsTn IA Plus IA Plus IA Plus
Target Target Target Target
(Troponin I) (Level 1) (Level 2) (Level 3)
5.0 22.0 10,000.0
60.0

Troponin I ng/L

2.3 11.6 19.8


LoD 5.6 Female Male
99th Percentile 99th
10%CV Percentile
URL
URL

17.5
IFCC Conc. 1 Consensus IFCC Conc. IFCC Conc.
99th Percentile 2 3
URL

*Please refer to lot specific package inserts for stability and performance claims.

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Independent Quality Controls and QC Software Solutions | 23

Multichem® Diabetes Quality Control


Our leading diabetes product is Multichem A1c, third party QC for haemoglobin A1c. The haemoglobin A1c test,
also called HbA1c, glycated haemoglobin test, or glyco-haemoglobin, is an important blood test that shows how
well a patient’s diabetes is being controlled. The full list of products available are shown below.

Multichem® A1c Instruments


Multichem A1c is suitable for use on all major platforms.

Order Information

Multichem A1c Config. Part Code

Assayed Bi-Level 2 x 6 x 1mL HB000A

Assayed Single Level (Level 1) 12 x 1mL HB001A


Assayed Single Level (Level 2) 12 x 1mL HB002A

Features Assayed Mini Kit 2 x 1 x 1mL HB000M


(Contains one vial of each level)
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use. Analyte List
HbA1c
Specifications
• 24 month closed vial stability at -20°C to -80°C.
• 30 day open vial stability at 2°C to 8°C*.

Multichem® Fertility Quality Control


Multichem AMH Control is intended for use as a third party, tri-level, liquid stable quality control material to
monitor the precision of laboratory testing procedures for Anti-Müllerian Hormone Assays.

Multichem® AMH Instruments


Multichem AMH is suitable for use on all major platforms.

Order Information

Multichem AMH Config. Part Code

Assayed Tri-Level 3 x 4 x 2mL AM500A

Unassayed Tri-Level 3 x 4 x 2mL AM500X

Features Unassayed Mini Kit


(Contains one vial of each level)
3 x 1 x 2mL AM500MX

• Human based matrix proprietary formulation.


• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use. Analyte List
Anti-Müllerian Hormone
Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 30 day open vial stability at 2°C to 8°C*.

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
24 | Independent Quality Controls and QC Software Solutions

Multichem® Immunosuppressant Quality Control


Multichem WBT (WBT for Whole Blood Transplant), provides tri-level QC to monitor the precision of laboratory
testing procedures for Cyclosporine, Tacrolimus and Sirolimus assays. The full list of products available are
shown below.

Multichem® WBT Instruments


Multichem WBT is suitable for use on all major platforms.

Order Information

Multichem WBT Config. Part Code

Assayed Tri-Level 3 x 4 x 2mL WB000A

Unassayed Tri-Level 3 x 4 x 2mL WB000X

Features
• Human based matrix proprietary formulation. Analyte List
• Mimics performance of patient samples.
• Targeted at key clinical decision points. Cyclosporine
• Liquid for ease of use. Folate*
Glucose*
Sirolimus
Specifications Tacrolimus
• 30 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C*.

Multichem® Coagulation Quality Control


Multichem D-Dimer Control is intended for use as a third party, bi-level, liquid stable quality control material to
monitor the precision of laboratory testing procedures for D-Dimer Assays

Multichem® D-Dimer Instruments


Multichem D-Dimer is suitable for use on all major
platforms.

Order Information

Multichem D-Dimer Config. Part Code

Assayed Single Level (Level 1) 12 x 1mL DM901A


Assayed Single Level (Level 2) 12 x 1mL DM902A

Unassayed Single Level (Level 1) 12 x 1mL DM901X


Unassayed Single Level (Level 12 12 x 1mL DM902X
Features
Assayed Bi-Level 2 x 6 x 1mL DM900A
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points. Unassayed Bi-Level 2 x 6 x 1mL DM900X
• Liquid for ease of use.

Specifications Unassayed Mini Kit


(Contains one vial of each level)
2 x 1 x 1mL DM900MX

• 36 month closed vial stability at -20°C to -80°C.


• 30 day open vial stability at 2°C to 8°C*. Analyte List
D-Dimer

*Please refer to lot specific package inserts for stability and performance claims.

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Independent Quality Controls and QC Software Solutions | 25

Multichem® Infectious Disease Quality Controls


Technopath’s Multichem ID (Infectious Disease) range has been specifically tested to match assays commonly
used for infectious diseases testing.

Multichem Serology Quality Controls


KIT
PRODUCT DESCRIPTION PART CODE
CONFIGURATION

SR101B1
Multichem ID-B Multi-Analyte Positive Control 4 x 5mL
SR104B2

Multi-Analyte Positive Control 1 x 5mL SR101MB1


Multichem ID-B Mini Kit
Multi-Analyte Positive Control 1 x 5mL SR104MB2*

Multichem ID-HIV p242 Positive Control 4 x 3mL SR111U

Multichem ID-HIV p24 Mini Kit2 Positive Control 1 x 3mL SR111MU

Multichem ID-SeroNeg Negative Control 4 x 5mL SR100N

Multichem ID-SeroNeg Mini Kit Negative Control 1 x 5mL SR100MN

1: Anti-HCV IgG values not provided for Alinity i and ARCHITECT i


2: Available soon
*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
26 | Independent Quality Controls and QC Software Solutions

Multichem® ID-B CE-marked assays approved for use in the EU:

Analyser Systems
Manufacturer System Assay Name

Anti-HBc II

HBsAg Qualitative II

Abbott Alinity i HIV Ag/Ab Combo

rHTLV I/II
Features Syphilis TP
• Ready to use liquid stable controls
• Manufactured using native human plasma Anti-HBc
• Direct sampling from control tubes
• Barcoded for ease of use Anti-HCV II
• Technical and Scientific support
HBsAg
Abbott Alinity s
Specifications HIV Ag/Ab Combo

• 24 month closed tube stability at 2°C to 8°C*. HTLV I/II


• 90 day open tube stability at 2°C to 8°C*.
Syphilis

Instruments Anti-HBc II CMIA

For information on instruments, please choose your country- Anti-HCV CMIA


specific Instructions for Use:
https://eifu.technopathcd.com HBsAg Qualitative II CMIA
Abbott Architect i
HIV Ag/Ab Combo CMIA

rHTLV-I/II CMIA
Order Information
Syphilis TP CMIA
Multichem ID-B Config. Part Code
Anti-HBc CLIA
SR101B1 DiaSorin Liaison
Positive Control 4 x 5mL Treponema Screen CLIA
SR104B2
HBsAg Quant CLIA

HCV Ab CLIA
Liaison Xl
Positive Control Mini Kit 1 x 5mL SR101MB DiaSorin
Murex
HIV Ab/Ag CLIA

recHTLV-I/II CLIA

Positive For Alinity, Alinity ci-series, Alinity c, Alinity i and ARCHITECT are
trademarks of Abbott Laboratories in various jurisdictions.
Anti-HIV-1 IgG
Anti-HCV IgG
Anti-HBc IgG
HBsAg
Anti-HTLV-I IgG
Anti-Treponema Pallidum IgG

*Please refer to lot specific package inserts for stability and performance claims.
1: Anti-HCV IgG values not provided for Alinity i and ARCHITECT i.
2: Available Soon.

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Independent Quality Controls and QC Software Solutions | 27

Multichem® ID-HIV p24 Multichem® ID-SeroNeg

Available
Soon

Features Features
• Ready to use liquid stable controls • Ready to use liquid stable controls
• Manufactured using native human plasma • Manufactured using native human plasma
• Direct sampling from control tubes • Direct sampling from control tubes
• Barcoded for ease of use • Barcoded for ease of use
• Technical and Scientific support • Technical and Scientific support

Specifications Specifications
• 24 month closed tube stability at 2°C to 8°C*. • 36 month closed tube stability at 2°C to 8°C*.
• 90 day open tube stability at 2°C to 8°C*. • 90 day open tube stability at 2°C to 8°C*.

Instruments Instruments
For information on instruments, please choose your For information on instruments, please choose your
country-specific Instructions for Use: country-specific Instructions for Use:
https://eifu.technopathcd.com https://eifu.technopathcd.com

Order Information Order Information

Multichem ID-HIV p24 Config. Part Code Multichem ID-SeroNeg Config. Part Code

Unassayed Positive Control 4 x 5mL SR111U Unassayed Negative Control 4 x 5mL SR100N

Unassayed Positive Control 1 x 5mL SR111MU Unassayed Negative Control 1 x 5mL SR100MN
Mini Kit Mini Kit

Positive For Negative For


HIV 1 p24 Antigen Anti-HIV-1 IgG
Anti-HCV IgG
Anti-HBc IgG
HBsAg
Anti-HTLV-I IgG
Anti-Treponema Pallidum IgG
HIV 1 p24 Antigen*

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
28 | Independent Quality Controls and QC Software Solutions

Multichem® Infectious Disease Quality Controls


- Available in USA -
Multichem COVID-19 Quality Controls
KIT
PRODUCT DESCRIPTION PART CODE
CONFIGURATION

Multichem ID-COVID19 G Unasssayed Positive Control 4 x 4mL CVG200P CVG300P

Multichem ID-COVID19Neg Unassayed Negative Control 4 x 4mL CVN200N

Multichem Serology Quality Controls


KIT
PRODUCT DESCRIPTION PART CODE
CONFIGURATION

Multichem ID-B Unassayed Multi-Analyte Positive Control 4 x 5mL SR103B

Multichem ID-B Mini Kit Unassayed Multi-Analyte Positive Control 1 x 5mL SR103MB**

Multichem ID-SeroNeg Unassayed Negative Control 4 x 5mL SR100N

Multichem ID-SeroNeg Mini Kit Unassayed Negative Control 1 x 5mL SR100MN

Multichem® ID-COVID19 G Multichem® ID-COVID19Neg


Features Features
• Ready to use liquid stable controls • Ready to use liquid stable controls
• Technical and Scientific support • Technical and Scientific support

Specifications Specifications
• 12 month closed vial stability at 2°C to 8°C. • 36 month closed vial stability at 2°C to 8°C.
• 21 day open vial stability at 2°C to 8°C. • 30 day open vial stability at 2°C to 8°C.

Instructions for Use: Instructions for Use:


https://eifu.technopathcd.com https://eifu.technopathcd.com

Order Information Order Information

Multichem ID-COVID19 G Config. Part Code Multichem ID-COVID19 G Config. Part Code

CVG200P Unassayed Negative Control 4 x 4mL CVN200N


Unassayed Positive Control 4 x 4mL
CVG300P

Negative For
Positive For Immunoglobulin G (IgG) antibodies to SARS-CoV-2

Immunoglobulin G (IgG) antibodies to SARS-CoV-2 NOTE


• This product is not intended for use in donor screening
NOTE testing.
• This product is not intended for use in donor screening • This is an unassayed product, with no platform claims
testing. in the USA
• This is an unassayed product, with no platform claims
in the USA

**Available soon.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 29

Multichem® ID-B Multichem® ID-SeroNeg

Features Features
• Ready to use liquid stable controls • Ready to use liquid stable controls
• Manufactured using native human plasma • Manufactured using native human plasma
• Direct sampling from control tubes • Direct sampling from control tubes
• Barcoded for ease of use • Barcoded for ease of use
• Technical and Scientific support • Technical and Scientific support

Specifications Specifications
• 24 month closed tube stability at 2°C to 8°C. • 36 month closed tube stability at 2°C to 8°C.
• 90 day open tube stability at 2°C to 8°C. • 90 day open tube stability at 2°C to 8°C.

Instructions for Use: Instructions For Use:


https://eifu.technopathcd.com https://eifu.technopathcd.com

Order Information Order Information

Multichem ID-B Config. Part Code Multichem ID-SeroNeg Config. Part Code

Unassayed Negative Control 4 x 5mL SR100N


Unassayed Multi-Analyte Positive Control 4 x 5mL SR103B

Unassayed Negative Control 1 x 5mL SR100MN


Unasayed Positive Control Mini Kit 1 x 5mL SR103MB* Mini Kit

Positive For Negative For


Anti-HIV-1 IgG Anti-HIV-1 IgG
Anti-HCV IgG Anti-HCV IgG
Anti-HBc IgG Anti-HBc IgG
HBsAg HBsAg
Anti-HTLV-I IgG Anti-HTLV-I IgG
Anti-Treponema Pallidum IgG Anti-Treponema Pallidum IgG
HIV 1 p24 Antigen*

INFORMATION FOR USA ONLY:


• This product is not intended for use in donor screening
testing. INFORMATION FOR USA ONLY:
• This is an unassayed product, with no platform claims • This product is not intended for use in donor screening
in the USA. testing.
• This is an unassayed product, with no platform claims
in the USA.

*Available soon.

technopathcd.com
30 | Independent Quality Controls and QC Software Solutions

Multichem® Independent Quality Controls


for use on Abbott Alinity and ARCHITECT ci Systems.
Targeted at Clinical decision proints, Technopath's Technopath is the ONLY validated and approved, on-
consolidated Multichem QC is value assigned for board independent QC for the Abbott Alinity ci-series
Alinity and ARCHITECT ci systems. Consolidated
controls increase laboratory efficiencies by reducing:
• Handling time
• Dead-volume waste
• Weight of waste consumables
• Storage reqquirements
• QC analyisis time with IAMQC® Software.

Clinical Chemistry.............................................31 Immunoassay.................................................. 38


Multichem S Plus Alinity Barcoded QC.................... 32 Multichem IA Plus Alinity Barcoded QC.................. 39
Multichem S Plus ARCHITECT................................... 33 Multichem IA Plus ARCHITECT.................................. 40

Immunology.................................................... 34 Cardiac............................................................41
Multichem P Alinity Barcoded QC............................ 34 Multichem hsTn ARCHITECT & Alinity..................... 41
Multichem P ARCHITECT............................................ 35
Diabetes......................................................... 42
Urine Chemistry............................................... 36 MultichemA1c ARCHITECT & Alinity........................ 42
Multichem U Alinity Barcoded QC........................... 36
Immunosuppressant........................................ 42
Multichem U ARCHITECT........................................... 37
Multichem WBT ARCHITECT & Alinity..................... 42

technopathcd.com
Independent Quality Controls and QC Software Solutions | 31

Multichem® Chemistry Quality Controls


for Abbott ARCHITECT & Alinity c Systems

Multichem Chemistry Quality Controls - Suitable for use on Abbott c systems


PRODUCT DESCRIPTION KIT CONFIGURATION PART CODE

Assayed Single Level (Level 1) 12 x 5mL 08P88-10

Assayed Single Level (Level 2) 12 x 5mL 08P88-11

Multichem S Plus for Assayed Single Level (Level 3) 12 x 5mL 08P88-12


Alinity c
Barcoded QC Unassayed Single Level (Level 1) 12 x 5mL 08P87-10

Unassayed Single Level (Level 2) 12 x 5mL 08P87-11

Unassayed Single Level (Level 3) 12 x 5mL 08P87-12

Assayed Single Level (Level 1) 12 x 5mL 05P78-10

Assayed Single Level (Level 2) 12 x 5mL 05P78-11

Assayed Single Level (Level 3) 12 x 5mL 05P78-12


Multichem S Plus for
ARCHITECT c
Unassayed Single Level (Level 1) 12 x 5mL 05P79-10

Unassayed Single Level (Level 2) 12 x 5mL 05P79-11

Unassayed Single Level (Level 3) 12 x 5mL 05P79-12

technopathcd.com
32 | Independent Quality Controls and QC Software Solutions

Features
Multichem® S Plus
• Human matrix based proprietary formulation.
• Mimics performance of patient samples.
Onboard and Offboard • Targeted at key clinical decision points.
• Liquid for ease of use.
Test consolidation for serum chemistry and
immunology QC in a liquid stable format for
Alinity and ARCHITECT systems Specifications
• 30 month closed vial stability at -20°C to -80°C*.
• 10 day open vial stability at 2°C to 8°C*.
• 5 day onboard storage*

Instruments
Barcoded Multichem S Plus, independent clinical chemistry
QC is value assigned for Abbott Alinity c and Architect c
series instruments.

Benefits Order Information


• On-board storage on the Alinity c system in a Multichem S Plus (Alinity) Config. Part Code
temperature controlled reagent carousel.
• Automatically runs directly from the vial at user-defined Assayed Single Level (Level 1) 12 x 5mL 08P88-10
intervals. Assayed Single Level (Level 2) 12 x 5mL 08P88-11
Assayed Single Level (Level 3) 12 x 5mL 08P88-12
• Barcoded vials make loading faster and easier -
minimizing errors.
Unassayed Single Level (Level 1) 12 x 5mL 08P87-10
• On-board stability is monitored by the Alinity system
Unassayed Single Level (Level 2) 12 x 5mL 08P87-11
software. Unassayed Single Level (Level 3) 12 x 5mL 08P87-12

Analyte List
Acetaminophen Chloride Lipase*
Acid Phosphatase* Cholesterol HDL Lipoprotein (a)*
ADNase B (Anti-Streptococcal DNase Cholesterol LDL Lithium
B)* Cholesterol Total Magnesium
Alanine Aminotransferase (ALT) Cholinesterase Osmolality*
Albumin BCG Complement C3 Phenobarbital
Alkaline Phosphatase (ALkP) Complement C4 Phenytoin
Alpha Hydroxybutyrate Copper* Phosphorous
Dehydrogenase* Cortisol* Potassium
Alpha-1 Acidglycoprotein C-Reactive Protein Prealbumin
Alpha-1 Antitrypsin Creatine Kinase (CK) Properdin Factor B*
Alpha-2-Macroglobulin* Creatinine Enzymatic Prostatic Acid Phosphatase*
Amikacin Cystatin C* Protein Electrophoresis*
Amylase Digoxin Protein, Total
Amylase Pancreatic Ethanol Retinol Binding Protein*
Angiotensin Converting Enzyme* Ferritin* Rheumatoid Factor
Anti-streptolysin O (ASO)* Fructosamine* Salicylate
Antithrombin III* Gamma Glutamyltransferase Sodium
Apolipoprotein A1 Gentamicin sTfR (Soluble Transferrin Receptor)*
Apolipoprotein B Glucose Theophylline
Aspartate Aminotransferase (AST) Haptoglobin Thyroxine, Total (TT4)*
Beta -2 Microglobulin Hemopexin* Tobramycin
Beta Hydroxybutyrate Dehydrogenase* IgE* Total Iron Binding Capacity*
Bile Acids IgG1, Subclass* Transferrin
Bilirubin Indirect* IgG2, Subclass* Triglycerides
Bilirubin, Direct IgG3, Subclass* Triiodothyronine, Total (TT3)*
Bilirubin, Total IgG4, Subclass* Unsaturated Iron Binding Capacity
C1 Inhibitor* Immunoglobulin A (UIBC)
Caffeine* Immunoglobulin G Urea Nitrogen
Calcium Immunoglobulin M Uric Acid
Calcium Ionized* Iron Valproic Acid
Carbamazepine Kappa Light Chain* Vancomycin
Carbon Dioxide (Bicarbonate) Lactate Zinc*
Ceruloplasmin Lactate Dehydrogenase (LDH)
CH50 (Total hemolytic Complement)* Lambda Light Chain*

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 33

Specifications
Multichem® S Plus
• 30 month closed vial stability at -20°C to -80°C*.
• 10 day open vial stability at 2°C to 8°C*.
Offboard
Test consolidation for serum chemistry and immunology QC
Instruments
in a liquid stable format for ARCHITECT systems
Multichem S Plus, independent clinical chemistry QC will
work on all Abbott platforms, but is value assigned for
ARCHITECT systems only.

Order Information

Multichem S Plus (ARCHITECT) Config. Part Code

Assayed Single Level (Level 1) 12 x 5mL 05P78-10


Assayed Single Level (Level 2) 12 x 5mL 05P78-11
Assayed Single Level (Level 3) 12 x 5mL 05P78-12

Features Unassayed Single Level (Level 1)


Unassayed Single Level (Level 2)
12 x 5mL
12 x 5mL
05P79-10
05P79-11
Unassayed Single Level (Level 3) 12 x 5mL 05P79-12
• Human matrix based proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Analyte List
Acetaminophen Chloride Lipase*
Acid Phosphatase* Cholesterol HDL Lipoprotein (a)*
ADNase B (Anti-Streptococcal DNase Cholesterol LDL Lithium
B)* Cholesterol Total Magnesium
Alanine Aminotransferase (ALT) Cholinesterase Osmolality*
Albumin BCG Complement C3 Phenobarbital
Alkaline Phosphatase (ALkP) Complement C4 Phenytoin
Alpha Hydroxybutyrate Copper* Phosphorous
Dehydrogenase* Cortisol* Potassium
Alpha-1 Acidglycoprotein C-Reactive Protein Prealbumin
Alpha-1 Antitrypsin Creatine Kinase (CK) Properdin Factor B*
Alpha-2-Macroglobulin* Creatinine Enzymatic Prostatic Acid Phosphatase*
Amikacin Cystatin C* Protein Electrophoresis*
Amylase Digoxin Protein, Total
Amylase Pancreatic Ethanol Retinol Binding Protein*
Angiotensin Converting Enzyme* Ferritin* Rheumatoid Factor
Anti-streptolysin O (ASO)* Fructosamine* Salicylate
Antithrombin III* Gamma Glutamyltransferase Sodium
Apolipoprotein A1 Gentamicin sTfR (Soluble Transferrin Receptor)*
Apolipoprotein B Glucose Theophylline
Aspartate Aminotransferase (AST) Haptoglobin Thyroxine, Total (TT4)*
Beta -2 Microglobulin Hemopexin* Tobramycin
Beta Hydroxybutyrate Dehydrogenase* IgE* Total Iron Binding Capacity*
Bile Acids IgG1, Subclass* Transferrin
Bilirubin Indirect* IgG2, Subclass* Triglycerides
Bilirubin, Direct IgG3, Subclass* Triiodothyronine, Total (TT3)*
Bilirubin, Total IgG4, Subclass* Unsaturated Iron Binding Capacity
C1 Inhibitor* Immunoglobulin A (UIBC)
Caffeine* Immunoglobulin G Urea Nitrogen
Calcium Immunoglobulin M Uric Acid
Calcium Ionized* Iron Valproic Acid
Carbamazepine Kappa Light Chain* Vancomycin
Carbon Dioxide (Bicarbonate) Lactate Zinc*
Ceruloplasmin Lactate Dehydrogenase (LDH)
CH50 (Total hemolytic Complement)* Lambda Light Chain*

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
34 | Independent Quality Controls and QC Software Solutions

Multichem® Immunology Quality Controls


for Abbott ARCHITECT & Alinity c Systems

Multichem Immunology Quality Controls - Suitable for use on Abbott c systems


PRODUCT DESCRIPTION KIT CONFIGURATION PART CODE

Multichem P for Alinity c


Assayed Single Level Kit 12 x 3mL 08P90-10
Barcoded QC

Multichem P for ARCHITECT c Assayed Single Level Kit 12 x 3mL 05P81-10

Features
Multichem® P
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
Onboard and Offboard • Targeted at key clinical decision points.
• Key elevated protein concentration for key medical
Test Consolidation for Serum elevated relevance.
Immunoprotein QC in a Liquid Stable Format • Liquid for ease of use
for Alinity and ARCHITECT systems

Specifications
• 30 month closed vial stability at -20°C to -80°C*.
• 14 day open vial stability at 2°C to 8°C*.
• 7 day onboard storage*

Instruments
Barcoded Multichem P is assayed for Abbott Alinity and
Architect c systems, and is value assigned for Alinity systems
Benefits only.

• On-board storage on the Alinity c system in a


temperature controlled reagent carousel. Order Information
• Automatically runs directly from the vial at user-defined
intervals. Multichem P (Alinity) Config. Part Code
• Barcoded vials make loading faster and easier -
minimizing errors. Assayed Single Level 12 x 3mL 08P90-10
• On-board stability is monitored by the Alinity system
software.

Analyte List
ADNase B (Anti-Streptococcal DNase)* CH50 (Total hemolytic Complement)* Immunoglobulin A
Albumin* Complement C3 Immunoglobulin G
Alpha 2-macroglobulin* Complement C4 Immunoglobulin M
Alpha-1 Antitrypsin C-Reactive Protein Kappa Light Chain*
Alpha-1-acid glycoprotein Cystatin C* Lambda Light Chain*
Angiotensin Converting Enzyme* Ferritin* Lipoprotein (a)*
Antistreptolysin O (ASO)* Haptoglobin Prealbumin
Antithrombin III* Hemopexin* Properdin Factor B*
Apolipoprotein A1 (APO A1) IgE* Retinol Binding Protein*
Apolipoprotein B (APO B) IgG1, Subclass* Rheumatoid Factor
Beta -2 Microglobulin IgG2, Subclass* sTfR (Soluble Transferrin Receptor)*
C1 Inhibitor* IgG3, Subclass* Total Protein*
Ceruloplasmin IgG4, Subclass* Transferrin

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 35

Specifications
Multichem® P
• 30 month closed vial stability at -20°C to -80°C*.
• 14 day open vial stability at 2°C to 8°C*.
Offboard
Test Consolidation for Serum elevated
Instruments
Immunoprotein QC in a Liquid Stable Format
Multichem P is assayed for Abbott Architect c instruments.
for ARCHITECT systems

Order Information

Multichem P (ARCHITECT) Config. Part Code

Assayed Single Level 12 x 3mL 05P81-10

Features
• Human based matrix proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Key elevated protein concentration for key medical
relevance.
• Liquid for ease of use

Analyte List
ADNase B (Anti-Streptococcal DNase)* CH50 (Total hemolytic Complement)* Immunoglobulin A
Albumin* Complement C3 Immunoglobulin G
Alpha 2-macroglobulin* Complement C4 Immunoglobulin M
Alpha-1 Antitrypsin C-Reactive Protein Kappa Light Chain*
Alpha-1-acid glycoprotein Cystatin C* Lambda Light Chain*
Angiotensin Converting Enzyme* Ferritin* Lipoprotein (a)*
Antistreptolysin O (ASO)* Haptoglobin Prealbumin
Antithrombin III* Hemopexin* Properdin Factor B*
Apolipoprotein A1 (APO A1) IgE* Retinol Binding Protein*
Apolipoprotein B (APO B) IgG1, Subclass* Rheumatoid Factor
Beta -2 Microglobulin IgG2, Subclass* sTfR (Soluble Transferrin Receptor)*
C1 Inhibitor* IgG3, Subclass* Total Protein*
Ceruloplasmin IgG4, Subclass* Transferrin

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
36 | Independent Quality Controls and QC Software Solutions

Multichem® Urine Chemistry Quality Control


for Abbott ARCHITECT & Alinity c Systems

Multichem Chemistry Quality Controls - Suitable for use on Abbott c systems

PRODUCT DESCRIPTION KIT CONFIGURATION PART CODE

Multichem U for Architect c


Assayed Bi-Level Kit 2 x 6 x 5mL 05P80-10

Multichem U for Alinity c


Assayed Bi-Level Kit 2 x 6 x 5mL 08P89-10
Barcoded QC

Features
Multichem® U
• Human matrix based proprietary formulation.
• Mimics performance of patient samples.
Onboard and Offboard • Targeted at key clinical decision points.
• Liquid for ease of use.
Test consolidation for urine chemistry QC
in a liquid stable format for
Alinity and ARCHITECT systems Specifications
• 24 month closed vial stability at 2°C to 8°C*.
• 30 day open vial stability at 2°C to 8°C*.
• 7 day onboard storage stability*

Instruments
Barcoded Multichem U is assayed for Abbott Alinity c and
Architect c series instruments, and is value assigned for
Alinity systems only.
Benefits
• On-board storage on the Alinity c system in temperature
controlled reagent carousel Order Information
• Automatically run directly from the vial at user-defined
intervals. Multichem U (Alinity) Config. Part Code
• Barcoded vials make loading faster and easier -
minimizing errors. Assayed Bi-Level 2 x 6 x 5mL 08P89-10
• On-board stability is monitored by the Alinity system
software.

Analyte List
Amylase Human Chorionic Gonadotropin* Sodium
Calcium Magnesium Specific Gravity*
Chloride Microalbumin Urea Nitrogen
Cortisol* Osmolality* Uric Acid
Creatinine Phosphorous Urinary Protein
Glucose Potassium

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 37

Multichem® U Specifications
• 24 month closed vial stability at 2°C to 8°C*.
Offboard • 30 day open vial stability at 2°C to 8°C*.

Test consolidation for urine chemistry QC


in a liquid stable format for ARCHITECT systems Instruments
Multichem U is assayed for Abbott ARCHITECT c series
instruments.

Order Information

Multichem U (ARCHITECT) Config. Part Code

Assayed Bi-Level 2 x 6 x 5mL 05P80-10

Features
• Human matrix based proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Analyte List
Amylase Human Chorionic Gonadotropin* Sodium
Calcium Magnesium Specific Gravity*
Chloride Microalbumin Urea Nitrogen
Cortisol* Osmolality* Uric Acid
Creatinine Phosphorous Urinary Protein
Glucose Potassium

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
38 | Independent Quality Controls and QC Software Solutions

Multichem® Immunoassay Quality Controls


for Abbott ARCHITECT & Alinity i Systems

Multichem Immunoassay Quality Controls - Suitable for use on Abbott i systems


PRODUCT DESCRIPTION KIT CONFIGURATION PART CODE

Multichem IA Plus for


Architect and Alinity i Assayed Tri-Level 3 x 4 x 5mL 08P86-10
Barcoded QC

Multichem IA Plus for


Assayed Tri-Level 3 x 4 x 5mL 05P76-10
ARCHITECT i

technopathcd.com
Independent Quality Controls and QC Software Solutions | 39

Features
Multichem® IA Plus
• Human matrix based proprietary formulation.
• Mimics performance of patient samples.
Onboard and Offboard • Targeted at key clinical decision points.
• Liquid for ease of use.
Test consolidation for serum immunoassay QC
in a liquid stable format for
Alinity and ARCHITECT systems Specifications
• 28 month closed vial stability at -20°C to -80°C*.
• 10 day open vial stability at 2°C to 8°C*.
• 5 day onboard storage*

1
Instruments
Barcoded Multichem IA Plus is assayed for Abbott Alinity i
and Architect i instruments, and is value assigned for Alinity
systems only.

Benefits Order Information


• On-board storage on the Alinity i system in a
temperature controlled reagent carousel. Multichem IA Plus (Alinity) Config. Part Code
• Automatically runs directly from the vial at user-defined
intervals. Assayed Tri-Level 3 x 4 x 5mL 08P86-10
• Barcoded vials make loading faster and easier -
minimizing errors.
• On-board stability is monitored by the Alinity system
software.

Analyte List

17-Hydroxyprogesterone* Estradiol Procainamide*


25-OH Vitamin D Estriol, Free* Procollagen NP Type 1*
Acetaminophen* Estriol, Total* Progesterone
Adrenocorticotrophic Hormone (ACTH)* Estrogen, Total* Prolactin
Aldosterone* Ethosuximide* Prostate Specific Antigen, Free
Alpha Fetoprotein (AFP) Ferritin Prostate Specific Antigen, Total
Amikacin* Folate Quinidine*
Androstenedione* Follicle Stimulating Hormone (FSH) Renin*
Angiotensin* Gentamicin* Salicylate*
Anti-thyroglobulin High Sensitive Troponin I Sex Hormone Binding Globulin
Anti-thyroperoxidase Homocysteine Testosterone
BNP (1-32) Human Chorionic Gonadotropin (BhCG) Testosterone, Free*
CA 125 Human Growth Hormone* Theophylline*
CA 15-3 Ibuprofen* Thyroglobulin*
CA 19-9 Immunoglobulin E* Thyroid Stimulating Hormone (TSH)
Caffeine* Insulin Thyroxine Binding Globulin*
Calcitonin* Insulin Like Growth Factor (IgF-1)* Thyroxine, Free (FT4)
Carbamazepine* Lidocaine* Thyroxine, Total (TT4)
Carbamazepine, Free* Lithium* Tobramycin*
Carcinogenic Embryonic Antigen (CEA) Luteinizing Hormone Triiodothyronine, Free (FT3)
Chloramphenicol* Myoglobin Triiodothyronine, Total (TT3)
CK-MB N-Acetyl procainamide* Troponin T*
Cortisol NT Pro-BNP* T-Uptake
C-Peptide Ostase* Ultra Sensitive CRP*
Cyclosporine* Parathyroid Hormone (PTH) (1-84) Valproic Acid*
DHEA-Sulfate Phenobarbital* Valproic Acid, Free*
Digoxin* Phenytoin* Vancomycin*
Disopyramide* Phenytoin, Free* Vitamin B12
EPO* Primidone*

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
40 | Independent Quality Controls and QC Software Solutions

Multichem® IA Plus Specifications


• 28 month closed vial stability at -20°C to -80°C*.
Offboard • 10 day open vial stability at 2°C to 8°C*.

Test consolidation for serum immunoassay QC


in a liquid stable format for ARCHITECT systems Instruments
Barcoded Multichem IA Plus is assayed for Abbott Architect
i series instruments.

Order Information

Multichem IA Plus (ARCHITECT) Config. Part Code

Assayed Tri-Level 3 x 4 x 5mL 05P76-10

Features
• Human matrix based proprietary formulation.
• Mimics performance of patient samples.
• Targeted at key clinical decision points.
• Liquid for ease of use.

Analyte List

17-Hydroxyprogesterone* Estriol, Free* Procainamide*


25 (OH) Vitamin D Estriol, Total* Procollagen type 1 amino-terminal
Acetaminophen* Estrogen, Total* propeptide (P1NP)*
Adrenocorticotropic hormone (ACTH)* Ethosuximide* Progesterone
Aldosterone* Ferritin Prolactin
Alpha Fetoprotein Folate Prostate Specific Antigen, Free
Amikacin* Follicle Stimulating Hormone Prostate Specific Antigen, Total
Androstenedione* Gentamicin Quinidine*
Angiotensin* High Sensitive Troponin I Renin*
Anti-Thyroglobulin Homocysteine Salicylate*
Anti-Thyroperoxidase Human Chorionic Gonadotropin (BhCG) Sex Hormone Binding Globulin (SHBG)
BNP (1-32) Human Growth Hormone* T Uptake
CA 125 Ibuprofen* Testosterone
CA 15-3 IgE Testosterone, Free*
CA 19-9 Insulin Theophylline
Caffeine* Insulin-like Growth Factor (IGF-1)* Thyroglobulin*
Calcitonin* Leutinizing Hormone Thyroid Stimulating Hormone (TSH)
Carbamazepine Lidocaine* Thyroxine Binding Globulin*
Carbamazepine, Free* Lithium* Thyroxine, Free (FT4)
Carcinogenic Embryonic Antigen Myoglobin Thyroxine, Total (TT4)
Chloramphenicol* N-Acelyl procainamide* Tobramycin*
CK-MB NT-proBNP* Triiodothyronine, Free (FT3)
Cortisol Ostase* Triiodothyronine, Total (TT3)
C-Peptide Parathyroid Hormone (PTH) (1-84) Troponin I
Cyclosporine* Parathyroid Hormone (PTH) (1-84) Troponin T*
DHEA Sulfate (STAT) Ultrasensitive CRP*
Digoxin Phenobarbital Valproic Acid
Disopyramide* Phenytoin Valproic Acid, Free*
Erythropoietin (EPO)* Phenytoin, Free* Vancomycin
Estradiol Primidone* Vitamin B12

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 41

Multichem® Cardiac Quality Control


for Abbott ARCHITECT & Alinity i Systems

Multichem® hsTn Specifications


• 36 month closed vial stability at -20°C to -80°C*.
• 10 day open vial stability at 2°C to 8°C*.
Offboard
Instruments
Barcoded Multichem hsTn is assayed for Abbott Alinity i
and ARCHITECT i series instruments, and is value assigned
for ARCHITECT systems only.

Order Information
Multichem hsTn Config. Part Code
(Alinity / ARCHITECT)

Features Assayed Single Level 12 x 3mL 04W26-10

• Human based matrix proprietary formulation.


• Mimics performance of patient samples.
• Targeted at key clinical decision points. Analyte List
• Liquid for ease of use.
Troponin I

Abbott Architect STAT High Sensitive Troponin-I


Multichem® Multichem® Multichem® Multichem®
hsTn (04W26-10) IA Plus (05P76-10) IA Plus (05P76-10) IA Plus (05P76-10)
Target Target Target Target
(Troponin I) (Level 1) (Level 2) (Level 3)
5.0 15.0 60.0 1000.0

Troponin I ng/L

1.9 4.7 15.6 34.2


LoD 10%CV Female 99th Male 99th
Percentile Percentile
3.2 URL URL
26.2
20% CV Consensus
LoQ IFCC 99th Percentile IFCC IFCC
Conc. 1 URL Conc. 2 Conc. 3

Abbott Alinity STAT High Sensitive Troponin-I


Multichem® Multichem® Multichem® Multichem®
hsTn (04W26-10) IA Plus (08P86-10) IA Plus (08P86-10) IA Plus (08P86-10)
Target Target Target Target
(Troponin I) (Level 1) (Level 2) (Level 3)
5.0 15.0 60.0 1000.0

Troponin I ng/L

1.6 5.1 15.6 34.2


LoD LOQ Female 99th Male 99th
10%CV Percentile Percentile
URL URL
26.2
Consensus
IFCC 99 Percentile
th IFCC IFCC
Conc. 1 URL Conc. 2 Conc. 3

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
42 | Independent Quality Controls and QC Software Solutions

Multichem® Diabetes Quality Control


for Abbott ARCHITECT & Alinity c Systems

Multichem® A1c Specifications


• 24 month closed vial stability at -20°C to -80°C*.
• 30 day open vial stability at 2°C to 8°C*.
Offboard
Instruments
Multichem A1c is assayed for Abbott Architect c4000,
c8000 and Alinity c systems.

Order Information
Multichem A1c Config. Part Code
(ARCHITECT)

Assayed Bi-Level 2 x 6 x 1mL 04V06-10

Features
• Human based matrix proprietary formulation. Analyte List
• Mimics performance of patient samples.
• Targeted at key clinical decision points. HbA1c
• Liquid for ease of use.

Multichem® Immunosuppressant Quality Control


for Abbott ARCHITECT & Alinity i Systems

Multichem® WBT Instruments


Multichem WBT is assayed for Abbott ARCHITECT and
Alinity systems.
Offboard
Order Information
- Please order through your local Abbott distributor -

Multichem WBT Config. Part Code


(Alinity / ARCHITECT)

Assayed Tri-Level for Architect 3 x 4 x 2mL 05P77-10

Assayed Tri-Level for Alinity 3 x 4 x 2mL 04S16-10


Features
• Human based matrix proprietary formulation.
• Mimics performance of patient samples. Analyte List
• Targeted at key clinical decision points.
• Liquid for ease of use. Cyclosporine
Folate*
Specifications Glucose*
Sirolimus
• 30 month closed vial stability at -20°C to -80°C*. Tacrolimus
• 10 day open vial stability at 2°C to 8°C*.

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 43

Streamline your QC
process further using the
script zone!
Eliminate the need to add separate
open-date, expiry and initials labels
to QC tubes!

Multichem® Independent Quality Controls


for use on Roche cobas® systems
Targeted at Clinical decision proints, Technopath's consolidated Multichem QC is value assigned for Roche
cobas® analyzer systems. Consolidated controls increase laboratory efficiencies by reducing:
• Handling time
• Dead-volume waste
• Weight of waste consumables
• Storage requirements
• QC analyisis time with IAMQC® Software.

Clinical Chemistry............................................ 44 Immunoassay.................................................. 47


Multichem S Plus......................................................... 44 Multichem IA Plus........................................................ 47

Immunology.................................................... 45 Infectious Disease............................................ 48


Multichem P................................................................. 45 Multichem ID-G*.......................................................... 48
Multichem ID-GNeg*.................................................. 48
Urine Chemistry............................................... 46
Multichem U ................................................................ 46

*Coming soon

technopathcd.com
44 | Independent Quality Controls and QC Software Solutions

Multichem® Clinical Chemistry Quality Control


for Roche cobas® systems

Multichem® S Plus Specifications


• 36 month closed vial stability at -20°C to -80°C.
Load-and-Go • 10 day open vial stability at 2°C to 8°C.

Test consolidation for serum chemistry and immunology QC


in a liquid stable format for Roche cobas® systems Instruments
Multichem S Plus, independent clinical chemistry QC is
assayed and value assigned for Roche cobas® systems.

Order Information
- Please order through Roche -

Multichem S Plus (cobas®) Config. Part Code

Assayed Single Level (Level 1) 12 x 4mL (48mL) 09339795190


Assayed Single Level (Level 2) 12 x 4mL (48mL) 09339809190
Features Assayed Single Level (Level 3) 12 x 4mL (48mL) 09339817190

• Human based proprietary formulation


• Mimics performance of patient samples
• Liquid frozen for ease of use
• Assayed Chemistry QC
• Facilitates tri-level utility for Cholesterol HDL & LDL, APO
A1, and Apo B
• Assayed and value assigned for Roche cobas
• Tri-level utility for immunoproteins

Analyte List
ACE* Cholesterol, HDL Lactate Dehydrogenase (LDH)
Acetaminophen Cholesterol, LDL Lambda Light Chain
Acid Phosphatase (Non Prostatic) Cholesterol, Total Lipase
Acid Phosphatase (Non Prostatic)* Cholinesterase Lipoprotein (a)
Acid Phosphatase (Total) CKMB* Lithium
ADNase B (Anti-Streptococcal DNase B)* Complement C3 Magnesium
Alanine Aminotransferase (ALT) Complement C4 Osmolality*
Albumin Copper* Phenobarbital
Alkaline Phosphatase (ALkP) Cortisol* Phenytoin
Alpha 2 Macroglobulin* C-Reactive Protein (CRP) Phosphate
Alpha-1 Acid Glycoprotein C-Reactive Protein (Ultra Sensitive) Phospholipids*
Alpha-1 Antitrypsin Creatine Kinase (CK) Potassium
Alpha-Hydroxybutyrate dehydrogenase Creatinine Prealbumin
Amikacin Cystatin C* Properdin Factor B*
Amylase, Pancreatic Dehydrogenase* Protein Electrophoresis*
Amylase, Total Digoxin Retinol Binding Protein*
Anti-streptolysin O (ASO) Ethanol Rheumatoid Factors (RF)
Anti-thrombin III* Ferritin** Salicylate
Apolipoprotein A1 (APO A1) Fructosamine Sodium
Apolipoprotein B (APO B) Gamma Glutamyltransferase (GGT) Soluble Transferrin Receptor
Aspartate Aminotransferase (AST) Gentamicin Theophylline
Beta Hydroxybutyrate* Glucose Thyroxine (T4)*
Beta-2 Microglobulin Haptoglobin Tobramycin
Bicarbonate (CO2) Hemopexin* Total Iron Binding Capacity *
Bile acids* Homocysteine** Total Protein
Bilirubin Direct IgE* Transferrin
Bilirubin Indirect* IgG1, Subclass* Triglycerides
Bilirubin Total IgG2, Subclass* Triiodothyronine*
C1 Inhibitor* IgG3, Subclass* Ultra sensitive CRP
Caffeine* IgG4, Subclass* Unsaturated Iron-Binding Capacity (UIBC)
Calcium Immunoglobulin A (IgA) Urea
Calcium Ionized* Immunoglobulin G (IgG) Uric Acid
Carbamazepine Immunoglobulin M (IgM) Valproic acid
Ceruloplasmin Iron Vancomycin
CH50 (Total hemolytic Complement)* Kappa Light Chain Zinc*
Chloride Lactate
*Please refer to lot specific package inserts for stability and performance claims.
**These analytes are transitioning to claimed status, please refer to lot specific IFU.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 45

Multichem® Immunology Quality Control


for Roche cobas® systems

Multichem® P Specifications
• 36 month closed vial stability at -20°C to -80°C.
• 14 day open vial stability at 2°C to 8°C.
Load-and-Go
Test Consolidation for Serum elevated Immunoprotein QC Instruments
in a Liquid Stable Format for Roche cobas® systems
Multichem S Plus, independent clinical chemistry QC is
assayed and value assigned for Roche cobas® systems.

Order Information
- Please order through Roche -

Multichem P Config. Part Code


(cobas®)
Features
Assayed Level P 12 x 4mL (48mL) 09339884190
• Human based proprietary formulation
• Mimics performance of patient samples
• Liquid frozen for ease of use
• Assayed and value assigned for Roche cobas
• Provides truly elevated values of specific proteins to
control the analytical range
• Supplementary single-level immunoprotein control to
complement Multichem S Plus
• Provides tri-level utility for RF when used in conjunction
with Multichem S Plus

Analyte List
Albumin Complement C3 Immunoglobulin G (IgG)
ADNase B (Anti-Streptococcal DNase B)* Complement C4 Immunoglobulin M (IgM)
Alpha-1 Acid Glycoprotein C-Reactive Protein (CRP) Kappa Light Chain*
Alpha-1 Antitrypsin C-Reactive Protein (Ultra Sensitive) Lambda Light Chain*
Alpha-2 Macroglobulin* Cystatin C* Lipoprotein (a)*
Angiotensin Converting Enzyme* Ferritin* Prealbumin
Antistreptolysin O (ASO)* Haptoglobin Properdin Factor B*
Antithrombin III* Hemopexin* Retinol Binding Protein*
Apolipoprotein A-1 (APO A1) IgE* Rheumatoid Factors (RF)
Apolipoprotein B (APO B) IgG1, Subclass* Soluble Transferrin Receptor
Beta-2 Microglobulin IgG2, Subclass * Total Protein
C1 Inhibitor* IgG3, Subclass* Transferrin
Ceruloplasmin IgG4, Subclass*
CH50 (Total hemolytic Complement)* Immunoglobulin A (IgA)

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
46 | Independent Quality Controls and QC Software Solutions

Multichem® Urine Chemistry Quality Control


for Roche cobas® systems

Multichem® U Specifications
• 24 month closed tube stability at 2°C to 8°C.
• 30 day open tube stability at 2°C to 8°C.
Load-and-Go
Instruments
Test consolidation for urinary chemistry QC in a liquid
stable format for Roche cobas® systems Multichem U, independent urinary chemistry QC is assayed
and value assigned for Roche cobas® systems.

Order Information
- Please order through Roche -

Multichem U Config. Part Code


(cobas®)

Features Assayed Single Level (Level 1) 12 x 3mL (36mL) 09339868190


Assayed Single Level (Level 2) 12 x 3mL (36mL) 09339876190
• Human based proprietary formulation
• Mimics performance of patient samples
• Liquid stable
• Assayed urine chemistry QC
• Bi-level utility
• Greater stability and performance for creatinine
• Assayed and value assigned for Roche cobas
• Addition of human based microalbumin provides greater
accuracy and performance

Analyte List
Amylase hCG* Sodium
Calcium Magnesium Specific Gravity*
Chloride Microalbumin Total Protein Urine
Cortisol* Osmolality* Urea
Creatinine Phosphate Uric Acid
Glucose Potassium

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 47

Multichem® Immunoassay Quality Control


for Roche cobas® systems

Multichem® IA Plus Specifications


• 36 month closed vial stability at -20°C to -80°C.
• 10 day open vial stability at 2°C to 8°C.
Load-and-Go
Test consolidation for serum chemistry and immunology QC Instruments
in a liquid stable format for Roche cobas® systems
Multichem IA Plus, independent clinical chemistry QC is
assayed and value assigned for Roche cobas® systems.

Order Information
- Please order through Roche -

Multichem IA Plus (cobas®) Config. Part Code

Assayed Single Level (Level 1) 12 x 4mL (48mL) 09339825190


Assayed Single Level (Level 2) 12 x 4mL (48mL) 09339841190
Features Assayed Single Level (Level 3) 12 x 4mL (48mL) 09339850190

• Human based proprietary formulation


• Mimics performance of patient samples
• Liquid frozen for ease of use
• Assayed Immunoassay QC
• Test consolidated immunoassay control includes general
IA, cardiac markers and tumor markers
• Assayed and value assigned for Roche cobas
• Tri-level utility

Analyte List
17-OH Progesterone* Estriol, Total* Progesterone
Acetaminophen* Estrogen, Total* Prolactin
Adrenocorticotropic hormone (ACTH) Ethosuximide* Prostate Specific Antigen, Free
Aldosterone* Ferritin Prostate Specific Antigen, Total
Alpha-Fetoprotein (AFP) Folate Quinidine*
Amikacin* Folicle Stimulating Hormone (FSH) Renin*
Androstenedione** Gentamicin* Salicylate*
Angiotensin* HcG STAT** Sex Hormone Binding Globulin (SHBG)
Anti-CCP* Homocysteine* T Uptake
Anti-Thyroglobulin (Anti-Tg) Human Chorionic Gonadotropin +ß Testosterone
Anti-Thyroperoxidase (Anti-TPO) (HcG+ß) Testosterone, Free*
BNP* Human Growth Hormone (hGH) Theophylline*
CA 125 Ibuprofen* Thyroglobulin (Tg)
CA 15-3 IGF-1** Thyroid Stimulating Hormone (TSH)
CA 19-9 Immunoglobulin E (IgE) Thyroxine Binding Globulin*
Caffeine* Insulin Thyroxine, Free (FT4)
Calcitonin Leutinizing Hormone (LH) Tobramycin*
Carbamazepine* Lidocaine* Total T3
Carbamazepine, Free* Lithium* Total T4
Carcinogenic Embryonic Antigen (CEA) Myoglobin Triiodothyronine, Free (FT3)
Chloramphenicol* N-Acetyl procainamide* Troponin I
CK-MB NT-pro BNP Troponin T
Cortisol Ostase* Ultra-sensitive CRP*
C-Peptide Parathyroid Hormone (PTH) Valproic Acid*
Cyclosporine* Parathyroid Hormone 1 - 84 (PTH)** Valproic Acid, Free*
DHEA-S Phenobarbital* Vancomycin*
Digoxin Phenytoin* Vitamin B12
Disopyramide* Phenytoin, Free* Vitamin D, Total
EPO* Primidone*
Estradiol Procainamide*
Estriol, Free* Procollagen NP Type 1*

*Please refer to lot specific package inserts for stability and performance claims.
**These analytes are transitioning to claimed status, please refer to lot specific IFU.

technopathcd.com
48 | Independent Quality Controls and QC Software Solutions

Multichem® Infectious Disease Quality Control


for Roche cobas® systems

Multichem® ID-G Specifications


• 24 month closed tube stability at 2°C to 8°C.
• 90 day open tube stability at 2°C to 8°C.
Load-and-Go
Instruments
Positive multi-analyte infectious disease QC
for Roche cobas® systems Multichem ID-G, independent serology QC is assayed and
value assigned for Roche cobas® systems.

Order Information
Coming - Please order through Roche -
Soon Multichem ID-G Config. Part Code
(cobas®)
Features Positive QC 4 x 4mL (16mL) 09339892190
• Human based proprietary formulation
• Mimics performance of patient samples
• Liquid for ease of use
• Technical and Scientific Support

Analyte List
Anti-HBc IgG Anti-HIV 1 IgG Anti-Treponema pallidum IgG
Anti-HCV IgG Anti-HTLV I IgG HBsAg

Multichem® ID-G Neg Specifications


• 36 month closed tube stability at 2°C to 8°C.
Load-and-Go • 90 day open tube stability at 2°C to 8°C.

Negative multi-analyte infectious disease QC Instruments


for Roche cobas® systems
Multichem ID-G neg, independent serology QC is assayed
and value assigned for Roche cobas® systems.

Order Information
Coming - Please order through Roche -
Soon
Multichem ID-G Neg Config. Part Code
(cobas®)
Features
Negative QC 4 x 4mL (16mL) 09339906190
• Human based proprietary formulation
• Mimics performance of patient samples
• Liquid for ease of use
• Technical and Scientific Support

Analyte List
Anti-HBc IgG Anit-HIV Group O HBsAg
Anti-HCV IgG Anti-HTLV I IgG HIV p24 Antigen
Anti-HIV 1 IgG Anti-Trypanosoma cruzi IgG (Chagas)
Anti-HIV 2 IgG Anti-Treponema pallidum IgG

*Please refer to lot specific package inserts for stability and performance claims.

technopathcd.com
Independent Quality Controls and QC Software Solutions | 49

QC Data Management Solutions


Product Description Ordering

Next generation cloud based software, designed to meet


IAMQC Infinity
your QC solution needs.
Contact our QC Software experts to find
the 'best fit' QC software solution for
your laboratory.
IAMQC Peer Real-time peer cloud-based comparison software
technopath.qcsoftware@lgcgroup.com

IAMQC Transfer Advanced connectivity solution for laboratories

Analyse QC results in real-time


IAMQC Software Products Help:
Designed to complement and support Technopath’s
Multichem® Quality Control (QC) product range,
IAMQC Software provides Laboratory Managers and BENCH TECHNOLOGISTS:
Technologists with a range of QC software tools to • Spend less time on false positive QC flags.
• Concentrate on tests that require their attention.
analyse their QC results in real-time. • Spend less time trouble-shooting QC.
• Know how to react when the mean shifts.
IAMQC Software products allow users to automate, • Assess the acceptability of new reagent lots and
calibration events.
centralise, standardise and improve QC processes in a • Solve QC problems.
laboratory setting. The software satisfies the varying • QC target data automatically downloaded to the
instrument*
levels of QC requirements in individual laboratories
and is easily applied to meet your quality goals. LAB MANAGERS:
• Choose QC rules to maximise true rejects and
Technopath's full suite of software products provide minimise false rejects.
• Quickly see the tests that require their attention.
clinical laboratories with significant cost and time • Skim graphics to quickly review current or historical
savings, whilst delivering higher confidence in data by lab, department, instrument or test.
• Monitor performance in groups of laboratories.
analytical testing methods. IAMQC software products
• Review problem tests and QA activities in local and
are practical, graphical, user-definable and easy to remote labs.
use.
LAB OR HOSPITAL ADMINISTRATORS:
• Save money.
• Improve quality.
• Improve service.
• Review Administrative Summary Reports to ensure
quality performance.

*Please contact with us for specific information for your


diagnostic platform.

technopathcd.com
50 | Independent Quality Controls and QC Software Solutions

IAMQC® Infinity

Next Generation Solutions Order Information


IAMQC Infinity is designed as a QC data management
Contact our QC Software experts to find the best QC
solution that complements and supports Technopath
software solution for your laboratory.
Clinical Diagnostics Multichem® Quality Control (QC)
product range, and provides Laboratory Managers technopath.qcsoftware@lgcgroup.com
and Technologists with a range of QC software
tools to analyse their QC results in real-time. IAMQC
Infinity is practical, graphical, and easy to use and
provides laboratories with a centralised standardised IAMQC Infinity - At a Glance
approach to QC data management.
Instant Comparison 
Laboratories today have many constraints in their
daily process including labour, time, and budget. Centralised Data Management 
IAMQC Infinity helps to address these issues through
Cloud Based SaaS Model 
a web-based system designed to manage QC data.

Providing access to advanced QC data management


Compliance with Standards 
tools through a software-as-a-service platform Westgard and/or user defined QC rules
fully supported 
removes the budgetary constraints that currently
exist with products available today. Setup wizards Focused Troubleshooting 
save time for laboratories by providing all options
available via drop-down lists and removing the need QC Monitor 
for manual entry by skilled laboratory technologists.
Configurable per Instrument and per
Test 
IAMQC Infinity allows users to automate, centralise,
standardise and improve QC processes in a laboratory
setting. Our combination of features in one system Benefits - IAMQC Infinity
satisfies the varying levels of QC requirements in
Design and select your exact QC
individual laboratories and is easily applied to meet system requirements 
different QC management expectations. IAMQC
Infinity provides clinical laboratories with significant
Automate your QC process 
cost and time savings, whilst delivering higher
confidence in analytical testing methods.
Consolidate all your QC Processes 
User-Friendly 
Centralised data management 
Automatic data submission 
Cloud based system 

technopathcd.com
Independent Quality Controls and QC Software Solutions | 51

IAMQC® Peer What is an interlaboratory program?


In its simplest form, an interlaboratory program
is a means for individual labs to compare their
performance against other labs. The comparison will
be against other labs using the same lot of quality
control (QC) material on the same test and on the
same instrument type. Interlaboratory programs
offer various reports to show how your instruments
in your lab compare against all others with these
reports being generated at the end of the month once
all data has been submitted. Some interlaboratory
Order Information programs offer real-time peer comparison where the
values displayed are based on all of the data that has
Contact our QC Software experts to find the best QC
been submitted up to the time of report generation or
software solution for your laboratory.
statistic viewing.
technopath.qcsoftware@lgcgroup.com
Why should you use an
interlaboratory program?
IAMQC Peer - At a Glance Any laboratory that strives to achieve ISO accreditation
should be part of an interlaboratory program:
Reagent Lot Report 
The inputs to management review shall be
Bias Report  recorded and shall include evaluations of results
Exception Notes Report  of participation in interlaboratory comparison
programmes;
Group Coordinator Report  ISO 15189, Fourth Edition 2022-12, "Medical laboratories -
Requirements for quality and competence",
Levey Jennings Report  subclause 8.9.2 (h).

Measurement of Uncertainty  This ISO standard specifies the quality management


Monthly Standard Report  system requirements particular to medical
laboratories and helps to set a level of performance
Sigma Metrics Report  and competency that labs should attain. The medical
laboratory is an important part of patient care as
Youden Plot Report  all tests results come from the lab so ensuring your
systems are in control is a vital part of this process.
An interlaboratory program can provide comfort to
the lab by demonstrating that your performance is in

Benefits - IAMQC Peer line with other labs. When your lab’s performance is
not in line with others, the interlaboratory program
Real-time Peer data comparison  highlights this to you quickly.

Facilitates Standards approvals 


Centralised data management 
Automatic data submission 
Cloud based system 
User-Friendly 

technopathcd.com
52 | Independent Quality Controls and QC Software Solutions

How does IAMQC Peer help with participation


in an interlaboratory program?
IAMQC Peer is a web based truly real time peer
comparison system. Truly real-time means that all
data submitted is included in the peer statistics at
the time of report generation or when viewing the
interactive peer statistics. IAMQC Peer shows labs
each of their individual instruments performance and
compares the accuracy and precision of the analytical
processes to their peer group. The peer group will
contain instruments of the same type from other
laboratories using the same lot of QC material and
using the same method for the test. The information
from the reports and interactive peer statistics in
IAMQC Peer can be extremely valuable, indicating
the user’s performance relative to their peer group
as well as providing powerful troubleshooting tools
when attempting to resolve potential problems.
IAMQC Peer has multiple interfacing solutions to
allow for the automation of data submission helping including monthly mean for each test and level, is
busy lab personnel to concentrate on the important displayed along with peer group values.
activities of testing and result interpretation.
Youden Plot
IAMQC Peer contains multiple reports, all of which
The Youden plot visualizes both bias and imprecision
provide key information to the lab in interpreting
graphically and can be used to evaluate systematic
their instrument performance.
and/or random error.

Reagent Lot Report


Six Sigma
Automates the tracking and reporting of reagent lot-
The six sigma report automatically calculates the
to-lot variation.
lab’s sigma score based on the Total Allowable Error
values entered.
Group Coordinator Report
A test-by-test listing of statistics of the laboratory
Measurement of Uncertainty
and its peer groups for up to 3 levels of control.
The system calculates the MoU value automatically
based on the time-range selected for the lot in
Levey-Jennings Report
question along with the Standard Error of the Mean
The LJ report displays individual QC values per
(SEM) value or the running SD of each test for the
analyte for the selected month. It also indicates when
time period selected.
a reagent lot was changed.

Bias Report
Exceptions Report
The bias report contains all the information in the
This report details the lab’s tests and analytical
Group Coordinator report plus a bias score against
methods which differ in performance from its peer
the cumulative peer mean for each test and is
group using SDI and CVI.
generated in Microsoft Excel format.

Monthly Summary Report


A rolling twelve-month window of summary statistics,

technopathcd.com
Independent Quality Controls and QC Software Solutions | 53

The most advanced connectivity solution


available for laboratory instrumentation.

IAMQC® Transfer
IAMQC Transfer is a connectivity device that can
communicate with Laboratory Information Systems
(LIS), Middleware, automated instrumentation and
Point Of Care platforms.

Through the use of our proprietary drivers and a single


board computer device, IAMQC Transfer processes
and communicates data from your system to IAMQC,
cloud-based software. Order Information
IAMQC Transfer features a plug-and-play set up, Contact our QC Software experts to find the best QC
combined with multiple connectivity options, ensuring software solution for your laboratory.
an un-matched level of flexibility – all within an
incredibly small, seamless enclosure. technopath.qcsoftware@lgcgroup.com

IAMQC Transfer - At a Glance


Simple Set Up 
Secure System 
Future Proof System 
Automatic QC Data Upload 

Benefits - IAMQC Transfer


Instant QC data comparison 
Facilitates Standards approvals 
Centralised data management 
Automatic data submission 
User-Friendly 

technopathcd.com
54 | Independent Quality Controls and QC Software Solutions

Notes

technopathcd.com
Technopath is part of LGC Clinical Diagnostics
LGC Clinical Diagnostics is a leading provider of Quality Measurement Tools, biological materials, and
reagents for the IVD and extended life science industry.

By bringing together four industry-leading companies, our combined and ever-growing capabilities
mean we are better positioned to support the needs of the clinical diagnostics industry.

Together, we are working to enable laboratories to deliver patient results with confidence.
LGCClinicalDiagnostics.com

Independent Quality Controls Quality Control & Diagnostics


& QC Software Solutions Development Solutions

Linearity and Calibration Verification Protein Production, Antibody


Test Kits for Clinical Analyzers Generation and Assay Development

technopathcd.com | technopath.info@lgcgroup.com | Tel: +353 61 525700


Technopath Life Sciences Park, Fort Henry, Ballina, Co. Tipperary, V94 FF1P, Ireland.

© 2023 Techno-path Manufacturing Limited. All rights reserved. No part of this publication may be reproduced or transmitted in any form
or by any means, electronic or mechanical, including photocopying, recording, scanning or otherwise, or through any information browsing,
storage or retrieval system, without permission in writing from Techno-path Manufacturing Limited. Multichem and IAMQC are trademarks of
Technopath Clinical Diagnostics.
All content correct at time of publishing. E &O.E.
MM_CAT_Digi_R19

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