PR83976

Technopath Clinical Diagnostics Expands Its Portfolio of Third-party Quality Control Solutions for COVID-19 as Clinical Laboratories Globally Ramp Up Antibody Testing

NEW YORK and BALLINA, Ireland, May 11, 2020, /PRNewswire=KYODO JBN/--

- Technopath is launching Multichem(R) ID-COVID-19 Quality Control Solutions

that will reduce potential errors, and allow laboratories to release patient

test results with confidence.

- Multichem COVID-19 Solutions are carefully manufactured to closely mimic

patient samples offering a clinically relevant solution irrespective of the

antibody test or instrument system.

- The Multichem Portfolio provides the clinical laboratory community the

assurance of independent quality control (QC) checks and longer-term QC

monitoring, helping laboratories detect instrument, reagent and procedural

errors.

Technopath Clinical Diagnostics today launched its Multichem ID-COVID-19

Quality Control Solutions offering laboratories third-party quality control

products enabling an independent, totally unbiased assessment of a diagnostic

device or method for COVID-19 antibody testing.

Triggered by a massive effort from the clinical diagnostic industry to

introduce antibody tests worldwide, Technopath is responding to the urgent need

from the laboratory community for third-party quality control solutions.

Third-party is the term used to describe a laboratory control not purposefully

designed or optimized for use with a specific test or instrument system.

"We are firmly resolute in supporting the global response to the COVID-19

pandemic by manufacturing independent quality solutions helping diagnostic

companies and laboratories get to optimal test performance as quickly as

possible," said Malcolm Bell, CEO and founder of Technopath. "With some

clinical labs processing up to 500,000 coronavirus antibody tests per month,

the company is laser-focused on assuring the quality of patient testing, and we

believe our third-party QC solutions will reduce potential errors allowing

laboratories to release patient results with confidence."

To date, the Foundation for Innovative New Diagnostics (FIND) has identified

280 antibody tests (immunoassays) in development or on the market. In the US

alone, the FDA has granted 12 antibody test authorizations, including Abbott,

Roche, Ortho Clinical Diagnostics, Cellex, Chembio Diagnostic Systems, the

Mount Sinai Health System, Autobio and DiaSorin.

"With antibody testing accelerating across nations, clinical laboratories

should be demanding data on validation studies, sensitivity and specificity,

and conducting those studies in their labs," said James O. Westgard, PhD,

longtime leader in clinical laboratory quality-control and founder of Westgard

QC. "Quality-control is one of the most critical aspects of laboratory testing,

and laboratories need to be adding third-party controls to their methods as

soon as possible."

The Importance of Independent Quality Controls

Quality Control material may be provided by the instrument manufacturer or by

an independent control manufacturer. The control materials provided by the

manufacturer of the instrument or reagents are often referred to as "in kit"

controls. Third party controls are manufactured independently of the test

system calibrators and reagents.

Often times a laboratory using an instrument manufacturer or in-kit control may

receive a different control lot with each new reagent lot. This does not

provide the laboratory with the benefits of long-term QC monitoring.

Third party controls with a longer shelf life allow use of the same control lot

over multiple changes in reagents and calibrators, giving the laboratory the

ability to detect shifts that may occur with new reagents or calibrators.

About Multichem COVID-19 (IgG, IgM and Neg) Solutions

These solutions are 3rd party quality control products that help provide an

independent assessment of a diagnostic device or method for COVID-19 antibody

testing. These controls are manufactured based on a human base matrix that

helps provide a product analogous to a patient sample.

About Technopath Clinical Diagnostics

Technopath Clinical Diagnostics is a global leader in the development and

manufacture of total quality control (QC) solutions for clinical laboratories.

In 2008, we launched the In-Vitro Diagnostic industry's first truly

consolidated Immunochemistry quality control materials. Consolidating multiple

tests into one QC product enables clinical laboratories to significantly

improve the efficiency and cost effectiveness of QC processes. Our IAMQC(R)

software platform automates the handling and management of QC data, while

facilitating laboratory accreditation requirements. Today, our products are

used by over 15,000 leading laboratories in over 130 countries. For more

information on Technopath, visit www.technopathcd.com.

Photo -

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Logo - https://mma.prnewswire.com/media/1165846/Technopath_Logo.jp

Contacts:

For Media:

Sunny Uberoi

Corporate Communications

Telephone: + 1 917-747-2018

Email: sunny@166media.com

For Business Development:

Conor Connolly

VP Commercial, Technopath Clinical Diagnostics

Email: conor.connolly@technopathcd.com

Telephone: + 353-61-525700

For Marketing & Communications:

Len Lloyd

Director  Marketing, Technopath Clinical Diagnostics

Email: len.lloyd @technopathcd.com

Telephone: + 353-61-525700

SOURCE: Technopath Clinical Diagnostics