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 technopath 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 clinical diagnostics.
“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, a 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 the 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.