Courtesy of Cellares

Cellares launches Cell Q

April 19, 2024
The automated cGMP QC Workcell for Cell Therapies, to resolve manual QC processing bottleneck and extend IDMO capabilities from manufacturing through quality control.
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Dear API Abby

The American Proficiency Institute (API), a global leader in proficiency testing programs, is dedicated to improving the accuracy and efficiency of clinical laboratory testing...
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Why a real-time QC reporting system is critical in the modern lab

Quality control (QC) remains one of the most important tasks of the medical laboratory to ensure the reliability and accuracy of reported patient results. Whenever results are...
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For emerging infectious diseases, reliable controls support QC efforts

Feb. 20, 2023
The spate of recent public health crises, beginning with COVID-19 and including the mpox outbreak that began last year, underscored the importance of quality control measures ...
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The focus of quality control strategies should be on patient outcomes, not technology

Laboratories use quality control (QC) procedures to assure the reliability of the test results they produce and report. According to ISO 15189, the International Organization ...
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More than cost: The true impact of errors

April 20, 2022
The cost of errors and its antithesis, the cost of quality, is often written about in terms of financial impact to medical laboratories and the healthcare system. This article...
Ideal layout for a molecular laboratory to reduce contamination events. This layout ensures separation of clean reagents and equipment from exogenous DNA sources (i.e., samples and/or amplicon containing material).

Preventing cross-contamination in a molecular laboratory

Polymerase Chain Reaction (PCR) is a standard laboratory technique used to amplify a specific sequence of DNA many times over. This technique has become an important tool in clinical...
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COLA gains pathology deemed status from CMS

March 8, 2022
COLA announced that the Centers for Medicare & Medicaid Services (CMS) has awarded COLA deemed status for the pathology specialty.“Now that COLA has deeming authority for the ...
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Document review, competency, proficiency testing, and correlation testing are among the standards cited most often during on-site surveys at clinical labs.

What clinical laboratories should do to become survey ready

Feb. 23, 2022
Laboratories conducting diagnostic testing, classified by the U.S. Food and Drug Administration (FDA) as non-waived, are required to be compliant with the 1988 regulations of ...
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CLSI publishes new guideline M39 — analysis and presentation of cumulative antimicrobial susceptibility test data

Feb. 17, 2022
The Clinical and Laboratory Standards Institute (CLSI) has published the 5th edition of M39 — Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data. This...
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FDA clears Streck’s MDx quality control for BioFire sepsis product

Jan. 31, 2022
Streck said its quality control kit for the BioFire BCID2 Panel for sepsis has been granted clearance by the U.S. Food and Drug Administration (FDA).MDx-Chex for BCID2 is a patient...