Standards

The Dot Corp Achieves ISO 9001:2015 Certification for Healthcare Fulfillment Services

California-based company adds quality management certification to existing FDA registration and pharmacy licensing for lab testing kit fulfillment operations.

Standards

Few UK Online STI Test Services Meet National Standards

Few online STI test services in the U.K. meet national recommended standards, with independent sector providers least likely to be compliant.

Standards

COLA Releases New eBook Series COLA Primers to Aid Laboratories

These eBooks are designed specifically to assist clinical laboratories in adhering to all federal, state, and local requirements.

Verichem Laboratories Offers Liquid Stable Ethanol Standard Kit

Mar 24, 2020 | Quality Systems, Standards

The six-level set of reference materials is free of azide, glycols, surfactants, and other interfering substances. The materials are expressly designed to be processed by the intended clinical measuring system in the same way as a patient specimen.

New American National Standard for Artificial Intelligence in Healthcare Published

Mar 10, 2020 | Computing Systems, Information Technology, Middleware & Software, Standards

The standard defines terms related to AI and associated technologies in healthcare.

Validate SP1 Kit for Roche Analyzers

Dec 30, 2019 | Standards

LGC Maine Standards releases Validate SP1 kit for fast, easy, and efficient linearity and calibration verification of serum proteins

FDA Clears Lumipulse G Whole PTH Assay

Dec 19, 2019 | Calibrators, Kidney Disease, Standards

Fujirebio’s latest offering is a third-generation assay that accurately measures biologically active parathyroid hormone levels resulting from disorders of calcium metabolism.

Tumor Mutational Burden Reference Materials

Dec 19, 2019 | Standards

SeraCare has released the first genomic DNA and formalin-fixed, paraffin-embedded reference materials for the measurement of tumor mutational burden via next-generation sequencing assays.

Roche Launches Cobas BKV and EBV Tests for Transplant Patients

Nov 12, 2019 | Standards

The tests provide reliable, standardized results to help clinicians manage the risk of infection and improve treatment of severely immunocompromised transplant patients.

Ductless Enclosures Protect Users from Chemicals, Vapors, and Powders

Nov 5, 2019 | Controls, Filters, Standards

Carbon filtration technology offers a high-performance alternative to conventional ducted fume hoods for a broad range of applications.

STI Incidence on the Rise

Oct 29, 2019 | Culture Media, Sexually Transmitted Diseases, Standards

Greater access to nucleic acid amplification tests is needed to address rising rates of extragenital chlamydia and gonorrhea.

GA4GH Approves Five New Standards for Genomic and Phenotypic Data Sharing

Oct 29, 2019 | Standards

The new guides add to GA4GH’s growing list that includes standards for streaming genomic data and for accessing the reference genome.

Ethically Sourced Biological Materials

Oct 21, 2019 | Standards

The materials can be used for developing new tests; validating assays; and manufacturing calibration, quality control, and proficiency testing materials.

Ready-to-Use Vials and Closures Minimize Waste

Oct 21, 2019 | Containers, Culture Media, Standards

Specialized borosilicate glass vials with secure closures and pretreatment options are custom-packaged to improve customer workflows.

Inside Track: Addressing Biotin Interference

Sep 7, 2019 | Immunoassay, Immunoassay Reagents & test Kits, Standards

A sector startup is taking on a widespread lab challenge.

Novel Noninvasive Test Proposed for Detecting Bowel Diseases

Aug 20, 2019 | Controls, Standards

A new study recommends a novel, noninvasive test for assessing gut function that may help screen and monitor treatment of gut diseases using only a small sample of blood and stool.

July 2019 Product Spotlight: AACC Exhibitors Showcase

Aug 7, 2019 | Blood Gas Analyzers, Coagulation Testing, Containers, Controls, Culture Media, Electrolytes, Gastrointestinal Infections, Hematology & Serology, Slides, Software, Standards, Tubes, Water Purification Systems

Innovative products featured by exhibitors at the American Association for Clinical Chemistry 2019 scientific meeting and clinical lab expo.

Diabetes and the Clinical Laboratory

Jul 15, 2019 | Culture Media, Library Preparation Systems, Standards

Clinical laboratories continue to play a vital role when it comes to diabetes diagnosis.

Category: Standards

Standards

Standards

Standards