CLSI Blog Articles

Read the latest articles about CLSI and laboratory standards in the official CLSI Blog. Browse our most recent blog articles below.

Regulation of Laboratory Tests Is About to Change

The bipartisan bill, Verifying Accurate Leading-edge IVCT Development Act (VALID), was introduced to Congress on March 5, 2020. This legislative effort, if enacted, will overhaul the regulatory oversight of in vitro diagnostics (IVDs) in the United States and create a single system for regulation of LDTs and manufacturers’ IVCTs.

Performing Pediatric Phlebotomy

Taking blood samples from children can be difficult for the phlebotomist. Ensuring safety while accounting for a pediatric patient’s emotional and physical well-being is of the utmost importance.

Measurement Procedure Comparison in the Clinical Lab

Measurement procedure comparison is one of the most common techniques used by both manufacturers and medical laboratorians to estimate the bias of an in vitro diagnostic (IVD) measurement procedure relative to a comparator.

CLSI’s Partnership with Tanzanian Laboratories

At the invitation of US Centers for Disease Control (CDC), CLSI’s Global Health Partnerships (GHP) visited Tanzania, one of the first countries with which GHP partnered, in 2005. This was to be the first of many visits and a long-term partnership.

Interference Screening in Clinical Chemistry

Interference screening in clinical chemistry is conducted by paired-difference testing: samples with and without the interferent are measured, and the measurand concentration difference is determined.

Testing Methods for Mycobacterium Tuberculosis Complex (MTBC)

M24 is an important foundation guideline that supports CLSI’s library of antimicrobial and antifungal susceptibility testing documents.

AST Updates

On February 26 and 27, 2020, CLSI will host its annual M100 updates webinar.

CLSI Internal Audit Workshop at MedLab Middle East

CLSI’s GHP team will be hosting a workshop on February 9-11th at the Medlab Middle East exhibition in Dubai. Participants will learn how a laboratory can establish an internal audit program to enhance the quality of its services through continual improvement.

Is It Necessary to Perform a Full Validation With All New Specimen Types? EP35 provides the answers.

EP35—Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition provides recommendations for assessing clinically equivalent performance for additional specimen types.

The One Health Initiative

January is One Health Awareness Month, when we promote the importance of public, animal, and environmental health. Learn about how CLSI has promotes the values of the One Health Initiative through its AST subcommittees that establish testing standards for the human and veterinary laboratory sectors.