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CLSI Blog Articles

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

Implementing a Laboratory Test Under Emergency Use Conditions

CLSI has published a white paper,  EP43—Implementing a Laboratory Test Under Emergency Use Conditions. EP43 covers public health emergencies (PHEs) in general, the ways in which emergency use authorizations (EUAs) may be used, and the ramifications of EUAs for medical laboratories and other testing sites.

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CLSI's Work in Zambia

With the support of the Ministry of Health Zambia and the US Centers for Disease Control and Prevention (CDC), CLSI, through its Global Health Partnerships (GHP) has been supporting laboratory strengthening activities in Zambia since 2010. More recently, in conjunction with Centre for Infectious Disease Research in Zambia-Lab Innovation for Excellence (CIDRZ LIFE) project, quality management system (QMS) activities have expanded to reach more laboratories.

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National HIV Testing Day

According to the Centers for Disease Control and Prevention (CDC), an estimated 1.2 million people in the United States have HIV, including about 161,800 people who are unaware of their status. Nearly 40% of new HIV infections are transmitted by people who don’t know they have the virus. For people with undiagnosed HIV, testing is the first step in maintaining a healthy life and preventing HIV transmission.

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CLSI M100 in China

Through an agreement with CLSI, a program to translate M100 into Chinese was developed by the China Antimicrobial Resistance Surveillance System, which includes 1,500 clinical laboratories as members.

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Imipenem-Relebactam and Aztreonam-Avibactam: What Do Clinical and Public Health Microbiologists Need to Know?

Novel antimicrobial agents like imipenem-relebactam (IMR), aztreonam-avibactam (AZT-AVI), and cefiderocol have been recently added to the antimicrobial armamentarium to combat multidrug resistant gram-negative infections. Guidelines for clinical microbiology laboratories regarding cefiderocol were addressed in the July 2020 CLSI AST News Update and included questions a laboratory should consider when deciding how to approach testing of these new agents. This current issue provides an update on IMR and AZT-AVI. AZT-AVI will be discussed in terms of in vitro testing and its investigational use for specific multidrug-resistant organisms (MDROs) as it is not currently US Food and Drug Administration (FDA)-approved for clinical use.

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Re-Exploring the Intermediate Interpretive Category

Clinical breakpoints provide an interpretation of the probability of treatment success, based on the MIC value or the area of growth inhibition by disk diffusion. Isolates with results within the susceptible category are predicted to be associated with a high chance of treatment success when the patient is administered that antimicrobial, whereas those in the resistant category are associated with low chance of treatment success.

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Will Your Lab be Ready for the Next Public Health Emergency?

When the COVID-19 pandemic hit full-force during March of 2020 and emergency use authorized (EUA) tests became available for measuring SARS-CoV-2, was your laboratory ready? Did you know what you needed to do before implementing the new tests? At CLSI, we know that time period was (and may still be) difficult and stressful for your laboratory, with many unknowns. To help you prepare for the next emergency event, we brought together a working group of experts to consolidate information on implementing such new laboratory tests.

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