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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Point of Care Testing for Infectious Diseases: Navigating CLIA Compliance and Ensuring Quality

Point of Care Testing for Infectious Diseases: Navigating CLIA Compliance and Ensuring Quality

Dark Daily White Paper HIV Drug Resistance Testing

Dark Daily’s free white paper, “Point of Care Testing for Infectious Diseases: Navigating CLIA Compliance and Ensuring Quality,”  is for the health laboratory community and has been produced in partnership with LGC Clinical Diagnostics. It is available for free download.

When it comes to point-of-care (POC) testing for infectious diseases, a meticulously crafted quality system is not just an option—it’s a necessity. Ensuring safety and satisfaction hinges on having the right practices in place.

This comprehensive white paper is designed to be your go-to guide, providing invaluable insights into critical success factors and essential functions crucial for maintaining compliance and delivering reliable results. Tailored for POC teams outside the clinical laboratory, this resource delves into the tangible aspects of good laboratory practice and regulatory compliance, offering practical knowledge applicable to both routine and urgent patient care settings.

Click here to download the free white paper. For additional information inquire at info@darkreport.com, or call Amanda Curtis at 512-264-7103.

Published November 20, 2023
Produced in partnership with

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University of Washington Researchers Use Genomic Analysis to Track Shigella Infections as Decreased Cost of Gene Sequencing Aids Public Health Research

Another study in the United Kingdom that also used genomic analysis to understand drug-resistant Shigella produced findings that may be useful for microbiologists and medical laboratory scientists

From the onset of an infectious disease outbreak, public health officials, microbiologists, and clinical laboratory managers find it valuable to trace the origin of the spread back to the “index case” or “patient zero”—the first documented patient in the disease epidemic. Given the decreased cost of genomic analysis and improved accuracy of gene sequencing, infectious disease researchers are finding that task easier and faster than ever.

One recent example is a genomic study conducted at University of Washington (UW) in Seattle that enabled researchers to “retrace” the origin and spread of a “multidrug-resistant Shigellosis outbreak” from 2017 to 2022. “The aim of the study was to better understand the community transmission of Shigella and spread of antimicrobial resistance in our population, and to treat these multi-drug resistant infections more effectively,” the UW scientists stated in a new release.

Shigellosis (aka, bacillary dysentery) is a highly contagious disease of the intestines that can lead to hospitalization. Symptoms include fever, stomach cramps, diarrhea, dysentery, and dehydration.

“Additional analysis of the gut pathogen and its transmission patterns helped direct approaches to testing, treatment, and public health responses,” the UW news release states.

Usually prevalent in countries with public health and sanitation limitations, the “opportunistic” Shigella pathogen is now being seen in high-income countries as well, UW reported.

The researchers published their findings in Lancet Infectious Diseases, titled, “Genomic Reconstruction and Directed Interventions in a Multidrug-Resistant Shigellosis Outbreak in Seattle, WA, USA: A Genomic Surveillance Study.”

Ferric Fang, MD

“You can’t really expect an infectious disease to remain confined to a specific at-risk population. [Shigella infections are] very much an emerging threat and something where our public health tools and therapeutic tools have significant limitations,” infectious disease specialist Ferric Fang, MD (above) told CIDRAP News. Fang is a UW professor of Microbiology and Clinical Laboratory Medicine and a corresponding author of the UW study. (Photo copyright: University of Washington.)

Why are Shigella Cases Increasing?

The US Centers for Disease Control and Prevention (CDC) records more than 450,000 shigellosis infections each year in the US. The most common species in the US, according to CDC statistics, is Shigellaa sonnei.

Other members of the genus include:

Generally, Shigella infects children, travelers, and men who have sex with men (MSM), the CDC noted.

The UW researchers were motivated to study Shigella when they noticed an uptick in drug-resistant shigellosis cases in Seattle’s homeless population in 2020 at the beginning of the COVID-19 pandemic, Center for Infectious Disease Research and Policy News (CIDRAP News) reported.

“Especially during the pandemic, a lot of public facilities were closed that homeless people were used to using,” infectious disease specialist Ferric Fang, MD, told CIDRAP News. Fang is Professor of Microbiology and Laboratory Medicine at University of Washington and corresponding author of the UW study.

The researchers studied 171 cases of Shigella identified from 2017 to 2022 by clinical laboratories at Harborview Medical Center and UW Medical Center in Seattle. According to CIDRAP News, the UW researchers found that:

  • 46% were men who have sex with men (MSM).
  • 51% were people experiencing homelessness (PEH).
  • Fifty-six patients were admitted to the hospital, with eight to an intensive care unit.
  • 51% of isolates were multi-drug resistant (MDR).

Whole-Genome Sequencing Reveals Origin

The UW scientists characterized the stool samples of Shigella isolates by species identification, phenotypic susceptibility testing, and whole-genome sequencing, according to their Lancet Infectious Diseases paper. The paper also noted that 143 patients received antimicrobial therapy, and 70% of them benefited from the treatment for the Shigella infection.

Whole-genome sequencing revealed that two strains of Shigella (S. flexneri and S. sonnei) appeared first in Seattle’s MSM population before infecting the PEM population.

The genomic analysis found the outbreak of drug-resistant Shigella had international links as well, according to CIDRAP News:

  • One S. flexneri isolate was associated with a multi-drug resistant (MDR) strain from China, and
  • S. sonnei isolates resembled a strain characteristic of a current outbreak of MDR Shigella in England.

“The most prevalent lineage in Seattle was probably introduced to Washington State via international travel, with subsequent domestic transmission between at-risk groups,” the researchers wrote.

“Genomic analysis elucidated not only outbreak origin, but directed optimal approaches to testing, treatment, and public health response. Rapid diagnostics combined with detailed knowledge of local epidemiology can enable high rates of appropriate empirical therapy even in multidrug-resistant infection,” they continued.

UK Shigella Study Also Uses Genomics

Another study based in the United Kingdom (UK) used genomic analysis to investigate a Shigella outbreak as well.

Motivated by a UK Health Security Agency report of an increase in drug-resistance to common strains since 2021, the UK researchers studied Shigella cases from September 2015 to June 2022.

According to a paper they published in Lancet Infectious Diseases, the UK researchers “reported an increase in cases of sexually transmitted S. flexneri harboring blaCTX-M-27 (an antibiotic-resistant gene) in England, which is known to confer resistance to third-generation cephalosporins (antibiotics),” the researchers wrote.

Their analysis of plasmids (DNA with genes having antibiotic resistance) revealed a link in two drug-resistant Shigella strains at the same time, CIDRAP News explained.

“Our study reveals a worsening outlook regarding antimicrobial-resistant Shigella strains among MSM and highlights the value of continued integration of genomic analysis into surveillance and research,” the UK-based scientists wrote.

Current challenges associated with Shigella, especially as it evades treatment, may continue to demand attention from microbiologists, clinical laboratory scientists, and infectious disease specialists. Fortunately, use of genomic analysis—due to its ongoing improvements that have lowered cost and improved accuracy—has made it possible for public health researchers to better track the origins of disease outbreak and spread.    

Donna Marie Pocius

Related Information:

Genomic Reconstruction and Directed Interventions in a Multidrug-Resistant Shigellosis Outbreak in Seattle, Washington, USA: a Genomic Surveillance Study.

Genomics Aids Study of Seattle 2017-22 Shigella Outbreak

Q/A: Shigella—Shigellosis

A Spotlight on Growing Threat of Drug-Resistant Shigella

Emergence of Extensively Drug-Resistant and Multidrug-Resistant Shigella flexneri serotype 2a Associated with Sexual Transmission Among Gay, Bisexual, and Other Men Who Have Sex with Men, in England: A Descriptive Epidemiological Study

Comparison of In Vitro Diagnostic Industry’s Top Five Trends for 2015 and 2016 Reveals Rapid Technology Advances Intended to Give Clinical Laboratories New Diagnostic Tools

Of the five trends described in a report published by Kalorama, only two made the list for both years: Consolidation within the IVD industry and growth in molecular point of care

What a difference one year can make in the most significant trends influencing the in vitro diagnostics (IVD) industry, which also influences clinical laboratories, the largest customers of IVD manufacturers. These insights come from comparing the top five IVD trends for 2016 as identified by Kalorama Information from its top five IVD trends that it says dominated during 2015.

Kalorama is a division of MarketResearch.com, a company that publishes market research in the life sciences. In a report titled, “Five IVD Market Trends to Watch for in 2016,” it published its picks for the top five trends in IVD testing for 2016. The five most prominent trends recognized by the healthcare research marketer are as follows: (more…)

As Medical Laboratory Test Utilization Grows, Health Insurers Develop Programs to Manage Rising Costs

After seeing a rise in the volume of clinical lab tests physicians order, managed care plans are develop a variety of strategies to manage utilization and costs

Health insurers are taking more aggressive actions to control the cost of clinical laboratory testing. For many years, clinical laboratories and pathology groups have been concerned about the strategies used by Medicare to control the utilization and costs of medical laboratory tests. Private health insurers usually follow the actions of Medicare, the nation’s largest health insurer. But today, managed care plans are developing their own lab-test-utilization strategies in addition to following those of Medicare.

Recently, Managed Care magazine explained many of the steps health insurers take to keep the costs of clinical laboratory tests under control. The cover story in the October issue of the magazine, “Health Plans Deploy New Systems To Control Use of Lab Tests,” outlined how health insurers Cigna, Group Health Cooperative, Priority Health, and UnitedHealthcare (UHC) are managing lab test utilization. (more…)

Australia’s ‘Hospital in the Home’ Care Model Demonstrates Major Cost Savings and Comparable Patient Outcomes

New report determines in-home patient care can save an average of 22% over inpatient care for six different health conditions

Momentum continues to build in favor of the “Hospital in the Home”, known by the acronym HITH. For certain health conditions, this care model allows the patient to remain in his or her home, instead of staying in a hospital. Caregivers, including specialist physicians, come to the residence with almost the same frequency as occurs for hospital inpatients.

Wider adoption of this model of patient care would directly affect pathologists and clinical laboratory managers who work in hospital laboratories. Over time, it could mean fewer inpatient admissions and thus, less medical laboratory test volumes for inpatient services. On the other hand, more HITH patients would increase the need to collect specimens in patient’s homes and get them to a local clinical laboratory for testing. Hospital-based medical laboratories—because they are central to the communities they serve—would be well-positioned to provide this diagnostic testing.

(more…)

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