Agencies Provide Important Updates

Over the past month, a significant amount of information has been communicated to the laboratory community by the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Laboratory Outreach Communication System (LOCS).

This issue of Did You Know? is dedicated to this important information. Topics covered include strategies for dealing with a shortage of sodium citrate tubes, a safety notice from the FDA, a CDC advisory on Burkholderia pseudomallei, and four LOCS messages related to SARS-CoV-2.  

Sodium Citrate Blood Specimen Collection Tubes

The U.S. is experiencing significant interruptions in the supply of sodium citrate blood specimen collection (light blue top) tubes because of an unprecedented increase in demand and the recent vendor supply challenges brought on by a recall. The FDA recently issued a Letter to Health Care and Laboratory Personnel that recommends the following conservation strategies:

• Do not use sodium citrate (light blue top) tubes unless medically necessary.
• Do not include sodium citrate (light blue top) tubes in routine collections of a variety of specimens at the time of other blood sampling or IV insertion.
• Do not use sodium citrate (light blue top) tubes as discard tubes. Consider clear top or red stopper (no additive) tubes as alternatives.
• Limit allocation of 1.8mL sodium citrate (light blue top) tubes for difficult blood collections.

Safety Communication

The FDA issued a safety communication warning test users and caregivers, healthcare providers, and testing program organizers to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use.

The FDA has significant concerns that the performance of the test has not been adequately established and its use could present a health risk. Additionally, the FDA has not authorized, cleared, or approved the test for commercial distribution or use in the U.S., as required by law. The FDA has classified this as a Class I recall, the most serious type of recall.

The Innova SARS-CoV-2 Antigen Rapid Qualitative Test is also distributed under the following names:

• Innova COVID-19 Self-Test Kit (3T Configuration).
• Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration).
• Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration).

CDC Health Advisory

On June 30, 2021, the CDC issued an official Health Advisory related to Burkholderia pseudomallei.

There is currently ongoing public health investigation regarding three cases of melioidosis caused by Burkholderia pseudomallei, identified in a Kansas resident in March 2021, a Texas resident in May 2021, and a Minnesota resident in May 2021. The isolates from all patients were submitted to the CDC for whole genome sequencing, which indicated genomic sequences were clonal to one another and were potentially of South Asian origin. None of the patients reported traveling outside of the continental United States.

This genomic analysis indicates that these patients were likely exposed to a common source, potentially an imported product or animal, but that source has not been identified to date.

Additional information: These resources provide additional information about Burkholderia pseudomallei.

• Culture of B. pseudomallei from any clinical specimen is considered diagnostic for melioidosis. Ideal specimens for culture include blood, urine, throat swab, and, when relevant, respiratory specimens, abscesses, or wound swabs. Serological testing is available at CDC for diagnostic testing but is less sensitive and requires paired sera.
• For additional information on B. pseudomallei, refer to the ASM Sentinel Level Clinical Laboratory Guidelines.
• Laboratory testing involving automated identification algorithms (i.e., MALDI-TOF, 16s, VITEK-2) may misidentify B. pseudomallei as another bacterium, such as occurred with the case in Texas, where the isolate was initially misidentified as Burkholderia thailandensis by MALDI-TOF. Misidentifications may include Burkholderia spp. (specifically B. cepacia and B. thailandensis), Chromobacterium violaceum, Ochrobactrum anthropi, and often Pseudomonas spp., Acinetobacter spp., and Aeromonas spp.
• Clinical laboratories that have identified any of the agents listed above from hospitalized patients from January 1, 2021, to present should consult with their state or local public health department to determine if referral to a Laboratory Response Network (LRN) laboratory for rule out of B. pseudomallei is indicated.

Biosafety practices: Follow biosafety practices when handling potential B. pseudomallei materials.

• Specimens suspected of containing Burkholderia pseudomallei should be clearly labeled as “suspected Burkholderia pseudomallei.”
• When handling specimens suspected to contain B. pseudomallei, increase biosafety practices to minimize laboratory exposure, including:

1. Use of BSL-2 practices, containment, and facilities when working with clinical specimens.
2. All specimen manipulations performed within a certified Class II (or higher) Biosafety Cabinet (BSC).

The CDC health alert notification (HAN) with recommendations can be found here.

Information from Laboratory Outreach Communication System (LOCS)

On June 29, 2021, the CDC announced the following changes to the SARS-CoV-2 variant classifications:

• Downgrading B.1.427/B.1.429 (Epsilon) from variants of concern to variants of interest. 
• Downgrading variant of interest B.1.617.
• Consolidating variant of interest B.1.526.1 with variant of interest B.1.526 (Iota).

The classification of a specific variant may change as new evidence emerges regarding its attributes. CDC and the SARS-CoV-2 Interagency Group continually review the available scientific evidence as well as the genomic surveillance data to assess the classification of variants. 

For more information, visit the SARS-CoV-2 Variant Classifications and Definitions page.

New resource: On June 25, 2021, CDC published the Biological Risk Management for Point-of-Care Testing web page as a companion to the recently published Biological Risk Assessment: General Considerations for Laboratories published in March 2021. This new resource for those who perform point-of-care testing introduces basic risk management concepts, outlines the five steps of the risk management process, and shares relevant resources, including a job hazard analysis tool that can be downloaded.

Classification “concern”: On June 15, 2021, CDC announced the classification of the SARS-CoV-2 variant B.1.617.2 (Delta) as a variant of concern. This variant was initially identified in India in December 2020 and was previously classified as a variant of interest. The B.1.617.2 (Delta) lineage has been detected in at least 66 countries, including the United States.

Investigations are underway to further characterize B.1.617.2 (Delta) and its potential impact on SARS-CoV-2 transmission, disease severity, and effectiveness of existing tests, vaccines, and treatments.

New testing tool: On June 14, 2021, CDC launched the new COVID-19 Viral Testing Tool. This interactive web-based tool is designed to help both healthcare providers and individuals understand COVID-19 testing options. The tool complements the recently updated Interim Guidance for SARS-CoV-2 Antigen Testing and other CDC testing guidance.

For healthcare providers, the tool provides clinical decision support to help determine what type of COVID-19 (SARS-CoV-2) testing they should perform. Healthcare providers can use this tool to quickly access the most relevant, actionable CDC testing-related content and use that information to make decisions about next steps:

• Whether or not to order testing and what kind of test to order. 
• How to interpret the test result.
• What to do with conflicting test results.
• Whether or not confirmatory (follow-up) testing is necessary.
• How vaccination impacts decisions for testing.

Updates from the CDC

The CDC recently updated the technical Guidance for Reporting SARS-CoV-2 Sequencing Results, including:

• Clarification on how laboratories may report sequencing results to patients and providers in compliance with CLIA regulations.
• Addition of 96895-8 as the preferred LOINC code to report sequencing results by molecular genetic methods and 98062-3 as the preferred code to identify sequencing studies.

The CDC also updated the following web pages:

• Interim Guidance for Use of Pooling Procedures in SARS-CoV-2 Diagnostic and Screening Testing.
• Overview of Testing for SARS-CoV-2 (COVID-19).

Biosafety guidelines: CDC recently updated the Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease. The update includes:       

• A new PowerPoint training resource for specimen packing and shipping.
• A link to Division of Laboratory Systems Risk Assessment web page.
• Links and resources from the National Institutes of Health, the Environmental Protection Agency, and the Occupational Safety and Health Administration.
• Information on personal protective equipment.
• Information about proper disposal of laboratory waste.
• Language on Animal Biosafety Level 3 (ABSL-3) practices during inoculation of animals with infectious wild-type SARS-CoV-2 virus.

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