Put It on the Board

Create PDF

Improving lab testing in a pandemic

March 2021—As the U.S. fights COVID-19 and prepares for new threats, its leaders need to “motivate and support a laboratory-based testing model that enables broad and distributed production capacity,” say the authors of a “Perspective” published Jan. 21 in the New England Journal of Medicine (2021;384[3]:197–199).

Yolanda Botti-Lodovico, MPP, and Pardis Sabeti, DPhil, MD, of the Broad Institute of Harvard and MIT, and Eric Rosenberg, MD, of the microbiology laboratories and Division of Infectious Diseases, Massachusetts General Hospital, and Department of Pathology, Harvard Medical School, say that by building distributed capacity and prioritizing resources in response to public health demands, the U.S. can transform its COVID-19 trajectory and preempt future pandemics. They identify three main steps:

• • • Support clinical laboratories to build laboratory-developed tests and navigate regulations with ease and speed. “[W]e must empower the FDA, the Centers for Disease Control and Prevention, and the public health community to support—by means of clear regulatory processes and training—broader, distributed capacity to build and administer tests in clinical labs,” they write.
    • Provide research and development resources. “Grants, loans, and incentives should be broadly administered under Title III of the DPA [Defense Production Act],” they say, “to enable clinical laboratories to acquire the equipment, consumables, and reagents needed for building, validating, and conducting tests.” They write that the DPA’s authority to allocate “should be used to encourage fair and need-based allocation of scarce testing supplies to laboratories in regions of high transmission risk.”
    • Prioritize test distribution. Successfully containing COVID-19 requires a strategy to facilitate equitable access to tests in accordance with need, they say. “In communities where the demand remains unmet,” the authors write, “decision makers will have to redirect existing clinical grade testing to symptomatic people, contacts, and high-prevalence areas before spending resources on surveillance testing of low-risk persons.”

Pre-COVID-19, they say, emergence of a novel “Disease X” had been predicted. “It’s here now,” the authors write, “and we still have not contained it. When ‘Disease Y’ arrives, will we have learned?”

FDA clears urine sample type for BKV quantitative test

The FDA has issued 510(k) clearance of stabilized urine samples to be used with the Cobas BKV test on the Cobas 6800/8800 systems. This test, previously designated as a breakthrough device and cleared for use with EDTA plasma samples to aid in managing BK virus in transplant patients, provides enhanced diagnosis of disease via noninvasive and easily collected, prepared, and stored urine samples, Roche said in its Feb. 11 press release.

The test has a limit of detection of 21.5 IU/mL and an expanded linear range from 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma. Urine stabilized in Cobas PCR media has a limit of detection of 12.2 IU/mL and a linear range from 200 IU/mL to 1E+08 IU/mL.

Roche said in its release that the test offers an alternative to lab-developed tests or analyte-specific reagent combinations, “potentially minimizing variability and complexity in testing, reducing workload, and alleviating risk for laboratories.”

Beckman Coulter launches DxH 560 AL

Beckman Coulter launched its DxH 560 AL tabletop analyzer with auto-loading functionality, closed-tube aspiration, and walkaway capabilities. Users can continually load up to 50 samples per run.

The DxH 560 AL provides results in 60 seconds or less, the company said in a Jan. 29 release, and needs only a 17-μL sample. The analyzer provides customizable user login, paperless data management, and fully traceable automated timeouts.

Hologic acquires Biotheranostics

Hologic announced Feb. 22 that it completed its acquisition of Biotheranostics for the approximate sum of $230 million. Biotheranostics develops and markets the Breast Cancer Index and CancerType ID tests.

Latest on COVID-19

Editor’s note: See captodayonline.com for news on SARS-CoV-2 tests (Coronavirus News). A list of FDA EUAs for COVID-19 can be found at https://j.mp/covid-19-EUA.