Multiple Studies Raise Questions About Reliability of Clinical Laboratory COVID-19 Diagnostic Tests

In the absence of a “gold standard,” researchers are finding a high frequency of false negatives among SARS-CoV-2 RT-PCR tests Serology tests designed to detect antibodies to the SARS-CoV-2 coronavirus that causes the COVID-19 illness have been dogged by well-publicized questions about accuracy. However, researchers also are raising concerns about the accuracy of molecular diagnostics which claim to detect the actual presence of the coronavirus itself. “Diagnostic tests, typically involving a...

Molecular Testing for Urinary Tract Infection (UTI): 2020 Update on Clinical Utility and Reimbursement Trends

Molecular tests are becoming more routine as diagnostic tools, with many now covered by Medicare and commercial insurers. Advantages of molecular tests based on PCR technology include their ability to identify uropathogens traditionally missed by culture-based tests.

Driven by urgent, unmet analytical and clinical care needs, the adoption of the rapid molecular test—particularly RT-PCR for urinary tract infection control and treatment—has important implications.

Medical Laboratory Test Data and Clinical Lab 2.0 are Powering Dashboards That Help Providers Mitigate COVID-19 and Improve Population Health

Coronavirus informatics companies are drawing clinical laboratory test data out of the shadows and into the light and compiling it into critical bioinformatics resources What better example do we have that clinical laboratory test data is critical to population health than the current COVID-19 pandemic? Medical laboratory scientists, bioinformatics developers, and government healthcare leaders are using lab test data to track the disease’s rate of infection, and through information system...

Mobile Device Software Companies Are Developing Smartphone Apps That Use Artificial Intelligence to Test for COVID-19, Potentially Bypassing the Clinical Laboratory Altogether

This is another example of technology companies working to develop medical laboratory testing that consumers can use without requiring a doctor’s order for the test Here’s new technology that could be a gamechanger in the fight against COVID-19 if further research allows it to be used in patient care. The goal of the researchers involved is to enable individuals to test for the SARS-CoV-2 coronavirus from home with the assistance of a smartphone app enhanced by artificial intelligence (AI)....

FDA’s Regulatory Hurdles ‘Paralyzed’ Efforts of CLIA-Certified Clinical Laboratories to Offer Alternatives to CDC’s Flawed COVID-19 Test

Washington Post investigation outlines scientists’ frustrations in the early days of the pandemic, as they worked to deploy laboratory-developed tests for the novel coronavirus In the wake of the failed rollout of the Centers for Disease Control and Prevention’s (CDC) COVID-19 diagnostic test last February, many CLIA-certified academic and public health laboratories were ready, and had the necessary resources, to develop their own coronavirus molecular diagnostic tests to help meet the...

With So Many New COVID-19 Serology Tests Obtaining EUAs from the FDA, How Can Clinical Laboratories Identify Tests That Should Perform Reliably?

As federal and state officials ease many regulatory requirements to speed new COVID-19 serology tests to market with minimum data about performance, labs are left with important questions to answer on their own Every day, elected officials at all levels of government call for a huge expansion of COVID-19 serology testing. But, as most clinical laboratory managers and pathologists know, it is a complex undertaking for a lab to select any serological test, validate it, then run it daily in...