LONDON – Getting a handle on the specificity and sensitivity of rapid COVID-19 antibody tests, how they compare to each other and how they should be applied in population screening to understand who has had the virus and how it has spread, has been a source of difficulty and dispute between manufacturers, clinicians and public health experts.

South San Francsico-based Twist Bioscience Corp. and Biotia Inc., of New York, received the first FDA emergency use authorization (EUA) for a capture-based next-generation sequencing (NGS) assay for the coronavirus that causes COVID-19. The technique reduces the likelihood of misdiagnosing or failing to identify mutations compared to standard sequencing.

TORONTO – A distinguished Canadian health care policy expert said a report from Canada’s COVID-19 Testing and Screening Expert Advisory Panel recommending testing and screening for school-age children and teachers comes “late in the game” now that the focus has shifted to vaccinating the Canadian population.

Fluxergy Inc. said Thursday that it has won CE-IVD marking for its one-hour COVID-19 real-time polymerase chain reaction (RT-PCR) test. The automated, sample-to-action Fluxergy diagnostic testing system can run multiple assay types – such as molecular, immunochemistry, chemistry and cytometry – simultaneously on the same cartridge. The SARS-CoV2 RT-PCR test is the first CE-marked product for the Fluxergy diagnostic platform.

Genetron Holdings Ltd. said its blood-based, early screening test for hepatocellular carcinoma (HCC) demonstrated 88% sensitivity and 93% specificity in 1,615 subjects in China vs. 71% sensitivity and 95% specificity with the use of ultrasound plus alpha-fetoprotein (AFP). The primary outcome, unveiled on March 25, came from a multicenter prospective trial that Beijing-based Genetron initiated together with The National Cancer Center China in 2019.

The rapidly expanding field artificial intelligence (AI)-aided image analysis received a boost with the FDA 510(k) clearance for Optellum Ltd.’s Virtual Nodule Clinic, which helps clinicians evaluate small, potentially malignant lung lesions or nodules. The action makes Optellum’s system the first cleared radiomic application for early lung cancer, an area of active research for the last five years.

The FDA is becoming more amenable to screening and surveillance tests for the COVID-19 pandemic, although the distinction between test uses is not always clear. Toby Lowe, the associate director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said on the agency’s weekly town hall that the difference between surveillance and screening tests is whether the individuals who are screened can act on the information thus derived.

Although artificial intelligence (AI) seems to be making only incremental headway in the world of medical technology, Brainscope Co. Inc., continues to advance its AI offerings with the launch of the Concussion Index (CI). This algorithm, used with the company’s disposable headset, has been demonstrated to reduce the need for cranial CT scans by 30%, making this a double win for patients and for health care spending in the U.S.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released three final guidances on its expectations on clinical performance requirements and risk mitigation for in vitro diagnostic (IVD) self-tests. The guidances outline clinical performance requirements and key risks that must be mitigated for IVDs to be used as self-tests for seasonal influenza; hepatitis B virus (HBV) and hepatitis C virus (HCV); and chlamydia, gonorrhea; and syphilis.